CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (NASDAQ:CYCN), today announced an update on its progress in catalyzing the Company's next stage of growth. The Company is leveraging its legacy soluble guanylate cyclase (sGC) stimulator assets to generate near-term revenues which will be used to implement its strategic building plan without near-term dilution. "These agreements demonstrate Cyclerion's progress in maximizing its legacy asset value while redirecting resources to ...

CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), today announced an update on its progress in catalyzing the Company’s next stage of growth. The Company is leveraging its legacy soluble guanylate cyclase (sGC) stimulator assets to generate near-term revenues which will be used to implement its strategic building plan without near-term dilution. “These agreements demonstrate Cyclerion’s progress in maximizing its legacy asset value while redirecting resources t ...

[PART I — FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Cyclerion Therapeutics' unaudited condensed consolidated financial statements, including a going concern disclosure [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20September%2030%2C%202024%20and%20December%2031%2C%202023) Total assets decreased to $8.9 million from $13.4 million, driven by reduced cash and cash equivalents, while equity declined to $8.2 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Items | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,872 | $7,571 | | Total current assets | $3,548 | $8,024 | | Other investment | $5,350 | $5,350 | | **Total assets** | **$8,898** | **$13,374** | | **Liabilities & Equity** | | | | Total current liabilities | $700 | $2,086 | | **Total stockholders' equity** | **$8,198** | **$11,288** | | **Total liabilities and stockholders' equity** | **$8,898** | **$13,374** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202024%20and%202023) Net loss remained $3.6 million for the nine months ended September 30, 2024, with improved loss from continuing operations due to new revenue and lower expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Total revenues | $194 | $0 | | Research and development | $230 | $1,491 | | General and administrative | $4,094 | $6,361 | | Loss from operations | $(4,130) | $(11,156) | | Net loss from continuing operations | $(3,587) | $(10,899) | | Gain from discontinued operations | $0 | $7,330 | | **Net loss** | **$(3,587)** | **$(3,569)** | | Basic net loss per share | $(1.43) | $(1.55) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20for%20Three%20and%20Nine%20Months%20Ended%20September%2030%2C%202024%20and%202023) Stockholders' equity decreased from $11.3 million to $8.2 million, primarily due to a $3.6 million net loss partially offset by share-based compensation Changes in Stockholders' Equity (in thousands) | Description | Amount | | :--- | :--- | | **Balance at December 31, 2023** | **$11,288** | | Net loss | $(3,587) | | Share-based compensation expense | $503 | | Other adjustments | $(12) | | **Balance at September 30, 2024** | **$8,198** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20Nine%20Months%20Ended%20September%2030%2C%202024%20and%202023) Net cash used in operating activities significantly decreased to $4.7 million in 2024, with no investing or financing activities, leading to a $4.7 million cash balance decrease Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,693) | $(19,704) | | Net cash provided by investing activities | $0 | $10,402 | | Net cash provided by financing activities | $0 | $5,024 | | **Net decrease in cash** | **$(4,699)** | **$(4,274)** | | **Cash at end of period** | **$2,872** | **$9,108** | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's strategic shift to new CNS assets, the sale of prior programs, current out-licensed assets, and a going concern conclusion - The company shifted its strategy to identify and acquire or license new non-sGC stimulator assets within the CNS therapeutic area to build a new portfolio[26](index=26&type=chunk) - On July 28, 2023, the company sold its zagociguat and CY3018 programs to Tisento Therapeutics, Inc. for cash and a **10% equity stake**, now presented as discontinued operations[24](index=24&type=chunk)[47](index=47&type=chunk) - In July 2024, the company entered an Option to License Agreement for its olinciguat asset, receiving an initial option fee of **$150,000** and generating **$0.2 million** in revenue for the quarter[83](index=83&type=chunk) - Management concluded that substantial doubt exists about the Company's ability to continue as a going concern, as current cash is expected to fund operations only through mid-2025, requiring additional funding[38](index=38&type=chunk)[39](index=39&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and strategic shift to new CNS assets, noting reduced operating expenses but substantial doubt about going concern - The company shifted its strategy to identify non-sGC stimulator assets, mainly within the CNS therapeutic area, to build a new portfolio after selling its primary assets to Tisento in 2023[98](index=98&type=chunk) - The company's retained assets include olinciguat, intended for out-licensing, and praliciguat, out-licensed to Akebia[97](index=97&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) - Due to recurring losses and future funding needs, management concluded that substantial doubt exists about the company's ability to continue as a going concern[132](index=132&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Loss from operations improved to $4.1 million due to new revenue and significant reductions in R&D and G&A expenses from workforce reductions Comparison of Operations (in thousands) | Item | Nine Months Ended Sep 30, 2024 | Nine Months Ended Sep 30, 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenues | $194 | $0 | 100% | | Research and development | $230 | $1,491 | (85%) | | General and administrative | $4,094 | $6,361 | (36%) | | **Loss from operations** | **$(4,130)** | **$(11,156)** | **(63%)** | - The decrease in R&D expense was driven by lower employee-related costs following the 2023 workforce reduction, and reduced spending on IT services, research studies, and lab-related costs[117](index=117&type=chunk)[118](index=118&type=chunk) - The decrease in G&A expense was primarily due to lower employee-related costs, a **$1.4 million** reduction in legal services, and lower audit, insurance, and IT service fees[119](index=119&type=chunk)[121](index=121&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company held $2.9 million in cash as of September 30, 2024, expected to fund operations only into mid-2025, raising substantial doubt about its going concern ability - The company had approximately **$2.9 million** in cash and cash equivalents as of September 30, 2024[129](index=129&type=chunk) - Cash is expected to fund operations into mid-2025, but additional funding is required to sustain operations, raising substantial doubt about the company's ability to continue as a going concern[132](index=132&type=chunk)[141](index=141&type=chunk) - Recent capital inflows include **$5.0 million** from a stock purchase in May 2023 and proceeds from the Tisento asset sale in July 2023[126](index=126&type=chunk)[127](index=127&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Cyclerion is not required to provide market risk disclosures under this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide information for this item[150](index=150&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2024, with no material changes in internal control - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[152](index=152&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter[153](index=153&type=chunk) [PART II — OTHER INFORMATION](index=31&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is not a party to any material legal proceedings[155](index=155&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, this section is not applicable, referring readers to the Annual Report on Form 10-K for risk factors - The company is a 'smaller reporting company' and is not required to provide risk factors in the 10-Q, referring instead to its most recent 10-K filing[156](index=156&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No director or Section 16 officer adopted or terminated Rule 10b5-1 trading plans or arrangements during the second quarter of 2024 - No director or Section 16 officer adopted or terminated any Rule 10b5-1 plans or other trading arrangements during the second quarter of 2024[157](index=157&type=chunk) [Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section refers to the Exhibit Index, listing certifications and XBRL data files submitted with the quarterly report - This section refers to the Exhibit Index on the following page of the report[158](index=158&type=chunk)

