Geron Corporation Presents New Data at ASH 2025 Highlighting the Relationship Between Treatment-Emergent Cytopenias and Clinical Benefit of RYTELO® (Imetelstat) in Lower-Risk MDS




Geron Corporation Presents New Data at ASH 2025 Highlighting the Relationship Between Treatment-Emergent Cytopenias and Clinical Benefit of RYTELO® (Imetelstat) in Lower-Risk MDS

Oral presentation from pooled analyses of the IMerge population suggests that treatment-emergent cytopenias may reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence in lower-risk MDS

Long-term follow-up analysis from IMerge supports favorable survival trends and durable clinical benefit in LR-MDS

Additional analyses in myelofibrosis and advanced MDS/AML offer important context for understanding the biology of telomerase inhibition

FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced new data presented at the 67^th American Society of Hematology (ASH) 2025 Annual Meeting being held in Orlando, FL. Collectively, the oral and poster presentations reinforce the growing body of evidence supporting the potential of RYTELO^® (imetelstat), Geron’s first-in-class telomerase inhibitor, across lower-risk myelodysplastic syndromes/neoplasms (LR-MDS) and myelofibrosis (MF).

“These new data confirm our understanding of how imetelstat works and highlight the potential long-term benefit in appropriate patients,” said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of Geron. “The data suggesting the association between early treatment-emergent cytopenias and subsequent hemoglobin and transfusion independence response with imetelstat, together with the long-term outcomes from IMerge presented at ASH, continue to reinforce imetelstat as a differentiated treatment option for eligible patients with lower-risk MDS.”

The oral presentation by Amer Zeidan, MBBS, MHS, Yale School of Medicine, and a principal investigator of the IMerge trial, featured pooled analyses of the IMerge population suggesting that early treatment-emergent neutropenia and thrombocytopenia may be associated with greater hemoglobin increases, which emerged as a main driver for achieving red blood cell transfusion independence (RBC-TI).

“What stands out in these analyses is the consistency between the clinical response we see in patients and the early treatment patterns observed in their blood counts when we use imetelstat in non-del5q lower-risk MDS patients with transfusion dependent anemia. This is reminiscent of similar trends we see with lenalidomide, which is a disease-modifying agent in del5q lower-risk MDS patients,” said Amer Zeidan, Chief of the Division of Hematologic Malignancies and Professor of Medicine at Yale Cancer Center. “For patients with lower-risk MDS, transfusion dependence places a considerable physical and logistical burden on daily life, and treatment options beyond ESAs remain limited. The association we observed between early blood count changes and later improvements in hemoglobin provides valuable insight for clinicians and underscores the meaningful benefit imetelstat may offer to this population.”

Additional poster presentations provided long-term outcomes data, including survival data in LR-MDS, exploratory biomarker analyses in MF, and ongoing combination and investigator-sponsored studies across the myeloid malignancy spectrum.

Highlights from the ASH 2025 Presentations

Correlation between Treatment-Emergent Cytopenias and Clinical Response with Imetelstat in Patients with Lower-Risk Myelodysplastic Syndromes: Analysis from the IMerge Trial (Zeidan et al., Oral #490)

This oral presentation reported findings from post-hoc analyses examining the potential relationship between treatment-emergent cytopenias within the first two cycles of imetelstat treatment and key clinical outcomes in the pooled IMerge patient population. These analyses evaluated reductions in platelets and neutrophils alongside hemoglobin (Hb) rise, achievement of ≥8- or ≥24-week RBC-TI, and achievement of Hb rise ≥1.5 g/dL lasting ≥8 weeks.

Across analyses looking at single clinical factors, patients who experienced ≥75% reductions in neutrophils or ≥50% reductions in platelets during the first two cycles of imetelstat had greater maximum Hb increases compared with those who did not experience such reductions. Numerically higher rates of ≥8- or ≥24-week RBC-TI were also observed in these groups. When the analyses accounted for multiple clinical factors at the same time, the associations between early cytopenias and Hb improvements remained consistent: ≥75% neutrophil reduction was associated with greater Hb increase, whereas maximum ≥50% platelet reduction was associated with achieving Hb rise ≥1.5 g/dL lasting ≥8 weeks. Further, Hb rise emerged as a main driver of achieving transfusion independence. A strong association between platelet and neutrophil reductions was also observed.

These findings offer deeper context for interpreting patient responses and provide insight into how imetelstat’s biological effects may translate into meaningful clinical outcomes.

Long-Term Outcomes and Overall Survival from the Randomized, Double-Blind, Placebo-Controlled, Phase 3 IMerge Trial of Imetelstat for Lower-Risk Myelodysplastic Syndromes (Santini et al., Poster #2074)

This poster reported updated long-term outcomes data from the double-blind, placebo-controlled IMerge Phase 3 trial assessing overall survival (OS), progression-free survival (PFS), and time to progression to acute myeloid leukemia (AML) in patients with transfusion-dependent LR-MDS treated with imetelstat.

At a median follow-up of 45 months, the analysis showed a favorable trend toward improved secondary endpoints of OS, PFS, and time to AML progression for imetelstat-treated patients compared with placebo recipients in the overall population. OS favored imetelstat versus placebo in most predefined subgroups, regardless of transfusion burden, serum EPO (erythropoietin) level, and ring sideroblast positive or negative status. Additionally, OS outcomes were numerically improved in patients who achieved RBC-TI or hemoglobin improvement.

These results suggest that imetelstat may provide meaningful long-term benefit for patients with lower-risk MDS who are transfusion independent, although the trial was not powered to detect statistical significance for OS. The data support continued clinical exploration of telomerase inhibition as a potential disease-modifying approach for LR-MDS.

Correlation between IL-8 and TNF-Alpha Levels and Overall Survival in Patients with Myelofibrosis Relapsed or Refractory to a JAKi Treated with Imetelstat in the IMbark Trial​ (Mascarenhas et al., Poster #5585)

This poster reported results from a post hoc analysis of inflammatory cytokines in the Phase 2 IMbark trial of patients with JAK inhibitor relapsed/refractory myelofibrosis treated with imetelstat. The analysis evaluated how cytokine changes corresponded with clinical endpoints, including symptom improvement, spleen volume reduction, and survival trends.

The findings showed that patients treated with imetelstat experienced dose-dependent reductions in IL-8 and TNF-a (proinflammatory cytokines), with the 8.9 mg/kg dose showing more pronounced effects compared to the 4.4 mg/kg dose. Reductions in these cytokines corresponded with reductions in total symptom score or spleen volume, consistent with previously reported clinical activity. A longer survival trend was observed in patients receiving the higher dose, particularly among patients with elevated baseline IL-8 and TNF-a levels, although subgroup sizes were small.

These results suggest that cytokine modulation may contribute to the clinical activity of imetelstat and provide further support for its potential disease-modifying properties in myelofibrosis. These findings build on prior biomarker work demonstrating imetelstat’s impact on malignant progenitor cells in myelofibrosis.

IMproveMF: Phase 1b Trial of Imetelstat Plus Ruxolitinib in Patients with Intermediate-1/2 or High-Risk Myelofibrosis (Mascarenhas, et al., Poster #2052)

This poster reported enrollment progress and emerging observations from the Phase 1b IMproveMF trial evaluating imetelstat in combination with ruxolitinib for patients with intermediate-2 or high-risk myelofibrosis. The study is designed to determine safety, tolerability, and recommended dosing for future development.

As of the July 2025 cutoff, the trial had enrolled three patients in part 2 of the study, with the first patient treated in January 2025. The part 1 dose escalation phase of the study is complete, with 8.9 mg/kg imetelstat IV every 4 weeks identified as the recommended dose to be combined with ruxolitinib.

Advanced Myelodysplastic Neoplasms or AML Failing HMA-based Therapy – Preliminary Results of the IMpress Study​ (Ades, et al, Poster #5115)

This poster reported interim results from an investigator-sponsored Phase 2 study evaluating imetelstat in patients with advanced myelodysplastic neoplasms or acute myeloid leukemia who were refractory to, relapsed after, or intolerant to hypomethylating agent, or HMA, therapy.

