Research, Consulting and Supply Agreements	9 Months Ended
Sep. 30, 2022
Research Consulting And Supply Agreements
Research, Consulting and Supply Agreements	Note 14: Research, Consulting and Supply Agreements In January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1 clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company has paid CHDR approximately $1,066,000. In April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement. For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $250,000. For the nine months ended September 30, 2022, the Company paid Polysciences $103,000. In April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that the study will cost approximately $8.2 million, which includes pass through costs of approximately $1.0 million and excludes certain third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete. On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $4.4 million, which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations. In December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance its capacity to produce Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity. For the period ended December 31, 2021, the Company has incurred an expense and paid Pii approximately $89,000. For the nine months ended September 30, 2022, the Company incurred an expense and paid Pii approximately $259,000.

Research, Consulting and Supply Agreements

9 Months Ended

Sep. 30, 2022

Research Consulting And Supply Agreements

Research, Consulting and Supply Agreements

Note 14: Research, Consulting and Supply Agreements

In January 2021, the Company entered into a Sponsor Agreement with the Centre for Human Drug Research (“CHDR”) for a Phase 1 clinical study to assess the safety, tolerability, and biological activity of Ampligen as a potential intranasal therapy. The Company has paid CHDR approximately $1,066,000.

In April 2021, the Company approved a proposal from Polysciences for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement. For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $250,000. For the nine months ended September 30, 2022, the Company paid Polysciences $103,000.

In April 2022, AIM executed a work order with Amarex Clinical Research LLC (“Amarex”), our contract research organization, pursuant to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that the study will cost approximately $8.2 million, which includes pass through costs of approximately $1.0 million and excludes certain third-party costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.

On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $4.4 million, which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations.

In December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance its capacity to produce Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings. The contracts augment our active and in-process fill and finish capacity. For the period ended December 31, 2021, the Company has incurred an expense and paid Pii approximately $89,000. For the nine months ended September 30, 2022, the Company incurred an expense and paid Pii approximately $259,000.