1 unchanged sentence
Disclosure Controls and Procedures
−Removed: We maintain “disclosure controls and procedures,”
−Removed: as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and our principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.
+Added: We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and our principal financial officers, as appropriate, to allow timely decisions regarding required disclosure.
With respect to the year ended December 31, 2023, under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of the design and operations of our disclosure controls and procedures.
−Removed: Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2022 to provide reasonable assurance that the information required to be disclosed by us in this Annual Report was (a) reported within the time periods specified by SEC rules and regulations and (b) communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding any required disclosure.
+Added: Based upon this evaluation, our President and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2023 to provide reasonable assurance that the information required to be disclosed by us in this Annual Report was (a) reported within the time periods specified by SEC rules and regulations and (b) communicated to our management, including our President and Chief Financial Officer, to allow timely decisions regarding any required disclosure.
Management's Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of consolidated financial statements for external purposes in accordance with U.S.
−Removed: generally accepted accounting principles (“GAAP”).
−Removed: Internal control over financial reporting is a process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
+Added: generally accepted accounting principles (“GAAP”).
+Added: Internal control over financial reporting is a process designed by, or under the supervision of, our President and Chief Financial Officer, and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
• Pertain to the maintenance of records that accurately and fairly reflect in reasonable detail the transactions and dispositions of the assets of our company;
2 unchanged sentences
Management assessed our internal control over financial reporting as of December 31, 2023, the end of our fiscal year.
−Removed: Management based its assessment on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).
−Removed: Management’s assessment included evaluation of elements such as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment.
+Added: Management based its assessment on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework).
+Added: Management’s assessment included evaluation of elements such as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment.
Based on this assessment, management has concluded that our internal controls over financial reporting were effective as of December 31, 2023 and provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with GAAP.
−Removed: We reviewed the results of management’s assessment with the Audit Committee of our Board of Directors.
+Added: We reviewed the results of management’s assessment with the Audit Committee of our Board of Directors.
Internal control over financial reporting has inherent limitations.
2 unchanged sentences
Because of such limitations, there is a risk that material misstatements will not be prevented or detected on a timely basis by internal control over financial reporting.
−Removed: However, these inherent limitations are known features of the financial reporting process.
+Added: However, these inherent
+Added: limitations are known features of the financial reporting process.
Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
1 unchanged sentence
This Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting.
−Removed: Our report was not subject to attestation by our independent registered public accounting firm pursuant to the rules of the Securities and Exchange Commission for “emerging growth companies”
−Removed: that permit us to provide only management’s report in this report.
+Added: Our report was not subject to attestation by our independent registered public accounting firm pursuant to the rules of the Securities and Exchange Commission for “emerging growth companies” that permit us to provide only management’s report in this report.
Changes in Internal Control over Financial Reporting
5 unchanged sentences
The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
−Removed: Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level.
+Added: Our management, including our President and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level.
However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud.
Other Information.
−Removed: Not applicable.
+Added: (b) Director and Officer Trading Arrangements
+Added: None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement, or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the fourth quarter ended December 31, 2023.
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections.
4 unchanged sentences
Directors, Executive Of ficers and Corporate Governance.
−Removed: The information required by this Item 10 will be included in our Proxy Statement under the captions “Information Regarding the Board of Directors and Corporate Governance,”
−Removed: “Election of Directors,”
−Removed: “Executive Officers”
−Removed: and “Section 16(a) Beneficial Ownership Reporting Compliance”
−Removed: and is incorporated herein by reference.
+Added: The information required by this Item 10 will be included in our Proxy Statement under the captions “Information Regarding the Board of Directors and Corporate Governance,” “Election of Directors,” “Executive Officers” and “Section 16(a) Beneficial Ownership Reporting Compliance” and is incorporated herein by reference.
Executiv e Compensation.
−Removed: The information required by this Item 11 will be included in our Proxy Statement under the captions “Executive Compensation”
−Removed: and “Director Compensation”
−Removed: and is incorporated herein by reference.
+Added: The information required by this Item 11 will be included in our Proxy Statement under the captions “Executive Compensation” and “Director Compensation” and is incorporated herein by reference.
Security Ownership of Certain Beneficial Ow ners and Management and Related Stockholder Matters.
−Removed: The information required by this Item 12 will be included in our Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and Management”
−Removed: and “Securities Authorized for Issuance under Equity Compensation Plans”
−Removed: and is incorporated herein by reference.
+Added: The information required by this Item 12 will be included in our Proxy Statement under the captions “Security Ownership of Certain Beneficial Owners and Management” and “Securities Authorized for Issuance under Equity Compensation Plans” and is incorporated herein by reference.
Certain Relationships and Related Transactions, and Director Independence.
−Removed: The information required by this Item 13 will be included in our Proxy Statement under the captions “Transactions with Related Persons”
−Removed: and “Independence of the Board of Directors”
−Removed: and is incorporated herein by reference.
+Added: The information required by this Item 13 will be included in our Proxy Statement under the captions “Transactions with Related Persons” and “Independence of the Board of Directors” and is incorporated herein by reference.
Principal Accou nting Fees and Services.
−Removed: The information required by this Item 14 will be included in our Proxy Statement under the caption “Ratification of Selection of Independent Registered Public Accounting Firm”
−Removed: and is incorporated herein by reference.
+Added: The information required by this Item 14 will be included in our Proxy Statement under the caption “Ratification of Selection of Independent Registered Public Accounting Firm” and is incorporated herein by reference.
Exhibits, Financ ial Statement Schedules.
10 unchanged sentences
(incorporated by reference to Exhibit 4.1 to Registration Statement on Form S-8 filed on March 29, 2019) (File No.
+Added: Articles of Amendment to Amended and Restated Articles of Incorporation dated May 15, 2023 (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed on May 15, 2023) (File No.001-38787)
+Added: Articles of Amendment to Amended and Restated Articles of Incorporation dated May 19, 2023 (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed on May 25, 2023) (File No.
Amended and Restated Bylaws of Cyclerion Therapeutics, Inc.
40 unchanged sentences
Non-Employee Director Compensation Policy (amended and restated as of December 17, 2021) (incorporated by reference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed on May 4, 2022 (File No.
−Removed: Open Market Sale Agreement, dated September 3, 2020, by and between Cyclerion Therapeutics, Inc.
−Removed: and Jefferies LLC (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on September 3, 2020 (File No.
License Agreement, dated as of June 3, 2021, by and between Cyclerion Therapeutics, Inc.
3 unchanged sentences
333-257145)).
+Added: Offer Letter to Regina Graul dated December 1, 2023
+Added: Consulting Agreement with Peter Hecht dated December 1, 2023
+Added: Restricted Stock Agreement with Regina Graul dated December 1, 2023.
+Added: Restricted Stock Agreement with Peter Hecht dated December 1, 2023.
+Added: Restricted Stock Agreement with Regina Graul dated January 1, 2024.
+Added: Restricted Stock Agreement with Peter Hecht dated January 1, 2024.
List of Subsidiaries
6 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
+Added: Policy for the Recovery of Erroneously Awarded Compensation adopted November 30, 2023
Inline XBRL Instance Document
Inline XBRL Taxonomy Extension Schema Document
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document
Cover Page Interactive Data File
5 unchanged sentences
CYCLERION THERAPEUTICS, INC.
−Removed: /s/ Peter Hecht
−Removed: Chief Executive Officer
+Added: /s/ Regina Graul
POWER OF ATTORNEY
−Removed: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Peter M.
−Removed: Hecht and Anjeza Gjino, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Cyclerion Therapeutics, Inc.,
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Regina Graul and Rhonda Chicko, jointly and severally, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Cyclerion Therapeutics, Inc.,
and any or all amendments thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorneys-in-fact and agents, or his, her or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on March 5, 2024.
−Removed: /s/ Peter Hecht
−Removed: Chief Executive Officer (Principal Executive Officer)
−Removed: /s/ Anjeza Gjino
+Added: /s/ Regina Graul
+Added: President (Principal Executive Officer)
+Added: /s/ Rhonda Chicko
+Added: Rhonda Chicko
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
1 unchanged sentence
Errol De Souza
−Removed: /s/ George Conrades
−Removed: George Conrades
−Removed: /s/ Marsha Fanucci
−Removed: Marsha Fanucci
−Removed: /s/ Ole Isacson
−Removed: /s/ Stephanie Lovell
−Removed: Stephanie Lovell
+Added: /s/ Peter Hecht
+Added: /s/ Michael Higgins
+Added: Michael Higgins
+Added: /s/ Steven Hyman
+Added: /s/ Dina Katabi
/s/ Terrance McGuire
Terrance McGuire
−Removed: /s/ Michael Mendelsohn
−Removed: Michael Mendelsohn
−Removed: /s/ Steven Hyman
Index to Consolidated Financial Statements of Cyclerion Therapeutics, Inc.
2 unchanged sentences
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2023 and 2022
−Removed: Consolidated Statement of Stockholders’
−Removed: Equity for the Years Ended December 31, 2022 and 2021
+Added: Consolidated Statement of Stockholders’ Equity for the Years Ended December 31, 2023 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
4 unchanged sentences
We have audited the accompanying consolidated balance sheets of Cyclerion Therapeutics, Inc.
−Removed: (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders' equity and cash flows for each of the two years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders' equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with U.S.
2 unchanged sentences
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations, has limited financial resources, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern.
−Removed: Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1.
+Added: As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations, has limited financial resources, and has stated that substantial doubt exists about the Company’s ability to continue as a going concern.
+Added: Management's evaluation of the events and conditions and management’s plans regarding these matters are also described in Note 1.
The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
1 unchanged sentence
These financial statements are the responsibility of the Company's management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
−Removed: We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
1 unchanged sentence
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
+Added: Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
2 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: We have served as the Company’s auditor since 2018.
+Added: We have served as the Company’s auditor since 2018.
Boston, Massachusetts
10 unchanged sentences
Total current assets
−Removed: Property and equipment, net
Operating lease right-of-use asset
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: Other investment
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
5 unchanged sentences
Stockholders' equity
−Removed: Common stock, no par value, 400,000,000 shares authorized and 43,518,724 issued and outstanding at December 31, 2022 and 400,000,000 shares authorized and 43,410,185 issued and outstanding at December 31, 2021
+Added: Preferred shares, no par value, 500,000 shares authorized and 351,037 series A convertible preferred stock issued and outstanding at December 31, 2023
+Added: Common stock, no par value, 20,000,000 shares authorized at December 31, 2023 and 2022;
+Added: 2,645,096 and 2,175,936 shares issued at December 31, 2023 and 2022, respectively;
+Added: 2,474,159 and 2,175,936 shares outstanding at December 31, 2023, and 2022, respectively (*)
Paid-in capital
4 unchanged sentences
The accompanying notes are an integral part of these consolidated financial statements.
+Added: *Adjusted retroactively for reverse stock split - see Note 1
Cyclerion Therapeutics, Inc.
2 unchanged sentences
Year Ended December 31,
−Removed: Revenue from license agreement
Revenue from development agreement
−Removed: Revenue from grants
Total revenues
2 unchanged sentences
General and administrative
−Removed: Loss on lease termination
+Added: Impairment loss
Total cost and expenses
Loss from operations
−Removed: Gain on extinguishment of debt
−Removed: Interest and other income (expenses), net
+Added: Interest and other income, net
+Added: Net loss from continuing operations
+Added: Discontinued operations:
+Added: Gain (loss) from discontinued operations
+Added: Net income (loss) per share - basic and diluted (*)
+Added: Net loss per share from continuing operations
+Added: Net income (loss) per share from discontinued operations
Net loss per share (*)
−Removed: Basic and diluted net loss per share
Weighted average shares used in calculating:
−Removed: Basic and diluted net loss per share
+Added: Basic and diluted shares (*)
Other comprehensive loss:
3 unchanged sentences
The accompanying notes are an integral part of these consolidated financial statements.
+Added: *Adjusted retroactively for reverse stock split - see Note 1
Cyclerion Therapeutics, Inc.
−Removed: Consolidated Statement s of Stockholders’
+Added: Consolidated Statement s of Stockholders’ Equity
(In thousands except share data)
+Added: Preferred Stock
comprehensive
−Removed: Stockholders’
+Added: Stockholders’
Balance at December 31, 2021
−Removed: Issuance of common stock - 2021 equity private placement and ATM
Issuance of common stock upon exercise of stock options, RSUs and employee stock purchase plan
Share-based compensation expense related to issuance of stock options and RSUs to employees and employee stock purchase plan
−Removed: Share-based compensation expense related to issuance of stock options and RSUs to non-employees
+Added: Share‑based compensation expense related to issuance of stock options to non-employees
Foreign currency translation adjustment
Balance at December 31, 2022
+Added: Issuance of common stock
+Added: Issuance of preferred stock
Issuance of common stock upon exercise of stock options, RSUs and employee stock purchase plan
+Added: Vesting of restricted stock awards
Share-based compensation expense related to issuance of stock options and RSUs to employees and employee stock purchase plan
−Removed: Share-based compensation expense related to issuance of stock options and RSUs to non-employees
+Added: Share‑based compensation expense related to issuance of stock options to non-employees
Foreign currency translation adjustment
+Added: Fractional shares issuance
Balance at December 31, 2023
The accompanying notes are an integral part of these consolidated financial statements.
+Added: *Adjusted retroactively for reverse stock split - see Note 1
Cyclerion Therapeutics, Inc.
4 unchanged sentences
Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Gain on disposal of discontinued operations
Depreciation and amortization
−Removed: Net loss on disposal of property and equipment
−Removed: Loss on lease termination
−Removed: Gain on extinguishment of debt
+Added: Impairment loss
Share-based compensation expense
1 unchanged sentence
Accounts receivable
−Removed: Related party accounts receivable
Prepaid expenses
2 unchanged sentences
Accounts payable
−Removed: Related party accounts payable
Accrued research and development costs
−Removed: Operating lease liabilities
Accrued expenses and other current liabilities
1 unchanged sentence
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Purchases of property and equipment
−Removed: Proceeds from sale of property and equipment
+Added: Net proceeds from disposal of discontinued operations
Net cash provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from equity private placement and ATM
+Added: Proceeds from stock purchase agreement
Proceeds from exercises of stock options and ESPP
4 unchanged sentences
Cash and cash equivalents, end of period
+Added: Supplemental cash flow disclosure:
+Added: Non-cash gain on disposal of discontinued operations
The accompanying notes are an integral part of these consolidated financial statements.
4 unchanged sentences
Cyclerion Therapeutics, Inc.
−Removed: (“Cyclerion”, the “Company”
−Removed: or “we”) is a biopharmaceutical company on a mission to develop treatments for serious diseases.
−Removed: Our lead internal asset, zagociguat, is a pioneering, central nervous system ("CNS")-penetrant, soluble guanylate cyclase ("sGC") stimulator that has shown rapid improvements across a range of endpoints reflecting multiple domains of disease activity, including mitochondrial disease-associated biomarkers.
−Removed: sGC stimulators are small molecules that act synergistically with nitric oxide ("NO") as positive allosteric modulators of sGC to boost production of cyclic guanosine monophosphate ("cGMP").
−Removed: cGMP is a key second messenger that, when produced by sGC, regulates diverse and critical biological functions such as mitochondrial function, neuronal function, inflammation, and vascular dynamics.
+Added: (“Cyclerion”, the “Company” or “we”) became an independent public company on April 1, 2019 after Ironwood Pharmaceuticals, Inc., or Ironwood, completed a tax-free spin-off of its sGC business, which we refer to herein as the "Separation".
+Added: Cyclerion has one employee as of December 31, 2023.
+Added: At inception, Cyclerion was a biopharmaceutical company focused on the treatment of serious diseases with novel soluble guanylate cyclase ("sGC") stimulators in both the CNS and the periphery.
+Added: The nitric oxide ("NO") sGC cyclic guanosine monophosphate ("cGMP") signaling pathway is a fundamental mechanism that precisely controls key aspects of physiology throughout the body.
+Added: The NO-sGC-cGMP pathway regulates diverse and critical biological functions in both the central nervous system ("CNS") and the periphery and has been successfully targeted with several drugs.
+Added: Praliciguat is an orally administered, once-daily systemic sGC stimulator.
+Added: On June 3, 2021, Cyclerion entered into a license agreement (as defined below) with Akebia Therapeutics Inc.
+Added: (“Akebia”) relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement.
+Added: Cyclerion is eligible to receive up to $ 585 million in total potential future development, regulatory, and commercialization milestone payments.
+Added: Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages and subject to reduction upon expiration of patent rights or the launch of a generic product.
+Added: Olinciguat is a phase 2 an orally administered, once-daily, vascular sGC stimulator that Cyclerion intends to out-license to an entity with strong cardiovascular and/or cardiopulmonary capabilities.
+Added: Zagociguat is a clinical-stage CNS-penetrant sGC stimulator that has shown rapid improvement in cerebral blood flow, functional brain connectivity, brain response to visual stimulus, cognitive performance, and biomarkers associated mitochondrial function and inflammation in clinical studies.
+Added: CY3018 is a CNS-targeted sGC stimulator that preferentially localizes to the brain and has a pharmacology profile that suggests its potential for the treatment of neuropsychiatric diseases and disorders.
+Added: On July 28, 2023, the Company sold Zagociguat and CY3018 to Tisento Therapeutics, Inc.
+Added: (“Tisento”), a newly formed private company focused on their development, in exchange for $ 8.0 million in cash consideration, $ 2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 for the period between signing and closing of the transaction, and 10 % of all of Tisento ’s parent’s outstanding equity securities.
+Added: See “Asset Purchase Agreement” and “Note 4” below.
+Added: Cyclerion is actively evaluating other activities aimed at enhancing shareholder value, which may potentially include collaborations, licenses, mergers, acquisitions and/or other targeted investments.
+Added: The Company has shifted its strategy to identify, non-sGC stimulator assets within the CNS therapeutic area to build a new portfolio.
+Added: If the Company identifies suitable new assets, they will develop the new assets and retain contract research, development and manufacturing organizations for these specific purposes.
+Added: Additionally, Cyclerion plans to raise funds for further research and development activities associated with any new assets.
+Added: The Company’s goal is to find the best combination of capital, capabilities, and transactions that will enable the advancement of current and any future assets the Company may acquire for patients in a way that maximizes shareholder value.
Cyclerion GmbH, a wholly owned subsidiary, was incorporated in Zug, Switzerland on May 3, 2019.
The functional currency is the Swiss franc.
+Added: Subsequent to December 31, 2023 , the liquidation process for Cyclerion GmbH has been concluded and the subsidiary is pending deregistration from the commercial registry.
+Added: Cyclerion GmbH has no employees.
Cyclerion Securities Corporation, a wholly owned subsidiary, was incorporated in Massachusetts on November 15, 2019 and was granted securities corporation status in Massachusetts for the 2019 tax year.
Cyclerion Securities Corporation has no employees.
−Removed: Company Overview
−Removed: The Company’s mission is to develop treatments for serious CNS diseases.
−Removed: Zagociguat is an orally administered CNS-penetrant sGC stimulator.
−Removed: As an sGC stimulator, zagociguat acts as a positive allosteric modulator to sensitize the sGC enzyme to NO, increase the production of cGMP, and thereby amplify endogenous NO signaling.
−Removed: By compensating for deficient NO-sGC-cGMP signaling, zagociguat may have broad therapeutic potential as a treatment to improve cognition and function in people with serious CNS diseases.