The results showed that imetelstat administered at 7.1 mg/kg IV every 2 weeks in this patient population did not appear to be associated with additional toxicity, and that treatment-emergent adverse events were manageable in this heavily pre-treated population. While limited single-agent clinical activity was observed – consistent with the aggressive disease biology and prior treatment history – several patients were able to complete protocol-specified visits, and one remained on treatment at the time of the analysis.

These findings suggest that single agent imetelstat has a predictable and manageable safety profile at this exposure in these advanced diseases and provides important insights for potential combination strategies in high-risk populations, where unmet needs remain substantial.

The ASH presentations are available on Geron’s website in the Investor section under publications.

Dr. Zeidan has served as a consultant for Geron and has received honoraria. The views expressed in this press release and in the presentation are his own and do not necessarily reflect those of his employer.

About RYTELO (imetelstat)
RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with LR-MDS with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.
In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

US IMPORTANT SAFETY INFORMATION ABOUT RYTELO^®

WARNINGS AND PRECAUTIONS

Thrombocytopenia

RYTELO can cause thrombocytopenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased platelets occurred in 65% of patients with MDS treated with RYTELO.
Monitor patients with thrombocytopenia for bleeding. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer platelet transfusions as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Neutropenia

RYTELO can cause neutropenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased neutrophils occurred in 72% of patients with MDS treated with RYTELO.
Monitor patients with Grade 3 or 4 neutropenia for infections, including sepsis. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Infusion-Related Reactions

RYTELO can cause infusion-related reactions. In the clinical trial, infusion-related reactions occurred in 8% of patients with MDS treated with RYTELO; Grade 3 or 4 infusion-related reactions occurred in 1.7%, including hypertensive crisis (0.8%). The most common infusion-related reaction was headache (4.2%). Infusion-related reactions usually occur during or shortly after the end of the infusion.
Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for at least one hour following the infusion as recommended. Manage symptoms of infusion-related reactions with supportive care and infusion interruptions, decrease infusion rate, or permanently discontinue as recommended.

Embryo-Fetal Toxicity

Based on animal findings, RYTELO can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYTELO and for 1 week after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 32% of patients who received RYTELO. Serious adverse reactions in >2% of patients included sepsis (4.2%) and fracture (3.4%), cardiac failure (2.5%), and hemorrhage (2.5%). Fatal adverse reactions occurred in 0.8% of patients who received RYTELO, including sepsis (0.8%).
Most common adverse reactions (≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities, were decreased platelets, decreased white blood cells, decreased neutrophils, increased AST, increased alkaline phosphatase, increased ALT, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at https://pi.geron.com/products/US/pi/rytelo_pi.pdf.

About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO^® (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with lower-risk myelodysplastic syndromes with transfusion dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor relapsed/refractory myelofibrosis, as well as studies in other myeloid hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to reduce proliferation and induce death of malignant cells. 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) clinical data from the IMerge pooled population suggesting that early treatment-emergent cytopenias with imetelstat may reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence, in LR-MDS; (ii) that long-term follow-up analysis from IMerge supports favorable survival trends and durable clinical benefit in LR-MDS; (iii) the Company’s understanding of how imetelstat works and the potential long-term benefit in appropriate patients; (iv) the Company’s belief that data continue to reinforce imetelstat as a differentiated treatment for eligible patients with LR-MDS; (v) the potential for imetelstat to have disease-modifying activity; (vi) the Company’s beliefs that the depth and breadth of its data reinforce the potential of imetelstat to address critical unmet needs in lower-risk MDS; (vii) the interpretations and expectations of the data on imetelstat presented at the ASH 2025 Annual Meeting; and (viii) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO’s approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron’s plans to commercialize RYTELO in the European Union, or EU, and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of clinical trials; (j) that the projected timing for the interim and final analyses of the Phase 3 IMpactMF trial in R/R MF may vary depending on actual death rates in the trial; and (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, and subsequent filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

Investor and Media:
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com

Geron Corporation Presents New Data at ASH 2025 Highlighting the Relationship Between Treatment-Emergent Cytopenias and Clinical Benefit of RYTELO® (Imetelstat) in Lower-Risk MDS




Geron Corporation Presents New Data at ASH 2025 Highlighting the Relationship Between Treatment-Emergent Cytopenias and Clinical Benefit of RYTELO® (Imetelstat) in Lower-Risk MDS

Oral presentation from pooled analyses of the IMerge population suggests that treatment-emergent cytopenias may reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence in lower-risk MDS

Long-term follow-up analysis from IMerge supports favorable survival trends and durable clinical benefit in LR-MDS

Additional analyses in myelofibrosis and advanced MDS/AML offer important context for understanding the biology of telomerase inhibition

FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced new data presented at the 67^th American Society of Hematology (ASH) 2025 Annual Meeting being held in Orlando, FL. Collectively, the oral and poster presentations reinforce the growing body of evidence supporting the potential of RYTELO^® (imetelstat), Geron’s first-in-class telomerase inhibitor, across lower-risk myelodysplastic syndromes/neoplasms (LR-MDS) and myelofibrosis (MF).

“These new data confirm our understanding of how imetelstat works and highlight the potential long-term benefit in appropriate patients,” said Joseph E. Eid, M.D., Executive Vice President, Research and Development and Chief Medical Officer of Geron. “The data suggesting the association between early treatment-emergent cytopenias and subsequent hemoglobin and transfusion independence response with imetelstat, together with the long-term outcomes from IMerge presented at ASH, continue to reinforce imetelstat as a differentiated treatment option for eligible patients with lower-risk MDS.”

The oral presentation by Amer Zeidan, MBBS, MHS, Yale School of Medicine, and a principal investigator of the IMerge trial, featured pooled analyses of the IMerge population suggesting that early treatment-emergent neutropenia and thrombocytopenia may be associated with greater hemoglobin increases, which emerged as a main driver for achieving red blood cell transfusion independence (RBC-TI).

“What stands out in these analyses is the consistency between the clinical response we see in patients and the early treatment patterns observed in their blood counts when we use imetelstat in non-del5q lower-risk MDS patients with transfusion dependent anemia. This is reminiscent of similar trends we see with lenalidomide, which is a disease-modifying agent in del5q lower-risk MDS patients,” said Amer Zeidan, Chief of the Division of Hematologic Malignancies and Professor of Medicine at Yale Cancer Center. “For patients with lower-risk MDS, transfusion dependence places a considerable physical and logistical burden on daily life, and treatment options beyond ESAs remain limited. The association we observed between early blood count changes and later improvements in hemoglobin provides valuable insight for clinicians and underscores the meaningful benefit imetelstat may offer to this population.”

Additional poster presentations provided long-term outcomes data, including survival data in LR-MDS, exploratory biomarker analyses in MF, and ongoing combination and investigator-sponsored studies across the myeloid malignancy spectrum.

Highlights from the ASH 2025 Presentations

Correlation between Treatment-Emergent Cytopenias and Clinical Response with Imetelstat in Patients with Lower-Risk Myelodysplastic Syndromes: Analysis from the IMerge Trial (Zeidan et al., Oral #490)

This oral presentation reported findings from post-hoc analyses examining the potential relationship between treatment-emergent cytopenias within the first two cycles of imetelstat treatment and key clinical outcomes in the pooled IMerge patient population. These analyses evaluated reductions in platelets and neutrophils alongside hemoglobin (Hb) rise, achievement of ≥8- or ≥24-week RBC-TI, and achievement of Hb rise ≥1.5 g/dL lasting ≥8 weeks.

Across analyses looking at single clinical factors, patients who experienced ≥75% reductions in neutrophils or ≥50% reductions in platelets during the first two cycles of imetelstat had greater maximum Hb increases compared with those who did not experience such reductions. Numerically higher rates of ≥8- or ≥24-week RBC-TI were also observed in these groups. When the analyses accounted for multiple clinical factors at the same time, the associations between early cytopenias and Hb improvements remained consistent: ≥75% neutrophil reduction was associated with greater Hb increase, whereas maximum ≥50% platelet reduction was associated with achieving Hb rise ≥1.5 g/dL lasting ≥8 weeks. Further, Hb rise emerged as a main driver of achieving transfusion independence. A strong association between platelet and neutrophil reductions was also observed.

These findings offer deeper context for interpreting patient responses and provide insight into how imetelstat’s biological effects may translate into meaningful clinical outcomes.

