GERN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• In addition to lower-risk MDS, we are developing imetelstat for the treatment of other myeloid hematologic malignancies. Our Phase 3 IMpactMF clinical trial is evaluating imetelstat in patients with intermediate-2 or high-risk myelofibrosis, or MF, who have relapsed after or are refractory to treatm…

• On November 1, 2024, we entered into a loan agreement, or the Pharmakon Loan Agreement, with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, which are investment funds managed by Pharmakon Advisors, LP, and BioPharma Credit PLC, as collateral agent, that provides for a 5-yea…

• In December 2025, we implemented a workforce reduction, representing approximately one-third of our workforce prior to the reduction in headcount. We recorded approximately $17.0 million in restructuring and restructuring-related charges in the fourth quarter of 2025, primarily consisting of one-tim…

• The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of RYTELO, our sole product. In this regard, our ability to generate meaningful revenue from product sales and achieve profitability is wholly depend…

• Our commercial strategy is designed to ensure that RYTELO reaches eligible patients when they are most likely to benefit. Our commercial execution is focused on targeted engagement with high-volume accounts that treat earlier-line patients, investment in non-personal promotion and third-party educat…

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• In addition to lower-risk MDS, we are developing imetelstat for the treatment of other myeloid hematologic malignancies. Our Phase 3 IMpactMF clinical trial is evaluating imetelstat in patients with intermediate-2 or

• high-risk myelofibrosis, or MF, who have relapsed after or are refractory to treatment with a janus associate kinase inhibitor, or JAK inhibitor, or relapsed/refractory MF with overall survival, or OS, as the primary endpoint. As of the end of September 2025, the trial has reached full enrollment. B…

• On November 1, 2024, we entered into a loan agreement, or the Pharmakon Loan Agreement, with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, each, a Lender, which are investment funds managed by Pharmakon Advisors, LP, and BioPharma Credit PLC, as collateral agent, that prov…

• The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of RYTELO, our sole product. In this regard, our ability to generate meaningful revenue from product sales and achieve profitability is wholly depend…

• Our priority is to drive new patient starts across the breadth of the eligible patient population in RYTELO’s approved indication in the U.S. Our strategy to drive sales growth in the U.S. is currently focused on three key areas:

Text added vs the prior filing · source: 10-Q · 2026-05-06

• There were no changes in our internal control over financial reporting during the quarter to which this Report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

• In designing and evaluating disclosure controls and procedures, our management recognizes that any system of controls, however well designed and operated, can provide only reasonable assurance, and not absolute assurance, that the desired control objectives of the system are met. In addition, the de…

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

• Management has identified a material weakness in our internal control over financial reporting. Specifically, management identified deficiencies in the design and operation of certain Information Technology General Controls, or ITGCs, related to user access and program change management for our Ente…

• We are currently in the process of implementing measures and taking steps designed to address the underlying causes of the material weakness, which we have determined were influenced by changes in our personnel and IT processes and the rapid growth of our company in 2025. Our remediation efforts wil…

• our ITGC-related controls, as well as providing training to relevant personnel on the design and operation of our ITGCs. We expect to complete implementation of the remediation measures by the end of the fourth quarter of 2025.

• While we are performing certain remediation activities to strengthen our controls to address the identified material weakness, control weaknesses are not considered remediated until enhanced internal controls have been operational for a period of time, are tested, and management concludes that these…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• •Although we have established commercial operations and sales, marketing and distribution infrastructure for RYTELO, we have limited experience in sustaining and scaling these operations and our commercialization efforts may be unsuccessful or less successful than anticipated.

• •We face competition from existing products, product candidates and technologies, and competitors may develop new products and technologies. If these products, product candidates or technologies are deemed by the healthcare community to be superior to or more cost-effective than RYTELO, it would sig…

• •We will be subject to pricing and reimbursement regulations in the European Union, or EU, which may materially affect our ability to commercialize and receive reimbursement coverage for RYTELO in the EU.

• •Our relationships with healthcare providers, including physicians and third-party payors, the methods by which we promote RYTELO, and the content of our promotional materials and programs, are subject to applicable promotional, anti-kickback, fraud and abuse, and other healthcare laws and regulatio…

• with these laws could expose us to criminal sanctions, civil penalties, exclusion from federal health care programs, contractual damages, reputational harm and may adversely affect our business and financial results.

Text removed vs the prior filing · source: 10-Q · 2025-11-07

• •We have limited experience as a commercial company and our sales, marketing, and distribution of RYTELO may be unsuccessful or less successful than anticipated.

• •If we do not maintain acceptable prices or adequate reimbursement for RYTELO, the use of RYTELO could be severely limited.

• •To be commercially successful, RYTELO must be accepted by the healthcare community, which can be slow to adopt or unreceptive to new technologies and products.

• •If the market opportunities for RYTELO are smaller than we believe, our revenue may be adversely affected, and our business may suffer.

• •If competitors develop products, product candidates or technologies that are superior to or more cost-effective than RYTELO, it would significantly impact the development and commercial viability of RYTELO, which would severely and adversely affect our financial results, business and business prosp…