AEMD 最新10-K变化

相对上期新增的文字 · 来源:10-K · 2026-06-10

• We are a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage investigational immunotherapeutic device designed to address unmet needs in oncology, life-threatening infectious diseases, organ transplantation and other disease states in which extracellular vesicl…

• In pre-clinical studies, the Hemopurifier has also demonstrated the ability to bind disease-associated extracellular vesicles (“EVs”) and a panel of enveloped viruses. The Hemopurifier has been evaluated in human studies, involving 173 treatment sessions in 44 patients with either viral infections o…

• · the treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and

• · the treatment of life-threatening viruses not addressed with approved therapies.

• We are currently advancing clinical development activities for the Hemopurifier in oncology. We are also evaluating the Hemopurifier’s potential in additional applications based on its mechanism of action and preclinical studies.

相对上期删除的文字 · 来源:10-K · 2025-06-26

• We are a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer, life-threatening viral infections, and organ transplantation and other areas of significant unmet needs. In human studies (164 sessions wi…

• · the treatment of individuals with advanced or metastatic cancer who are unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease; and

• the treatment of life-threatening viruses for which no approved therapies currently exist.

• We are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.

• We believe that the Hemopurifier may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful remove harmful extracellular vesicles particles that promote the growth and spread of tumors. In October 2022, we formed…

相对上期新增的文字 · 来源:10-K · 2026-06-10

• We expect to seek additional capital through equity financings and other potential sources of funding; however, there can be no assurance that such financing will be available on acceptable terms, in sufficient amounts, or at all.

• There is substantial doubt about our ability to continue as a going concern.

• · are more adaptable and easier to integrate into existing standards of care;

• Our success depends in part on our ability to obtain, maintain, protect and enforce intellectual property protection for our proprietary technologies and products.

• We rely on a combination of patent, trade secret, copyright and trademark laws, as well as confidentiality agreements, licensing agreements and other agreements, to establish and protect our proprietary rights. Our success also depends, in part, on our ability to avoid infringing patents issued to o…

相对上期删除的文字 · 来源:10-K · 2025-06-26

• We do plan to access the equity markets for additional capital, however, there can be no assurance that we will be able to access such additional capital.

• We may not currently or in the future be able to continue as a going concern.

• As disclosed in Item 9A in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024, management identified a material weakness in the segregation of duties within our financial systems. Specifically, user access controls were not sufficiently maintained to properly restrict both user …

• Since that time, we have implemented several remediation measures, including enhanced user access controls, segregation of duties, relocation of check stock to a secure, access-controlled area, and the implementation of a quarterly review process for all significant accruals. Management has also con…

• As of March 31, 2025, management has concluded that the previously identified material weakness has been remediated. While we are committed to maintaining a robust control environment, there can be no assurance that future material weaknesses will not be identified.

相对上期新增的文字 · 来源:10-K · 2026-06-10

• We are a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device designed to address unmet needs in oncology, life-threatening infectious diseases, organ transplantation and other disease states in which extracellular vesicles (EVs) contrib…

• We believe the Hemopurifier may be a potential treatment for patients with advanced and metastatic cancer through its ability to bind to and remove extracellular vesicles (“EVs”) particles that may promote tumor growth and metastasis. In October 2022, we formed a wholly-owned subsidiary in Australia…

• We previously completed an in vitro binding study of utilizing cancer patient samples, to evaluate the Hemopurifier’s ability to remove EVs from plasma. Results from this translational study provided pre-clinical evidence supporting the design of our oncology clinical trial involving patients with s…

• We are currently conducting a safety, feasibility and dose-finding clinical trial in Australia evaluating the Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment. The trial is designed to enroll approximately 9 to 18 participants. …

• Three clinical sites in Australia— Royal Adelaide Hospital in Adelaide, and Pindara Private Hospital on the Gold Coast and GenesisCare North Shore Hospital in Sydney— are currently open for patient enrollment. During fiscal year 2026, we completed enrollment and treatment of the first cohort of thre…

相对上期删除的文字 · 来源:10-K · 2025-06-26

• We are a medical therapeutic company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer, life-threatening viral infections, and organ transplantation and other areas of significant unmet needs. In human studies (164 sessions wi…

• We are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical findings.

• We believe that the Hemopurifier may be a substantial advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful remove harmful extracellular vesicles particles that promote the growth and spread of tumors. In October 2022, we formed…

• We completed an in vitro binding study of extracellular vesicles from cancer patient samples, to provide pre-clinical evidence to support our trial design and translational endpoints. Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular…

• We have launched in an Australia safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary endpoint…