Long-Term Outcomes and Overall Survival from the Randomized, Double-Blind, Placebo-Controlled, Phase 3 IMerge Trial of Imetelstat for Lower-Risk Myelodysplastic Syndromes (Santini et al., Poster #2074)

This poster reported updated long-term outcomes data from the double-blind, placebo-controlled IMerge Phase 3 trial assessing overall survival (OS), progression-free survival (PFS), and time to progression to acute myeloid leukemia (AML) in patients with transfusion-dependent LR-MDS treated with imetelstat.

At a median follow-up of 45 months, the analysis showed a favorable trend toward improved secondary endpoints of OS, PFS, and time to AML progression for imetelstat-treated patients compared with placebo recipients in the overall population. OS favored imetelstat versus placebo in most predefined subgroups, regardless of transfusion burden, serum EPO (erythropoietin) level, and ring sideroblast positive or negative status. Additionally, OS outcomes were numerically improved in patients who achieved RBC-TI or hemoglobin improvement.

These results suggest that imetelstat may provide meaningful long-term benefit for patients with lower-risk MDS who are transfusion independent, although the trial was not powered to detect statistical significance for OS. The data support continued clinical exploration of telomerase inhibition as a potential disease-modifying approach for LR-MDS.

Correlation between IL-8 and TNF-Alpha Levels and Overall Survival in Patients with Myelofibrosis Relapsed or Refractory to a JAKi Treated with Imetelstat in the IMbark Trial​ (Mascarenhas et al., Poster #5585)

This poster reported results from a post hoc analysis of inflammatory cytokines in the Phase 2 IMbark trial of patients with JAK inhibitor relapsed/refractory myelofibrosis treated with imetelstat. The analysis evaluated how cytokine changes corresponded with clinical endpoints, including symptom improvement, spleen volume reduction, and survival trends.

The findings showed that patients treated with imetelstat experienced dose-dependent reductions in IL-8 and TNF-a (proinflammatory cytokines), with the 8.9 mg/kg dose showing more pronounced effects compared to the 4.4 mg/kg dose. Reductions in these cytokines corresponded with reductions in total symptom score or spleen volume, consistent with previously reported clinical activity. A longer survival trend was observed in patients receiving the higher dose, particularly among patients with elevated baseline IL-8 and TNF-a levels, although subgroup sizes were small.

These results suggest that cytokine modulation may contribute to the clinical activity of imetelstat and provide further support for its potential disease-modifying properties in myelofibrosis. These findings build on prior biomarker work demonstrating imetelstat’s impact on malignant progenitor cells in myelofibrosis.

IMproveMF: Phase 1b Trial of Imetelstat Plus Ruxolitinib in Patients with Intermediate-1/2 or High-Risk Myelofibrosis (Mascarenhas, et al., Poster #2052)

This poster reported enrollment progress and emerging observations from the Phase 1b IMproveMF trial evaluating imetelstat in combination with ruxolitinib for patients with intermediate-2 or high-risk myelofibrosis. The study is designed to determine safety, tolerability, and recommended dosing for future development.

As of the July 2025 cutoff, the trial had enrolled three patients in part 2 of the study, with the first patient treated in January 2025. The part 1 dose escalation phase of the study is complete, with 8.9 mg/kg imetelstat IV every 4 weeks identified as the recommended dose to be combined with ruxolitinib.

Advanced Myelodysplastic Neoplasms or AML Failing HMA-based Therapy – Preliminary Results of the IMpress Study​ (Ades, et al, Poster #5115)

This poster reported interim results from an investigator-sponsored Phase 2 study evaluating imetelstat in patients with advanced myelodysplastic neoplasms or acute myeloid leukemia who were refractory to, relapsed after, or intolerant to hypomethylating agent, or HMA, therapy.

The results showed that imetelstat administered at 7.1 mg/kg IV every 2 weeks in this patient population did not appear to be associated with additional toxicity, and that treatment-emergent adverse events were manageable in this heavily pre-treated population. While limited single-agent clinical activity was observed – consistent with the aggressive disease biology and prior treatment history – several patients were able to complete protocol-specified visits, and one remained on treatment at the time of the analysis.

These findings suggest that single agent imetelstat has a predictable and manageable safety profile at this exposure in these advanced diseases and provides important insights for potential combination strategies in high-risk populations, where unmet needs remain substantial.

The ASH presentations are available on Geron’s website in the Investor section under publications.

Dr. Zeidan has served as a consultant for Geron and has received honoraria. The views expressed in this press release and in the presentation are his own and do not necessarily reflect those of his employer.

About RYTELO (imetelstat)
RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with LR-MDS with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.
In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

US IMPORTANT SAFETY INFORMATION ABOUT RYTELO^®

WARNINGS AND PRECAUTIONS

Thrombocytopenia

RYTELO can cause thrombocytopenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased platelets occurred in 65% of patients with MDS treated with RYTELO.
Monitor patients with thrombocytopenia for bleeding. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer platelet transfusions as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Neutropenia

RYTELO can cause neutropenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased neutrophils occurred in 72% of patients with MDS treated with RYTELO.
Monitor patients with Grade 3 or 4 neutropenia for infections, including sepsis. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.

Infusion-Related Reactions

RYTELO can cause infusion-related reactions. In the clinical trial, infusion-related reactions occurred in 8% of patients with MDS treated with RYTELO; Grade 3 or 4 infusion-related reactions occurred in 1.7%, including hypertensive crisis (0.8%). The most common infusion-related reaction was headache (4.2%). Infusion-related reactions usually occur during or shortly after the end of the infusion.
Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for at least one hour following the infusion as recommended. Manage symptoms of infusion-related reactions with supportive care and infusion interruptions, decrease infusion rate, or permanently discontinue as recommended.

Embryo-Fetal Toxicity

Based on animal findings, RYTELO can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYTELO and for 1 week after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 32% of patients who received RYTELO. Serious adverse reactions in >2% of patients included sepsis (4.2%) and fracture (3.4%), cardiac failure (2.5%), and hemorrhage (2.5%). Fatal adverse reactions occurred in 0.8% of patients who received RYTELO, including sepsis (0.8%).
Most common adverse reactions (≥10% with a difference between arms of >5% compared to placebo), including laboratory abnormalities, were decreased platelets, decreased white blood cells, decreased neutrophils, increased AST, increased alkaline phosphatase, increased ALT, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at https://pi.geron.com/products/US/pi/rytelo_pi.pdf.

About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO^® (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with lower-risk myelodysplastic syndromes with transfusion dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor relapsed/refractory myelofibrosis, as well as studies in other myeloid hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to reduce proliferation and induce death of malignant cells. 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) clinical data from the IMerge pooled population suggesting that early treatment-emergent cytopenias with imetelstat may reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence, in LR-MDS; (ii) that long-term follow-up analysis from IMerge supports favorable survival trends and durable clinical benefit in LR-MDS; (iii) the Company’s understanding of how imetelstat works and the potential long-term benefit in appropriate patients; (iv) the Company’s belief that data continue to reinforce imetelstat as a differentiated treatment for eligible patients with LR-MDS; (v) the potential for imetelstat to have disease-modifying activity; (vi) the Company’s beliefs that the depth and breadth of its data reinforce the potential of imetelstat to address critical unmet needs in lower-risk MDS; (vii) the interpretations and expectations of the data on imetelstat presented at the ASH 2025 Annual Meeting; and (viii) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO’s approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron’s plans to commercialize RYTELO in the European Union, or EU, and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of clinical trials; (j) that the projected timing for the interim and final analyses of the Phase 3 IMpactMF trial in R/R MF may vary depending on actual death rates in the trial; and (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, and subsequent filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

Investor and Media:
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com

RESTEM Announces First-Patient-Dosed in the Phase 1/2a Study of Restem-L in Facioscapulohumeral Muscular Dystrophy




RESTEM Announces First-Patient-Dosed in the Phase 1/2a Study of Restem-L in Facioscapulohumeral Muscular Dystrophy

− First patient with facioscapulohumeral muscular dystrophy (FSHD) dosed with Restem-L umbilical lining modified progenitor cells (UMPCs)

− The Phase 1/2a study will evaluate the safety and preliminary efficacy of Restem-L in patients with FSHD

− Clinical study is funded by SOLVE FSHD

MIAMI and VANCOUVER, British Columbia, Dec. 08, 2025 (GLOBE NEWSWIRE) — RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today announced the initiation of a Phase 1/2a study of Restem-L, the Company’s umbilical lining modified progenitor cells (UMPCs) off-the-shelf platform, for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The study is funded by SOLVE FSHD, a venture philanthropic organization dedicated to accelerating treatments for FSHD.

