Geron Corp. Announces Q1 2024 Financial Results and Business Highlights

Geron Corporation, a late-stage clinical biopharmaceutical company listed on Nasdaq as GERN, is progressing with the development of imetelstat, an innovative first-in-class telomerase inhibitor aimed at treating hematologic malignancies. The company has shared its financial performance and key business updates for the first quarter of 2024.

Following the FDA Oncologic Drugs Advisory Committee's favorable recommendation in March, which voted 12 to 2 in support of the clinical benefit-risk profile of imetelstat for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS), Geron is collaborating closely with the FDA as the New Drug Application (NDA) undergoes review. The target action date for the Prescription Drug User Fee Act (PDUFA) is set for June 16, 2024. CEO John A. Scarlett expressed the company's proactive measures for a potential U.S. launch of imetelstat, including the recent onboarding of a sales force and enhancing market research and organizational capabilities.

In preparation for commercial activities in the U.S., Geron has finalized the onboarding of its commercial team and sales organization as of April. The company is advancing with other preparations, such as developing company processes and systems to support the anticipated commercial launch, refining market research for transfusion-dependent lower-risk MDS, and undertaking marketing, commercial access, payer, and reimbursement initiatives.

In clinical development news, the Phase 3 IMpactMF trial, which focuses on myelofibrosis patients who are relapsed/refractory to JAK inhibitors, is ongoing. Following a recent review by the data monitoring committee, which recommended the trial continuation based on unblinded data, Geron has extended its timeline guidance. Interim analysis is now anticipated for early 2026, with the final analysis expected in early 2027, due to lower-than-expected enrollment rates and death rates.

Financially, Geron reported a net loss of $55.4 million for the first quarter of 2024, translating to $0.09 per share, compared to a net loss of $38.1 million or $0.07 per share in the same period of the previous year. The company had approximately $465 million in cash and marketable securities as of March 31, 2024, bolstered by proceeds from a public offering in March. Revenues for the first quarter reached $304,000, significantly higher than the $21,000 reported in the same quarter of 2023, driven by estimated royalties from cell-based research products linked to the company's previously divested stem cell assets.

Geron's operating expenses rose to $56.4 million in the first quarter of 2024 from $40.1 million in the prior year, with research and development expenses increasing to $29.4 million from $27.2 million. This increase is attributed to higher manufacturing costs and personnel-related expenses. General and administrative expenses also saw a significant rise to $27.1 million from $12.9 million, reflecting costs for commercial preparations and increased headcount.

Interest income was reported at $4.2 million, up from $3.9 million, due to a larger marketable securities portfolio and higher yields. However, interest expenses also increased to $3.4 million from $1.9 million, primarily due to higher interest rates on an outstanding principal debt of $80 million.

Looking ahead, Geron anticipates total operating expenses for 2024 to be between $270 million and $280 million. This projection includes costs associated with regulatory processes, ongoing clinical trials support, commercial inventory manufacturing, commercial organization buildout, and interest payments. Based on current plans and potential approval of imetelstat, Geron believes its existing financial resources will suffice to meet its operating requirements into the second quarter of 2026.

As of the end of the first quarter, Geron employed 162 full-time employees, with plans to expand to approximately 250-300 employees by the year's end, contingent on the approval of imetelstat in the U.S.