Cyclerion Therapeutics, Inc. · NASDAQ:CYCN
Cyclerion Therapeutics — Investor Presentation (January 2026)
22 slides from Cyclerion Therapeutics's investor presentation, January 2026
Slide 1: Cyclerion: Pioneering a New Era in Neuropsychiatric Therapies
Cyclerion: Pioneering a New Era in Neuropsychiatric Therapies January 2026
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation has been prepared by Cyclerion Therapeutics, Inc. and its consolidated subsidiaries (“the Company,” “Cyclerion,” “we,” “us,” and “our”). Certain matters discussed in this presentation are “forward-looking statements.” We may, in some cases, use terms such as “poten
Slide 3: Cyclerion Therapeutics: A Pioneering Neuropsychiatric-focused Company
Cyclerion Therapeutics: A Pioneering Neuropsychiatric-focused Company ✓ A foundational platform for anesthetic-based therapeutic innovation in neuropsychiatry ✓ First asset, CYC-126, a potentially first-in-class, anesthetic-based, drug-device, closed- loop therapy for Treatment Resistant Depression
Slide 4: Cyclerion's Neuropsychiatric Expertise and Agility in Action
Cyclerion’s Neuropsychiatric Expertise and Agility in Action Key Management and Clinical Advisors Board of Directors Regina Graul, PhD; Chief Executive Officer • Experienced biopharma executive with significant clinical-stage expertise Errol De Souza, Steven Hyman, MD PhD, Chair Broad Institute of R
Slide 5: Building a Pipeline of Innovative Therapies Focused on Neuropsychiatric Disorders
Building a Pipeline of Innovative Therapies Focused on Neuropsychiatric Disorders Our Pipeline Foundational Product: CYC-126 for TRD Significant Recent Progress for CYC-126 • Potentially first-in-class, anesthetic-based, drug- ✓ Unmet need: a new treatment layer for the 3M TRD device, closed-loop th
Slide 6: CYC-126: Potential to be the First Individualized Treatment for TRD
CYC-126: Potential to be the First Individualized Treatment for TRD WHAT Generic IV1 anesthetics (propofol + dexmedetomidine) with extensive clinical safety experience, and a personalized delivery system operating as a co-pilot to anesthesiologist We believe sedation could recalibrate brain region c
Slide 7: CYC-126: A Potentially Novel Closed-Loop Treatment for TRD
CYC-126: A Potentially Novel Closed-Loop Treatment for TRD 1 Drugs: Propofol + Dexmedetomidine 4 2 Measure: Delivery: Infusion Pump Brain Activity via EEG1 • A potential closed-loop, EEG1-guided, tech- 3 enabled system Decisions: • Designed to personalize and reproducibly Controller & induce specifi
Slide 8: CYC-126: Key Components
CYC-126: Key Components Proprietary sedation- Computational Leverages previously control software and Control Module announced Medsteer TRD-specific protocol collaboration EEG Monitor Minimizes hardware & Leveraging FDA- regulatory risk while cleared components Infusion Pump staying capital efficien
Slide 9: Treatment-Resistant Depression is a Growing Crisis
Treatment-Resistant Depression is a Growing Crisis1 3 Million TRD Patients Of the 21 Million Major Depression Major clinical burden Massive cost burden $40B MDD Cost Burden Disorder (MDD) Patients in the U.S.… • 2-10x incidence of suicide Health care, unemployment, a year or suicide attempts & the p
Slide 10: The Pressing Need for Better Approved Treatment Options
The Pressing Need for Better Approved Treatment Options for the 3M+ U.S. Patients that Progress to TRD 3M TRD Patients that Progress through Therapy Cyclerion Product: Potentially Applicable to All TRD Patients Spravato1: 35K Patients in 2024 rTMS3: 44K Patients in 2023 ECT5: 100K Patients in 2024 1
Slide 11: Proven Mode of Action for Use of Sedation for TRD
Proven Mode of Action for Use of Sedation for TRD Brain regions communicate with each other via oscillatory brain waves: Patient with TRD CYC-126 Healthy Patients Oscillations Synchronized are not Specific states of oscillations synchronized general anesthesia could facilitate resynchronized communi
