Geron Corp (GERN, Financial), a late-stage clinical biopharmaceutical company, released its Q3 2023 financial results and business highlights on November 2, 2023. The company is currently developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies. Imetelstat is under regulatory review by the FDA and EMA for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS. The company is planning for a potential commercial launch in the U.S. in mid-2024.
Business Highlights
The company received acceptance from the FDA for the New Drug Application (NDA) submitted for imetelstat for the treatment of transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS). The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024. The Marketing Authorization Application (MAA) for imetelstat received validation from the European Medicines Agency (EMA) and is under regulatory review. The review of the MAA is expected to be completed by the end of 2024.
Financial Performance
As of September 30, 2023, Geron Corp (GERN, Financial) had $381.9 million in cash, cash equivalents, and marketable securities. The company received $28.3 million upon the cash exercise of outstanding warrants during the third quarter. Based on the company's current operating plans, Geron projects that its existing financial resources will be sufficient to fund its projected operating requirements through the end of Q3 2025.
Revenues for the three and nine months ended September 30, 2023, were $164,000 and $214,000, respectively. Total operating expenses for the same periods were $47.8 million and $139.9 million, respectively. Research and development expenses were $29.4 million and $92.1 million, respectively, while general and administrative expenses were $18.4 million and $47.7 million, respectively.
Projected 2023 Financial Guidance
For fiscal year 2023, Geron Corp (GERN, Financial) expects total expenses in the range of approximately $200 million to $210 million. The company plans to grow to a total of approximately 160 employees by year-end 2023.
The company's financial results and business highlights reflect its ongoing efforts to develop and commercialize imetelstat, which could potentially play a significant role in the treatment landscape for lower risk MDS.
Explore the complete 8-K earnings release (here) from Geron Corp for further details.
