UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38787 Massachusetts (State or other jurisdiction of incorporation or organization) 245 First Street, 18 Floor, Cambridge, Ma ...

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential opportunities for traders [1] Premarket Gainers - PepGen Inc. (PEPG) is up 151% at $6.68 [3] - 22nd Century Group, Inc. (XXII) is up 27% at $1.93 [3] - Immuneering Corporation (IMRX) is up 23% at $11.36 [3] - uniQure N.V. (QURE) is up 10% at $52.58 [3] - Lithium Americas Corp. (LAC) is up 9% at $6.60 [3] - Jasper Therapeutics, Inc. (JSPR) is up 9% at $2.55 [3] - American Shared Hospital Services (AMS) is up 8% at $2.75 [3] - PSQ Holdings, Inc. (PSQH) is up 7% at $3.06 [3] - K Wave Media Ltd. (KWM) is up 7% at $2.48 [3] - ClearPoint Neuro, Inc. (CLPT) is up 5% at $20.48 [3] Premarket Losers - Transocean Ltd. (RIG) is down 14% at $3.11 [4] - Cyclerion Therapeutics, Inc. (CYCN) is down 12% at $2.83 [4] - CarMax, Inc. (KMX) is down 11% at $50.38 [4] - ARB IOT Group Limited (ARBB) is down 11% at $10.45 [4] - SHF Holdings, Inc. (SHFS) is down 10% at $6.49 [4] - Digital Brands Group, Inc. (DBGI) is down 10% at $6.21 [4] - Aqua Metals, Inc. (AQMS) is down 9% at $5.29 [4] - Akanda Corp. (AKAN) is down 8% at $3.96 [4] - Galecto, Inc. (GLTO) is down 8% at $3.88 [4] - Platinum Analytics Cayman Limited (PLTS) is down 7% at $11.12 [4]

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PresentationRegina GraulCEO, President & Director Good morning, everyone. Yesterday, we announced Cyclerion's transformational relaunch as a neuropsychiatric company, supported by an MIT licensing agreement that secures foundational intellectual property. A copy of this release and presentation to accompany this call are available on the Investor Relations section of our website at ir.cyclerion.com. I am Regina Graul, Chief Executive Officer of Cyclerion Therapeutics. Thank you for joining us for the Cycler ...

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SHF Holdings, Inc. (SHFS) increased by 150% to $8.17 - Lithium Americas Corp. (LAC) rose by 69% to $5.18 - Aqua Metals, Inc. (AQMS) gained 50% reaching $6.11 - CleanCore Solutions, Inc. (ZONE) up by 44% at $2.87 - Cyclerion Therapeutics, Inc. (CYCN) increased by 33% to $4.03 - Twin Vee Powercats Co. (VEEE) rose by 17% to $2.92 - Solidion Technology, Inc. (STI) up by 11% at $5.09 - China Pharma Holdings, Inc. (CPHI) increased by 11% to $2.18 - Stardust Power Inc. (SDST) rose by 10% to $3.04 - Aligos Therapeutics, Inc. (ALGS) increased by 7% to $11.03 [3] Premarket Losers - Aytu BioPharma, Inc. (AYTU) decreased by 15% to $2.11 - Professional Diversity Network, Inc. (IPDN) down by 13% to $4.10 - STRATA Skin Sciences, Inc. (SSKN) fell by 10% to $2.31 - Cohu, Inc. (COHU) decreased by 9% to $20.68 - Super League Enterprise, Inc. (SLE) down by 9% to $7.74 - CTW Cayman (CTW) fell by 9% to $2.29 - Fitell Corporation (FTEL) decreased by 8% to $7.70 - Soluna Holdings, Inc. (SLNH) down by 8% to $2.16 - StableX Technologies, Inc. (SBLX) decreased by 5% to $5.22 - Indaptus Therapeutics, Inc. (INDP) down by 5% to $2.95 [4]

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

– Cyclerion Relaunches, Advancing a Phase 2–Ready Program for Millions Living with Treatment-Resistant Depression Through MIT License Agreement – – Webcast to be held September 24, 2025 at 10:30 a.m. ET – CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. today announced that it has entered into a licensing agreement with the Massachusetts Institute of Technology (“MIT”), securing the intellectual property that will serve as the cornerstone of its strategic relaunch. This agre ...

[Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns that forward-looking statements are subject to significant risks and uncertainties, potentially causing actual results to differ materially from projections - Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, potentially causing actual results to differ materially from expectations[10](index=10&type=chunk) - Substantial doubt exists regarding the company's ability to continue as a going concern, necessitating near-term capital raising to maintain operations[10](index=10&type=chunk) - Key risks include challenges in acquiring and developing new product candidates, obtaining regulatory approvals, maintaining Nasdaq listing, and uncertainties regarding the investment in Tisento Therapeutics Inc[10](index=10&type=chunk) [PART I — Financial Information](index=5&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section provides the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, and cash flows, with detailed notes [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------- | :------------ | :---------------- | :--------- | :--------- | | Total Assets | $9,370 | $9,575 | $(205) | (2.14)% | | Total Current Assets | $4,020 | $4,225 | $(205) | (4.85)% | | Cash and cash equivalents | $3,006 | $3,232 | $(226) | (6.99)% | | Total Current Liabilities | $800 | $725 | $75 | 10.34% | | Total Stockholders' Equity | $8,570 | $8,850 | $(280) | (3.16)% | | Accumulated Deficit | $(269,245) | $(267,492) | $(1,753) | 0.66% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss over specific reporting periods, including comprehensive loss Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Total Revenues | $93 | $0 | $93 | 100% | $174 | $0 | $174 | 100% | | Total Cost and Expenses | $1,765 | $1,384 | $381 | 27.53% | $3,303 | $3,002 | $301 | 10.03% | | Loss from Operations | $(1,672) | $(1,384) | $(288) | 20.81% | $(3,129) | $(3,002) | $(127) | 4.23% | | Total Other Income, Net | $1,348 | $62 | $1,286 | 2074.19% | $1,376 | $138 | $1,238 | 897.10% | | Net Loss | $(324) | $(1,322) | $998 | (75.49)% | $(1,753) | $(2,864) | $1,111 | (38.79)% | | Basic and Diluted Net Loss per Share | $(0.11) | $(0.53) | $0.42 | (79.25)% | $(0.62) | $(1.14) | $0.52 | (45.61)% | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, reflecting net loss, stock issuances, and share-based compensation over time - Total stockholders' equity decreased from **$8,850 thousand** at December 31, 2024, to **$8,570 thousand** at June 30, 2025, primarily due to a net loss of **$1,753 thousand**, partially offset by **$1,245 thousand** from a private placement of common stock and **$228 thousand** in share-based compensation[20](index=20&type=chunk) - The company issued **499,998 shares** of common stock through a private placement, contributing **$1,245 thousand** to paid-in capital during the six months ended June 30, 2025[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(1,471) | $(2,977) | $1,506 | (50.59)% | | Net cash provided by investing activities | $0 | $0 | $0 | 0% | | Net cash provided by financing activities | $1,245 | $0 | $1,245 | 100% | | Net decrease in cash and cash equivalents | $(226) | $(2,983) | $2,757 | (92.49)% | | Cash and cash equivalents, end of period | $3,006 | $4,588 | $(1,582) | (34.48)% | [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [Note 1. Nature of Business](index=9&type=section&id=1.%20Nature%20of%20Business) This note describes Cyclerion's strategic shift to neuropsychiatric diseases, its foundational TRD product candidate, and financial outlook - Cyclerion is focused on building a new pipeline with therapeutics to treat certain neuropsychiatric diseases, prioritizing an individualized therapy for treatment resistant depression (TRD) as its foundational product candidate[26](index=26&type=chunk)[83](index=83&type=chunk) - The company has discontinued its prior strategy of internal research and development on sGC stimulators, instead leveraging legacy sGC assets (Praliciguat, Olinciguat, Zagociguat/CY3018) to generate revenue[27](index=27&type=chunk) - In March 2025, the company completed a private placement of **499,998 common shares** for approximately **$1.375 million** gross proceeds[34](index=34&type=chunk) - The company expects its cash and cash equivalents to fund operations into **Q1 2026** but requires additional funding due to anticipated operating losses, raising substantial doubt about its ability to continue as a going concern[44](index=44&type=chunk)[127](index=127&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and policies applied in preparing the condensed consolidated financial statements - The company's accounting policies are consistent with those outlined in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024[46](index=46&type=chunk) - No new accounting pronouncements adopted during the six months ended June 30, 2025, had a material impact on the condensed consolidated financial statements[47](index=47&type=chunk) [Note 3. Fair Value of Financial Instruments](index=12&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) This note details the fair value measurements of financial instruments, primarily cash equivalents, and other short-term assets and liabilities Fair Value Measurements of Cash Equivalents (in thousands) | Cash Equivalents | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Money market funds (Level 1) | $2,856 | $3,025 | - The carrying amounts of accounts receivable, prepaid expenses, other current assets, accounts payable, and accrued expenses approximate their fair value due to their short-term nature[50](index=50&type=chunk) [Note 4. Other Investment](index=12&type=section&id=4.