CAMBRIDGE, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), today announced that Regina Graul, Ph.D., has been promoted to Chief Executive Officer, President, and member of the Board of Directors. Since Dr. Graul joined Cyclerion as President in early December 2023, she has strengthened all aspects of the company. She has been working closely with the Board of Directors to prioritize building shareholder value by reducing Cyclerion's operating costs while leading a world ...

Financial Performance - Net loss from continuing operations for Q2 2024 was $1.322 million, a 27% improvement compared to $1.803 million in Q2 2023[97]. - The company incurred a net loss of $2.9 million for the six months ended June 30, 2024, with an accumulated deficit of $267.3 million[106]. - The company reported a decrease in loss from discontinued operations of approximately $2.4 million for Q2 2024 compared to Q2 2023, attributed to the sale of Transferred Assets[100]. Expenses - Research and development expenses for Q2 2024 were $105,000, a decrease of 69% compared to $339,000 in Q2 2023[97]. - General and administrative expenses for Q2 2024 were $1.279 million, down 16% from $1.526 million in Q2 2023[97]. - Total expenses for Q2 2024 were $1.384 million, a 26% decrease from $1.865 million in Q2 2023[97]. - The company anticipates further reductions in research and development expenses due to workforce reductions and strategic shifts[98]. Cash Flow and Funding - As of June 30, 2024, the company had approximately $4.6 million of unrestricted cash and cash equivalents, which is expected to fund operations into mid-2025[104]. - Net cash used in operating activities was $2.977 million for the six months ended June 30, 2024, a decrease of 77% compared to $12.769 million for the same period in 2023[109]. - The company expects to need additional funding to sustain operations due to anticipated ongoing operating losses[106]. - There was no financing activity in the six months ended June 30, 2024, while net cash provided by financing activities was $5 million in the same period of 2023[112]. Stock and Equity Transactions - Cyclerion sold two CNS assets to Tisento for $8.0 million in cash and $2.4 million for operating expenses, along with 10% equity in Tisento's parent company[84]. - The company sold 225,000 shares of common stock and 351,037 shares of Series A Preferred Stock for total gross proceeds of approximately $5 million[103]. - The company executed a 1-for-20 reverse stock split effective May 16, 2023, impacting all share amounts retroactively[108]. - The company did not sell any shares under its Shelf Registration from January 1, 2022, to July 2023, which expired in July 2023[102]. Other Financial Information - Cyclerion is eligible to receive up to $585 million in milestone payments from Akebia related to praliciguat, along with tiered sales-based royalties[87]. - The company has no uncertain tax positions as of June 30, 2024[117]. - The company does not have any off-balance sheet arrangements or relationships with unconsolidated entities[119]. - The company paid $0.1 million in separation benefits to the former Chief Financial Officer in May 2024[118]. - The company is seeking to identify non-sGC stimulator assets within the CNS therapeutic area to build a new portfolio[85].

Financial Performance - The net loss from continuing operations for the three months ended March 31, 2024, was $1.54 million, a 52% improvement compared to a net loss of $3.19 million for the same period in 2023[118]. - The company incurred a net loss of $1.5 million for the three months ended March 31, 2024, with an accumulated deficit of $266.0 million[130]. - The net loss for the three months ended March 31, 2024, was primarily due to a $1.5 million net loss from operations, offset by stock-based compensation expense of $0.2 million[134]. - The loss from discontinued operations decreased by approximately $3.8 million for the three months ended March 31, 2024, due to the sale of Transferred Assets[121]. Expenses - Cyclerion reported a total research and development expense of $44,000 for the three months ended March 31, 2024, a decrease of 92% compared to $572,000 for the same period in 2023[118]. - General and administrative expenses decreased by approximately $1.1 million, from $2.7 million in Q1 2023 to $1.6 million in Q1 2024, representing a 42% reduction[119]. - Net cash used in operating activities was $1.9 million for the three months ended March 31, 2024, a decrease of 70% compared to $6.2 million for the same period in 2023[133]. - Interest and other income decreased by a minimal amount for the three months ended March 31, 2024, compared to the same period in 2023[122]. - The company anticipates fluctuations in expenses as it seeks to broaden its portfolio through in-licensing of assets[136]. Cash Position and Funding - As of March 31, 2024, Cyclerion had approximately $5.7 million in unrestricted cash and cash equivalents[127]. - The company expects cash and cash equivalents as of March 31, 2024, to be sufficient to fund operations through the second quarter of 2025, but will need additional funding to sustain operations[136]. - The company may need to raise funds through public or private equity offerings, debt financings, or collaborations, which could dilute existing equity ownership[139]. - The company anticipates that its principal uses of cash in the future will be to fund operations, working capital needs, and capital expenditures[126]. Strategic Changes - Cyclerion sold two CNS assets to Tisento for $8.0 million in cash and $2.4 million in reimbursement for operating expenses, along with 10% of Tisento's Parent's outstanding equity securities[100]. - The company plans to shift its strategy to identify non-sGC stimulator assets within the CNS therapeutic area to build a new portfolio[101]. Going Concern - The company has concluded that substantial doubt exists about its ability to continue as a going concern due to expected ongoing operating losses[130]. - The company filed for a 1-for-20 reverse stock split effective May 16, 2023, which has been retroactively adjusted in the financial statements[132]. Other Obligations - The company has no uncertain tax positions as of March 31, 2024[141]. - The company has contractual obligations to pay $0.1 million to its former Chief Financial Officer on specific anniversaries if full-time employment is not secured[142].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 CYCLERION THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Massachusetts (State or other jurisdiction of incorpor ...