−Removed: On January 13, 2020, we announced positive results from our Phase 1 first-in-human study that provided the foundation for continued development of zagociguat.
−Removed: The results from this study indicate that zagociguat was well tolerated.
−Removed: Pharmacokinetic data, obtained from both blood and cerebral spinal fluid ("CSF"), support once-daily dosing, with or without food, and demonstrated zagociguat penetration of the blood-brain-barrier with CSF concentrations expected to be pharmacologically active.
−Removed: On October 14, 2020, we announced positive topline results from our zagociguat Phase 1 translational pharmacology study in healthy elderly participants.
−Removed: Treatment with zagociguat for 15-days in this 24-subject study confirmed and extended results seen in the earlier first-in-human Phase 1 study:
−Removed: once daily oral treatment demonstrated blood-brain-barrier penetration with expected CNS exposure and target engagement.
−Removed: Results also showed significant improvements in neurophysiological and objective performance measures as well as in inflammatory biomarkers associated with aging and neurodegenerative diseases.
−Removed: Zagociguat was safe and generally well tolerated in this study.
−Removed: These results, together with nonclinical data, supported the continued development of zagociguat as a potential new medicine for serious diseases involving the CNS.
−Removed: On June 10, 2022, we announced positive topline clinical data for zagociguat in our signal-seeking clinical study for the potential treatment of MELAS.
−Removed: In this open-label, single-arm study of the oral, once-daily sGC stimulator in eight adults aged 18 or older with MELAS, improvements were seen across a range of endpoints reflecting multiple domains of disease activity, including mitochondrial disease-associated biomarker such as lactate and GDF-15, a broad panel of inflammatory biomarkers, cerebral blood flow, and functional connectivity between neural networks.
−Removed: These positive effects after 29 days of dosing were supported by correlations across several endpoints with each other and with zagociguat plasma concentrations.
−Removed: Zagociguat was well tolerated with no adverse events and no events leading to discontinuation.
−Removed: Pharmacokinetics were consistent with the Phase 1 studies in healthy volunteers.
−Removed: The positive data from this study support the potential of zagociguat to provide therapeutic
−Removed: benefit to people living with mitochondrial diseases, including Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes ("MELAS").
−Removed: On July 28, 2022, we announced positive topline data from our signal-seeking clinical study of zagociguat for the potential treatment of Cognitive Impairment Associated with Schizophrenia ("CIAS").
−Removed: Data from the 14-day, double blind, randomized, placebo-controlled, multiple-ascending-dose study in 48 adults aged 18-50 with stable schizophrenia on a stable, single atypical antipsychotic regimen demonstrate that once-daily zagociguat was safe and well tolerated, with no reports of serious adverse events, severe adverse events, or treatment discontinuation due to adverse events.
−Removed: We further announced that study data demonstrated a strong effect on cognitive performance after two weeks of 15mg once-daily dosing and that positive movement on inflammatory biomarkers was also observed.
−Removed: These signals on exploratory endpoints are consistent with pro-cognitive and anti-inflammatory effects of zagociguat observed in preclinical studies and prior clinical trials and support the further development of oral, once-daily zagociguat.
−Removed: In October 2022, the WHO International Nonproprietary Names committee and the United States Adopted Name council selected zagociguat as a nonproprietary name for CY6463.
−Removed: On October 6, 2022, we announced that we had recently capped enrollment in our signal-seeking clinical study of zagociguat for the potential treatment of Alzheimer's disease with vascular pathology ("ADv")..Data from the ADv study are expected in the first half of 2023.
−Removed: The ADv study is supported in part by a $2 million grant from the Alzheimer’s Association’s Part the Cloud-Gates Partnership Grant Program (the "PTC Grant").
−Removed: On March 22, 2023, we announced that given the significant capital and capabilities necessary to ensure that the MELAS Phase 2b study is executed efficiently and with the highest quality, and the currently unfavorable capital market conditions, we are actively evaluating the best combination of capital, capabilities, and transactions available to us to advance the development of zagociguat and our other clinical development candidates and to maximize shareholder value.
−Removed: CY3018 is a CNS-targeted sGC stimulator in preclinical development that preferentially localizes to the brain and has a pharmacology profile that suggests its potential for the treatment of neuropsychiatric diseases and disorders.
−Removed: Praliciguat is an orally administered, once-daily systemic sGC stimulator.
−Removed: On June 3, 2021, we entered into the Akebia License Agreement (as defined below) relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing praliciguat and other related products and forms thereof enumerated in such agreement.
−Removed: Cyclerion is eligible to receive up to $ 225 million in pre-commercial milestones and total potential future development, regulatory, and commercialization milestone payments could result in up to $ 585 million.
−Removed: Cyclerion is also eligible to receive tiered, sales-based royalties ranging from single-digit to high-teen percentages.
−Removed: Olinciguat is an orally administered, once-daily, vascular sGC stimulator that was evaluated in a Phase 2 study of participants with sickle cell disease.
−Removed: We released topline results from this study in October 2020.
−Removed: We continue to work to out-license olinciguat to an entity with strong cardiovascular and/or cardiopulmonary capabilities.
−Removed: 2021 Equity Private Placement
−Removed: On June 3, 2021, the Company entered into a Common Stock Purchase Agreement (the “2021 Equity Private Placement”) for the private placement of 5,735,988 shares of the Company’s common stock, for total gross proceeds of approximately $ 18 million.
−Removed: The closing of the 2021 Equity Private Placement occurred on June 7, 2021.
−Removed: The Company did not utilize the services of a placement agent or broker and accordingly incurred no material related transaction fees or commissions.
+Added: Stock Purchase Agreement
+Added: In March 2023, the Company entered into a stock purchase agreement with the Company's former Chief Executive Officer (the “CEO”) pursuant to which he invested $ 5 million in cash for 225,000 shares of common stock and 351,037 shares of Series A Convertible Preferred Stock of the Company at a price of $ 8.68 per share (after giving effect to the 1-for-20 reverse stock split the Company implemented on May 15, 2023).
+Added: Such Series A Convertible Preferred Stock is convertible into shares of our common stock on a one-to-one basis.
+Added: The closing of the equity investment took place on May 19, 2023, and (to comply with Nasdaq listing requirements) our shareholders approved such convertibility on July 19, 2023.
+Added: Asset Purchase Agreement
+Added: On May 11, 2023, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with an investor group that included the former CEO, JW Celtics Investment Corp and JW Cycle Inc.
+Added: which subsequently changed their names to Tisento Therapeutics Holdings Inc.
+Added: (“Tisento Parent”) and Tisento.
+Added: Upon the closing on July 28, 2023, of the transactions contemplated by the Asset Purchase Agreement, the Company sold to Tisento specified assets relating to the Company’s zagociguat and CY3018 programs (the "Transferred Assets") and Tisento assumed certain liabilities relating thereto, including, but not limited to (i) liabilities, costs and expenses arising after the date of the Asset Purchase Agreement relating to the employment of certain Cyclerion employees and the conduct of certain preclinical and clinical trial activities prior to the closing of the transactions contemplated by the Asset Purchase Agreement, and (ii) liabilities relating to such assets to the extent relating to the period after the closing of the transaction.
+Added: In consideration for such sale and assumption, at such closing the Company received proceeds of $8.0 million as cash consideration, $2.4 million as reimbursement for certain operating expenses related to such assets for the period between signing and closing of the Asset Purchase Agreement, and shares of common stock of Tisento Parent comprising 10% of the then issued and outstanding equity securities of Tisento Parent immediately following such closing, subject to certain protections against dilution.
+Added: Reverse Stock Split
+Added: On May 15, 2023, the Company filed Articles of Amendment to the Company's Restated Articles of Organization with the Secretary of Commonwealth of Massachusetts to effect a 1-for-20 reverse stock split of the Company's issued and outstanding shares of common stock.
+Added: The reverse stock split was reflected on the Nasdaq Capital Market beginning with the opening of trading on May 16, 2023.
+Added: All share amounts and per share amounts disclosed in this Annual Report on Form 10-K have been adjusted retroactively to reflect the reverse stock split for all periods presented.
At-the-Market Offering
−Removed: On July 24, 2020, the Company filed a Registration Statement on Form S-3 (the "Shelf") with the Securities and Exchange Commission (the “SEC”) in relation to the registration of common stock, preferred stock, debt securities, warrants and units of any combination thereof for an aggregate initial offering price not to exceed $ 150.0 million.
−Removed: The Shelf was declared effective as of July 31, 2020.
−Removed: On September 3, 2020, the Company entered into a Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering (the “ATM Offering”) under the Shelf.
−Removed: Under the ATM Offering, the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million through Jefferies as its sales agent.
−Removed: The Company will pay to Jefferies cash commissions of 3.0 percent of the gross proceeds of sales of common stock under the Sales Agreement.
−Removed: The Company has sold 3,353,059 shares of its common stock for net proceeds of $ 12.5 million under the ATM Offering for the year ended December 31, 2021.
−Removed: No shares of common stock have been issued or sold under the ATM Offering during the year ended December 31, 2022.
+Added: On September 3, 2020, the Company entered into a Sales Agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) with respect to an at-the-market offering (the “ATM Offering”) under the Shelf.
+Added: Under the ATM Offering, the Company could offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $ 50.0 million through Jefferies as its sales agent.
+Added: The Company agreed to pay Jefferies cash commissions of 3.0 percent of the gross proceeds of sales of common stock which could be sold under the Sales Agreement.
+Added: Prior to January 1, 2022, the Company sold 3,353,059 shares of its common stock for net proceeds of $ 12.5 million under the ATM Offering, since entering into the Sales Agreement.
+Added: No shares of common stock have been issued or sold under the ATM Offering in 2022 or 2023.
+Added: The Shelf expired in July 31, 2023.
+Added: Due to the current market value of our publicly traded common stock held by non-affiliates, our ability to raise future funding though a shelf offering will be limited.