%20Other%20Investment) This note describes the company's investment in Tisento Parent, accounted for at cost less impairment, and its non-consolidation rationale - The company's investment in Tisento Parent is an equity security accounted for at cost less impairment, as it does not provide controlling financial interest or significant influence[53](index=53&type=chunk) - Despite Tisento Parent being identified as a Variable Interest Entity (VIE), Cyclerion does not consolidate it because it does not unilaterally control the activities that most significantly impact Tisento Parent's economic performance[52](index=52&type=chunk) [Note 5. Property and Equipment](index=13&type=section&id=5.%20Property%20and%20Equipment) This note provides details on the company's property and equipment, including gross amounts and accumulated depreciation Property and Equipment, Net (in thousands) | Property and Equipment | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Software, gross | $126 | $126 | | Less: accumulated depreciation | $(126) | $(126) | | Property and equipment, net | $0 | $0 | [Note 6. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=6.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the composition of accrued expenses and other current liabilities, including professional fees and other obligations Accrued Expenses and Other Current Liabilities (in thousands) | Accrued Expenses | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Professional fees | $206 | $220 | | Other | $60 | $63 | | Total | $266 | $283 | [Note 7. Commitments and Contingencies](index=13&type=section&id=7.%20Commitments%20and%20Contingencies) This note outlines the company's contractual commitments, indemnification obligations, and insurance recoveries related to material losses - The company enters into cancellable contracts for clinical and preclinical research, generally without significant cancellation penalties[56](index=56&type=chunk) - Indemnification obligations for officers, directors, and business partners are in the ordinary course of business, with no material costs incurred to date, resulting in minimal estimated fair value of these obligations[58](index=58&type=chunk) - The company recorded **$1.3 million** in insurance recoveries related to the loss of advanced intermediated GMP finished materials during the three and six months ended June 30, 2025[61](index=61&type=chunk) [Note 8. Share-based Compensation Plans](index=14&type=section&id=8.%20Share-based%20Compensation%20Plans) This note describes the company's share-based compensation plans and the associated expense recognized for stock options and restricted stock - Cyclerion's share-based compensation plans include the 2019 Employee Stock Purchase Plan, the 2019 Equity Incentive Plan (for stock options, RSAs, RSUs), and mirrored plans from Ironwood Pharmaceuticals[62](index=62&type=chunk)[63](index=63&type=chunk) Share-based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $12 | $24 | $24 | $50 | | General and administrative | $102 | $160 | $204 | $315 | | Total | $114 | $184 | $228 | $365 | - As of June 30, 2025, unrecognized share-based compensation expense for unvested stock options is **$0.2 million** (expected recognition over **3.45 years**) and for unvested RSAs is **$0.3 million** (expected recognition over **2.18 years**)[66](index=66&type=chunk)[70](index=70&type=chunk) [Note 9. Loss per share](index=16&type=section&id=9.%20Loss%20per%20share) This note presents the calculation of basic and diluted net loss per share, including the impact of anti-dilutive securities Net Loss Per Share (in thousands, except per share) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(324) | $(1,322) | $(1,753) | $(2,864) | | Weighted average shares outstanding | 3,071 | 2,510 | 2,842 | 2,502 | | Net loss per share (basic and diluted) | $(0.11) | $(0.53) | $(0.62) | $(1.14) | - Potential shares from Preferred Stock, stock options, and RSAs (totaling **799,800** at June 30, 2025) were excluded from diluted EPS calculations due to their anti-dilutive effect[71](index=71&type=chunk) [Note 10. Option/License Agreement](index=16&type=section&id=10.%20Option/License%20Agreement) This note details the company's option and license agreements for olinciguat and praliciguat, including fees and potential milestone payments - The Option to License Agreement for olinciguat was extended in May 2025 for an additional three months with a **$55,000** extension fee, leading to recognized revenue of **$93,000** and **$174,000** for the three and six months ended June 30, 2025, respectively[74](index=74&type=chunk) - Under the amended Akebia License Agreement for praliciguat, Cyclerion received **$1.25 million** in December 2024, is due **$0.5 million** by September 2025, and is eligible for up to **$558.5 million** in future development, regulatory, and commercialization milestone payments, plus tiered sales-based royalties (mid-single-digits to twenty percent)[77](index=77&type=chunk) - Akebia has assumed control and expenses for certain praliciguat patents earlier than originally agreed[77](index=77&type=chunk) [Note 11. Subsequent Events](index=17&type=section&id=11.%20Subsequent%20Events) This note discloses significant events occurring after the reporting period, such as common stock sales through an ATM program - Subsequent to June 30, 2025, the company sold **129,246 common shares** through its At-the-Market (ATM) program, generating approximately **$0.4 million** in net proceeds by August 4, 2025[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance and condition, discussing its strategic shift to neuropsychiatric diseases, particularly TRD, and efforts to leverage legacy sGC assets for revenue. It analyzes the results of operations, liquidity, capital resources, and the ongoing going concern uncertainty [Overview](index=18&type=section&id=Overview) This overview outlines Cyclerion's strategic focus on neuropsychiatric diseases, efforts to reduce expenses, and financing plans for its TRD product candidate - Cyclerion's core strategy is to develop therapeutics for neuropsychiatric diseases, with a foundational product candidate in individualized therapy for treatment-resistant depression (TRD)[83](index=83&type=chunk) - The company aims to significantly reduce operating expenses and generate revenue from legacy sGC stimulator assets while pursuing a financing strategy, including an S-3 Shelf Registration, to fund TRD product plans[84](index=84&type=chunk) - Regina Graul, Ph.D., was promoted to CEO in August 2024, and Rhonda Chicko was hired as CFO in 2024, with the company primarily using consultants to manage operating expenses[85](index=85&type=chunk) [Financial Overview](index=18&type=section&id=Financial%20Overview) This section summarizes key financial developments, including reduced R&D expenses, amended license agreements, and updates on Tisento Therapeutics - Research and development expenses decreased significantly after July 28, 2023, due to the sale of Zagociguat and CY3018, leading to a reduction in R&D efforts[92](index=92&type=chunk) - The Akebia license agreement for Praliciguat was amended, providing for **$1.75 million** in amendment payments (**$1.25 million** received, **$0.5 million** due Sep 2025), up to **$558.5 million** in potential future milestones, and higher-tiered sales-based royalties[89](index=89&type=chunk) - The Option to License Agreement for Olinciguat was extended in May 2025 for an additional three months, with an extension fee of **$55,000** received in June 2025[91](index=91&type=chunk) - Tisento Therapeutics, Inc., which acquired Zagociguat and CY3018, announced the first patient dosed in its global Phase 2b PRIZM study for MELAS in January 2025, and received FDA Fast Track designation for zagociguat in June 2025[93](index=93&type=chunk) Research and Development Expenses (in thousands) | R&D Expenses | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Personnel and related internal costs | $12 | $24 | $24 | $61 | | Others | $44 | $81 | $68 | $88 | | Total R&D expenses | $56 | $105 | $92 | $149 | [Critical Accounting Policies and Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses the significant judgments and estimates involved in preparing financial statements, particularly regarding research and development expenses - The preparation of financial statements requires significant judgments and estimates, which are based on historical experience and reasonable assumptions[102](index=102&type=chunk) - All research and development expenses are expensed as incurred, while nonrefundable advance payments for R&D activities are deferred and capitalized until goods are received or services performed[104](index=104&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in revenue, expenses, and net loss for the reporting periods Results of Operations Highlights (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Revenue from option agreement | $93 | $0 | $93 | 100% | $174 | $0 | $174 | 100% | | Research and development | $56 | $105 | $(49) | (47)% | $92 | $149 | $(57) | (38)% | | General and administrative | $1,709 | $1,279 | $430 | 34% | $3,211 | $2,853 | $358 | 13% | | Interest income | $31 | $62 | $(31) | (50)% | $59 | $138 | $(79) | (57)% | | Gain from insurance