Geron Corp - GERN STOCK NEWS

Geron (Nasdaq: GERN) received a positive opinion from the European Medicines Agency's CHMP recommending the approval of RYTELO (imetelstat) for treating adult patients with transfusion-dependent anemia due to lower-risk myelodysplastic syndromes (LR-MDS). The treatment is specifically for patients without an isolated deletion 5q cytogenetic abnormality who had unsatisfactory response to or are ineligible for erythropoietin-based therapy.

The recommendation is based on the IMerge Phase 3 clinical trial results, which demonstrated reduced need for red blood cell transfusions in the first 24 weeks compared to placebo. If approved by the European Commission, RYTELO would become the first telomerase inhibitor available in Europe, administered as 47 mg and 188 mg lyophilized powder for intravenous infusion.

Geron (GERN) presented Phase 1 findings from the IMproveMF study at the 66th ASH Annual Meeting, demonstrating the tolerability of RYTELO™ (imetelstat) combined with ruxolitinib as frontline therapy for myelofibrosis patients. No dose-limiting toxicities were observed across all dose levels, and pharmacokinetic profiles aligned with previous monotherapy studies.

Based on safety results, imetelstat 9.4 mg/kg dosed every four weeks with ruxolitinib was selected for the dose expansion Part 2, which is currently enrolling patients. Grade 3 treatment-emergent adverse events were reported in 47% of patients, with no Grade 4 or 5 events observed. The study showed preliminary evidence of variant allele frequency reductions and symptom improvement across dose cohorts.

Geron (GERN) presented new analyses from the IMerge clinical trial at the 66th ASH Annual Meeting, demonstrating RYTELO™ (imetelstat)'s clinical activity in lower-risk myelodysplastic syndromes (LR-MDS) patients. The data suggests effectiveness regardless of prior therapies, including in patients who previously received luspatercept or lenalidomide.

Key findings from pooled data of 226 imetelstat-treated patients showed consistent clinical activity with the IMerge Phase 3 pivotal trial. The QTc substudy demonstrated an absence of proarrhythmic risk and confirmed efficacy in patients with prior treatments. Patient-reported outcomes showed sustained improvement in fatigue and maintenance of quality of life compared to placebo.

Geron (Nasdaq: GERN) has announced its upcoming participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management team will engage in a fireside chat at the event, scheduled for December 4, 2024, at 8:20 a.m. ET in Coral Gables, Florida. A webcast of the presentation will be accessible through the Investors and Media section of Geron's website under Events and will remain available for replay for 30 days following the event.

Geron (Nasdaq: GERN) announced the granting of non-statutory stock options to newly hired employees. The company granted options to purchase 1,017,000 shares of common stock at an exercise price of $3.99 per share, matching the closing price on November 20, 2024. The options have a 10-year term and vest over four years, with 12.5% vesting after six months and the remainder vesting over 42 months in equal installments. These grants were made as employment inducements under Nasdaq Listing Rule 5635(c)(4) and are subject to Geron's 2018 Inducement Award Plan.

Geron (Nasdaq: GERN) has appointed Joseph Eid, M.D. as Executive Vice President, Research and Development, effective November 11, 2024. Dr. Eid brings over two decades of experience in medical affairs and clinical development, having previously served at Dragonfly Therapeutics and Luzsana Bio. He will lead Geron's R&D organization, overseeing medical, clinical, and safety teams to support RYTELO™ commercially. As part of his employment agreement, Dr. Eid received a stock option grant for 2,500,000 shares at $4.12 per share, vesting over four years.

Geron (Nasdaq: GERN) announced its management team will participate in a fireside chat at the Stifel 2024 Healthcare Conference in New York City. The presentation is scheduled for Monday, November 18th, 2024, at 1:50pm ET.

The company will make a webcast of the fireside chat accessible through the Investors and Media section of Geron's website under Events. The webcast recording will remain available for replay for 30 days following the presentation.

Geron (GERN) has secured up to $375 million in financing through agreements with Royalty Pharma and Pharmakon Advisors. The deal includes $250 million received at closing and access to an additional $125 million in debt. The funding comprises a $125 million synthetic royalty agreement with Royalty Pharma and $250 million in senior secured debt from Pharmakon Advisors. The financing will support RYTELO's commercial launch in the U.S., potential EU launch, Phase 3 IMpactMF trial in myelofibrosis, and supply chain investments.

Geron (GERN) reported Q3 2024 financial results, achieving $28.2 million in RYTELO™ net product revenue in its first full quarter of sales. The company secured $250 million in financing through agreements with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt. Q3 net loss was $26.4 million, or $0.04 per share. Total operating expenses were $56.5 million. The company expects 2024 total operating expenses between $260-270 million. Cash position as of September 30, 2024, was $378.9 million, with pro forma cash of $542.4 million including recent financing proceeds.