IMA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• You should read the following discussion and analysis of our financial condition and results of operations together with the condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report and the audited financial statements and the related note…

• We are a clinical-stage biopharmaceutical company developing therapeutics for patients with immunological, autoimmune and inflammatory diseases. Our lead asset, IMG-007, is a non-depleting anti-OX40 monoclonal antibody that binds specifically to OX40 receptor on activated T cells to block receptor b…

• A multi-country Phase 2b dose-finding AD study began in 2025 and is progressing under an amended protocol. The amendment enables optimized dosing of patients with a range of dose exposures. Topline data from the Phase 2b clinical trial is expected in the fourth quarter of 2027.

• We expect to initiate a Phase 2 study in AA by the end of 2026. The study objectives will be characterization of the benefit-risk of IMG-007 and dose selection for future pivotal studies. We expect to have initial data from the Phase 2 study in AA in 2028.

• In April 2026, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors (the “Investors”), pursuant to which we issued and sold pre-funded warrants to purchase up to 5,770,335 shares of voting common stock (the “Warrant Shares”) a…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• You should read the following discussion and analysis of our financial condition and results of operations together with the condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and the audited fi…

• We are a clinical-stage biopharmaceutical company developing therapeutics for patients with immunological, autoimmune and inflammatory diseases. Our lead asset IMG-007 is a non-depleting anti-OX40 monoclonal antibody which binds specifically to OX40 receptor on activated T cells to block their bindi…

• Autoimmune and inflammatory diseases have a large and growing unmet medical need affecting hundreds of millions of patients worldwide. The global immunology market is expected to grow from approximately $103 billion in 2024 to approximately $257 billion by 2032. Many of these diseases are chronic, h…

• IMG-007 targets the OX40 receptor and is initially being developed for the treatment of AD with the potential to grow into a “pipeline within a product” for the treatment of various immunological, autoimmune and inflammatory conditions. We believe IMG-007 has the potential to demonstrate a different…

• OX40 signaling is thought to be important in driving the pathogenesis of a wide spectrum of immunological, autoimmune and inflammatory diseases including dermatological, respiratory, gastrointestinal, and rheumatic diseases, and we intend to explore additional indications with IMG-007 including alop…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• 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. We did not de…

• However, this material weakness could result in a misstatement of substantially all of our accounts or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented or detected.

• To remediate the material weakness, we plan to design and implement control activities in response to the risks posed as a result of the lack of segregation of duties related to journal entries and account reconciliations, including general controls over information systems. The material weakness wi…

• There have been no changes in the Company's internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarterly period ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal contr…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• In connection with the preparation of Legacy Inmagene’s financial statements for the years ended December 31, 2024 and 2023, a material weakness was identified in its internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control o…

• Legacy Inmagene did not design and maintain effective controls related to the period-end financial reporting process to ensure adequate segregation of duties, including controls related to account reconciliations and journal entries. Specifically, certain personnel have incompatible duties including…

• However, this material weakness could result in a misstatement of substantially all of the Legacy Inmagene accounts or disclosures that would result in a material misstatement of our annual or interim financial statements that would not be prevented or detected.

• To remediate the material weakness, we plan to design and implement control activities in response to the risks posed as a result of the lack of segregation of duties related to journal entries and account reconciliations, including general controls over information systems. The material weakness wi…

• measures described above, the controls operate for a sufficient period of time and management has concluded, through testing, that the controls are effective. The measures we have taken to date, and are continuing to design and implement, may not be sufficient to remediate the material weakness we h…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Information with respect to legal proceedings is included in Note 9 - Commitments and Contingencies of the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report, which is incorporated herein by reference.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• From time to time, we may become involved in litigation or other legal proceedings.

• In connection with the proposed merger, two actions have been filed against the Company and its board of directors in the Supreme Court for the State of New York, County of New York, captioned Smith v. Ikena Oncology, Inc., et al., No. 653576/2025 (filed June 12, 2025) and Kent v. Ikena Oncology, In…

• The Company cannot predict the outcome of the Complaints or the Demands. The Company believes that the Complaints and the Demands are without merit, and the Company and the individual defendants intend to vigorously defend against the Complaints and the Demands and any subsequently filed similar act…

• Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and the significant risk that product candidates will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commer…

• outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between interim, topline or preliminary data and final data could significantly harm our business prospects.

• Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value, approvability or commercialization of IMG-007 or any future pr…

• delays or failure due to restrictions or other mandated requirements imposed by FDA or other regulatory bodies on the conduct of the clinical development program based on either internal or external data, such as emerging data with other molecules, either in development or approved, that target the …

• Manipulation of the immune system via therapeutic agents can result in a spectrum of immunosuppression depending on the target and the disease being treated. In general terms immunosuppression has been associated with increased risk of infection and, with long term immunosuppression, malignancies. T…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and the significant risk that product candidates will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commer…

• December 31, 2024, our net losses were $38.4 million and $36.6 million, respectively. As of September 30, 2025, we had an accumulated deficit of $223.1 million. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from gene…

• Further, others, including regulatory authorities, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value, approvability or commercialization of IMG-007 or any future pr…

• support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of IMG-007 or any future product candidates.

• There may be undesirable side effects and adverse events associated with IMG-007 or any future product candidates. Undesirable side effects or adverse events that may be caused by IMG-007 or any future product candidates could cause us or