Basis of Presentation
1 unchanged sentence
generally accepted accounting principles .
−Removed: In the opinion of management, the consolidated financial statements reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial position and the results of its operations for the fiscal years presented.
+Added: In the opinion of management, the consolidated financial statements reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial position and the results of its operations for the fiscal years presented.
The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries, Cyclerion GmbH, and Cyclerion Securities Corporation.
1 unchanged sentence
Going Concern
−Removed: At each reporting period, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
−Removed: The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs and comparing those needs to the current cash and cash equivalent balances.
−Removed: The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern.
−Removed: In accordance with Accounting Standards Codification ("ASC") 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
−Removed: This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued.
−Removed: When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern.
−Removed: The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
+Added: At each reporting period, in accordance with Accounting Standards Codification ("ASC") 205-40, Going Concern, the Company evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
+Added: The Company’s evaluation entails analyzing prospective operating budgets and forecasts for expectations of the Company’s cash needs and comparing those needs to the current cash and cash equivalent balances.
+Added: The Company is required to make certain additional disclosures if it concludes substantial doubt exists and it is not alleviated by the Company’s plans or when its plans alleviate substantial doubt about the Company’s ability to continue as a going concern.
+Added: This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued.
+Added: When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern.
+Added: The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable.
−Removed: Under ASC 205-40, the future receipt of potential funding from future partnerships, equity or debt issuances, and the potential milestones from the Akebia agreement cannot be considered probable at this time because these plans are not entirely within the Company’s control and/or have not been approved by the Board of Directors as of the date of these consolidated financial statements.
−Removed: The Company has incurred recurring losses since its inception, including a net loss of $ 44.1 million for the year ended December 31, 2022.
−Removed: In addition, as of December 31, 2022 , the Company had an accumulated deficit of $ 259.2 million.
−Removed: The Company expects to continue to generate operating losses for the foreseeable future.
−Removed: Company expects that its cash, cash equivalents and marketable securities as of December 31, 2022 will not be sufficient to fund operations for at least the next twelve months from the date of issuance of these consolidated financial statements and the Company will need to obtain additional funding.
−Removed: Accordingly, the Company has concluded that substantial doubt exists about the Company's ability to continue as a going concern for a period of at least 12 months from the date of issuance of these consolidated financial statements.
+Added: Under ASC 205-40, the future receipt of potential funding from future partnerships, equity or debt issuances, certain cost reduction measures and the potential milestones from the Akebia agreement cannot be considered probable at this time because these plans are not entirely within the Company’s control and/or have not been approved by the Board of Directors as of the date of these consolidated financial statements.
+Added: The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2023 , will be sufficient to fund operations through the first quarter of 2025, however the Company will need to obtain additional funding to sustain operations as it expects to continue to generate operating losses for the foreseeable future.
+Added: The Company's expectation to generate negative operating cash flows in the future and the need for additional funding to support its planned operations, raise substantial doubt regarding the Company’s ability to continue as a going concern.
+Added: Management's plans to alleviate the conditions that raise substantial doubt include reduced spending, and the pursuit of additional capital.
+Added: Management has concluded the likelihood that its plan to successfully obtain sufficient funding, or adequately reduce expenditures, while reasonably possible, is less than probable.
+Added: Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business.
The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
−Removed: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
−Removed: On June 1, 2022, the Company received a notice from the Nasdaq Stock Market ("Nasdaq") notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company's common stock listed on Nasdaq has been below the minimum $ 1.00 per share required for continued listing on the Nasdaq Global Select Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the "Bid Price Requirement").
−Removed: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a period of 180 calendar days, or until November 28, 2022, to regain compliance with the Bid Price Requirement.
−Removed: The Company did not regain compliance with the Bid Price Requirement by the Initial compliance Date.
−Removed: On November 29, 2022, Nasdaq notified the Company that it is eligible for an additional 180 calendar day period, or until May 29, 2023 (the "Extended Compliance Date"), to regain compliance with the Bid Price Requirement.
−Removed: Nasdaq’s determination was based on the Company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the Bid Price Requirement, and the Company’s written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.
−Removed: Effective November 25, 2022, the Company transferred its listing of the Company’s common stock from the Nasdaq Global Market to the Nasdaq Capital Market, a continuous trading market that operates in substantially the same manner as the Nasdaq Global Market.
−Removed: The Company’s common stock continues to trade under the symbol “CYCN”.
−Removed: If at any time before May 29, 2023, the bid price of the Company's common stock closes at a $ 1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will provide written notification to the Company that it has regained compliance with the Bid Price Requirement.
−Removed: If the Company does not regain compliance with the Bid Price Requirement by the end of the second compliance period, the Company's stock will be subject to delisting.
−Removed: The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Bid Price Requirement, including initiating a reverse stock split.
−Removed: However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules.
Summary of Significant Accounting Policies
−Removed: Principles of Consolidation
−Removed: The accompanying consolidated financial statements include the accounts of Cyclerion Therapeutics, Inc.
−Removed: and its wholly owned subsidiaries, Cyclerion GmbH and Cyclerion Securities Corporation.
−Removed: All intercompany transactions and balances are eliminated in consolidation.
Segment Information
−Removed: Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company's Chief Executive Officer who is the chief operating decision maker in
−Removed: deciding how to allocate resources and in assessing performance.
+Added: Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company's President who is the chief operating decision maker in deciding how to allocate resources and in assessing performance.
The Company currently operates in one reportable business segment - human therapeutics.
+Added: Discontinued Operations
+Added: In accordance with ASC 205-20 “Presentation of Financial Statements:
+Added: Discontinued Operations”, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results.
+Added: In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations and disclosed in the notes to financial statements.
+Added: At the same time, the results of all discontinued operations, less applicable income taxes, shall be reported as components of net loss separate from the net income (loss) of continuing operations.
+Added: The Transferred Assets met the definition of a discontinued operation.
+Added: Accordingly, the Company has classified the results of the Transferred Assets as discontinued operations in its consolidated statements of operations for all periods presented.
+Added: All assets and liabilities associated with the Transferred Assets were classified as assets and liabilities of discontinued operations in the Note 4, "Discontinued Operations".
+Added: All amounts included in the notes to the consolidated financial statements relate to continuing operations unless otherwise noted.
+Added: For additional information, see Note 4, “Discontinued Operations”.
+Added: Variable Interest Entities
+Added: The Company reviews each legal entity in which it has a financial interest to determine whether or not the entity is a variable interest entity, or VIE.
+Added: If the entity is a VIE, the Company assesses whether or not it is the primary beneficiary of that VIE based on a number of factors, including (i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the parties’ contractual rights and responsibilities pursuant to any contractual agreements and (iii) which party has the obligation to absorb losses or the right to receive benefits from the VIE.
+Added: If the Company determines that it is the primary beneficiary of a VIE, it consolidates the financial statements of the VIE into its consolidated financial statements at the time that determination is made.
+Added: On a quarterly basis, the Company evaluates whether it continues to be the primary beneficiary of any consolidated VIEs.
+Added: If the Company determines that it is no longer the primary beneficiary of a consolidated VIE, or no longer has a variable interest in the VIE, the Company deconsolidates the VIE in the period that the determination is made.
+Added: The Company accounts for investments in equity securities without a readily determinable fair value at cost, minus impairment.
+Added: If the Company identifies observable price changes in orderly transactions for an identical or a similar investment of the same issuer, the Company will measure the equity security at fair value as of the date that the observable transaction occurred in accordance with ASC Topic 321, Investments-Equity Securities.
Use of Estimates
The preparation of consolidated financial statements in accordance with U.S.
−Removed: generally accepted accounting principles ("GAAP") requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the amounts of expenses during the reported periods.
−Removed: On an ongoing basis, the Company’s management evaluates its estimates, judgments and methodologies.
−Removed: Significant estimates and assumptions in the consolidated financial statements include those related to revenue, impairment of long-lived assets, valuation procedures for right-of-use ("ROU") assets and operating lease liabilities, income taxes, including the valuation allowance for deferred tax assets, research and development expenses, contingencies, share-based compensation, and going concern.
+Added: generally accepted accounting principles ("GAAP") requires the Company’s management to make estimates and judgments that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the amounts of expenses during the reported periods.
+Added: On an ongoing basis, the Company’s management evaluates its estimates, judgments and methodologies.
+Added: Significant estimates and
+Added: assumptions in the consolidated financial statements include those related to revenue, fair value determination of other investment, impairment of long-lived assets, valuation procedures for right-of-use ("ROU") assets and operating lease liabilities, income taxes, including the valuation allowance for deferred tax assets, research and development expenses, contingencies, share-based compensation and going concern.
The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
6 unchanged sentences
Property and Equipment
−Removed: Property and equipment, including leasehold improvements, are recorded at cost, and are depreciated when placed into service using the straight-line method based on their estimated useful lives as follows:
+Added: Property and equipment are recorded at cost, and are depreciated when placed into service using the straight-line method based on their estimated useful lives as follows:
Asset Description
1 unchanged sentence
Life (In Years)
−Removed: Laboratory equipment
−Removed: Computer and office equipment
−Removed: Furniture and fixtures
+Added: Computer equipment
Software costs incurred during the preliminary project stage are expensed as incurred, while costs incurred during the application development stage are capitalized and amortized over the estimated useful life of the software.
3 unchanged sentences
Maintenance and repair costs are expensed as incurred.
−Removed: Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the lease term.
Property and equipment that is no longer required for the business is considered disposed of when it ceases to be used.
4 unchanged sentences
Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
−Removed: Level 1 —
−Removed: Quoted prices in active markets for identical assets or liabilities.
−Removed: Level 2 —
−Removed: Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
−Removed: Level 3 —
−Removed: Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
+Added: • Level 1 — Quoted prices in active markets for identical assets or liabilities.