“We are excited to partner with SOLVE FSHD and initiate this Phase 1/2a clinical trial of Restem-L in patients with FSHD. This clinical trial allows us to explore Restem-L’s potential beyond autoimmune diseases, and expand our reach to other inflammatory-driven serious conditions with high unmet medical needs such as FSHD – a genetic neuromuscular disease with no approved therapies,” said Andres Isaias, Chief Executive Officer of RESTEM. “Our collaboration with SOLVE FSHD highlights the growing interest in Restem-L, and further underscores the increasing recognition of these cells as a potentially potent, efficacious and safe next generation, immune-modulatory cell therapy. We are grateful for this collaboration and look forward to further building on the already strong safety profile and compelling results demonstrated with Restem-L in different indications.”

“We are delighted to partner with RESTEM and have the first patient with FSHD dosed with Restem-L in the Phase 1/2a trial, marking an important milestone in our efforts to advance potential therapies for this debilitating condition, where there are currently no effective available treatments,” commented Eva Chin, Ph.D., Executive Director of SOLVE FSHD. “FSHD is a rare neuromuscular disease characterized by immune cell infiltration and inflammation in skeletal muscles, ultimately leading to their degeneration, progressive weakness and loss of facial and upper body function and eventually impaired mobility. We were very impressed with the ability of RESTEM’s UMPCs to modulate key inflammatory factors in related muscle inflammatory indications, and chose to fund this study after reviewing numerous other technologies and platforms. The initiation of this trial inches us closer to bringing hope to the up to 1 million patients estimated to suffer from FSHD worldwide.”

The Phase 1/2a study (NCT07086521) is a double-blind, randomized, dose-repeating, placebo-controlled, cross over study to assess the safety and preliminary efficacy of allogeneic UMPCs on disease severity in patients with FSHD. The trial, led by John Day, M.D., Ph.D. in Stanford University, aims to enroll 16 patients, randomized 1:1 to receive either Restem-L or placebo for 6 months, and then crossed-over to receive either placebo or Restem-L, respectively for additional 6 months, with a treatment duration of 12 months and study follow up at 15 and 21 months. The primary endpoint of the study is safety with secondary and exploratory outcomes including serum markers of immune/inflammatory response, patient and clinician reported functional outcomes, MRI and muscle biopsy biomarkers.

About Facioscapulohumeral Muscular Dystrophy (FSHD)

FSHD is a genetic muscle disorder characterized by progressive muscle weakness, primarily affecting the face, shoulder blades, and upper arms. It is one of the most common forms of muscular dystrophy and typically begins in adolescence or early adulthood, though one can vary. It affects approximately 1 in 8000 people worldwide, and while there is currently no cure, available treatments focus on managing symptoms, slowing disease progression, and enhancing quality of life.

About RESTEM

RESTEM is a leading clinical-stage biotechnology company focused on developing off-the-shelf, next-generation cell therapies for autoimmune, inflammatory, and age-related diseases. Leveraging proprietary products, deep clinical expertise, and advanced manufacturing capabilities, RESTEM is advancing two potentially transformative programs, Restem-L, our umbilical cord lining progenitor cells (UMPCs) therapy for autoimmune diseases, and activated natural killer cell (aNK) therapeutics targeting senescence and age-associated disorders.  Our therapies are designed to reprogram the immune system rather than focusing solely on symptom management, offering patients with limited options the potential to address underlying disease mechanisms. RESTEM is headquartered in Miami, Florida. For more information, please visit www.restem.com and follow us on X and LinkedIn.

About SOLVE FSHD
SOLVE FSHD is a venture philanthropic organization established to catalyze innovation and accelerate key research in finding a cure for FSHD. Established by renowned Canadian entrepreneur and philanthropist Chip Wilson, widely known as the founder of lululemon and part owner of Amer Sports which holds renowned brands such as Arc’teryx, Salomon and Wilson Sports. Chip has committed $100 million to kick-start funding into projects that support the organization’s mission to find a cure for FSHD by 2027. The goal of SOLVE FSHD is to find a solution that can stop muscle degeneration, increase muscle regeneration and strength, and improve the quality of life for those living with FSHD. For more information, visit  https://solvefshd.com/

Investor Contact

Daniel Ferry
LifeSci Advisors
+1.617.430.7576
daniel@lifesciadvisors.com

Media Contact

Nelson Cabautan
Restem Group, Inc.
+1.800.490.0924
ncabatuan@restem.com

RESTEM Announces First-Patient-Dosed in the Phase 1/2a Study of Restem-L in Facioscapulohumeral Muscular Dystrophy




RESTEM Announces First-Patient-Dosed in the Phase 1/2a Study of Restem-L in Facioscapulohumeral Muscular Dystrophy

− First patient with facioscapulohumeral muscular dystrophy (FSHD) dosed with Restem-L umbilical lining modified progenitor cells (UMPCs)

− The Phase 1/2a study will evaluate the safety and preliminary efficacy of Restem-L in patients with FSHD

− Clinical study is funded by SOLVE FSHD

MIAMI and VANCOUVER, British Columbia, Dec. 08, 2025 (GLOBE NEWSWIRE) — RESTEM – a clinical-stage biotechnology company that develops off-the-shelf, next-generation cell therapies designed to modulate the immune system, today announced the initiation of a Phase 1/2a study of Restem-L, the Company’s umbilical lining modified progenitor cells (UMPCs) off-the-shelf platform, for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The study is funded by SOLVE FSHD, a venture philanthropic organization dedicated to accelerating treatments for FSHD.

“We are excited to partner with SOLVE FSHD and initiate this Phase 1/2a clinical trial of Restem-L in patients with FSHD. This clinical trial allows us to explore Restem-L’s potential beyond autoimmune diseases, and expand our reach to other inflammatory-driven serious conditions with high unmet medical needs such as FSHD – a genetic neuromuscular disease with no approved therapies,” said Andres Isaias, Chief Executive Officer of RESTEM. “Our collaboration with SOLVE FSHD highlights the growing interest in Restem-L, and further underscores the increasing recognition of these cells as a potentially potent, efficacious and safe next generation, immune-modulatory cell therapy. We are grateful for this collaboration and look forward to further building on the already strong safety profile and compelling results demonstrated with Restem-L in different indications.”

“We are delighted to partner with RESTEM and have the first patient with FSHD dosed with Restem-L in the Phase 1/2a trial, marking an important milestone in our efforts to advance potential therapies for this debilitating condition, where there are currently no effective available treatments,” commented Eva Chin, Ph.D., Executive Director of SOLVE FSHD. “FSHD is a rare neuromuscular disease characterized by immune cell infiltration and inflammation in skeletal muscles, ultimately leading to their degeneration, progressive weakness and loss of facial and upper body function and eventually impaired mobility. We were very impressed with the ability of RESTEM’s UMPCs to modulate key inflammatory factors in related muscle inflammatory indications, and chose to fund this study after reviewing numerous other technologies and platforms. The initiation of this trial inches us closer to bringing hope to the up to 1 million patients estimated to suffer from FSHD worldwide.”

The Phase 1/2a study (NCT07086521) is a double-blind, randomized, dose-repeating, placebo-controlled, cross over study to assess the safety and preliminary efficacy of allogeneic UMPCs on disease severity in patients with FSHD. The trial, led by John Day, M.D., Ph.D. in Stanford University, aims to enroll 16 patients, randomized 1:1 to receive either Restem-L or placebo for 6 months, and then crossed-over to receive either placebo or Restem-L, respectively for additional 6 months, with a treatment duration of 12 months and study follow up at 15 and 21 months. The primary endpoint of the study is safety with secondary and exploratory outcomes including serum markers of immune/inflammatory response, patient and clinician reported functional outcomes, MRI and muscle biopsy biomarkers.

About Facioscapulohumeral Muscular Dystrophy (FSHD)

FSHD is a genetic muscle disorder characterized by progressive muscle weakness, primarily affecting the face, shoulder blades, and upper arms. It is one of the most common forms of muscular dystrophy and typically begins in adolescence or early adulthood, though one can vary. It affects approximately 1 in 8000 people worldwide, and while there is currently no cure, available treatments focus on managing symptoms, slowing disease progression, and enhancing quality of life.

About RESTEM

RESTEM is a leading clinical-stage biotechnology company focused on developing off-the-shelf, next-generation cell therapies for autoimmune, inflammatory, and age-related diseases. Leveraging proprietary products, deep clinical expertise, and advanced manufacturing capabilities, RESTEM is advancing two potentially transformative programs, Restem-L, our umbilical cord lining progenitor cells (UMPCs) therapy for autoimmune diseases, and activated natural killer cell (aNK) therapeutics targeting senescence and age-associated disorders.  Our therapies are designed to reprogram the immune system rather than focusing solely on symptom management, offering patients with limited options the potential to address underlying disease mechanisms. RESTEM is headquartered in Miami, Florida. For more information, please visit www.restem.com and follow us on X and LinkedIn.

About SOLVE FSHD
SOLVE FSHD is a venture philanthropic organization established to catalyze innovation and accelerate key research in finding a cure for FSHD. Established by renowned Canadian entrepreneur and philanthropist Chip Wilson, widely known as the founder of lululemon and part owner of Amer Sports which holds renowned brands such as Arc’teryx, Salomon and Wilson Sports. Chip has committed $100 million to kick-start funding into projects that support the organization’s mission to find a cure for FSHD by 2027. The goal of SOLVE FSHD is to find a solution that can stop muscle degeneration, increase muscle regeneration and strength, and improve the quality of life for those living with FSHD. For more information, visit  https://solvefshd.com/

Investor Contact

Daniel Ferry
LifeSci Advisors
+1.617.430.7576
daniel@lifesciadvisors.com

Media Contact

Nelson Cabautan
Restem Group, Inc.
+1.800.490.0924
ncabatuan@restem.com

Tessera Therapeutics Showcases New Preclinical Data Demonstrating Progress of In Vivo Programs for Sickle Cell Disease and T Cell Therapies at the 67th American Society of Hematology Annual Meeting




Tessera Therapeutics Showcases New Preclinical Data Demonstrating Progress of In Vivo Programs for Sickle Cell Disease and T Cell Therapies at the 67th American Society of Hematology Annual Meeting

• Presented new data in non-human primates (NHP) for sickle cell disease (SCD), where RNA Gene Writer achieved approximately 40% and 60% of long-term hematopoietic stem cells (LT-HSCs) with at least one edited allele after 1 or 2 doses, respectively, exceeding the anticipated curative threshold
• Evidence in NHP that T cell directed lipid nanoparticles (LNP) produced functional chimeric antigen receptor (CAR)-T cells in vivo, with significant B cell clearance observed in blood and lymph nodes

SOMERVILLE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, is presenting updates across its in vivo genetic medicine programs for SCD and T cell therapies, including its proprietary delivery platform that enables extra-hepatic LNP delivery to hematopoietic stem cells (HSCs) and T cells. These data were shared across three poster presentations at the American Society of Hematology (ASH) Annual Meeting taking place in Orlando, Florida, December 6 – 9, 2025.

“These latest data highlight meaningful progress towards a potentially curative, non-viral approach for treating sickle cell disease (SCD), with our Gene Writers achieving in vivo editing levels in long-term stem cells that exceed the established efficacy thresholds for transformative clinical benefit, without the use of stem cell mobilization, toxic myeloablative pre-conditioning, or transplantation,” said Michael Severino, M.D., CEO of Tessera Therapeutics. “We are also encouraged by our T cell engineering results, which demonstrate the ability to generate functional CAR-T cells in NHPs in vivo. Together, these findings underscore the broad potential of our Gene Writing and delivery platforms to pioneer a new generation of in vivo therapies for patients.”

In Vivo SCD Data

SCD is the most common lethal monogenic disease globally, arising from a mutation in the hemoglobin beta-globin (HBB) gene that results in hemoglobin S, which can cause red blood cell sickling, acute and chronic pain, and widespread organ damage.

• Based on single cell analysis of LT-HSCs collected from NHPs treated with an optimized Gene Writer formulated in LNP, approximately 40% and 60% of cells after 1 or 2 doses, respectively, had at least one edited HBB gene. This data improves upon earlier data presented at the American Society of Gene and Cell Therapy 28^th Annual Meeting, where 35-50% of cells had mono or bi-allelic HBB editing after 2 doses of Gene Writer administered.
• This level of % edited cells exceeds the observed efficacy threshold of 20-30% edited HSCs associated with significant clinical benefit, including resolution of vaso-occlusive crises (VOCs) and improved anemia^1–4.
• Edited LT-HSCs continue to demonstrate durability in NHP, including out to 15 months with beta-2 microglobulin (B2M) surrogate editing and out to approximately 14 months with HBB editing. These cells showed intact HSC function, with editing seen in multiple hematopoietic lineages with continued follow-up.
• RNA Gene Writers achieved efficient levels of in vivo HBB editing with a single intravenous administration, including ~35% correction to wild type in humanized mice engrafted with mobilized peripheral blood cells across SCD donors, and >50% editing across multiple healthy donors.
• HSC targeted LNPs demonstrated favorable pharmacokinetics in NHP, including higher early plasma concentrations and slower initial clearance compared to liver LNP, resulting in improved systemic persistence after intravenous dosing.

Advances Towards In Vivo T-Cell Therapies

Tessera is applying its Gene Writing and proprietary LNP delivery platforms to develop in vivo cell therapies for potential oncology and autoimmune disease applications.

• For the first time, demonstrated proof-of-concept in NHP that T cell directed LNP with CD20 targeted CAR cargo successfully delivered to T cells in vivo, which enabled robust and rapid CAR-T cell expansion and B cell clearance was observed in peripheral blood and immunohistochemistry (IHC) further confirmed significant B cell clearance in lymph nodes.
• Proof-of-concept in a naïve humanized mouse model, with a single intravenous infusion of RNA Gene Writer delivered in a proprietary LNP, successfully generated functional CAR-T cells in vivo targeting CD20, resulting in the elimination of circulating human B cells.
• Further, we highlighted the ability to multiplex different edits in a single step, including two different CARs, CD19 and CD20, with these dual edited CAR-T cells demonstrating superior cancer cell killing in vitro.

¹ Lenoard A, et al., Blood Advances. 2024
² Magnani A, et al., Haematologica. 2020
³ Fitzhugh CD, et al., Blood. 2017
⁴ Kanter J, et al. Am J Hematol. 2023

About Tessera Therapeutics

Tessera Therapeutics is pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, with the aim to unlock broad new therapeutic frontiers. Our Gene Writing platform is designed to write therapeutic messages into the genome by efficiently changing single or multiple DNA base pairs, precisely correcting insertions and deletions, or adding exon-length sequences and whole genes. Our proprietary lipid nanoparticle delivery platform is designed to enable the in vivo delivery of RNA to targeted cell types. We believe our Gene Writing and delivery platforms will enable transformative genetic medicines to not only cure diseases that arise from errors in a single gene, but also modify inherited risk factors for common diseases and create engineered cells to treat cancer and potentially autoimmune and other diseases. Tessera Therapeutics was founded in 2018 by Flagship Pioneering, a life sciences innovation enterprise that conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability.

For more information about Tessera, please visit www.tesseratherapeutics.com.

Contact

Jonathan Pappas
LifeSci Communications, LLC
jpappas@lifescicomms.com

Tessera Therapeutics Showcases New Preclinical Data Demonstrating Progress of In Vivo Programs for Sickle Cell Disease and T Cell Therapies at the 67th American Society of Hematology Annual Meeting




Tessera Therapeutics Showcases New Preclinical Data Demonstrating Progress of In Vivo Programs for Sickle Cell Disease and T Cell Therapies at the 67th American Society of Hematology Annual Meeting

• Presented new data in non-human primates (NHP) for sickle cell disease (SCD), where RNA Gene Writer achieved approximately 40% and 60% of long-term hematopoietic stem cells (LT-HSCs) with at least one edited allele after 1 or 2 doses, respectively, exceeding the anticipated curative threshold
• Evidence in NHP that T cell directed lipid nanoparticles (LNP) produced functional chimeric antigen receptor (CAR)-T cells in vivo, with significant B cell clearance observed in blood and lymph nodes

SOMERVILLE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, is presenting updates across its in vivo genetic medicine programs for SCD and T cell therapies, including its proprietary delivery platform that enables extra-hepatic LNP delivery to hematopoietic stem cells (HSCs) and T cells. These data were shared across three poster presentations at the American Society of Hematology (ASH) Annual Meeting taking place in Orlando, Florida, December 6 – 9, 2025.