Financial Performance - Total revenues for the three months ended September 30, 2023, were $0, a decrease of 100% compared to $297,000 in the same period of 2022[121] - The net loss from continuing operations for the three months ended September 30, 2023, was $5,908,000, an increase of 34% compared to a loss of $4,407,000 in the same period of 2022[121] - The total cost and expenses for the three months ended September 30, 2023, were $6,015,000, an increase of 33% compared to $4,518,000 in the same period of 2022[121] - The company incurred a net loss of $3.6 million for the nine months ended September 30, 2023, with an accumulated deficit of $259.2 million[138] - The gain from discontinued operations increased by $19.6 million for the three months ended September 30, 2023, primarily driven by a one-time gain of approximately $15.8 million and a $5.0 million decrease in research and development expenses[129] - For the nine months ended September 30, 2023, the gain from discontinued operations increased by approximately $30.3 million, with a one-time gain of approximately $15.8 million and a $17.8 million decrease in research and development expenses[130] Expenses - Research and development expenses for the three months ended September 30, 2023, were $580,000, a decrease of approximately 59% from $1,414,000 in the same period of 2022[121] - General and administrative expenses for the three months ended September 30, 2023, were $2,131,000, a decrease of approximately 31% from $3,104,000 in the same period of 2022[121] - Research and development expenses for the nine months ended September 30, 2023, were $1,491,000, a decrease of approximately 69% from $4,803,000 in the same period of 2022[121] - General and administrative expenses for the nine months ended September 30, 2023, were $6,361,000, a decrease of approximately 34% from $9,579,000 in the same period of 2022[121] Cash Flow - Net cash used in operating activities was $19.7 million for the nine months ended September 30, 2023, a decrease of 41% compared to $33.6 million for the same period in 2022[142] - Net cash provided by investing activities for the nine months ended September 30, 2023, was $10.4 million, attributed to cash proceeds from the disposal of discontinued operations[143] - Net cash provided by financing activities for the nine months ended September 30, 2023, was $5.0 million, resulting from a stock purchase agreement[144] - As of September 30, 2023, the company had approximately $9.1 million of unrestricted cash and cash equivalents[136] - The company expects its cash, cash equivalents, and marketable securities as of September 30, 2023, to be sufficient to fund operations into 2025, but additional funding will be needed to sustain operations[145] Company Outlook - The company anticipates making ongoing determinations regarding which additional programs to pursue based on study data and competitive landscape assessments[114] - The company has incurred recurring losses since inception and substantial doubt exists about its ability to continue as a going concern[138] Corporate Actions - A reverse stock split of 1-for-20 was executed on May 15, 2023, affecting all share amounts and per share amounts disclosed in the report[140] Impairment - The impairment loss recognized during the three months ended September 30, 2023, was approximately $3.3 million, with no impairment loss recorded in the same period of 2022[128] Future Milestones - The company is eligible to receive up to $585 million in total potential future milestone payments related to the development and commercialization of praliciguat[107]

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 June 30, 2023 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 CYCLERION THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Massachusetts Registrant's Telephone Nu ...

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 March 31, 2023 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 CYCLERION THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Massachusetts (State or other jurisdic ...