+Added: • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
+Added: • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Foreign Currency Translation Adjustment
−Removed: The functional currency of the Company’s foreign subsidiary is its local currency, the Swiss franc.
−Removed: The assets and liabilities of the Company’s foreign subsidiary are translated into U.S.
+Added: The functional currency of the Company’s foreign subsidiary is its local currency, the Swiss franc.
+Added: The assets and liabilities of the Company’s foreign subsidiary are translated into U.S.
dollars at exchange rates in effect at the balance sheet date.
Income and expense items are translated at the average exchange rates prevailing during the period.
−Removed: The cumulative translation effect for the Company’s foreign subsidiary is included as a foreign currency translation adjustment in the consolidated statements of stockholders’
−Removed: equity and as a component of comprehensive loss in the consolidated statements of operations and comprehensive loss.
−Removed: The Company’s intercompany accounts are typically denominated in the functional currency of the foreign subsidiary.
+Added: The cumulative translation effect for the Company’s foreign subsidiary is included as a foreign currency translation adjustment in the consolidated statements of stockholders’ equity and as a component of comprehensive loss in the consolidated statements of operations and comprehensive loss.
+Added: The Company’s intercompany accounts are typically denominated in the functional currency of the foreign subsidiary.
Gains and losses resulting from the re-measurement of intercompany balances are recorded in the consolidated statements of operations.
2 unchanged sentences
Provisions are made based upon a specific review of all significant outstanding invoices.
−Removed: The Company’s receivables primarily relate to amounts earned under a development agreement with Ironwood, licensing agreement, and supply agreement.
+Added: The Company’s receivables primarily relate to amounts earned under a development agreement with Ironwood, licensing agreement, and supply agreement.
The Company believes that credit risks associated with these agreements are not significant.
2 unchanged sentences
The Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist, which warrant adjustments to carrying values or estimated useful lives.
−Removed: If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable.
+Added: If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable.
If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value.
−Removed: There were no significant impairments of long-lived assets for the years ended December 31, 2022 or 2021 .
−Removed: Effective January 1, 2019, the Company adopted Accounting Standards Codification (“ASC”) Topic 842, Leases (“ASC 842”) using the optional transition method.
−Removed: The adoption of ASC 842 represents a change in accounting principle that aims to increase transparency and comparability among organizations by requiring the
−Removed: recognition of right-of-use assets and lease liabilities on the balance sheet for both operating and finance leases.
+Added: There were no significant impairments of long-lived assets for the years ended December 31, 2023 or 2022, except for the impairment loss of ROU assets recognized during the year ended December 31, 2023 .
+Added: Effective January 1, 2019, the Company adopted Accounting Standards Codification (“ASC”) Topic 842, Leases (“ASC 842”) using the optional transition method.
+Added: The adoption of ASC 842 represents a change in accounting principle that aims to increase transparency and comparability among organizations by requiring the recognition of right-of-use assets and lease liabilities on the balance sheet for both operating and finance leases.
In addition, the standard requires enhanced disclosures that meet the objective of enabling financial statement users to assess the amount, timing, and uncertainty of cash flows arising from leases.
The reported results for the years ended December 31, 2023 and 2022 reflect the application of ASC 842 guidance.
−Removed: The recognition of right-of-use assets and lease liabilities related to the Company’s operating leases under ASC 842 has had a material impact on the Company’s consolidated financial statements.
+Added: The recognition of right-of-use assets and lease liabilities related to the Company’s operating leases under ASC 842 has had a material impact on the Company’s consolidated financial statements.
As part of the ASC 842 adoption, the Company has used certain practical expedients outlined in the guidance.
6 unchanged sentences
• An entity need not reassess initial direct costs for any existing leases.
−Removed: The Company had a property lease for its headquarters location at 301 Binney Street, Cambridge, MA (the “Head Lease”).
+Added: The Company had a property lease for its headquarters location at 301 Binney Street, Cambridge, MA (the “Head Lease”).
The Company determined if the arrangement was a lease at the inception of the contract.
−Removed: The asset component of the Company’s operating leases was recorded as operating lease right-of-use assets, and the liability component was recorded as current portion of operating lease liabilities and operating lease liabilities, net of current portion, in the Company’s consolidated balance sheets.
+Added: The asset component of the Company’s operating leases was recorded as operating lease right-of-use assets, and the liability component was recorded as current portion of operating lease liabilities and operating lease liabilities, net of current portion, in the Company’s consolidated balance sheets.
ROU assets and operating lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date.
6 unchanged sentences
The Company reviewed any changes to its lease agreements for potential modifications and/or indicators of impairment of the respective ROU asset.
−Removed: On April 30, 2021, the Company entered into a Termination Agreement (the "Termination Agreement") for its Head Lease as initially amended on February 28, 2020, and further amended on September 15, 2020.
−Removed: Pursuant to the Termination Agreement, the Company surrendered the leased space of approximately 57,000 square feet to the building’s landlord.
−Removed: The Company did not pay any termination fees with the Termination Agreement.
−Removed: As a result of the termination of the Head Lease, the related right-of-use asset was written off, the lease liability was derecognized, and the $ 3.8 million security deposit was returned to the Company and recorded as part of our cash balance.
−Removed: In total, the Company recognized a loss on the termination of the Head Lease of $ 0.9 million for the year ended December 31, 2021.
−Removed: The loss is included in “General and administrative”
−Removed: expenses on our consolidated statement of operations and comprehensive loss.
−Removed: On September 15, 2020, the Company entered into a Sublease Termination Agreement (the "Sublease Termination Agreement") to terminate its sublease of 15,700 rentable square feet, of its leased premises under the Head Lease.
−Removed: Under the terms of the Sublease Termination Agreement, the subtenant was relieved of its obligation to provide future cash rental payments to the Company.
−Removed: The agreements requiring the former subtenant to provide
−Removed: licensed rooms and services to the Company free of charge through the original sublease term survived the sublease termination.
−Removed: The Company gained access to the licensed rooms and services beginning in the third quarter of 2021.
−Removed: The letter of credit security deposit related to the sublease was released.
−Removed: The Company determined that the Sublease Termination Agreement constituted a non-monetary exchange under ASC 845 Nonmonetary Transactions ("ASC 845") where, in return for the free rooms and the services, the Company agreed to terminate its rights and obligations under the sublease agreement.
−Removed: In accordance with ASC 845, the Company determined that the accounting for the transaction should be based on the fair value of assets or services involved.
−Removed: The Company estimated the fair value of the rooms and services to be approximately $ 1.5 million and $ 2.9 million, respectively.
−Removed: The Company determined that the licensed rooms represent a lease under ASC Topic 842 Leases.
−Removed: The Company obtained control of the rooms in the third quarter of 2021 and the prepaid rooms balance of approximately $ 1.4 million was reclassified from other assets to a ROU asset.
−Removed: The related lease expense is recognized on a straight-line basis over the lease term of 8.88 years.
−Removed: The Company determined that the licensed services represent a non-lease component, which is recognized separately from the lease component for this asset class.
−Removed: The expense related to the licensed services is recognized on a straight-line basis over the period the services are received.
−Removed: Both the lease expense and services expense are recognized as a component of research and development costs in the consolidated statements of operations and comprehensive loss.
−Removed: In May 2021 the Company signed a 12-month membership agreement to lease space with WeWork at 501 Boylston Street, Boston, Massachusetts, commencing on August 1, 2021.
−Removed: The agreement was extended for six months on August 1, 2022.
−Removed: The 12-month agreement and 6-month extension are accounted for as short-term leases.
−Removed: Paycheck Protection Program Loan
−Removed: On April 21, 2020, the Company received loan proceeds in the amount of approximately $ 3.5 million pursuant to a promissory note agreement with a bank under the Paycheck Protection Program.
−Removed: The Paycheck Protection Program, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business.
−Removed: The Promissory Note had an original loan maturity of April 20, 2022, a stated interest rate of 1.0% per annum, and had payments of principal and interest that were due monthly after an initial six-month deferral period where interest accrued, but no payments were due.
−Removed: The Promissory Note provided for customary events of default, including, among others, those relating to failure to make payment when due and breaches of representations.
−Removed: The loan was subject to all the terms and conditions applicable under the PPP and was subject to review by the SBA for compliance with program requirements, including the Company’s certification that the economic uncertainty, at the time, made the PPP loan request necessary to support ongoing operations.
−Removed: On October 2, 2020, the SBA issued procedural guidance with respect to PPP loans and changes in ownership and the Company believes that it is compliant with respect to the 2020 Equity Private Placement and the ATM Offering.
−Removed: In June 2020, the Payroll Protection Program Flexibility Act was signed into law adjusting certain key terms of loans issued under the PPP.
−Removed: In accordance with the PPPFA, the initial deferral period may be extended from six to up to ten months and the loan maturity may be extended from two to five years.
−Removed: The PPPFA also provided for certain other changes, including the extent to which the loan may be forgiven.
−Removed: The loan’s principal and accrued interest were forgivable to the extent that the proceeds were used for eligible purposes, subject to certain limitations, and that the Company maintained its payroll levels over a twenty-four-week period following the loan date.
−Removed: The loan forgiveness amount may have been reduced if the Company terminated employees or reduced salaries during the twenty-four-week period.
−Removed: PPP loans are subject to audit and the SBA has indicated that companies that received over $2 million in proceeds should expect an audit.
−Removed: The Company believes that it has used the proceeds for eligible purposes consistent with the provisions of the PPPFA.
−Removed: As the legal form of the Promissory Note is a debt obligation, the Company accounted for it as debt under Accounting Standards Codification (ASC) 470, Debt and recorded a short-term liability of $ 3.5 million in the consolidated balance sheets upon receipt of the loan proceeds.
−Removed: The Company accrued interest over the term of the loan and did not record additional interest at a market rate because the guidance on imputing interest in ASC 835-30, Interest excludes transactions where interest rates are prescribed by a government agency.
