KYTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• our ability to efficiently and cost-effectively conduct our current and future clinical trials;

• time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report on Form 10-Q. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be …

• We are currently focused on advancing our neuroimmunology CAR T franchise, which includes evaluating miv-cel in stiff person syndrome, or SPS, and generalized myasthenia gravis, or gMG, both serious and highly debilitating autoimmune diseases with significant unmet medical need.

• SPS is a rare and progressive neurologic autoimmune disease with no FDA-approved therapies. Patients with SPS have substantial disease burden, with symptoms characterized by muscle stiffness and painful muscle spasms, impacting mobility. 80% of patients lose mobility over time, and need walking aid …

• Myasthenia gravis, or MG, is a B-cell and antibody-mediated neuromuscular autoimmune disease that causes fluctuating muscle weakness and fatigue. The disease includes gMG, which impacts muscles beyond the eyes and may involve bulbar, limb, and respiratory muscles. Most patients develop gMG within tw…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• Our focused clinical development pipeline includes registrational trials for stiff person syndrome, or SPS, and generalized myasthenia gravis, or MG, and two multi-center Phase 1/2 trials for patients with lupus nephritis, or LN. We are also harnessing investigator-initiated trials, or IITs, and oth…

• Our current focus is to advance our first-in-class neuroimmunology CAR T franchise with SPS and MG. We have aligned with the U.S. Food and Drug Administration, or the FDA, on our KYSA-8 registrational Phase 2 trial design in SPS. We completed patient enrollment for the Phase 2 trial in SPS during th…

• The KYSA-6 Phase 2 trial in MG was amended into a registrational Phase 2/3 trial following an end-of-Phase 2 meeting with the FDA in early 2025. In October 2025, we presented positive interim data from the Phase 2 portion of the registrational KYSA-6 clinical trial of KYV-101 in MG at the American A…

• For our KYSA-1 and KYSA-3 Phase 1 trials for LN, patient enrollment has concluded and we expect to share data from these trials in a peer-reviewed publication in 2026.

• We also continue to expect to file an investigational new drug, or IND, application for KYV-102 in the fourth quarter of 2025.

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• Based on their evaluation, the CEO and the CFO have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2026.

• During the year ended December 31, 2025, our management, with the oversight of the audit committee of our board of directors, designed and implemented measures to remediate the control deficiencies that previously contributed to the material weaknesses and completed testing of the design and operati…

• We have hired additional accounting and IT personnel, including but not limited to the hiring of a Vice President of Accounting/Corporate Controller and a Head of Information Technology;

• We have completed our annual risk assessment and risk assessment based on the principles of the Committee of Sponsoring Organizations of the Treadway Commissions, or COSO;

• Through testing of our internal controls, management has determined that the controls related to the remediation actions discussed above were effectively designed and operated effectively for a sufficient period of time to enable us to conclude that the material weaknesses had been remediated as of …

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• Based on their evaluation, the CEO and the CFO have concluded that our disclosure controls and procedures were not effective as of September 30, 2025, because of the material weaknesses in our internal control over financial reporting described below, which we continued remediating as of September 3…

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

• In connection with our audit of the financial statements for the year ended December 31, 2024, we identified material weaknesses in the design and operating effectiveness of our internal control over financial reporting related to the fact that we did not appropriately design and maintain entity-lev…

• oversight and accountability over the performance of controls, including retention of control evidence, (ii) ineffective identification and assessment of risks impacting internal control over financial reporting, and (iii) insufficient evaluation and determination as to whether the components of int…

• These material weaknesses contributed to the following additional material weakness: we did not design and maintain effective (i) general controls over information systems that support the financial reporting process, (ii) controls over the completeness and accuracy of information used in the operat…

相对上期新增的文字 · 来源:10-Q · 2026-05-12

• During the year ended December 31, 2025, our management, with the oversight of the audit committee of our board of directors, designed and implemented measures to remediate the control deficiencies contributing to the material weaknesses and completed testing of the design and operating effectivenes…

• However, we may discover new weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control sy…

• If, in the future, we identify material weaknesses in our internal controls over financial reporting or fail to meet the demands that are placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act, we may be unable to accurately report our financial results or report th…

• In the event of a default in connection with our bankruptcy, insolvency, liquidation, or reorganization, Oxford Finance would have a prior right to substantially all of our assets to the exclusion of our general unsecured creditors. Only after satisfying the claims of Oxford Finance and any unsecure…

• The pledge of these assets and other restrictions imposed in the Loan and Security Agreement may limit our flexibility in raising capital for other purposes. Because substantially all of our assets are pledged to secure the Loan and Security Agreement obligations, our ability to incur additional ind…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• We have identified material weaknesses in our internal control over financial reporting. If we fail to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future…

• These material weaknesses 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.

• During the year ended December 31, 2024, and as of September 30, 2025, our management, with the oversight of the Audit Committee of our board of directors, took substantial measures toward remediating the control deficiencies contributing to the material weaknesses described in detail in our Annual …

• However, we have determined that the controls implemented have not operated for a sufficient period of time to fully conclude that the material weaknesses have been remediated as of September 30, 2025. Our management is committed to continuing to make efforts to address each of the identified materi…

• We may discover additional weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control syst…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• Aggregate Number of Shares of Common Stock to be Sold Pursuant to Trading Arrangement

• Up to 67,997 shares, plus 100% of net shares issued upon vesting of restricted stock units with respect to 20,000 shares on April 11, 2026, after giving effect to shares surrendered or sold to cover withholding taxes

• May 1, 2026, or such earlier date upon which all transactions are completed or expire without execution

• April 1, 2026, or such earlier date upon which all transactions are completed or expire without execution