“These latest data highlight meaningful progress towards a potentially curative, non-viral approach for treating sickle cell disease (SCD), with our Gene Writers achieving in vivo editing levels in long-term stem cells that exceed the established efficacy thresholds for transformative clinical benefit, without the use of stem cell mobilization, toxic myeloablative pre-conditioning, or transplantation,” said Michael Severino, M.D., CEO of Tessera Therapeutics. “We are also encouraged by our T cell engineering results, which demonstrate the ability to generate functional CAR-T cells in NHPs in vivo. Together, these findings underscore the broad potential of our Gene Writing and delivery platforms to pioneer a new generation of in vivo therapies for patients.”

In Vivo SCD Data

SCD is the most common lethal monogenic disease globally, arising from a mutation in the hemoglobin beta-globin (HBB) gene that results in hemoglobin S, which can cause red blood cell sickling, acute and chronic pain, and widespread organ damage.

• Based on single cell analysis of LT-HSCs collected from NHPs treated with an optimized Gene Writer formulated in LNP, approximately 40% and 60% of cells after 1 or 2 doses, respectively, had at least one edited HBB gene. This data improves upon earlier data presented at the American Society of Gene and Cell Therapy 28^th Annual Meeting, where 35-50% of cells had mono or bi-allelic HBB editing after 2 doses of Gene Writer administered.
• This level of % edited cells exceeds the observed efficacy threshold of 20-30% edited HSCs associated with significant clinical benefit, including resolution of vaso-occlusive crises (VOCs) and improved anemia^1–4.
• Edited LT-HSCs continue to demonstrate durability in NHP, including out to 15 months with beta-2 microglobulin (B2M) surrogate editing and out to approximately 14 months with HBB editing. These cells showed intact HSC function, with editing seen in multiple hematopoietic lineages with continued follow-up.
• RNA Gene Writers achieved efficient levels of in vivo HBB editing with a single intravenous administration, including ~35% correction to wild type in humanized mice engrafted with mobilized peripheral blood cells across SCD donors, and >50% editing across multiple healthy donors.
• HSC targeted LNPs demonstrated favorable pharmacokinetics in NHP, including higher early plasma concentrations and slower initial clearance compared to liver LNP, resulting in improved systemic persistence after intravenous dosing.

Advances Towards In Vivo T-Cell Therapies

Tessera is applying its Gene Writing and proprietary LNP delivery platforms to develop in vivo cell therapies for potential oncology and autoimmune disease applications.

• For the first time, demonstrated proof-of-concept in NHP that T cell directed LNP with CD20 targeted CAR cargo successfully delivered to T cells in vivo, which enabled robust and rapid CAR-T cell expansion and B cell clearance was observed in peripheral blood and immunohistochemistry (IHC) further confirmed significant B cell clearance in lymph nodes.
• Proof-of-concept in a naïve humanized mouse model, with a single intravenous infusion of RNA Gene Writer delivered in a proprietary LNP, successfully generated functional CAR-T cells in vivo targeting CD20, resulting in the elimination of circulating human B cells.
• Further, we highlighted the ability to multiplex different edits in a single step, including two different CARs, CD19 and CD20, with these dual edited CAR-T cells demonstrating superior cancer cell killing in vitro.

¹ Lenoard A, et al., Blood Advances. 2024
² Magnani A, et al., Haematologica. 2020
³ Fitzhugh CD, et al., Blood. 2017
⁴ Kanter J, et al. Am J Hematol. 2023

About Tessera Therapeutics

Tessera Therapeutics is pioneering a new approach to genome engineering through the development of its Gene Writing™ and delivery platforms, with the aim to unlock broad new therapeutic frontiers. Our Gene Writing platform is designed to write therapeutic messages into the genome by efficiently changing single or multiple DNA base pairs, precisely correcting insertions and deletions, or adding exon-length sequences and whole genes. Our proprietary lipid nanoparticle delivery platform is designed to enable the in vivo delivery of RNA to targeted cell types. We believe our Gene Writing and delivery platforms will enable transformative genetic medicines to not only cure diseases that arise from errors in a single gene, but also modify inherited risk factors for common diseases and create engineered cells to treat cancer and potentially autoimmune and other diseases. Tessera Therapeutics was founded in 2018 by Flagship Pioneering, a life sciences innovation enterprise that conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability.

For more information about Tessera, please visit www.tesseratherapeutics.com.

Contact

Jonathan Pappas
LifeSci Communications, LLC
jpappas@lifescicomms.com

Neurona Therapeutics Presents New Long-Term Clinical Data from NRTX-1001 Cell Therapy Trials at 2025 Annual Meeting of the American Epilepsy Society




Neurona Therapeutics Presents New Long-Term Clinical Data from NRTX-1001 Cell Therapy Trials at 2025 Annual Meeting of the American Epilepsy Society

– NON-MTS & BILATERAL MTLE: First data reported from non-MTS and bilateral MTLE subjects demonstrate robust seizure reduction

– LOW DOSE COHORT: 89% median reduction in disabling seizures for unilateral subjects with MTS at the primary efficacy evaluation period of 7-12 months post administration (n=9)

– HIGH DOSE COHORT: 78% median reduction in disabling seizures for unilateral subjects with MTS at interim efficacy evaluation period of 4-6 months post administration (n=9)

– DURABILITY: Several subjects have now surpassed the two-year mark, maintaining substantial seizure reduction

– COGNITION: No significant impairments detected in either dose cohort, with significantly increased test scores for some subjects

– SAFETY: NRTX-1001 continues to be well-tolerated at both high and low doses in bilateral and unilateral MTLE subjects, with and without MTS. No serious adverse events have been attributed to the cell therapy

– PIVOTAL TRIAL: EPIC Phase 3 trial of NRTX-1001 in drug-resistant MTLE is planned to dose first subjects in 1H 2026

SAN FRANCISCO, Dec. 08, 2025 (GLOBE NEWSWIRE) — Neurona Therapeutics, a clinical-stage biotherapeutics company focused on advancing regenerative cell therapies for disorders of the nervous system, today presented new clinical results from its ongoing Phase 1/2 trials evaluating NRTX-1001, a one-time, allogeneic inhibitory interneuron cell therapy for drug-resistant mesial temporal lobe epilepsy (MTLE). The data were presented at the Annual Meeting of the American Epilepsy Society (AES), taking place December 5-9, 2025, in Atlanta, Georgia.

The updates include the first announcement of results from subjects without mesial temporal sclerosis (MTS) and from those with bilateral MTLE, expanding the clinical efficacy dataset for NRTX-1001 across a broader MTLE population. Additionally, several treated subjects have now been followed for more than two years, providing the most mature assessment to date of the therapy’s durability, safety, and impact on seizure burden.

“We are delighted to share this expanded 2025 clinical dataset at AES, which now includes our first outcomes from non-MTS and bilateral MTLE participants,” said Cory R. Nicholas, Ph.D., Neurona’s Co-Founder and Chief Executive Officer. “Across the program, we continue to see durable seizure reduction from a single administration of the product in most subjects, including median decreases of nearly 90% in the unilateral MTS low-dose cohort at the 7–12-month primary efficacy window, and more than 90% reduction in a subset of participants followed beyond 12 months. Moreover, several individuals have now surpassed the two-year mark, maintaining substantial seizure reduction with a consistent safety profile to date. These results further reinforce the potential of NRTX-1001 to deliver long-lasting, clinically meaningful benefits across a broader spectrum of people living with drug-resistant focal epilepsy.”

“We are now following some of our earliest participants out past two years, and the durability of their seizure reduction remains remarkable,” said Eduardo Dunayevich, M.D., Neurona Therapeutic’s Chief Medical Officer. “This year’s dataset also offers encouraging evidence that NRTX-1001 may extend benefits beyond the classic unilateral MTS population. The improvements we’re seeing across these patient cohorts continue to support the promise of NRTX-1001 as a potential treatment option for people with diverse forms of difficult-to-treat focal epilepsy. We look forward to treating the first participants in the Phase 3 EPIC trial in the first half of 2026.”

