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Note 5 - Significant Agreements and Contracts | 9 Months Ended
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Sep. 30, 2025
Notes to Financial Statements |
Collaborative Arrangement Disclosure [Text Block] | 5. Significant Agreements and Contracts Vertex Option and License Agreement In August 2012, the Company entered the Vertex Agreement to acquire an exclusive license to develop and commercialize a drug candidate, “VX-745,” from Vertex. In August 2014, the Company exercised its option to acquire the license and paid an option fee of $100,000, which was expensed as incurred as a component of research and development expense. The Vertex Agreement granted the Company the exclusive worldwide use of VX-745 in the field of diagnosis, treatment and prevention of AD and related central nervous system disorders in humans. As part of the Vertex Agreement, the Company is obligated to make certain payments totaling up to approximately $117.0 million upon achievement of certain regulatory and sales milestones, and royalties on net sales of products on indications covered by the Vertex Agreement. The first expected milestone events concern filing of an NDA with the FDA for marketing approval of neflamapimod in the U.S., or a similar filing for a non-U.S. major market, as specified in the Vertex Agreement, and such royalties will be on a sliding scale of percentages of net sales in the low- to mid-teens, depending on the amount of net sales in the applicable years. The Company is also obligated to make a milestone payment to Vertex upon net sales reaching a certain specified amount in any 12-month period. The Vertex Agreement states that royalties will be reduced by 50% during any portion of the royalty term when there is no valid claim of an issued patent within specified patent rights covering the licensed product. The Company also has the right to deduct, on a country by country basis, from royalties otherwise payable to Vertex under the terms of the Vertex Agreement, 50% of all royalties, upfront fees, milestones and other payments paid by the Company or any of the Company’s affiliates or sublicensees to third parties under licenses that are necessary for the development, manufacture, sale or use of a licensed product, provided that in no event will the royalty payable to Vertex be reduced to less than 50% of the rates specified in the Vertex Agreement, subject to certain adjustments specified therein. The Company has made a total of $100,000 in payments to Vertex related to the Vertex Agreement. No payments were made during the three and nine months ended September 30, 2025 and 2024. National Institute of Aging Grant In January 2023, the Company was awarded a $21.0 million grant from the NIA to support its RewinD-LB Trial, a Phase 2b study of neflamapimod in patients with DLB and, in August 2024, the Company was awarded an additional $0.3 million under the grant. The grant monies are expected to be received over a period of three years including $6.7 million in 2023, $8.4 million in 2024 and $6.2 million in 2025. The total revenue recognized from the NIA Grant was $4.0 million and $7.6 million for the nine months ended September 30, 2025 and 2024, respectively. The total revenue recognized from the NIA Grant was $0.3 million and $1.9 million for the three months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, aggregate total cash funding of $19.5 million has been received from the NIA Grant, resulting in approximately $1.6 million in funding remaining (or $1.8 million if the final 2% of current year funding described below is received). The Company has recorded $1.4 million as a receivable in the unaudited interim condensed consolidated balance sheet at September 30, 2025, for allowable expenses incurred prior to September 30, 2025, which is expected to be received subsequent to September 30, 2025. As of December 31, 2024, $2.3 million was recorded as a receivable in the consolidated balance sheet, for allowable expenses incurred during the year ended December 31, 2024. The Company received access to the current year 3 funding in the amount of $5.6 million in March 2025. In June 2025, the Company received access to an additional $0.5 million. The total $6.1 million access received in 2025 was 98% of the full year 3 amount provided for in the NIA Grant due to current NIA policy as a result of the U.S. government currently being funded on the basis of a continuing resolution. The timing of the Company’s receipt of the remaining 2% of the grant of current year funding, if any, is dependent upon and subject to U.S. congressional approval of a final appropriations bill, which remains subject to ongoing uncertainty. Accordingly, as of September 30, 2025, the Company determined that the receipt of the remaining 2% of funding is not probable and will not account for the remaining 2% of funding unless and until received.

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