Geron(GERN)
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Geron(GERN) - 2023 Q2 - Earnings Call Presentation
2023-08-03 23:41
OLIVIA BLOOM EVP, Chief Financial Officer Andrew J. Grethlein, Ph.D. EVP, Chief Operating Officer 3 Key Q2 Achievements Drive Geron Toward Potential Launch • Commercial planning on track for launch readiness in early 2024 5 • Expect to submit MAA in EU for LR MDS in Q4 2023 New IMerge Phase 3 Data and Analyses Presented at ASCO and EHA Highly statistically significant (p<0.001) and clinically meaningful increases in mean change in hemoglobin levels over time for imetelstat-treated patients versus placebo In ...
Geron(GERN) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 75-2287752 (State or other jurisdiction ...
Geron(GERN) - 2023 Q1 - Earnings Call Transcript
2023-05-11 17:38
Geron Corporation (NASDAQ:GERN) Q1 2023 Results Conference Call May 11, 2023 10:30 AM ET Company Participants Aron Feingold - VP, IR and Corporate Communications Dr. John Scarlett - Chairman and CEO Olivia Bloom - EVP and CFO Dr. Faye Feller - EVP and CMO Anil Kapur - EVP, Corporate Strategy and Chief Commercial Officer Conference Call Participants Stephen Willey - Stifel Kalpit Patel - B. Riley Joel Beatty - Baird Gil Blum - Needham & Company Corinne Jenkins - Goldman Sachs Operator Good morning. My name i ...
Geron(GERN) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 75-2287752 (State or other jurisdictio ...
Geron(GERN) - 2022 Q4 - Earnings Call Transcript
2023-03-17 00:53
Geron Corporation (NASDAQ:GERN) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET Company Participants Aron Feingold - Vice President, Investor Relations and Corporate Communications John Scarlett - Chairman and Chief Executive Officer Olivia Bloom - Executive Vice President and Chief Financial Officer Faye Feller - Executive Vice President and Chief Medical Officer Anil Kapur - Executive Vice President, Corporate Strategy and Chief Commercial Officer Conference Call Participants Kalpit Patel - B. ...
Geron(GERN) - 2022 Q4 - Annual Report
2023-03-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) | Delaware | | 75-2287752 | | --- | --- | --- | | ( ...
Geron(GERN) - 2022 Q3 - Earnings Call Transcript
2022-11-03 17:07
Financial Data and Key Metrics - As of September 30, 2022, the company had approximately $195 million in cash and marketable securities, including $4 million from warrant exercises [53] - Operating expenses increased for the three and nine-month periods ended September 30, 2022, due to higher activity levels and a $7 million accrual for a class action lawsuit settlement [54][56] - Non-GAAP total operating expenses for 2022 are expected to be up to $150 million, with $140 million in cash and marketable securities projected at the time of the low-risk MDS top-line results in early 2023 [57] - The company expects up to $171 million in additional funding in 2023, including $121 million from warrant exercises and $50 million from potential debt drawdowns [58] Business Line Data and Key Metrics - The company is focused on developing and commercializing imetelstat, a telomerase inhibitor, for hematologic malignancies, particularly lower-risk MDS and relapsed/refractory myelofibrosis (MF) [7][8] - In the Phase 2 lower-risk MDS study, approximately one-third of patients achieved one year or more of transfusion independence, with a median duration of 1.8 years [13][27] - In the Phase 2 relapsed/refractory MF study, median overall survival improved almost twice as long as reported in medical literature [14] - The company is preparing for the top-line results of the IMerge Phase 3 trial in lower-risk MDS, expected in early January 2023, with regulatory submissions planned for 2023 [15][16] Market Data and Key Metrics - The company is targeting a market for imetelstat that is approximately three times larger than the patient group indicated for luspatercept, which is limited to RS-positive patients [69] - The IMpactMF Phase 3 trial, targeting relapsed/refractory MF, is the first and only Phase 3 MF trial with overall survival as the primary endpoint, with an interim analysis expected in 2024 [35][36] - The company is exploring imetelstat in combination with ruxolitinib for frontline MF, with preliminary data expected by the end of 2023 [38][40] Company Strategy and Industry Competition - The company aims to become a leader in the treatment of hematologic malignancies, with imetelstat as a key driver of this strategy [7][61] - Imetelstat's unique mechanism of action, targeting malignant stem and progenitor