−Removed: Approximately $ 0.1 million of interest expense has been recognized within interest and other income, net in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2021.
−Removed: In August 2021, the Company applied
−Removed: with the SBA for forgiveness of the PPP loan and was notified on November 4, 2021 that the SBA has approved our application to forgive the entire amount of the loan and accrued interest.
−Removed: The Company recorded a gain on extinguishment of debt of $ 3.6 million in the December 31, 2021 consolidated statements of operations and comprehensive loss, representing the principal and accrued interest for the PPP Loan.
+Added: During the year ended December 31, 2023, the Company recorded $ 3.3 million for impairment of ROU asset.
+Added: See Note 9, “Leases,” for additional information.
Upon executing a revenue generating arrangement, the Company assesses whether it is probable the Company will collect consideration in exchange for the good or service it transfers to the customer.
−Removed: To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), it performs the following five steps:
+Added: To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), it performs the following five steps:
(i) identify the contract(s) with a customer;
6 unchanged sentences
The Company derives revenue from (1) license agreement and (2) supply agreement which are fully described in Note 15, License Agreement .
−Removed: The Company generated revenue from a Development Agreement with Ironwood, pursuant to which the Company provided certain research and development services with respect to certain of Ironwood’s products and product candidates.
−Removed: Such research and development activities were governed by a joint steering committee composed of representatives of both companies.
−Removed: Services performed were invoiced at a mutually agreed upon rate and the initial term of the agreement was two years from the date of Separation and automatically renewed for one year unless either party notified the other at least six months prior to the expiration.
−Removed: Ironwood and the Company agreed that the Development Agreement would not be renewed beyond its initial term which ended on March 31, 2021.
The Company generates revenue from research and development grants under contracts with third parties that do not create customer-vendor relationships.
−Removed: The Company’s research and development grants are non-exchange transactions and are not within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).
−Removed: Contribution revenue earned from activities performed pursuant to research and development grants is reported as grant revenue in the Company’s consolidated statements of operations.
+Added: The Company’s research and development grants are non-exchange transactions and are not within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”).
+Added: Contribution revenue earned from activities performed pursuant to research and development grants is reported as grant revenue in the Company’s consolidated statements of operations.
Revenue from these grants is recognized as the Company incurs qualifying expenses as stipulated by the terms of the respective grant.
16 unchanged sentences
The Company expenses general and administrative costs to operations as incurred.
−Removed: General and administrative expense consists of compensation, share-based compensation, benefits and other employee-related expenses for personnel in the Company’s administrative, finance, legal, information technology, business development and human resource functions.
−Removed: Other costs include the legal costs of pursuing patent protection of the Company’s intellectual property, general and administrative related facility costs, insurance costs and professional fees for accounting and legal services.
+Added: General and administrative expense consists of compensation, share-based compensation, benefits and other employee-related expenses for personnel in the Company’s administrative, finance, legal, information technology, business development and human resource functions.
+Added: Other costs include the legal costs of pursuing patent protection of the Company’s intellectual property, general and administrative related facility costs, insurance costs and professional fees for accounting and legal services.
The Company is primarily subject to U.S.
4 unchanged sentences
Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable.
−Removed: The tax positions taken or expected to be taken in the course of preparing the Company tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not”
−Removed: of being sustained by the applicable tax authority.
+Added: The tax positions taken or expected to be taken in the course of preparing the Company tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority.
Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year.
4 unchanged sentences
There were no uncertain tax positions that require accrual or disclosure in the consolidated financial statements as of December 31, 2023, and 2022.
−Removed: The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense.
+Added: The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense.
As of December 31, 2023 and 2022 , the Company has no accruals for interest or penalties related to income tax matters.
Patent fees and patent related costs in connection with filing and prosecuting patent applications are expensed as incurred and are classified as general and administrative expenses in the accompanying consolidated financial statements.
−Removed: The Company incurred and recorded as operating expense legal and other fees related to patents of approximately $ 1.7 million and $ 1.4 million for the years ended December 31, 2022 and 2021 , respectively.
+Added: The Company incurred and recorded as operating expense legal and other fees related to
+Added: patents of approximately $ 1.1 million and $ 1.7 million for the years ended December 31, 2023 and 2022 , respectively.
Interest and Other Income, Net
−Removed: For the year ended December 31, 2022, interest and other income, net consisted of a $ 0.3 million of interest income related to interest generated from our cash and cash equivalents balances.
−Removed: For the year ended December 31, 2021 , interest and other income, net consisted of a de minimis amount of interest income related to interest generated from our cash and cash equivalents balances and a de minimis amount of interest expense related to the PPP loan.
+Added: For the year ended December 31, 2023 and 2022, interest and other income, net consisted of a $ 0.4 million and $ 0.3 million of interest income related to interest generated from the Company's cash and cash equivalents balances, respectively.
Subsequent Events
−Removed: The Company considers events or transactions that have occurred after the balance sheet date of December 31, 2022, but prior to the filing of the financial statements with the Securities and Exchange Commission, to provide additional evidence relative to certain estimates or to identify matters that require additional recognition
−Removed: or disclosure.
+Added: The Company considers events or transactions that have occurred after the balance sheet date of December 31, 2023, but prior to the filing of the financial statements with the Securities and Exchange Commission, to provide additional evidence relative to certain estimates or to identify matters that require additional recognition or disclosure.
Subsequent events have been evaluated through the filing of the financial statements accompanying this Annual Report on Form 10-K.
1 unchanged sentence
Recently Issued Accounting Pronouncements
−Removed: From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date.
+Added: From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date.
Except as discussed elsewhere in the notes to the consolidated financial statements, the Company did not adopt any new accounting pronouncements during the years ended December 31, 2023 and 2022, that had a material effect on its consolidated financial statements.
+Added: Recently Adopted Accounting Pronouncements
In June 2016 the FASB issued ASU 2016-13, Financial Instruments-Credit Losses.
This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts.
−Removed: As a smaller reporting company, ASU 2016-13 will become effective for the Company for fiscal years beginning after December 15, 2022, and early adoption is permitted.
−Removed: The Company is currently evaluating the impact that ASU 2016-13 will have on its financial statements and related disclosures.
−Removed: Recently Adopted Accounting Pronouncements
−Removed: In May 2021 the FASB issued Accounting Standards Update No.
−Removed: 2021-04, Earnings Per Share ("Topic 260"), Debt-Modifications and Extinguishments ("Subtopic 470-50"), Compensation-Stock Compensation ("Topic 718"), and Derivatives and Hedging-Contracts in Entity’s Own Equity ("Subtopic 815-40"):
−Removed: Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options, a consensus of the Emerging Issues Task Force ("EITF") , which amends the FASB Accounting Standards Codification ("ASC" or the “Codification”) to provide explicit guidance, and, thus, reduce diversity in practice, on accounting by issuers for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after the modification or exchange.
−Removed: This amendment provides that for an entity that presents earnings per share ("EPS") in accordance with Topic 260, the effects of a modification or an exchange of a freestanding equity-classified written call option that is recognized as a dividend should be an adjustment to net income (or net loss) in the basic EPS calculation.
−Removed: The amended guidance effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years, and should be applied prospectively to modifications or exchanges occurring on or after the effective date.
+Added: As a smaller reporting company, ASU 2016-13 became effective for the Company for fiscal years beginning after December 15, 2022.
The Company adopted ASU 2016-13 in the first quarter of 2023, and the adoption of this standard did not have any impact on the Company's financial position or results of operations.
−Removed: No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s consolidated financial statements upon adoption.
+Added: No other accounting standards known by the Company to be applicable to it that have been issued by the FASB or other standard-setting bodies and that do not require adoption until a future date are expected to have a material impact on the Company’s consolidated financial statements upon adoption.
Fair Value of Financial Instruments
−Removed: The Company’s cash equivalents are generally classified within Level 1 of the fair value hierarchy.
−Removed: The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values as of December 31, 2022 and December 31, 2021 (in thousands):
+Added: The Company’s cash equivalents are generally classified within Level 1 of the fair value hierarchy.
+Added: The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values as of December 31, 2023 and December 31, 2022 (in thousands):
Fair Value Measurements as of December 31, 2023:
9 unchanged sentences
The Company believes the carrying amounts of its prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their fair value due to the short-term nature of these amounts.
+Added: Discontinued Operations
+Added: On May 11, 2023, the Company entered into the Purchase Agreement with Tisento for Tisento’s acquisition of substantially all of the assets comprising the Company’s zagociguat and CY3018 programs, in exchange for consideration at closing of $ 8.0 million, the reimbursement of employee expenses or R&D expenses of $ 2.4 million that Tisento reimbursed the Company for upon closing, and 10 % of the issued and outstanding shares of Tisento Parent (Note 5).
+Added: Upon closing of the transaction, the Company transferred certain fully depreciated software included within property and equipment to Tisento.
+Added: The carrying value of the disposal group was lower than its fair value, less costs to sell, and accordingly, a gain on disposal was recorded during the year ended December 31, 2023.
+Added: The operations of the Transferred Assets are presented as discontinued for all periods presented.
+Added: The transaction closed on July 28, 2023.
+Added: The following table presents the results of the discontinued operations for the year ended December 31, 2023 and 2022 (in thousands):
+Added: Year Ended December 31,
+Added: Revenue from grants
+Added: Total revenues
+Added: Cost and expenses:
+Added: Research and development
+Added: General and administrative
+Added: Total cost and expenses
+Added: Loss from operations
+Added: Gain on disposal of discontinued operations
+Added: Net gain (loss) from discontinued operations
+Added: The following table summarizes the carrying amounts of major classes of assets and liabilities of discontinued operations as of December 31, 2022 (in thousands).