Results (n=26, data cut as of October 2025):

Low-Dose Cohort 1: Unilateral MTLE with MTS

• Interim Efficacy Endpoint: Months 4-6 Post-Administration (n=9)
  • 80% median reduction in disabling seizures
  • 78% (7/9) responder rate with ≥50% reduction in disabling seizures
• Primary Efficacy Endpoint: Months 7-12 Post-Administration (n=9)
  
  • 89% median reduction in disabling seizures
  • 78% (7/9) responder rate with ≥50% reduction in disabling seizures
• Long-Term Durability: Months 13+ (n=7)
  
  • 92% median reduction in disabling seizures
  • 86% (6/7) responder rate with ≥50% reduction in disabling seizures

High-Dose Cohort 2: Unilateral MTLE with MTS

• Interim Efficacy Endpoint: Months 4-6 Post-Administration (n=9)
  • 78% median reduction in disabling seizures
  • 89% (8/9) responder rate with ≥50% reduction in disabling seizures
• Primary Efficacy Endpoint: Months 7-12 Post-Administration (n=5)*
  
  • 58% median reduction in disabling seizures
  • 80% (4/5) responder rate with ≥50% reduction in disabling seizures

*(Four subjects have not yet reached 12-months of follow-up.)

Low-Dose Cohort 3: Unilateral MTLE without MTS

• Early Efficacy: Months 1-6 Post-Administration (n=4)*
  • 88% median reduction in disabling seizures
  • 67% (2/3) responder rate with ≥50% reduction in disabling seizures

*(Two subjects completed 6-months; One subject completed 3-months; One subject has not yet reached 1-month.)

Low-Dose Bilateral Study: Bilateral MTLE with or without MTS

• Early Efficacy: Months 1-6 Post-Administration (n=4)*
  • 93% median reduction in disabling seizures
  • 75% (3/4) responder rate with ≥50% reduction in disabling seizures

*(Two subjects completed 6-months; One subject completed 2-months; One subject completed 1-month.)

Safety Across All Cohorts

• No serious adverse events attributed to NRTX-1001 or the administration procedure.
• Procedure-related adverse events were mild to moderate and temporary.
• Immunosuppression-related adverse events were mild to moderate in severity and resolved in 9 of 10 participants who completed the regimen per protocol; one participant continues to report mild fatigue, irritability, and dizziness.
• Serious adverse events that did occur were consistent with underlying disease or unrelated conditions (e.g., episodes of status epilepticus consistent with prior histories, acute kidney injury in the context of illness, events related to a car accident).

Cognition and Quality of Life

• No group trends for decline in cognitive performance across word retrieval, verbal memory, or visuospatial memory assessments.
• 75% (6/8) of subjects demonstrated significant improvements in quality of life in epilepsy (QOLIE) test scores at 18 months post-treatment.

Neurona Therapeutics’ multicenter, open-label Phase 1/2 clinical program is designed to evaluate the safety, tolerability, and preliminary efficacy of a single administration of NRTX-1001 for drug-resistant MTLE. The ongoing unilateral MTLE study includes adults with and without MTS and has now enrolled participants across low- and high-dose cohorts. A parallel Phase 1/2 trial is evaluating NRTX-1001 in adults with bilateral MTLE, following low-dose administration to each hippocampus. Participants in both studies are monitored for safety, seizure frequency, and neuropsychological function.

In addition to completing enrollment of the current Phase 1/2 cohorts, Neurona is preparing to initiate the Phase 3 EPIC Trial, a randomized, sham-controlled, double-blind study designed to further evaluate NRTX-1001 in adults with drug-resistant MTLE. The EPIC study will randomize participants 2:1 to NRTX-1001 or sham control, with a six-month blinded period followed by the option for all eligible participants to receive treatment after unblinding.

For more information about Neurona’s clinical trials, please contact NeuronaMedInfo@neuronatx.com.

About Neurona Therapeutics

Neurona is developing allogeneic, off-the-shelf, regenerative neural cell therapies with the potential to provide long-term targeted repair of the nervous system following a single administration. Neurona’s lead product candidate, NRTX-1001, comprising GABAergic interneurons, is currently being studied for safety and efficacy in two ongoing open-label, multicenter Phase 1/2 trials: NCT05135091 for drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), and NCT06422923 for drug-resistant bilateral MTLE, with expansion to neocortical focal epilepsy and other indications planned in the future. The Phase 1/2 MTLE clinical trials are supported by grants from the California Institute for Regenerative Medicine (CIRM; CLIN2-13355 and CLIN2-17135). The FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to NRTX-1001 in June 2024. The EMA granted the Priority Medicines (PRIME) designation to NRTX-1001 in October 2025. Consistent with Neurona’s discussion with regulatory authorities, the Phase 3 EPIC (EPIlepsy Cell Therapy) trial is planned to dose first subjects in 1H 2026. For more information about Neurona, visit: www.neuronatherapeutics.com.

Investor Contact:
Laurence Watts
New Street Investor Relations
laurence@newstreetir.com

HealthLynked Appoints Duncan McGillivray as Chief Operating Officer to Accelerate National Expansion and Nasdaq Uplisting Strategy




HealthLynked Appoints Duncan McGillivray as Chief Operating Officer to Accelerate National Expansion and Nasdaq Uplisting Strategy

NAPLES, Fla., Dec. 08, 2025 (GLOBE NEWSWIRE) — via IBN — HealthLynked Corp. (OTCQB: HLYK), the nation’s leading patient-centric healthcare networking platform, today announced the appointment of Duncan McGillivray, MBA, as its new Chief Operating Officer (COO). McGillivray brings more than 30 years of executive leadership across healthcare, technology, capital markets, and large-scale project finance. In his new role, he will drive HealthLynked’s operational scale-up, support national payer and employer partnerships, and lead capital formation and banking relations as the company advances its efforts to uplist to the Nasdaq Capital Market.

Proven Executive With Deep Healthcare, Technology & Financial Expertise

Mr. McGillivray holds an MBA from Columbia Business School and a BA from Pomona College, two of the nation’s most prestigious academic institutions. His career spans senior leadership roles across healthcare systems, fintech, AI-driven health analytics, community development finance, and capital project advisory work.

Over his 35-year career, he has:

• Advised on more than $1 billion in hospital and healthcare facility development projects, including major ground-up construction, rehabilitation, and acquisition initiatives.
• Served as Senior Vice President & COO of Healthcare Community Development Group, working with hospital CEOs, CFOs, and Boards across the U.S. and facilitating complex financing structures through the U.S. Treasury’s $76 billion of allocation sized New Markets Tax Credit program.
• Acted as a National Capital Project Advisor for a U.S. Department of Health & Human Services’ (HRSA) national cooperative partner Capital Link, where he helped guide the nation’s approximately 1,400 Federally Qualified Health Centers and supported over $200 million in funded healthcare projects.
• Led discussions regarding advanced analytics, AI-enabled care models, and interoperability-driven system transformation with the CIOs and CMIOs at many large hospitals across the USA while representing a hospital focused digital EHR management company whose investors include Microsoft and whose clients have included NASA, MIT, Disney and Catholic Health Initiatives.

Driving Capital Strategy & Nasdaq Uplisting

In addition to leading daily operations, McGillivray will oversee HealthLynked’s capital-raising strategy, investor-engagement programs, and banking relationships that support the company’s planned Nasdaq uplisting in 2026. His extensive background in finance, including prior roles with Bank of America, Morgan Guaranty Trust, Union Bank, and the Bank of California—positions him to accelerate HealthLynked’s growth trajectory as it expands nationwide.

“With Duncan’s combination of operational leadership, healthcare expertise, and sophisticated capital markets experience, HealthLynked is significantly strengthening its executive team at a pivotal time,” said Dr. Michael Dent, Founder, Chairman & CEO of HealthLynked. “His experience working with national health systems, payers, technology platforms, and financing partners will be instrumental as we expand ARI, scale our provider network, and advance toward our Nasdaq listing.”

