Geron Corporation (GERN) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of the clinical benefit/risk profile of pipeline candidate, imetelstat, for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).The ODAC voted 12:2 in favor of imetelstat’s benefits over risks.Consequently, sh ...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 ...

ktsimage Investment Overview I last updated on Geron Corporation (NASDAQ:GERN), the Foster City, California-based biotech primarily focused on securing commercial approval in the U.S. for its lead candidate, imetelstat, in the indication of transfusion-dependent anemia in adult patients, with low-to-intermediate-1 risk myelodysplastic syndromes ("MDS"), in a note for Seeking Alpha back in early December last year. I gave the company and its stock a "Buy" rating, based on my belief that the FDA is likely to ...

Regulatory Approvals - The NDA for imetelstat in lower-risk MDS was accepted by the U.S. FDA with a PDUFA action date of June 16, 2024, and an advisory committee meeting scheduled for March 14, 2024[29]. - The FDA has scheduled a review of the MAA submitted in Europe for imetelstat, with completion expected in early 2025[29]. - The FDA granted Fast Track designation to imetelstat for treating adult patients with transfusion-dependent anemia due to lower-risk MDS in October 2017 and for Intermediate-2 or High-Risk MF in September 2019[109][110]. - The FDA has accepted the NDA for imetelstat for treating transfusion-dependent anemia in adult patients with lower-risk MDS, and the EMA has validated the MAA for the same indication, but timely approval is not assured[206]. - Regulatory authorities may require additional clinical testing or further analyses before granting approval for imetelstat, which could increase costs and delay revenue generation[206]. Clinical Trials and Results - The IMerge Phase 3 clinical trial demonstrated a statistically significant transfusion independence rate of ≥ 8 weeks with a p-value of <0.001[30]. - IMerge Phase 3 trial enrolled 178 patients, with a 2:1 randomization to imetelstat (n=118) or placebo (n=60) and demonstrated statistically significant results for RBC transfusion independence[55]. - The primary endpoint of ≥ 8-week RBC transfusion independence (RBC-TI) was achieved with 39.8% of imetelstat patients versus 15.0% in the placebo group, a difference of 24.8% (p<0.001)[60]. - For patients achieving ≥ 8-week TI, median hemoglobin increase was 3.6 g/dL for imetelstat compared to 0.8 g/dL for placebo, indicating a highly statistically significant improvement (p<0.001)[56]. - The trial showed a one-year median duration of TI for imetelstat responders, with over 50% variant allele frequency decreases in key mutations, suggesting potential disease modification[61]. Market Potential - The potential combined total addressable market for imetelstat in the U.S. and Europe is approximately $7.0 billion, with lower-risk MDS and relapsed/refractory MF each representing about $3.5 billion[35]. - Approximately 70% of MDS patients fall into lower-risk groups at diagnosis, highlighting a significant patient population for potential treatment[49]. - The approval of Reblozyl in August 2023 for anemia in very low-to-intermediate-risk MDS patients indicates a competitive landscape for imetelstat[50]. - Imetelstat is expected to compete against existing therapies for lower-risk MDS, including ESAs and immunomodulators, with potential for meaningful and durable transfusion independence[117][118]. - In the relapsed/refractory MF segment, data from the IMbark study suggest potential disease-modifying activity with imetelstat treatment and a meaningful improvement in overall survival[123]. Safety and Efficacy - Safety results were consistent with prior trials, with no new safety signals identified; the most common non-hematologic adverse events included asthenia (18.6%) and COVID-19 (17.8%)[62]. - Safety results from the IMbark trial showed manageable Grade 3/4 thrombocytopenia in 41% of patients and neutropenia in 32% of patients, with over 70% resolving to Grade 2 or lower within four weeks[79]. - Adverse events and dose-limiting toxicities observed in clinical trials could impact the benefit-risk profile of imetelstat[184]. Competition and Market Landscape - Imetelstat will compete against currently approved JAK inhibitors such as Jakafi and Inrebic, as well as other treatments for myelofibrosis (MF) approved in recent years[124]. - Competitors in Phase 3 development for MF include momelotinib by GSK and pelabresib by MorphoSys AG, which may obtain regulatory approval before imetelstat[125]. - Increased competition is anticipated as new companies explore treatments for myeloid hematologic malignancies, potentially impacting the commercial viability of imetelstat[127]. Corporate Structure and Workforce - The executive team includes John A. Scarlett, M.D. as President and CEO, with extensive experience in the biopharmaceutical industry[152]. - As of December 31, 2023, the company had 141 full-time employees, with 20 holding Ph.D. degrees and 63 holding other advanced degrees[164]. - The workforce grew by 46 employees in 2023, including 23 in the commercial team, to support the commercialization of imetelstat[166]. - Approximately 56% of employees in managerial roles were women, and about 48% of executive management were women as of December 31, 2023[170]. Financial and Regulatory Risks - The company faces significant risks related to the development of imetelstat, including potential delays in clinical trials and regulatory approvals[182]. - The lengthy and uncertain process of obtaining marketing approvals may significantly harm the business prospects for imetelstat if delays occur[205]. - Any delay or failure to obtain required approvals for imetelstat could severely affect the company's financial results and business prospects[217]. - The company may face penalties or product withdrawal if it fails to comply with regulatory requirements post-approval[218]. Intellectual Property - Composition of matter patent coverage for imetelstat in the U.S. extends until December 2025, with method of treatment patent rights for MDS and MF expiring in March 2033[95]. - Potential patent term extensions may be available upon drug product approval, which could extend the patent term for imetelstat in the U.S. until December 2030[98]. Corporate Culture and Values - The corporate values emphasize authenticity, accountability, excellence, integrity, and respect, guiding employee interactions and decision-making[163]. - The company is committed to fostering a strong corporate culture that supports diversity, equity, and inclusion[170].

*Mutation data were available for 18/21 patients receiving imetelstat with ≥1-year TI LR-MDS: lower-risk myelodysplastic syndromes; TI: transfusion independence; VAF: variant allele frequency Conclusion • With a median TI duration over 2 years, • Elimination of MDSassociated mutations suggests the potential of imetelstat to have disease-modifying activity. ASH 2023: Durable TI Associated with Better Survival Abstract #2440 Conclusion For transfusion dependent patients achievement of TI with second line trea ...

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 September 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 jurisdi ...

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 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 ...

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 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. ...