+Added: December 31, 2022
+Added: Prepaid expenses
+Added: Other current assets
+Added: Total current assets of discontinued operations
+Added: Total assets of discontinued operations
+Added: Accounts payable
+Added: Accrued research and development costs
+Added: Accrued expenses and other current liabilities
+Added: Total current liabilities of discontinued operations
+Added: Total liabilities of discontinued operations
+Added: Net liabilities of discontinued operations
+Added: The following table presents the significant non-cash item for the discontinued operations that are included in the accompanying consolidated statements of cash flows (in thousands):
+Added: Year Ended December 31,
+Added: Cash flows from operating activities:
+Added: Share-based compensation expense
+Added: The transaction consideration received from the sale of the Transferred Assets were as follows (in thousands):
+Added: Closing payment
+Added: Expense reimbursement
+Added: Investment in Tisento Parent
+Added: Gross transaction consideration from the sale
+Added: Net assets sold
+Added: Gain on disposal of discontinued operations
+Added: During the year ended December 31, 2023 , the Company incurred $ 1.3 million in closing costs associated with the sale of the Transferred Assets.
+Added: The Company also incurred $ 0.9 million in transaction costs associated with the sale of the Transferred Assets during the year ended December 31, 2023 , respectively.
+Added: All of the closing and transaction costs were recognized as part of discontinued operations - general and administrative.
+Added: Other Investment
+Added: On July 28, 2023, the Company closed the transactions contemplated by the Asset Purchase Agreement receiving proceeds of $ 8.0 million as cash consideration, approximately $ 2.4 million as reimbursement for certain operating expenses related to zagociguat and CY3018 programs for the period between signing and closing of the transaction, and 10 % of all of Tisento Parent's outstanding equity securities which fair value was determined to be $ 5.3 million at the time of closing.
+Added: The Company’s investment in Tisento Parent does not provide it with significant influence over Tisento Parent.
+Added: The Company has determined that the Company’s investment in Tisento Parent is an equity security, whereby such investment does not give the Company a controlling financial interest or significant influence over the investee.
+Added: Further, the Company assessed the accounting for its investment in Tisento Parent in accordance with ASC 810-10, Consolidation—Overall.
+Added: After determining that no scope exception applies under the guidance of ASC 810-10-15-12 and ASC 810-10-15-17, the Company concluded that it has a variable interest in Tisento Parent through its investment in Tisento Parent common stock.
+Added: Tisento Parent does not have sufficient equity to finance its activities without additional subordinated financial support as Tisento Parent is a startup entity in its early
+Added: stages of raising funds and will require significant capital to advance its programs to commercial stage.
+Added: Therefore, the Company concluded that its investment in Tisento Parent is a variable interest entity (“VIE”) in accordance with ASC 810-10-15-14(a) and is subject to potential consolidation under the VIE model.
+Added: However, all activities that most significantly impact Tisento Parent and its subsidiary’s economic performance are directed by the Tisento Parent board and the board approves decisions by a simple majority.
+Added: Based on the board composition, the Company determined that no one party has control over the Tisento Parent board and power is not shared because the activities that most significantly affect Tisento Parent and its subsidiary’s economic performance do not require the consent of all of the parties.
+Added: Rather, all decisions are made by a simple majority vote of the Tisento Parent board.
+Added: Therefore, because the Company controls no director of Tisento Parent, the Company cannot unilaterally direct any of the activities that most significantly impact Tisento Parent and its subsidiary’s economic performance.
+Added: Accordingly, the Company does not hold a controlling financial interest in Tisento Parent.
+Added: Because both criteria (a) and (b) above have to be met for the application of the guidance in ASC 810-10-25-44B and criteria (a) has not been met, The Company concluded that it should not consolidate Tisento under the VIE model.
+Added: Accordingly, the Company has accounted for the investment as a financial instrument without a readily determinable fair value.
+Added: Such investment is recorded using the measurement alternative for investments without readily determinable fair values, whereby the investment is measured at cost less any impairment recorded or adjustments for observable price changes.
+Added: An impairment loss is recognized in the consolidated statements of operations and comprehensive loss equal to the amount by which the carrying value exceeds the fair value of the investment.
+Added: As of December 31, 2023 , no impairment loss was recognized.
+Added: The Company considers the cost of the investment to be the maximum exposure to loss as a result of its involvement with the non-affiliated entity.
+Added: The initial fair value of the investment in Tisento Parent was determined by reference to the risk-adjusted net assets value using the discounted cash flow method.
+Added: The estimated net assets value of Tisento Parent includes the cash generated/used from the operations and the proceeds from equity financing.
+Added: Valuations were derived by reference to observable valuation measures for comparable companies or transactions, including weighted average cost of capital ( 21 % to 23 %), terminal decline rate ( 25 % to 75 %) and the discount rate referenced by a two-year treasury rate of 4.01 %.
Property and Equipment
4 unchanged sentences
Property and equipment, net
−Removed: As of December 31, 2022, and 2021, the Company’s property and equipment was primarily located in Boston, Massachusetts.
−Removed: Depreciation and amortization expense of the Company’s property and equipment was approximately $ 0.1 million and $ 0.5 million for the years ended December 31, 2022 and 2021 , respectively.
+Added: As of December 31, 2023, and 2022, the Company’s property and equipment was primarily located in Boston, Massachusetts.
+Added: During the year ended December 31, 2023 , the Company did no t record depreciation and amortization expenses.
+Added: The Company recorded $ 0.1 million of depreciation and amortization expenses for the year ended December 31, 2022.
Accrued Expenses and Other Current Liabilities
8 unchanged sentences
In the normal course of business, the Company enters into contracts with clinical research organizations and other third parties for clinical and preclinical research studies and other services and products for operating purposes.
−Removed: These contracts are generally cancellable, with notice, at the Company’s option and do not have any significant cancellation penalties.
+Added: These contracts are generally cancellable, with notice, at the Company’s option and do not have any significant cancellation penalties.
On September 6, 2018, Cyclerion was incorporated in Massachusetts and its officers and directors are indemnified for certain events or occurrences while they are serving in such capacity.
1 unchanged sentence
These typically include agreements with directors and officers, business partners, contractors, clinical sites and customers.
−Removed: Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities.
+Added: Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company’s activities.
These indemnification provisions generally survive termination of the underlying agreements.
3 unchanged sentences
Accordingly, the Company did not have any liabilities recorded for these obligations as of December 31, 2023 or December 31, 2022.
−Removed: On April 30, 2021, the Company entered into a Termination Agreement (the "Termination Agreement") for its Head Lease (the "Head Lease") for the Company's former headquarters located at 301 Binney Street, Cambridge, MA, as initially amended on February 28, 2020, and further amended on September 15, 2020.
−Removed: Pursuant to the Termination Agreement, the Company surrendered the leased space of approximately 57,000 square feet to the building’s landlord.
−Removed: The Company did not pay any termination fees in connection with the Termination Agreement.
−Removed: As a result of the termination of the Head Lease, the related right-of-use asset was written off, the lease liability was derecognized, and the $ 3.8 million security deposit was returned to the Company and recorded as part of our cash balance.
−Removed: Lease cost was recognized on a straight-line basis over the lease term.
−Removed: For the year ended December 31, 2021 , the Company recognized approximately $ 2.4 million of total lease costs and $ 0.7 million of variable lease costs, related to the Head Lease.
−Removed: The Company did no t record any lease costs related to the Head Lease during the year ended December 31, 2022.
+Added: Separation Benefits
+Added: As part of the separation benefit of former Chief Financial Officer, the Company shall pay to former Chief Financial Officer a payment of $ 0.1 million on each of the six-month and nine-month anniversaries of November 15, 2023, in the event the former Chief Financial Officer has not secured full-time employment prior to the anniversary date.
In May 2021 the Company signed a 12-month membership agreement to lease space with WeWork at 501 Boylston Street, Boston, Massachusetts, commencing on August 1, 2021.
1 unchanged sentence
The 12-month agreement and 6-month extension are accounted for as short-term leases.
+Added: The lease agreement was terminated during the year ended December 31, 2023.
The Company recorded $ 0.1 million and $ 0.1 million, respectively, in lease expense associated with the membership agreement during the years ended December 31, 2023, and 2022.
−Removed: Supplemental cash flow information related to leases for the periods reported is as follows:
−Removed: Year Ended December 31,
−Removed: Decrease in right-of-use assets related to lease modifications and termination
−Removed: Decrease in operating lease liabilities due to lease modifications and termination
−Removed: Cash paid for amounts included in the measurement of lease liabilities (in thousands)
−Removed: Weighted-average remaining lease term of operating leases (in years)
−Removed: Weighted-average discount rate of operating leases
On September 15, 2020, the Company entered into a Sublease Termination Agreement (the "Sublease Termination Agreement") to terminate its sublease of 15,700 rentable square feet, of its leased premises under the Head Lease.
−Removed: Under the terms of the Sublease Termination Agreement, the subtenant was relieved of its obligation to provide future cash rental payments to the Company.
+Added: Under the terms of the Sublease Termination Agreement, the subtenant was relieved of its obligation to
+Added: provide future cash rental payments to the Company.
The agreements requiring the former subtenant to provide licensed rooms and services to the Company free of charge through the original sublease term survived the sublease termination.
1 unchanged sentence
The letter of credit security deposit related to the sublease was released.
−Removed: The Company determined that the Sublease Termination Agreement constituted a non-monetary exchange under ASC 845 Nonmonetary Transactions (“ASC 845”) where, in return for the free rooms and the services, the Company agreed to terminate its rights and obligations under the sublease agreement.
+Added: The Company determined that the Sublease Termination Agreement constituted a non-monetary exchange under ASC 845 Nonmonetary Transactions (“ASC 845”) where, in return for the free rooms and the services, the Company agreed to terminate its rights and obligations under the sublease agreement.
In accordance with ASC 845, the Company determined that the accounting for the transaction should be based on the fair value of assets or services involved.
−Removed: The Company estimated the fair value of the rooms and services to be approximately $ 1.5 million and $ 2.9 million, respectively.