Slide 12: Clinical Precedent for Use of Propofol in TRD
Clinical Precedent for Use of Propofol in TRD Three early-phase clinical studies1 support propofol’s potential as a rapid-acting antidepressant in TRD Propofol showed consistent signals of Difficult to achieve and maintain specific EEG state efficacy with favorable safety profiles1 (BS or SWA) with
Slide 13: Expect to Initiate Multi-national POC Study in 2026
Expect to Initiate Multi-national POC Study in 2026 To confirm existing clinical precedent with CYC-126 Expected Phase 2 PART A: Safety and RCT1, Two Part, POC PART B: Safety & Efficacy Pharmacodynamics (PD) Study Design RCT, double-blind RCT, double-blind Design 3 arms: GA12, GA23, Sham 3 arms: GA1
Slide 14: Proof-of-Concept Study Design: Expect Initial POC Data in 27
Proof-of-Concept Study Design: Expect Initial POC Data in 2027 Expected Phase 2 RCT, Two Part, POC PART A: Safety and PD PART B: Safety & Efficacy Study Design Patient Population Key Criteria W1 W2 W3 M1 M2 W1 W2 W3 M1 M2 • 18-65 yrs Assessment Assessment Treatment Treatment • TRD; Failed 2+ ADM/D1
Slide 15: Potential Efficiency of Workflow for Patients, Providers, and Facilities
Potential Efficiency of Workflow for Patients, Providers, and Facilities Opportunity for physicians and centers to provide effective & safe care, at scale, to people living with TRD Hospital Check-in Undergo treatment in Referral Recovery in PACU Completed Consultation PACU/Procedure room Anesthesio
Slide 16: Potential to be the Preferred Option for Patients, Providers, and Hospitals
Potential to be the Preferred Option for Patients, Providers, and Hospitals Patient Preference Provider Preference Hospital Preference Potential for a safe, Potential for lower Potential reimbursement efficacious, and well- provider burden to for procedure, device, tolerated treatment administer tre
Slide 17: Expected Milestones and Capital Requirements
Expected Milestones and Capital Requirements 2025 2026 2027 2028 ✓ Pre-IND meeting • FDA pre-IND • Phase 2 Part A • Full Phase 2 proof- package prepared feedback (Q1) Safety and PD of-concept data data ✓ Finalized details of • CTN filing following • Preparing for end POC Study Design HREC approval o
Slide 18: Cyclerion Therapeutics: A Pioneering Neuropsychiatric-focused Company
Cyclerion Therapeutics: A Pioneering Neuropsychiatric-focused Company ✓ A foundational platform for anesthetic-based therapeutic innovation in neuropsychiatry ✓ First asset, CYC-126, a potentially first-in-class, anesthetic-based, drug-device, closed- loop therapy for Treatment Resistant Depression
Slide 19: Appendix
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Slide 20: Recent collaborations enable faster, lower-risk development of closed-loop system
We believe recent collaborations enable faster, lower-risk development of our closed-loop system with common anesthetics Has significant expertise in closed-loop anesthesia delivery • Using EEG signal inputs & proprietary algorithms to administer a precise rate of drug to achieve a specific sedation
Slide 21: Regulatory strategy: Multinational path to Phase 2 POC
Regulatory strategy: Multinational path to Phase 2 POC Single Australia (AUS) and United States (US) study for Cyclerion drug-device combination product AUS TGA1: enables early FPI2 • TGA CTN3 anticipated, ethics (HREC4) lead review • Enable FPI with commercially sourced drugs • Expect submission an
Slide 22: Compelling Clinical Data for use of propofol for TRD
Compelling Clinical Data for use of propofol for TRD Propofol dosing and enhancement of slow wave sleep predict antidepressant response in geriatric patients with treatment-resistant depression [Poster presentation]. Palanca, B. J. A., Ching, S., Farber, N. B., Lin, N., Lucey, B. P., Reynolds, C. F.
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