recovery | $1,317 | $0 | $1,317 | 100% | $1,317 | $0 | $1,317 | 100% | | Net loss | $(324) | $(1,322) | $998 | (75)% | $(1,753) | $(2,864) | $1,111 | (39)% | - The increase in general and administrative expenses for the three and six months ended June 30, 2025, was primarily due to higher professional consulting and corporate legal fees, partially offset by reduced employee-related expenses[109](index=109&type=chunk)[110](index=110&type=chunk) - Interest income decreased due to a lower money market fund balance[111](index=111&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations, discussing cash position, financing activities, and future funding needs - In March 2025, the company completed a private placement, raising approximately **$1.375 million** in gross proceeds from the sale of **499,998 common shares**[113](index=113&type=chunk) - An 'at the market' (ATM) equity offering program was established in May 2025, allowing the sale of up to **$20 million** in common stock, with **$0.4 million** in net proceeds generated from July 1 to August 4, 2025[115](index=115&type=chunk)[120](index=120&type=chunk) - As of June 30, 2025, the company had **$3.0 million** in unrestricted cash and cash equivalents, expected to fund operations into the **first quarter of 2026**[125](index=125&type=chunk)[127](index=127&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and the need for additional funding to sustain operations beyond **Q1 2026**[127](index=127&type=chunk) Cash Flows Summary (in thousands) | Cash Flows | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change ($) | Change (%) | | :------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | | Net cash used in operating activities | $(1,471) | $(2,977) | $1,506 | (51)% | | Net cash provided by financing activities | $1,245 | $0 | $1,245 | 100% | - Future funding requirements are highly uncertain and depend on the scope, progress, and costs of product candidate development, regulatory review, commercialization, intellectual property, and market conditions[135](index=135&type=chunk)[142](index=142&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cyclerion Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Cyclerion is exempt from providing quantitative and qualitative disclosures about market risk[144](index=144&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and concluded they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the period - The company's disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2025[145](index=145&type=chunk) - No material changes in internal control over financial reporting occurred during the period covered by this report[146](index=146&type=chunk) [PART II — Other Information](index=27&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This part includes information on legal proceedings, risk factors, other significant events, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may be subject to various claims in the ordinary course of business - The company is not a party to any material legal proceedings at this time[149](index=149&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Cyclerion is not required to provide new risk factors in this quarterly report but refers readers to the 'Risk Factors' section in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - As a smaller reporting company, the registrant refers to the 'Risk Factors' section in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, for a comprehensive review of factors that could materially affect its business[150](index=150&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) On August 4, 2025, the company entered into a Consulting Agreement with Rhonda Chicko, formalizing her role as Chief Financial Officer with an hourly compensation and a stock option grant. No Rule 10b5-1 plans were adopted or terminated by directors or Section 16 officers during Q2 2025 - On August 4, 2025, Cyclerion entered into a Consulting Agreement with Rhonda Chicko, formalizing her role as CFO with an hourly rate of **$525.00** and a stock option grant for up to **25,000 shares**[151](index=151&type=chunk) - No Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or Section 16 officers during the second quarter of 2025[152](index=152&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including the Consulting Agreement with Rhonda Chicko, CEO and CFO certifications, and XBRL documents - The report includes Exhibit 10.1, the Consulting Agreement with Rhonda Chicko dated August 4, 2025, and various certifications (31.1, 31.2, 32.1, 32.2) from the CEO and CFO[155](index=155&type=chunk) [Signatures](index=29&type=section&id=SIGNATURES) This section confirms the official signing of the report by the company's President, CEO, and CFO on August 5, 2025 - The report was signed by Regina Graul, President and CEO, and Rhonda Chicko, CFO, on August 5, 2025[158](index=158&type=chunk)[159](index=159&type=chunk)

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) This section provides essential details of the SEC filing, including its type, registrant, and securities information [Basic Filing Details](index=1&type=section&id=Basic%20Filing%20Details) This section provides the fundamental details of the SEC filing, identifying it as a Quarterly Report for the period ended March 31, 2025, and specifying its Commission File Number - The document is a Quarterly Report (Form 10-Q) for the period ended March 31, 2025[2](index=2&type=chunk) - The Commission File Number is **001-38787**[2](index=2&type=chunk) [Registrant Information](index=1&type=section&id=Registrant%20Information) This section identifies Cyclerion Therapeutics, Inc. as the registrant, detailing its state of incorporation and the address of its principal executive offices - Registrant: CYCLERION THERAPEUTICS, INC[2](index=2&type=chunk) - State of incorporation: Massachusetts[2](index=2&type=chunk) - Principal executive offices: 245 First Street, 18th Floor, Cambridge, Massachusetts 02142[2](index=2&type=chunk)[5](index=5&type=chunk) [Securities and Filer Status](index=1&type=section&id=Securities%20and%20Filer%20Status) This section outlines the company's registered securities, confirms its compliance with SEC filing requirements, and specifies its filer status as a non-accelerated filer and smaller reporting company Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common Stock, no par value | CYCN | The Nasdaq Capital Market LLC | - The registrant has filed all required reports and submitted every Interactive Data File during the preceding **12 months**[3](index=3&type=chunk) - Filer Status: Non-accelerated filer and Smaller reporting company[4](index=4&type=chunk) - As of May 2, 2025, there were **3,210,094 shares** of common stock outstanding[4](index=4&type=chunk) [CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns that the report contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ [General Statement](index=3&type=section&id=General%20Statement) This section advises that the report contains forward-looking statements, which are based on current expectations and assumptions but are subject to inherent uncertainties and risks that could cause actual results to differ materially - The report contains forward-looking statements, which are not historical facts and involve substantial risks and uncertainties[9](index=9&type=chunk) - Forward-looking statements are based on current expectations and assumptions, but actual results may differ materially due to inherent uncertainties, risks, and changes in circumstances[10](index=10&type=chunk) [Important Factors and Risks](index=3&type=section&id=Important%20Factors%20and%20Risks) This section details specific factors that could materially affect the company's actual results, including challenges in acquiring and developing new product candidates, significant doubt about its ability to continue as a going concern, and various operational and financial risks - Risks include potential failure to acquire license rights for new product candidates, establish clinical studies, obtain regulatory approvals, or successfully commercialize products[10](index=10&type=chunk) - There is substantial doubt regarding the company's ability to continue as a going concern, necessitating near-term capital raising[10](index=10&type=chunk) - Uncertainties exist regarding future financial performance, potential revenues, expense levels, cash flows, and profitability[10](index=10&type=chunk) - Other risks include inability to maintain Nasdaq listing, risks associated with the investment in Tisento Therapeutics Inc., and potential failure to out-license olinciguat technology[10](index=10&type=chunk)[12](index=12&type=chunk) [PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Cyclerion Therapeutics, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with comprehensive notes explaining the basis of presentation, significant accounting policies, and details of various financial accounts and agreements. A critical note addresses the company's 'Going Concern' status due to recurring losses and the need for additional funding [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $3,639 | $3,232 | | Accounts receivable | 581 | 556 | | Prepaid expenses | 256 | 421 | | Other current assets | 21 | 16 | | Total current assets | 4,497 | 4,225 | | Other investment | 5,350 | 5,350 | | Total assets | $9,847 | $9,575 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Accounts payable | $483 | $390 | | Accrued research and development costs | 50 | 52 | | Accrued expenses and other current liabilities | 534 | 283 | | Total current liabilities | 1,067 | 725 | | Total stockholders' equity | 8,780 | 8,850 | | Total liabilities and stockholders' equity | $9,847 | $9,575 | - Total assets increased by **$272 thousand** from **$9,575 thousand** at December 31, 2024, to **$9,847 thousand** at March 31, 2025[14](index=14&type=chunk) - Total current liabilities increased by **$342 thousand** from **$725 thousand** at December 31, 2024, to **$1,067 thousand** at March 31, 2025[14](index=14&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance, including revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenues: | | | | Revenue from option agreement | $81 | $— | | Total revenues | 81 | — | | Cost and expenses: | | | | Research and development | 36 | 44 | | General and administrative | 1,502 | 1,574 | | Total cost and expenses | 1,538 | 1,618 | | Loss from operations | (1,457) | (1,618) | | Other income, net: | | | | Interest income | 28 | 76 | | Total other income, net | 28 | 76 | | Net loss | $(1,429) | $(1,542) | | Basic and diluted net loss per share | $(0.56) | $(0.62) | | Comprehensive loss | $(1,429) | $(1,546) | - Total revenues increased from **$0** in Q1 2024 to **$81 thousand** in Q1 2025, primarily from an option agreement[17](index=17&type=chunk) - Net loss decreased by **$113 thousand**, from **$(1,542) thousand** in Q1 2024 to **$(1,429) thousand** in Q1 2025[17](index=17&type=chunk) - Basic and diluted net loss per share improved from **$(0.62)** in Q1 2024 to **$(0.56)** in Q1 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section details changes in the company's equity, including net loss, stock issuance, and share-based compensation Condensed Consolidated Statements of Stockholders' Equity (in thousands, except share data) | | Balance at December 31, 2024 | Net loss | Issuance of common stock - private placement, net of issuance cost | Vesting of restricted stock awards | Share-based compensation expense | Balance at March 31, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Common Stock Shares | 2,545,922 | — | 499,998 | 15,024 | — | 3,060,944 | | Paid-in capital | $276,342 | — | $1,245 | — | $114 | $277,701 | | Accumulated deficit | $(267,492) | $(1,429) | — | — | — | $(268,921) | | Total Stockholders' equity | $8,850 | $(1,429) | $1,245 | — | $114 | $8,780 | - Total stockholders' equity decreased from **$8,850 thousand** at December 31, 2024, to **$8,780 thousand** at March 31, 2025, primarily due to net loss offset by proceeds from private placement and share-based compensation[20](index=20&type=chunk) - **499,998 shares** of common stock were issued through a private placement, contributing **$1,245 thousand** to paid-in capital[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(968) | $(1,871) | | Net cash provided by financing activities | $1,375 | $— | | Effect of exchange rate changes on cash and cash equivalents | — | (4) | | Net increase (decrease) in cash and cash equivalents | $407 | $(1,875) | | Cash and cash equivalents, beginning of period | $3,232 | $7,571 | | Cash and cash equivalents, end of period | $3,639 | $5,696 | - Net cash used in operating activities decreased significantly from **$(1,871) thousand** in Q1 2024 to **$(968) thousand** in Q1 2025[23](index=23&type=chunk) - Net cash provided by financing activities was **$1,375 thousand** in Q1 2025 due to a private placement, compared to **$0** in Q1 2024[23](index=23&type=chunk) - Cash and cash equivalents increased by **$407 thousand** in Q1 2025, ending at **$3,639 thousand**[23](index=23&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section presents comprehensive notes explaining the basis of presentation, significant accounting policies, and details of various financial accounts and agreements [1. Nature of Business](index=9&type=section&id=1.%20Nature%20of%20Business) This note describes the company's strategic shift to neuropsychiatric diseases, its operational model, and revenue generation from legacy assets - Cyclerion Therapeutics, Inc. became an independent public company on April 1, 2019, after a tax-free spin-off from Ironwood Pharmaceuticals, Inc[26](index=26&type=chunk) - The company is now focused on building a new pipeline for neuropsychiatric diseases, prioritizing an individualized therapy for treatment-resistant depression (TRD) as its foundational product candidate[26](index=26&type=chunk) - Cyclerion has discontinued internal research and development of sGC stimulators, instead leveraging legacy sGC assets (Praliciguat, Olinciguat, Zagociguat, CY3018) to generate revenue[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - As of March 31, 2025, Cyclerion has **one employee** and utilizes consultants to manage operating expenses[26](index=26&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the accounting principles used in preparing the financial statements, including the going concern assessment - The condensed consolidated financial statements are unaudited and prepared in accordance with GAAP, with certain disclosures condensed or omitted[36](index=36&type=chunk) - Management evaluates the company's ability to continue as a going concern, analyzing prospective operating budgets and cash needs[39](index=39&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, as current cash is expected to fund operations only through Q3 2025, and additional funding is needed[41](index=41&type=chunk) - No new accounting pronouncements adopted during the three months ended March 31, 2025, had a material effect on the financial statements, and no future standards are expected to have a material impact[43](index=43&type=chunk)[44](index=44&type=chunk) [3. Fair Value of Financial Instruments](index=12&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) This note details the fair value measurements of financial instruments, primarily cash equivalents Fair Value Measurements of Cash Equivalents (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Money market funds (Level 1) | $3,376 | $3,025 | | Total Cash equivalents | $3,376 | $3,025 | - Cash equivalents, primarily money market funds, are classified within Level 1 of the fair value hierarchy, based on quoted market prices in active markets[45](index=45&type=chunk) - The carrying amounts of accounts receivable, prepaid expenses, other current assets, accounts payable, and accrued expenses approximate their fair value due to their short-term nature[46](index=46&type=chunk) [4. Other Investment](index=12&type=section&id=4.%20Other%20Investment) This note describes the company's investment in Tisento Parent, accounted for at cost less impairment - The company's investment in Tisento Parent is accounted for as an equity security without a readily determinable fair value, measured at cost less any impairment[48](index=48&type=chunk) - Despite having a variable interest in Tisento Parent, the company does not hold a controlling financial interest and therefore does not consolidate Tisento under the VIE model[47](index=47&type=chunk) - No impairment loss was recognized on the Tisento investment as of March 31, 2025[48](index=48&type=chunk) [5. Property and Equipment](index=13&type=section&id=5.%20Property%20and%20Equipment) This note provides details on the company's property and equipment, which is fully depreciated Property and Equipment, Net (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Software | $126 | $126 | | Property and equipment, gross | 126 | 126 | | Less: accumulated depreciation and amortization | (126) | (126) | | Property and equipment, net | $— | $— | - Property and equipment, net, was **$0** as of March 31, 2025, and December 31, 2024, due to full accumulated depreciation[49](index=49&type=chunk) - No depreciation and amortization expenses were recorded during the three months ended March 31, 2025 and 2024[49](index=49&type=chunk) [6. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=6.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the composition and changes in accrued expenses and other current liabilities Accrued Expenses and Other Current Liabilities (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Professional fees | $489 | $220 | | Other | 45 | 63 | | Total Accrued expenses and other current liabilities | $534 | $283 | - Accrued expenses and other current liabilities increased by **$251 thousand**, from **$283 thousand** at December 31, 2024, to **$534 thousand** at March 31, 2025, primarily due to an increase in professional fees[50](index=50&type=chunk) [7. Commitments and Contingencies](index=13&type=section&id=7.%20Commitments%20and%20Contingencies) This note outlines the company's contractual commitments, indemnification obligations, and separation benefits - The company enters into cancellable contracts for clinical and preclinical research and other services, generally without significant cancellation penalties[51](index=51&type=chunk) - Officers and directors are indemnified, and the company also indemnifies business partners, contractors, clinical sites, and customers in the ordinary course of business[52](index=52&type=chunk)[53](index=53&type=chunk) - No material costs have been incurred for indemnification obligations to date, and the estimated fair value of these obligations is minimal[53](index=53&type=chunk)[54](index=54&type=chunk) - Final separation benefits of **$0.2 million** were paid to the former Chief Financial Officer in May and August 2024, with no further obligations as of March 31, 2025[55](index=55&type=chunk) [8. Share-based Compensation Plans](index=14&type=section&id=8.%20Share-based%20Compensation%20Plans) This note describes the company's equity incentive plans and the associated share-based compensation expense - Cyclerion adopted the 2019 Employee Stock Purchase Plan (ESPP) and 2019 Equity Incentive Plan, and mirrored Ironwood's 2005 and 2010 Equity Plans for equity conversion post-separation[56](index=56&type=chunk)[57](index=57&type=chunk) Share-based Compensation Expense (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $12 | $26 | | General and administrative | 102 | 155 | | Total | $114 | $181 | - Total share-based compensation expense decreased from **$181 thousand** in Q1 2024 to **$114 thousand** in Q1 2025[58](index=58&type=chunk) - As of March 31, 2025, unrecognized share-based compensation expense for unvested stock options is **$0.3 million** (weighted average period **3.56 years**) and for unvested RSAs is **$0.3 million** (weighted average period **2.43 years**)[61](index=61&type=chunk)[64](index=64&type=chunk) [9. Loss per share](index=16&type=section&id=9.%20Loss%20per%20share) This note details the calculation of basic and diluted net loss per share, including anti-dilutive securities Net Loss Per Share (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net loss | $(1,429) | $(1,542) | | Weighted average shares used in calculating net loss per share — basic and diluted | 2,556 | 2,494 | | Net loss per share — basic and diluted | $(0.56) | $(0.62) | - Basic and diluted net loss per share improved to **$(0.56)** in Q1 2025 from **$(0.62)** in Q1 2024[66](index=66&type=chunk) - Potential shares from Preferred Stock, stock options, and RSAs (totaling **829,645** in Q1 2025) were excluded from diluted EPS calculation as they were anti-dilutive[66](index=66&type=chunk) [10. Option/License Agreement](index=16&type=section&id=10.%20Option/License%20Agreement) This note provides details on the company's option and license agreements for its sGC stimulator assets - The Option Agreement for Olinciguat was extended to May 2025, with the Optionee paying a **$150,000 fee** in August 2024 and an additional **$25,000** for the extension, plus reimbursement for patent expenses[67](index=67&type=chunk) - The Akebia License Agreement for Praliciguat was amended in December 2024, resulting in **$1.25 million** paid in December 2024 and an additional **$0.5 million** due by September 30, 2025[69](index=69&type=chunk)[70](index=70&type=chunk) - Under the amended Akebia agreement, Cyclerion is eligible for up to **$558.5 million** in future development, regulatory, and commercialization milestone payments, and tiered royalties ranging from **mid-single-digits to twenty percent** of net sales[70](index=70&type=chunk) - Akebia has assumed control and expenses for certain Praliciguat patents earlier than originally agreed[70](index=70&type=chunk) [11. Subsequent Events](index=17&type=section&id=11.%20Subsequent%20Events) This note confirms that no material events occurred after the balance sheet date requiring recognition or disclosure - No events or transactions requiring recognition or disclosure occurred after the balance sheet date through the date the consolidated financial statements were issued[74](index=74&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance and condition, discussing its strategic shift to neuropsychiatric diseases, particularly treatment-resistant depression (TRD), and efforts to leverage legacy sGC assets for revenue. It details the financial results for the quarter, including revenue from option agreements, changes in R&D and G&A expenses, and the company's liquidity position, emphasizing the 'going concern' uncertainty and future funding requirements [Overview](index=18&type=section&id=Overview) This section outlines Cyclerion's strategic shift to neuropsychiatric diseases, efforts to reduce expenses, and revenue generation from legacy assets - Cyclerion's strategy is to build a new pipeline for neuropsychiatric diseases, with a foundational product candidate for treatment-resistant depression (TRD) identified through asset evaluations[76](index=76&type=chunk) - The company aims to significantly reduce operating expenses, generate revenue from legacy soluble guanylate cyclase (sGC) stimulator clinical assets, and raise funds to support TRD product plans[77](index=77&type=chunk) - Regina Graul, Ph.D., was promoted to CEO in August 2024, and Rhonda Chicko was hired as CFO contractor; Dr. Graul is the only current employee, with consultants used to limit operating expenses[78](index=78&type=chunk) [Financial Overview](index=18&type=section&id=Financial%20Overview) This section provides a summary of the company's financial strategy, including R&D expenses and key licensing agreements - Research and development expenses are primarily for compensation, benefits, facilities, and third-party contracts related to manufacturing, nonclinical studies, and clinical trials, and are charged to operations as incurred[79](index=79&type=chunk)[97](index=97&type=chunk) - The Praliciguat license agreement with Akebia was amended in December 2024, providing **$1.75 million** in amendment payments (**$1.25 million** received, **$0.5 million** due Sep 2025) and potential milestones up to **$558.5 million** plus tiered sales-based royalties[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - The Olinciguat option agreement with a third party was extended to May 2025, with an option fee of **$150,000** received in August 2024 and an additional **$25,000** for the extension[83](index=83&type=chunk) - Zagociguat and CY3018 were sold to Tisento Therapeutics, Inc. in July 2023 for **$8.0 million** cash, **$2.4 million** expense reimbursement, and **10%** equity in Tisento Parent, leading to a significant decrease in R&D expenses[84](index=84&type=chunk) - Tisento announced the first patient dosed in its global Phase 2b PRIZM study for zagociguat in MELAS on January 27, 2025[85](index=85&type=chunk)[86](index=86&type=chunk) Research and Development Expenses (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Personnel and related internal costs | $12 | $37 | | Others | 24 | 7 | | Total research and development expenses | $36 | $44 | [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in revenues, expenses, and net loss for the period Summary of Results of Operations (in thousands) | | March 31, 2025 | March 31, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue from option agreement | $81 | $— | $81 | 100% | | Total revenues | $81 | $— | $81 | 100% | | Research and development | $36 | $44 | $(8) | (18)% | | General and administrative | $1,502 | $1,574 | $(72) | (5)% | | Total cost and expenses | $1,538 | $1,618 | $(80) | (5)% | | Loss from operations | $(1,457) | $(1,618) | $161 | (10)% | | Interest income | $28 | $76 | $(48) | (63)% | | Net loss | $(1,429) | $(1,542) | $113 | (7)% | - Revenue of **$0.1 million** was recognized in Q1 2025 from the Olinciguat option extension fee and expense reimbursement[101](index=101&type=chunk) - General and administrative expenses decreased by approximately **$0.1 million** due to lower insurance and board member fees, partially offset by increased professional consulting[103](index=103&type=chunk) - Interest income decreased by **$0.1 million** for the three months ended March 31, 2025, primarily attributable to a decrease in the money market fund balance[104](index=104&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, capital raising activities, and future funding requirements, highlighting going concern uncertainty - On March 21, 2025, the company closed a private placement of **499,998 common shares** for gross proceeds of approximately **$1.375 million**[105](index=105&type=chunk) - A Registration Statement on Form S-3 (Shelf) was filed and declared effective in February 2025, allowing for the sale of up to **$25.0 million** in securities, limited to one-third of the public float[106](index=106&type=chunk) - As of March 31, 2025, unrestricted cash and cash equivalents were approximately **$3.6 million**[110](index=110&type=chunk) - The company expects current cash to fund operations through Q3 2025 but needs additional funding due to anticipated operating losses, leading to substantial doubt about its ability to continue as a going concern[112](index=112&type=chunk)[118](index=118&type=chunk) Summary of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(968) | $(1,871) | $903 | (48)% | | Net cash provided by financing activities | $1,375 | $— | $1,375 | — | | Net increase (decrease) in cash and cash equivalents | $407 | $(1,875) | $2,282 | 122% | - Net cash used in operating activities decreased by **$903 thousand**, from **$(1,871) thousand** in Q1 2024 to **$(968) thousand** in Q1 2025, primarily due to lower net loss and changes in working capital[115](index=115&type=chunk)[116](index=116&type=chunk) - Net cash provided by financing activities was **$1.4 million** in Q1 2025 from the private placement[117](index=117&type=chunk) - Future funding requirements are uncertain and depend on the scope, progress, and costs of R&D, regulatory review, commercialization, intellectual property, and market conditions[119](index=119&type=chunk)[126](index=126&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cyclerion Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk in this report - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2025, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the period [Evaluation of Disclosure Controls and Procedures](index=25&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms management's assessment of the effectiveness of disclosure controls and procedures - Management, with the participation of the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025[129](index=129&type=chunk) - Control systems have inherent limitations and can only provide reasonable, not absolute, assurance that objectives are met, and cannot prevent all errors or fraud[129](index=129&type=chunk) [Changes in Internal Control over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in internal control over financial reporting during the period - No changes in internal control over financial reporting occurred during the period covered by this report that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[130](index=130&type=chunk) [PART II — OTHER INFORMATION](index=26&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, unregistered sales of equity, other information, and exhibits [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings, though it acknowledges the potential for future claims - The company is not a party to any material legal proceedings at this time[133](index=133&type=chunk) - The company may be subject to various legal proceedings and claims in the future, which could have a material adverse effect on its financial position or results of operations[133](index=133&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Cyclerion Therapeutics, Inc. is not required to present risk factors in this quarterly report, directing readers to its Annual Report on Form 10-K for a comprehensive discussion of risks - As a 'smaller reporting company,' the company is not required to provide risk factors in this Quarterly Report on Form 10-Q[134](index=134&type=chunk) - Readers are directed to the 'Risk Factors' section in Part I, Item 1A of the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, for a further description of factors that could materially affect the business[134](index=134&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the completion of a private placement of unregistered common stock in March 2025, which generated $1.375 million in net proceeds intended for general corporate purposes - On March 21, 2025, the company completed a private placement of **499,998 unregistered shares** of common stock at **$2.75** per share, resulting in net proceeds of **$1.375 million**[135](index=135&type=chunk) - The net proceeds are intended for general corporate purposes[135](index=135&type=chunk) - The private placement was made to several accredited investors under Regulation D of the Securities Act of 1933[135](index=135&type=chunk) [Item 5. Other Information](index=26&type=section&id=Item%205.%20Other%20Information) This section confirms that no directors or Section 16 officers engaged in specific trading plan activities during the first quarter of 2025 - No director or Section 16 officer adopted or terminated any Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements during the first quarter of 2025[136](index=136&type=chunk) [Item 6. Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section refers to the Exhibit Index, which lists various documents filed as exhibits to the Quarterly Report, including certifications and XBRL data - The report includes an Exhibit Index listing various certificates (CEO, CFO pursuant to Sarbanes-Oxley Act) and Inline XBRL documents[137](index=137&type=chunk)[140](index=140&type=chunk) [Signatures](index=28&type=section&id=Signatures) This section contains the official signatures of the company's authorized officers, certifying the report's submission - The report is signed by Regina Graul, President and Chief Executive Officer, and Rhonda Chicko, Chief Financial Officer, on May 6, 2025[143](index=143&type=chunk)[144](index=144&type=chunk)

Part I [Business](index=5&type=section&id=Item%201.%20Business) Cyclerion Therapeutics has pivoted to developing neuropsychiatric disease therapeutics, monetizing legacy assets to fund its new strategy [Overview and Strategy](index=5&type=section&id=Overview%20and%20Strategy) The company is building a new pipeline for neuropsychiatric diseases, focusing on an individualized therapy for treatment-resistant depression (TRD) - Cyclerion's new strategy is to build a pipeline for neuropsychiatric diseases, starting with a foundational product candidate for **treatment-resistant depression (TRD)**[23](index=23&type=chunk) - The company has entered into a non-binding option to license agreement for the intellectual property associated with the TRD product candidate[23](index=23&type=chunk) - To support its new strategy, the company filed a **Form S-3 Shelf Registration**, which was declared effective in February 2025, to allow for the sale of common stock[24](index=24&type=chunk) - The company operates with a lean structure, with only **one full-time employee** (CEO Dr. Regina Graul) as of year-end, utilizing consultants for other key roles like CFO[25](index=25&type=chunk) [Legacy sGC Portfolio and Monetization](index=5&type=section&id=Legacy%20sGC%20Portfolio%20and%20Monetization) The company is monetizing its legacy sGC stimulator portfolio through asset sales and licensing agreements to generate revenue - The company's CNS assets, zagociguat and CY3018, were sold to Tisento Therapeutics in July 2023 for **$8.0 million in cash**, expense reimbursements, and a **10% equity stake** in Tisento's parent company[34](index=34&type=chunk) - The praliciguat license agreement with Akebia was amended in December 2024, providing Cyclerion with **$1.75 million in payments** and eligibility for up to **$558.5 million in future milestones** plus tiered royalties[30](index=30&type=chunk)[31](index=31&type=chunk) - In July 2024, Cyclerion entered into an exclusive non-binding option agreement for its vascular sGC stimulator, olinciguat, with a third party for an initial fee of **$150,000**[33](index=33&type=chunk) [Intellectual Property](index=8&type=section&id=Intellectual%20Property) The company protects its technology through a portfolio of U.S. and foreign patents, trade secrets, and proprietary know-how - The company holds **20 issued U.S. patents** and 11 pending U.S. patent applications for its sGC programs[40](index=40&type=chunk) - The praliciguat patent portfolio includes 13 issued U.S. patents, with the key composition of matter patent expiring in **2034** and other patents extending to **2039**[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The olinciguat patent portfolio includes 14 issued U.S. patents, with the key composition of matter patent expiring in **2034** and other patents extending as far as **2042**[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) [Government Regulation](index=10&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA and similar foreign authorities, requiring a lengthy and expensive approval process - The FDA drug approval process involves extensive nonclinical studies, submission of an IND, and performance of adequate and well-controlled human clinical trials (**Phase 1, 2, and 3**) before an NDA can be submitted[55](index=55&type=chunk)[58](index=58&type=chunk)[62](index=62&type=chunk) - The FDA has programs to expedite development and review, including **Fast Track designation**, **Breakthrough Therapy designation**, and **Priority Review**, for drugs treating serious conditions with unmet medical needs[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - Post-approval, the company is subject to continuous FDA regulation, including requirements for recordkeeping, reporting of adverse events, and compliance with **current Good Manufacturing Practices (GMP)**[75](index=75&type=chunk)[77](index=77&type=chunk) [Competition](index=16&type=section&id=Competition) The company anticipates significant competition for its potential TRD product from major pharmaceutical companies and other biotechs - The company will face competition from major pharmaceutical, biopharmaceutical, and biotechnology companies, as well as academic and research organizations[86](index=86&type=chunk) - Current treatments for TRD fall into three main categories: **pharmacotherapies** (antidepressants, antipsychotics), **somatic therapies** (ECT, rTMS), and **psychotherapeutic approaches**[87](index=87&type=chunk)[88](index=88&type=chunk) - Only two pharmacotherapies are specifically approved for TRD in the U.S: **Spravato (esketamine)** and **Symbyax (olanzapine/fluoxetine)**[88](index=88&type=chunk) [Manufacturing, Human Capital, and Corporate Information](index=17&type=section&id=Manufacturing%2C%20Human%20Capital%2C%20and%20Corporate%20Information) Cyclerion outsources all manufacturing, operates with minimal staff, and trades on the Nasdaq Capital Market under the symbol "CYCN" - The company **outsources all manufacturing activities** to third-party CMOs and has no plans to establish its own facilities[92](index=92&type=chunk) - As of December 31, 2024, the company had **one employee** and utilized several consultants, including its Chief Financial Officer[94](index=94&type=chunk) [Risk Factors](index=18&type=section&id=Item%201A.