cells, differentiates it from other therapies and addresses unmet needs in lower-risk MDS and relapsed/refractory MF [9][11] - The company is preparing for potential commercialization of imetelstat, including hiring key personnel and building a foundation for a successful launch in lower-risk MDS [17] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the upcoming milestones, including the IMerge Phase 3 top-line results and regulatory submissions, which could unlock significant value for patients and shareholders [15][61] - The company is actively preparing for commercialization and regulatory submissions, with a focus on building a strong foundation for imetelstat's potential launch [16][17] - Management highlighted the durability of clinical effects observed in Phase 2 studies, which they believe will translate into a highly differentiated clinical profile in Phase 3 trials [14][32] Other Important Information - The company is exploring imetelstat in other indications, including acute myeloid leukemia (AML) and lymphoid malignancies, with non-clinical data presented at ASH 2022 [41][46] - A next-generation telomerase inhibitor program is underway, with lead compounds expected to be identified in 2023 [50] - The company is supporting investigator-led studies in relapsed/refractory AML and higher-risk MDS, with the first site expected to open by the end of 2022 [43][44] Q&A Session Summary Question: Implications of Bristol Myers Squibb's COMMAND study on imetelstat's path [64] - The company believes imetelstat will be part of the standard of care for lower-risk MDS, addressing a broader patient population than luspatercept [65][69] Question: Level of detail expected in the IMerge Phase 3 top-line results [70] - The top-line results will include primary and secondary endpoints, such as 24-week transfusion independence and safety data, but one-year TI rates may not be included [70][71] Question: Subgroup analysis in the IMerge Phase 3 top-line results [74] - Subgroup analysis will be provided at the time of the top-line results, with additional data presented at future medical meetings [75] Question: Enrollment milestones for the IMpactMF trial [79] - The company plans to communicate enrollment milestones, such as 50% enrollment, but the interim analysis is event-driven and expected in 2024 [80][81] Question: Potential for an overall survival study in MDS [85] - Overall survival and progression-free survival are secondary endpoints in the IMerge Phase 3 trial, and the company will closely monitor these metrics [87] Question: DSMB review of the IMerge Phase 3 trial [94] - An independent data monitoring committee has reviewed safety data and recommended the study proceed as planned [94] Question: Enrollment progress in the IMproveMF Phase 1 trial [104] - Two of three trial sites are open, and enrollment is progressing as expected, with preliminary safety data expected in 2023 [106][108] Question: Combination therapy in AML [89] - The company is exploring imetelstat in combination with other therapies, with a focus on safety and potential efficacy signals [89][90]
Geron(GERN) - 2022 Q2 - Earnings Call Transcript
2022-08-12 00:27
Geron Corporation (NASDAQ:GERN) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Aron Feingold - Vice President, Investor Relations and Corporate Communications Dr. John Scarlett - Chairman and CEO Olivia Bloom - Executive Vice President, Finance and CFO and Treasurer Dr. Faye Feller - Executive Vice President and CMO Anil Kapur - Executive Vice President, Corporate Strategy and CCO Conference Call Participants Kalpit Patel - B. Riley Securities Joel Beatty - Baird Stephen Wi ...
Geron(GERN) - 2022 Q2 - Earnings Call Presentation
2022-08-12 00:09
() geron 2Q 2022 EARNINGS CALL August 11, 2022 Welcome and Introduction DR. JOHN SCARLETT Chairman and Chief Executive Officer OLIVIA BLOOM EVP, Chief Financial Officer DR. FAYE FELLER EVP, Chief Medical Officer ANIL KAPUR EVP, Corp. Strategy and Chief Commercial Officer 2 Forward-Looking Statements Except for the historical information contained herein, this presentation contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 ...
Geron(GERN) - 2022 Q1 - Earnings Call Presentation
2022-05-10 15:07
() geron 1Q 2022 EARNINGS CALL May 9, 2022 Welcome and Introduction Dr. John Scarlett Chairman and Chief Executive Officer Olivia Bloom EVP, Chief Financial Officer Dr. Aleksandra Rizo EVP, Chief Medical Officer Anil Kapur EVP, Corp. Strategy and Chief Commercial Officer 2 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 199 ...