Research, Consulting and Supply Agreements |
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| Research, Consulting and Supply Agreements | Note 10: Research, Consulting and Supply Agreements
The Company has entered into research, consulting and supply agreements with third party service providers to perform research and development activities on therapeutics, including clinical trials. The identification of research and development costs involves reviewing open contracts and purchase orders, communicating with applicable company and third-party personnel to identify services that have been performed, and corroborating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual expenses. The Company expenses these research and development costs when incurred.
The Company’s research and development expenses were comprised of the following:
The following summarizes the most substantial of our contracts relating to research, consulting, and supply costs for AIM as they related to research and development costs for the three months and six months ended June 30, 2026.
Amarex Clinical Research LLC
Amarex is the principal administrator of several of AIM’s largest clinical studies. AIM has multiple contracts with Amarex Clinical Research LLC (“Amarex”). During the six months ended June 30, 2026 and 2025, the Company incurred $118 thousand and $200 thousand, respectively, related to these ongoing agreements:
Costs incurred pursuant to the Amarex agreements were as follows (thousands):
Sterling Pharma Solutions
In 2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.
Subsequently, on July 31, 2026, the Company entered into a proposal (the “Sterling Proposal Agreement”) with Sterling Pharma Solutions (“Sterling”) that is related to the Master Service Agreement and a Quality Agreement entered into between the Company and Sterling in 2022. Pursuant to the Sterling Proposal Agreement, Sterling agreed to manufacture further batches of the polynucleotide drug substances PolyI and Poly C12U and transfer of associated test methods at Sterling’s Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen. The estimated cost to the Company under the Sterling Proposal Agreement is approximately $1.5 million to be paid over a period of 12 months, as set forth in more detail in the Sterling Proposal Agreement. The Company anticipates using the manufactured product for ongoing and future clinical trials, including potentially a Phase 3 clinical trial for metastatic pancreatic cancer.
Costs incurred pursuant to the Sterling Pharma agreements were as follows (thousands):
Azenova Sales International
In October 2023, the Company entered into a consulting agreement with Azenova, LLC where Azenova will provide business development services for AIM’s Ampligen product for solid tumors for a 12-month term that is extendable upon the agreement of the parties. In exchange for its services, Azenova received a monthly retainer of $30,000 in addition to stock options that vest monthly. The monthly retainer was reduced to $10,000 in August 2024 and subsequently amended to payments based on hourly billing only. The agreement will end on April 30, 2028, but may be extended upon written agreement of the parties.
Costs incurred pursuant to the Azenova agreements were as follows (thousands):
Alcami
In September 2023, the Company entered into an agreement with Alcami Corporation to perform an extractables study for a primary packaging component. The agreement called for fixed costs of $30 thousand upon completion of the study and issue of the final report, along with solvent costs, and pass through items to be billed on a per activity basis. The study is now finalized.
Costs incurred pursuant to the Alcami agreements were as follows (thousands):
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