IMRX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• We are a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive. We are developing and seeking to commercialize an entirely new category of anti-cancer medicines, Deep Cyclic Inhibitors, which we believe have the potential to be more effective and bette…

• Deep Cyclic Inhibition® ("DCI") is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. Our Deep Cyclic Inhibitors inhibit clinically-validated core signal…

• Our lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve durability and tolerability across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. We are currently recruiting patients for a Phase …

• MAPKeeper 301 is designed as a global Phase 3 registrational trial that will evaluate atebimetinib (320 mg once-daily) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic PDAC. The primary endpoint of MAPKeeper 301 is overall survival, and secondary endpoints i…

• In January 2026, we announced positive interim response and safety data from our ongoing Phase 2a clinical trial arm evaluating atebimetinib in combination with mGnP in first-line pancreatic cancer patients, which is part of our ongoing Phase 1/2a clinical trial of atebimetinib in patients with adva…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• We are a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive. We aim to achieve this goal through Deep Cyclic Inhibitors ("DCIs") of clinically-validated core signaling pathways such as the mitogen-activated protein kinase ("MAPK") pathway, impacting canc…

• We are currently evaluating our lead product candidate, atebimetinib (also referred to as IMM-1-104), in a Phase 1/2a clinical trial in patients with advanced or metastatic solid tumors. Atebimetinib is being developed as a once-daily oral deep cyclic inhibitor of the MAPK signaling pathway, specifi…

• DCIs aim to achieve durability by outpacing cancer, pulsing faster than cancer can adapt so tumors shrink slowly but durably, while depriving tumor cells of the sustained proliferative signaling required for rapid growth, and sparing healthy cells through a cadenced, normalized level of signaling. T…

• In September 2022, the FDA cleared our IND application for atebimetinib and, in November 2022, we commenced dosing in our Phase 1/2a clinical trial of atebimetinib for the potential treatment of patients with advanced or metastatic solid tumors. The Phase 2a portion includes evaluating atebimetinib …

• In February 2025, we announced entry into a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo® (cemiplimab), which intends to support the evaluation of atebimetinib in combination with Libtayo in a planned clinical trial in patients with unresectable or meta…

相对上期新增的文字 · 来源:10-Q · 2026-05-15

• We have incurred net losses in each reporting period for the past several years, have not generated any revenue from product sales to date and have financed our operations principally through our historical computational biology services to pharmaceutical and biotechnology companies (which have sinc…

• Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA, EMA or compar…

• Patients in our clinical trials may in the future suffer significant drug-related adverse events or other side effects, including those not observed in our preclinical studies or previous clinical trials. Some of our product candidates may be used as chronic therapies or be used in pediatric populat…

• If significant drug-related adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development effort…

• Patient enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods. We may not be able to initiate or cont…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• We have incurred net losses in each reporting period for the past several years, have not generated any revenue from product sales to date and have financed our operations principally through our historical computational biology services to pharmaceutical and biotechnology companies (which have sinc…

• our convertible preferred stock, Class A common stock and warrants exercisable for common stock. We have incurred net losses of approximately $44.4 million and $61.0 million for the nine months ended September 30, 2025 and year ended December 31, 2024, respectively. As of September 30, 2025, we had …

• failure to become and remain profitable would depress our value and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.

• them, our development programs may be significantly delayed, and we may need to conduct additional studies or collect additional data independently. In either case, our development costs would increase, perhaps substantially.

• Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable …