ADDED
As of March 26, 2026, there were 4,330,314 shares of common stock outstanding.
regulatory requirements, including any post-approval development and regulatory requirements, or our potential future product candidates are unable to comply with such requirements, our operating results may suffer; we, Tisento and our current licensee and potentially any future licensees may be unable to obtain reimbursement from the U.S.
Business Overview and Strategy We focus on building a pipeline of innovative therapeutics to address serious neuropsychiatric disorders with significant unmet medical need.
Our current strategic focus is centered on the development of a novel therapeutic approach for neuropsychiatric conditions, with the lead indication being treatment-resistant depression ( TRD ), which we believe represents a substantial clinical and commercial opportunity.
Primary Focus on New Potential Treatment for Treatment Resistant Depression ( TRD ) Over the past year, we have refined our strategic direction toward programs that combine established pharmacologic agents with enabling technologies designed to improve precision, reproducibility, and patient outcomes.
As part of this strategy, Cyclerion has evaluated multiple opportunities and prioritized CYC-126, an individualized therapy for TRD as our foundational development program.
In September 2025, we entered into a license agreement with the Massachusetts Institute of Technology ( MIT ) for intellectual property supporting this program (the MIT License Agreement ).
Under the terms of the MIT License Agreement, MIT will be eligible to receive up to $4.4 million upon the achievement of certain development, regulatory and sales milestone payments.
MIT will also receive tiered royalties in a range of percentages in the low single digits based on future net sales of licensed products as set forth in the MIT License Agreement.
Further, we are required to pay MIT varying percentages of income received as consideration for any sublicenses granted.
REMOVED
As of February 28, 2025, there were 2,710,096 shares of common stock outstanding.
will be achieved; 3 we are seeking to out-license our olinciguat technology to a third party which holds an option to negotiate a license to this technology and if the third party elects not to exercise the option or if we are unable to reach agreement on license terms, we may not reach agreement on the terms of a license arrangement; our product candidates and those we have sold or out-licensed have not been approved for sale by regulatory agencies and may not prove to meet safety and efficacy requirements and if we are unable to comply with U.S.
regulatory requirements, including any post-approval development and regulatory requirements, or our potential future product candidates are unable to comply with such requirements, our operating results may suffer; we may be unable to obtain reimbursement from the U.S.
Business Overview and Strategy Our strategy for Cyclerion is to build a new pipeline with therapeutics to treat certain neuropsychiatric diseases.
Over the past year, Cyclerion s diligence team which is composed of committed external experts and internal personnel in their respective fields, have been conducting asset evaluations in many therapeutic areas.
Throughout this process, the team identified and assessed dozens of products and other opportunities directed at addressing patient s needs and increasing shareholder value.
The team prioritized an individualized therapy for treatment resistant depression ( TRD ) as our foundational product candidate and we have entered into a non-binding option to license agreement for the intellectual property associated with this product.
With the large unmet medical need in TRD, the clinical development stage of this asset, and the strong commercial opportunity, we believe that this product is well suited to be the foundation moving forward for Cyclerion.
The program team is currently developing an integrated development and commercial strategy in TRD.
In addition to significantly reducing operating expenses and the potential to obtain revenues from our legacy soluble guanylate cyclase (sGC) stimulator clinical assets, we intend to raise funds to support the execution of the product plans in TRD.