Supporting National Expansion & AI-Driven Healthcare Transformation

McGillivray will also help guide the rollout of ARI, HealthLynked’s patented AI healthcare guide, as well as the company’s participation in nationwide initiatives such as TEFCA interoperability, “Kill the Clipboard,” and the federal government’s recently launched Genesis Mission to accelerate AI-driven scientific discovery.

“I’m excited to join HealthLynked at a moment when AI, interoperability, and consumer-driven platforms are reshaping the future of healthcare,” said McGillivray. “HealthLynked has the key building blocks—technology, partnerships, and a national vision—to deliver real change, and I’m honored to help drive its next phase of growth.”

About HealthLynked Corp.

HealthLynked Corp. enhances healthcare through personalized care management that improves outcomes and reduces costs. Its cloud-based platform connects patients with providers for virtual or in-office appointments and consolidates medical records into one secure, accessible location.

With AI-driven insights and integrated telehealth services, HealthLynked empowers patients and providers to coordinate care more effectively, while delivering substantial savings on prescriptions and healthcare services. The platform supports enterprise partnerships, offering scalable solutions to healthcare networks and digital health innovators.
Learn more at www.hlykgroup.com

Download the HealthLynked App:

• Apple App Store
• Google Play Store

Forward-Looking Statements

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Such statements are inherently uncertain and may differ materially from actual results. Forward-looking statements reflect management’s current expectations and are subject to risks, uncertainties, and assumptions. HealthLynked disclaims any obligation to update these statements except as required by law.

Investor & Media Contact

HealthLynked Corp.
1265 Creekside Parkway, Suite 200
Naples, FL 34108
Phone: +1 (800) 928-7144
Email: IR@healthlynked.com

Wire Service Contact:
IBN
Austin, Texas
www.InvestorBrandNetwork.com
512.354.7000 Office
Editor@InvestorBrandNetwork.com

Pan Cancer T Secures EUR 10 Million to Advance First-in-Human Trial of Novel TCR-T Cell Therapy for Triple-Negative Breast Cancer




Pan Cancer T Secures EUR 10 Million to Advance First-in-Human Trial of Novel TCR-T Cell Therapy for Triple-Negative Breast Cancer

ROTTERDAM, the Netherlands, Dec. 08, 2025 (GLOBE NEWSWIRE) — Pan Cancer T B.V., a biotech company pioneering next-generation T cell therapies for solid tumours, today announced a EUR 10 million financing to advance its lead program, PCT1:CO-STIM, into a first-in-human clinical trial for women with triple-negative breast cancer (TNBC).

The financing includes EUR 5 million from existing investors Van Herk Ventures, Thuja Capital, Erasmus MC O&O Holdings, and InnovationQuarter, in addition to a EUR 5 million Innovation Credit loan from the Dutch Ministry of Economic Affairs. This funding will enable the company to treat TNBC patients at leading cancer centres in the Netherlands.

“Our mission is to empower a patient’s own immune cells to tackle hard-to-treat cancers like TNBC,” said Rachel Abbott, Chief Executive Officer of Pan Cancer T. “This significant investment marks a pivotal moment as we transition from preclinical validation to treating patients with our first novel T-cell receptor (TCR) T cell therapy, PCT1:CO-STIM, following our planned regulatory filing with the EMA in 2026. We are deeply grateful to our investors and the Netherlands Enterprise Agency (RVO) for their confidence in our approach.”

“Thuja Capital is dedicated to investing in the most innovative life sciences companies. Pan Cancer T’s TCR-T platform addresses hard-to-treat solid tumours, such as TNBC, that are the greatest challenge in oncology. Following our recent success in the cell and gene therapy field, with AstraZeneca’s acquisition of our portfolio company EsoBiotec, we are delighted to continue backing another pioneer in the C&GT space,” said Michel Briejer, Managing Partner at Thuja Capital and member of Pan Cancer T’s Supervisory Board.

The upcoming trial will assess safety, tolerability, and preliminary efficacy of a therapeutic dose of PCT1:CO-STIM in TNBC patients. These patients have an urgent unmet medical need, with a 5-year survival rate following metastatic progression of approximately 12% and median overall survival of less than 6 months.

PCT1:CO-STIM is being developed as an autologous T cell therapy but also has the potential to be delivered in vivo at a later stage. It features a proprietary TCR highly specific for ROPN1, a novel tumour-restricted target expressed in over 90% of TNBC and melanoma cases. The therapy also incorporates a unique co-stimulatory technology designed to overcome immune resistance in solid tumours, aiming to deliver durable responses in patients with few treatment options.

About Pan Cancer T

Pan Cancer T is advancing next-generation TCR-T cell therapies for hard-to-treat solid tumours. Its approach combines two key innovations:

• Exclusive tumour targets robustly expressed across multiple solid cancers.
• Enhanced T cell durability through proprietary technologies.

The company’s R&D pipeline includes programs for triple-negative breast cancer (TNBC) and cancers of the skin, colorectum, stomach, oesophagus, ovary and uterus.

Founded in 2020 as a spin-out from Erasmus MC in Rotterdam, the Netherlands, Pan Cancer T has raised approximately €21 million to date, including €2 million in grants and the €5 million Innovation Credit loan. Investors include Van Herk Ventures, Thuja Capital, Erasmus MC O&O Holdings, InnovationQuarter, and Swanbridge Capital.

For more information, visit www.pancancer-t.com and follow us on LinkedIn.

Media contacts

Pan Cancer T
Rachel Abbott, CEO
info@pancancer-t.com

Scius Communications 
Katja Stout 
+44 778 943 5990
katja@sciuscommunications.com
Daniel Gooch
+44 7747 875479
daniel@sciuscommunications.com

Geneva College of Longevity Science and DrVibe.ai Launch the GCLS AI Academy for Longevity Sciences




Geneva College of Longevity Science and DrVibe.ai Launch the GCLS AI Academy for Longevity Sciences

First Multi-Agent AI System for Higher Longevity Education to Offer Free Courses and Pave the Way for a Master’s Degree in AI in Healthcare

New Website: https://gcls.ai

GENEVA, Dec. 08, 2025 (GLOBE NEWSWIRE) — The Geneva College of Longevity Science (GCLS), in partnership with DrVibe.ai, today announced the launch of the GCLS AI Academy for Longevity Sciences—the world’s first educational platform powered by a coordinated multi-agent artificial intelligence system dedicated to longevity sciences and AI-driven healthcare innovation. Designed to democratize access to longevity education and deliver it in a format optimized for younger learners and digital-native students, the Academy is now live at https://gcls.ai.

This new initiative will be led by Fady Hannah-Shmouni, MD, FRCPC, who will serve as Director, with Dr. Dominik Thor, MSc appointed as President of the Academy.

AI-Driven Higher Education

The GCLS AI Academy leverages academic expertise with a network of collaborative AI agents to deliver personalized, up-to-date instruction across longevity science, biomedical innovation, and clinical AI applications. Each AI agent specializes in a domain—from geroscience fundamentals to computational biology—creating a dynamic, adaptive learning environment designed to keep pace with rapid scientific evolution.

“The future of longevity education must be faster, smarter, and globally accessible,” said Dominik Thor, President of the GCLS AI Academy.

“Our mission is to democratize longevity science education at scale,” said Fady Hannah-Shmouni, MD, FRCPC, Director of the GCLS AI Academy. “By offering high-quality, AI-enhanced courses for free, we are removing barriers and accelerating the global shift toward health-span-focused medicine.”

Free Courses Available Worldwide

At launch, the GCLS AI Academy offers free, self-paced courses tailored for students, clinicians, researchers, and health innovators.

The AI Academy also establishes a technological and academic basis for the forthcoming Master’s Degree in AI in Healthcare—expected to be the world’s first graduate-level program at the intersection of artificial intelligence and clinical longevity practice.

A Joint Venture Built on Science and Innovation

The partnership between GCLS and DrVibe.ai integrates institutional scientific oversight with state-of-the-art AI systems, ensuring that all educational content is grounded in validated research, global best practices, and emerging translational insights.

The Geneva College of Longevity Science (https://www.gcls.study) is a Swiss institute of higher education with a global footprint and student community.

DrVibe.ai is an AI-driven EdTech developing intelligent systems that support scalable digital education for healthcare and wellness providers.

Press Contact

GCLS AI Academy for Longevity Sciences
Email: press@gcls.study
Website: https://gcls.ai