%20Risk%20Factors.) The company faces substantial financial, developmental, and operational risks, including a "going concern" warning and heavy reliance on third parties [Risks Related to Financial Position and Capital Needs](index=20&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Capital%20Needs) The company has a history of losses and insufficient cash to fund operations beyond mid-2025, raising substantial doubt about its viability - There is **substantial doubt** regarding the company's ability to continue as a **going concern**[99](index=99&type=chunk)[111](index=111&type=chunk) - As of December 31, 2024, the company had **$3.2 million in cash and cash equivalents**, which is not sufficient to fund operations beyond the second quarter of 2025[111](index=111&type=chunk) - The company has a history of significant losses, with net losses of **$3.1 million in 2024** and **$5.3 million in 2023**, and may never achieve profitability[108](index=108&type=chunk) [Risks Related to Development and Clinical Testing](index=22&type=section&id=Risks%20Related%20to%20Development%20and%20Clinical%20Testing%20of%20Our%20Products%20and%20Product%20Candidates) The company's success depends on the inherently risky and lengthy process of clinical development and regulatory approval for its product candidates - Research and development of biopharmaceutical products is inherently risky, and the company may fail to demonstrate the **safety and efficacy** of its product candidates to the satisfaction of regulatory authorities[117](index=117&type=chunk) - The company could face difficulties in **enrolling participants in clinical studies**, which could delay or prevent the progress of its product candidates[119](index=119&type=chunk) - The regulatory approval process is lengthy, time-consuming, and unpredictable, and it is possible that **none of the company's product candidates will ever obtain regulatory approval**[121](index=121&type=chunk) [Risks Related to Reliance on Licensees, Tisento and Third Parties](index=25&type=section&id=Risks%20Related%20to%20Reliance%20on%20Licensees%2C%20Tisento%20and%20Third%20Parties) The company's financial prospects are highly dependent on the performance of its partners and its reliance on third-party service providers - The company's investment in Tisento is risky, as Tisento is an early-stage company and Cyclerion has **no operational control**, meaning the equity value could be diluted or lost entirely[134](index=134&type=chunk)[135](index=135&type=chunk) - Future revenue from the Akebia license for praliciguat is uncertain, as Akebia may not be successful and can **terminate the agreement with 180 days' notice**[133](index=133&type=chunk) - The company expects to continue relying on third-party **CROs to conduct clinical studies** and **CMOs to manufacture drug supplies**, and if these parties do not perform successfully, development could be delayed or harmed[100](index=100&type=chunk)[137](index=137&type=chunk)[142](index=142&type=chunk) [Risks Related to Intellectual Property](index=29&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20Rights) The company's success depends on its ability to obtain, maintain, and defend its patent portfolio against challenges and potential infringement claims - The company may be **unable to obtain and maintain issued patents** sufficient to protect its product candidates, which could allow competitors to more directly compete[145](index=145&type=chunk) - The company may **infringe on the intellectual property rights of others**, which could prevent or delay development efforts and lead to costly litigation or royalty payments[159](index=159&type=chunk)[161](index=161&type=chunk) - Changes in U.S. patent law, such as the **America Invents Act**, have created uncertainty and could weaken the company's ability to obtain and enforce patents[172](index=172&type=chunk) [Risks Related to Commercialization](index=34&type=section&id=Risks%20Related%20to%20the%20Future%20Commercialization%20of%20our%20Potential%20Future%20Product%20Candidates) The company faces significant commercialization hurdles, including market acceptance, pricing, reimbursement, and competition from well-resourced rivals - The **market opportunities** for product candidates may be **smaller than estimated**, which would harm revenue and profitability[177](index=177&type=chunk) - Even if approved, product candidates may not achieve broad market acceptance, and **securing adequate reimbursement** may be difficult[180](index=180&type=chunk)[182](index=182&type=chunk) - The company faces significant competition from companies with **greater financial resources**, and competitors may develop safer, more effective, or less expensive therapies[189](index=189&type=chunk)[191](index=191&type=chunk) [Risks Related to Business Operations](index=39&type=section&id=Risks%20Related%20to%20Our%20Business%20Operations) Operational risks include high dependency on its sole employee, potential product liability, cybersecurity threats, and maintaining internal controls - The company is **highly dependent on its President and CEO, Regina Graul**, who is currently its sole employee[200](index=200&type=chunk) - The company faces significant risk from **cybersecurity threats**, which could compromise sensitive data, leading to regulatory action, litigation, and operational interruptions[212](index=212&type=chunk)[213](index=213&type=chunk)[218](index=218&type=chunk) - The use of product candidates in clinical studies exposes the company to **product liability claims**, which could result in substantial liabilities and damage its reputation[203](index=203&type=chunk) [Risks Related to Ownership of Common Stock](index=44&type=section&id=Risks%20Related%20to%20the%20holders%20of%20Our%20Common%20Stock) Ownership of the company's common stock involves risks of Nasdaq delisting, high price volatility, and potential classification as an investment company - The company could be **delisted from Nasdaq** if it fails to maintain the minimum $1.00 bid price requirement in the future; it previously regained compliance via a **20:1 reverse stock split** in May 2023[226](index=226&type=chunk)[228](index=228&type=chunk) - The market price of the common stock is **highly volatile** and may fluctuate widely due to numerous factors, including clinical trial results and financing efforts[231](index=231&type=chunk)[233](index=233&type=chunk) - The company runs the risk of being deemed an **investment company** under the Investment Company Act of 1940, which would severely restrict its operations[234](index=234&type=chunk) [Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company reports that it has no unresolved staff comments - None[248](index=248&type=chunk) [Cybersecurity](index=50&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risks through internal processes and third-party vendors, with oversight from the Board's Audit Committee [Risk Management and Strategy](index=50&type=section&id=Risk%20Management%20and%20Strategy) The company employs monitoring tools, threat assessments, and mitigation plans to manage cybersecurity risks integrated into its enterprise risk management - The company uses automated tools for monitoring, **threat detection**, and **intrusion prevention** to manage cybersecurity risks[250](index=250&type=chunk) - Mitigation strategies include **incident response plans**, disaster recovery plans, encryption, access controls, and employee training[251](index=251&type=chunk) - A **vendor management program** is in place to oversee and manage cybersecurity risks associated with third-party providers like CROs and CMOs[254](index=254&type=chunk) [Governance](index=51&type=section&id=Governance) The Board of Directors, through its Audit Committee, oversees cybersecurity risk management, which is implemented by management and IT consultants - The Board of Directors provides general oversight of cybersecurity risk, with the **Audit Committee** specifically overseeing the risk management program starting in 2024[256](index=256&type=chunk) - **Management and IT consultants** are responsible for the day-to-day implementation and maintenance of the cybersecurity program[257](index=257&type=chunk) - The Board receives **regular reports from management** regarding the cybersecurity risk management program, threats, and mitigation efforts[260](index=260&type=chunk) [Properties](index=51&type=section&id=Item%202.%20Properties) The company operates with a virtual model, leasing office space as needed and outsourcing all laboratory work - The company currently leases office space on an **"as-needed" basis** and outsources all research and development laboratory work[261](index=261&type=chunk) [Legal Proceedings](index=52&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the report date, the company is **not a party to any material legal proceedings**[262](index=262&type=chunk) [Mine Safety Disclosures](index=52&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[263](index=263&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=53&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) The company's common stock trades on the Nasdaq Capital Market, and it does not anticipate paying dividends in the foreseeable future - The company's common stock trades on the **Nasdaq Capital Market** under the symbol "**CYCN**"[266](index=266&type=chunk) - The company has **never declared or paid cash dividends** and does not intend to in the foreseeable future[267](index=267&type=chunk) [Selected Financial Data](index=53&type=section&id=Item%206.%20Selected%20Financial%20Data.) As a smaller reporting company, Cyclerion is not required to provide the information for this item - The company is a **smaller reporting company** and is not required to provide the information under this item[270](index=270&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=54&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) The company's net loss improved in FY2024 due to new licensing revenue and reduced expenses, but a "going concern" warning remains [Results of Operations](index=56&type=section&id=Results%20of%20Operations) For FY2024, the company generated $2.0 million in revenue and significantly reduced its operating loss to $3.6 million from $13.0 million in FY2023 Consolidated Statements of Operations Summary | | Year Ended December 31, | | Change | | | :--- | :--- | :--- | :--- | :--- | | (dollars in thousands) | **2024** | **2023** | **$** | **%** | | **Total revenues** | $2,000 | $— | $2,000 | 100% | | Research and development | 286 | 1,515 | (1,229) | (81)% | | General and administrative | 5,342 | 8,132 | (2,790) | (34)% | | Impairment loss | — | 3,304 | (3,304) | (100)% | | **Total cost and expenses** | 5,628 | 12,951 | (7,323) | (57)% | | **Loss from operations** | (3,628) | (12,951) | 9,323 | (72)% | | **Net loss from continuing operations** | (3,057) | (12,593) | 9,536 | (76)% | | Gain from discontinued operations | — | 7,330 | (7,330) | (100)% | | **Net loss** | $(3,057) | $(5,263) | $2,206 | (42)% | - Revenue of **$2.0 million in 2024** was generated from the amended Akebia license agreement ($1.75M) and the olinciguat option agreement ($0.25M)[294](index=294&type=chunk) - The **$1.2 million decrease in R&D expenses** was driven by reduced employee-related costs, IT services, and research study costs following the 2023 asset sale and workforce reduction[295](index=295&type=chunk) - The **$2.8 million decrease in G&A expenses** was primarily due to savings in legal services ($1.5M), reduced employee costs, and lower audit, insurance, and IT expenses[296](index=296&type=chunk) [Liquidity and Capital Resources](index=58&type=section&id=Liquidity%20and%20Capital%20Resources) With only $3.2 million in cash, management has substantial doubt about the company's ability to continue as a going concern beyond mid-2025 - The company had **$3.2 million in unrestricted cash and cash equivalents** as of December 31, 2024[306](index=306&type=chunk) - Management concluded that **substantial doubt exists** about the company's ability to continue as a **going concern**, as current cash is only sufficient to fund operations through mid-2025[309](index=309&type=chunk)[405](index=405&type=chunk) - A new **Shelf Registration on Form S-3** was filed in February 2025 for up to $25.0 million, but the amount sellable is restricted to one-third of the public float[302](index=302&type=chunk) Cash Flow Summary | | Year Ended December 31, | | Change | | | :--- | :--- | :--- | :--- | :--- | | (dollars in thousands) | **2024** | **2023** | **$** | **%** | | Net cash used in operating activities | $(4,333) | $(21,245) | $16,912 | (80)% | | Net cash provided by investing activities | $— | $10,402 | $(10,402) | (100)% | | Net cash provided by financing activities | $— | $5,024 | $(5,024) | (100)% | [Quantitative and Qualitative Disclosures About Market Risk](index=61&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Cyclerion is not required to provide the information for this item - The company is a **smaller reporting company** and is not required to provide the information under this item[326](index=326&type=chunk) [Financial Statements and Supplementary Data](index=61&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This section contains the company's audited consolidated financial statements, notes, and the independent auditor's report with a "going concern" paragraph [Report of Independent Registered Public Accounting Firm](index=69&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report expresses an unqualified opinion but includes a paragraph highlighting substantial doubt about the company's ability to continue as a going concern - The auditor's report contains a **"Going Concern" paragraph**, highlighting substantial doubt about the company's ability to continue as a going concern[369](index=369&type=chunk) [Consolidated Financial Statements](index=70&type=section&id=Consolidated%20Financial%20Statements) The financial statements show a decrease in total assets to $9.6 million and an improved net loss of $3.1 million for 2024 Key Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,232 | $7,571 | | Total current assets | $4,225 | $8,024 | | Total assets | $9,575 | $13,374 | | Total current liabilities | $725 | $2,086 | | Total stockholders' equity | $8,850 | $11,288 | Key Operations Data (in thousands, except per share) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Total revenues | $2,000 | $— | | Loss from operations | $(3,628) | $(12,951) | | Net loss | $(3,057) | $(5,263) | | Net loss per share | $(1.21) | $(2.25) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=61&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) The company reports no changes in or disagreements with its accountants - None[328](index=328&type=chunk) [Controls and Procedures](index=61&type=section&id=Item%209A.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2024 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2024[331](index=331&type=chunk) - Management concluded that the company's **internal controls over financial reporting were effective** as of December 31, 2024[334](index=334&type=chunk) - The annual report **does not include an attestation report** from the independent registered public accounting firm regarding internal control over financial reporting, as permitted by SEC rules[336](index=336&type=chunk) [Other Information](index=63&type=section&id=Item%209B.%20Other%20Information.) The company reports no other information for this item - None[340](index=340&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=63&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20That%20Prevent%20Inspections.) This item is not applicable to the company - Not applicable[341](index=341&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=64&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance.) Information for this item is incorporated by reference from the company's 2025 Proxy Statement - Information for this item is **incorporated by reference** from the company's 2025 Proxy Statement[344](index=344&type=chunk)[345](index=345&type=chunk) [Executive Compensation](index=64&type=section&id=Item%2011.%20Executive%20Compensation.) Information for this item is incorporated by reference from the company's 2025 Proxy Statement - Information for this item is **incorporated by reference** from the company's 2025 Proxy Statement[344](index=344&type=chunk)[346](index=346&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=64&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) Information for this item is incorporated by reference from the company's 2025 Proxy Statement - Information for this item is **incorporated by reference** from the company's 2025 Proxy Statement[344](index=344&type=chunk)[347](index=347&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=64&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence.) Information for this item is incorporated by reference from the company's 2025 Proxy Statement - Information for this item is **incorporated by reference** from the company's 2025 Proxy Statement[344](index=344&type=chunk)[348](index=348&type=chunk) [Principal Accounting Fees and Services](index=64&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services.) Information for this item is incorporated by reference from the company's 2025 Proxy Statement - Information for this item is **incorporated by reference** from the company's 2025 Proxy Statement[344](index=344&type=chunk)[349](index=349&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=65&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules.) This section contains an index to the financial statements and a list of all exhibits filed with the Form 10-K - This item provides an index to the financial statements and a list of exhibits filed with the report[352](index=352&type=chunk)[354](index=354&type=chunk) [Form 10-K Summary](index=66&type=section&id=Item%2016.%20Form%2010-K%20Summary.) This item is not applicable to the company - Not applicable[358](index=358&type=chunk)