Geron Corp - GERN STOCK NEWS

Geron (Nasdaq: GERN) announced Q2 2024 financial results and business highlights. The company launched its first commercial product, RYTELO™, in June 2024, for lower-risk myelodysplastic syndromes (LR-MDS) patients with transfusion-dependent anemia. By July 31, approximately 160 patients were treated with RYTELO. The National Comprehensive Cancer Network updated its guidelines to include RYTELO as a treatment for LR-MDS. Geron's Phase 3 IMpactMF trial achieved 70% enrollment. The company reported $882,000 in total quarterly revenue, a significant increase from $29,000 in Q2 2023. However, Geron also reported a net loss of $67.4 million, increased from $49.2 million year-over-year. Total operating expenses rose to $70.2 million due to higher launch costs and headcount increases.

Geron projects total operating expenses for FY 2024 to be between $270 million and $280 million. The company has $430.4 million in cash and equivalents, expected to fund operations into Q2 2026.

Geron (Nasdaq: GERN) announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for Myelodysplastic Syndromes (MDS) to recommend RYTELO™ (imetelstat) as a Category 1 and 2A treatment for symptomatic anemia in lower-risk MDS patients. RYTELO is recommended as a Category 1 second-line treatment for both RS+ and RS- patients with serum EPO ≤500 mU/mL, and as a Category 2A first-line treatment for patients with serum EPO >500 mU/mL. This update follows the FDA's approval of RYTELO in June 2024 for treating adult patients with low- to intermediate-1 risk MDS with transfusion-dependent anemia. The company believes these updates will increase awareness and uptake of RYTELO as a new treatment option for eligible lower-risk MDS patients.

Geron (Nasdaq: GERN) announced that Anil Kapur, Executive Vice President, Corporate Strategy and Chief Commercial Officer, will depart the company on August 31, 2024. A search for a new Chief Commercial Officer is underway. In the interim, Andrew Grethlein, Ph.D., Executive Vice President, Chief Operating Officer, will lead the commercial organization, supported by Board member Dawn Carter Bir.

The company expressed confidence in the uptake of RYTELO™ in its first month of launch and the positive customer feedback. CEO John A. Scarlett thanked Kapur for his contributions over the past five years, particularly in defining RYTELO's potential market and building a strong commercial organization.

Geron (Nasdaq: GERN), a commercial-stage biopharmaceutical company, has announced that it will release its second quarter 2024 financial results and business highlights on Thursday, August 8, 2024. The company will issue a press release before the market opens, which will be available on their website. Additionally, Geron will host a conference call and webcast at 8:00 a.m. ET on the same day to discuss the financial results and business highlights. Interested parties can access the webcast by registering online through the provided link. An archive of the webcast will be available on the company's website for 30 days following the event.

Geron , a biopharmaceutical company, announced inducement grants under Nasdaq Listing Rule 5635(c)(4). The company granted non-statutory stock options for 222,660 shares to new employees as of June 19, 2024. The exercise price is $4.49 per share, equal to the closing price of Geron stock on the grant date. These options have a 10-year term and vest over four years, with 12.5% vesting after six months and the remainder vesting in equal installments over 42 months, subject to continued employment. The grants are part of Geron's 2018 Inducement Award Plan.

Geron has announced FDA approval for RYTELO™ (imetelstat), the first telomerase inhibitor, to treat adults with lower-risk myelodysplastic syndromes (MDS) suffering from transfusion-dependent anemia. The approval covers ESA ineligible and relapsed/refractory patients, regardless of ring sideroblast status. The IMerge Phase 3 clinical trial revealed significant improvements in transfusion independence and hemoglobin levels. The common Grade 3/4 adverse reactions were thrombocytopenia and neutropenia but were generally manageable. A conference call is scheduled for June 7, 2024, at 8 am ET to discuss these developments.

Geron (Nasdaq: GERN) announced the grant of non-statutory stock options to purchase 2,910,780 shares of common stock as inducements for newly hired employees. The options were granted on May 15, 2024, at an exercise price of $3.90 per share, matching the closing price on the grant date. The options, which have a 10-year term, will vest over four years, starting with 12.5% on the six-month anniversary of employment, followed by equal monthly installments over the next 42 months. These inducements are in line with Nasdaq Listing Rule 5635(c)(4) and Geron's 2018 Inducement Award Plan.

Geron (Nasdaq: GERN) reported financial results for the first quarter of 2024, including a net loss of $55.4 million and revenues of $304,000. The company has completed commercial team onboarding and is preparing for the potential U.S. launch of imetelstat pending FDA approval. The Phase 3 IMpactMF trial continues with updated timelines. Geron expects total operating expenses for fiscal year 2024 to be $270-280 million.