+Added: During the year ended December 31, 2020, the Company estimated the fair value of the rooms and services to be approximately $ 1.5 million and $ 2.9 million, respectively.
The Company determined that the licensed rooms represent a lease under ASC Topic 842 Leases.
6 unchanged sentences
Both the lease expense and services expense are recognized as a component of research and development costs in the consolidated statements of operations and comprehensive loss.
+Added: After the closing of the Asset Purchase Agreement, the Company had no plans in the foreseeable future to use the licensed rooms and the Company is restricted from subleasing the rooms.
+Added: In August 2023, the ROU asset and other assets were fully impaired, and the Company recognized a $ 3.3 million impairment loss during the year ended December 31, 2023 .
Share-based Compensation Plans
In 2019, Cyclerion adopted share-based compensation plans.
−Removed: Specifically, Cyclerion adopted the 2019 Employee Stock Purchase Plan (“2019 ESPP”) and the 2019 Equity Incentive Plan (“2019 Equity Plan”).
+Added: Specifically, Cyclerion adopted the 2019 Employee Stock Purchase Plan (“2019 ESPP”) and the 2019 Equity Incentive Plan (“2019 Equity Plan”).
Under the 2019 ESPP, eligible employees may use payroll deductions to purchase shares of stock in offerings under the plan, and thereby acquire an interest in the future of the Company.
−Removed: The 2019 Equity Plan provides for stock options and restricted stock units (“RSUs”).
+Added: The 2019 Equity Plan provides for stock options, restricted stock awards ("RSAs") and restricted stock units (“RSUs”).
Cyclerion also mirrored two of Ironwood Pharmaceuticals, Inc.
−Removed: ("Ironwood") existing plans, the Amended and Restated 2005 Stock Incentive Plan (“2005 Equity Plan”) and the Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan (“2010 Equity Plan").
+Added: ("Ironwood") existing plans, the Amended and Restated 2005 Stock Incentive Plan (“2005 Equity Plan”) and the Amended and Restated 2010 Employee, Director and Consultant Equity Incentive Plan (“2010 Equity Plan").
These mirror plans were adopted to facilitate the exchange of Ironwood equity awards for Cyclerion equity awards upon the Separation as part of the equity conversion.
1 unchanged sentence
For employees that were ultimately employed by Cyclerion, unvested Ironwood options and RSUs were converted to unvested Cyclerion options and RSUs.
−Removed: The following table provides share-based compensation reflected in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2022 and 2021 (in thousands):
+Added: The following table provides share-based compensation reflected in the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2023 and 2022 (in thousands):
Research and development
1 unchanged sentence
Stock Options
−Removed: Stock options granted under the Company’s equity plans generally have a ten-year term and vest over a period of four years, provided the individual continues to serve at the Company through the vesting dates.
+Added: Stock options granted under the Company’s equity plans generally have a ten-year term and vest over a period of four years, provided the individual continues to serve at the Company through the vesting dates.
Options granted under all equity plans are exercisable at a price per share not less than the fair market value of the underlying common stock on the date of grant.
6 unchanged sentences
During the years ended December 31, 2023 and 2022, the Company granted stock options to purchase an aggregate of 4,000 shares and 84,765 shares, respectively, at weighted average grant fair values per option share of $ 2.95 and $ 18.20 respectively.
−Removed: The total grant fair value of options granted during the years ended December 31, 2022 and 2021 was $ 1.5 million and $ 2.6 million, respectively.
−Removed: The total intrinsic value of options exercised for the year ended December 31, 2021 was $ 0.1 million.
−Removed: There were no options exercised during the year ended December 31, 2022.
−Removed: As of December 31, 2022, the unrecognized share-based compensation expense, net of estimated forfeitures, related to all unvested time-based stock options held by the Company’s employees is $ 2.1 million and the weighted average period over which that expense is expected to be recognized is 3.3 years.
−Removed: The weighted-average Black-Scholes assumptions used in estimating the fair value of the stock options granted by Cyclerion following the Separation during the years ended December 31, 2022 and 2021 were as follows:
+Added: There were no options exercised during the year ended December 31, 2023 and 2022.
+Added: As of December 31, 2023, the unrecognized share-based compensation expense, net of estimated forfeitures, related to all unvested time-based stock options held by the Company’s employees is $ 0.3 million and the weighted average period over which that expense is expected to be recognized is 3.46 years.
+Added: The weighted-average Black-Scholes assumptions used in estimating the fair value of the stock options granted by Cyclerion during the years ended December 31, 2023 and 2022 were as follows:
Year ended December 31,
5 unchanged sentences
The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available.
−Removed: The Company has granted to certain employees performance based options to purchase shares of common stock.
+Added: The Company has granted certain employees performance-based options to purchase shares of common stock.
These options are subject to performance-based milestone vesting.
2 unchanged sentences
Market-based Stock Options
−Removed: The Company also has granted to certain employees stock options containing market conditions that vest upon the achievement of specified price targets of the Company’s share price for a period through December 31, 2024.
−Removed: Vesting is measured based upon the average closing price of the Company’s share price for any thirty consecutive trading days, subject to certain service requirements.
+Added: The Company also has granted to certain employees stock options containing market conditions that vest upon the achievement of specified price targets of the Company’s share price for a period through December 31,
+Added: Vesting is measured based upon the average closing price of the Company’s share price for any thirty consecutive trading days, subject to certain service requirements.
Stock compensation cost is expensed on a straight-line basis over the derived service period for each stock price target within the award, ranging from approximately 4.0 to 4.6 years.
1 unchanged sentence
The Company does not reverse expense recognized if the share price target(s) are ultimately not achieved but expense is reversed when a stock award recipient has a break in service prior to the completion of the derived service period.
−Removed: As of December 31, 2022, there was $ 0.1 million of unrecognized compensation costs related to
−Removed: stock options containing market conditions, which is expected to be recognized over a weighted-average period of 1.2 years.
−Removed: A summary of stock awards containing market conditions activity for the years ended December 31, 2022 and 2021 is as follows:
+Added: As of December 31, 2023, there were 7,500 outstanding stock options containing market conditions with a weighted average exercise price of $ 40.20 .
+Added: As of December 31, 2023, there was a de minimis amount of unrecognized compensation costs related to stock options containing market conditions, which is expected to be recognized over a weighted-average period of 0.35 years.
+Added: A summary of stock awards containing market conditions activity for the year ended December 31, 2023 is as follows:
Outstanding as of December 31, 2022
2 unchanged sentences
Exercisable at December 31, 2023
−Removed: The fair value of stock options containing market conditions is estimated using Monte Carlo simulations.
No stock options containing market conditions were granted during the years ended December 31, 2023 and 2022.
1 unchanged sentence
The RSUs generally vest 25 % per year on the approximate anniversary of the date of grant until fully vested, provided the employee remains continuously employed with the Company through each vesting date.
−Removed: Shares of the Company’s common stock are delivered to the employee upon vesting, subject to payment of applicable withholding taxes.
−Removed: The fair value of all RSUs is based on the market value of the Company’s common stock on the date of grant.
+Added: Shares of the Company’s common stock are delivered to the employee upon vesting, subject to payment of applicable withholding taxes.
+Added: The fair value of all RSUs is based on the market value of the Company’s common stock on the date of grant.
Compensation expense, including the effect of estimated forfeitures, is recognized over the applicable service period.
3 unchanged sentences
Unvested as of December 31, 2023
−Removed: As of December 31, 2022, the unrecognized share-based compensation expense, net of estimated forfeitures, related to all unvested restricted stock units by the Company’s employees is $ 0.4 million and the weighted-average period over which that expense is expected to be recognized is 0.8 years.
+Added: Restricted Stock Awards
+Added: The Company granted 200,000 RSAs during the year ended December 31, 2023.
+Added: 28,750 RSAs vest upon grant.
+Added: 113,750 RSAs vest ratably over a 42-month period, 2,500 RSAs vest over a 6-month period and 55,000 RSAs vest ratably over a 48-month period, provided the grantee remains continuously as a director or an employee of the Company through each vesting date .
+Added: Shares of the Company’s common stock are delivered to the employee upon vesting, subject to payment of applicable withholding taxes.
+Added: The fair value of all RSAs is based on the market value
+Added: of the Company’s common stock on the date of grant.
+Added: Compensation expense, including the effect of estimated forfeitures, is recognized over the applicable service period.
+Added: A summary of RSA activity for the years ended December 31, 2023 is as follows:
+Added: Weighted Average
+Added: Unvested as of December 31, 2022
+Added: Unvested as of December 31, 2023
+Added: As of December 31, 2023, the unrecognized share-based compensation expense, net of estimated forfeitures, related to all unvested RSAs held by the Company’s directors is $ 0.4 million and the weighted average period over which that expense is expected to be recognized is 3.53 years.
Loss per share
Basic and diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period as follows:
−Removed: Net loss (in thousands)
−Removed: Weighted average shares used in calculating net loss per share —
−Removed: basic and diluted (in thousands)
−Removed: Net loss per share —
−Removed: basic and diluted
−Removed: We exclude shares of common stock related to stock options and RSUs from the calculation of diluted net loss per share since the inclusion of such shares would be anti-dilutive.
+Added: Net loss from continuing operations (in thousands)
+Added: Net gain (loss) from discontinued operations (in thousands)
+Added: Total net loss (in thousands)
+Added: Weighted average shares used in calculating net gain (loss) per share — basic and diluted (in thousands) (*)
+Added: Net gain (loss) per share — basic and diluted
+Added: Net loss per share from continuing operations
+Added: Net gain (loss) per share from discontinued operations
+Added: Total loss per share
+Added: *Adjusted retroactively for reverse stock split - see Note 1
+Added: We exclude shares of common stock related to Preferred Stock, stock options, RSUs and RSAs from the calculation of diluted net loss per share since the inclusion of such shares would be anti-dilutive.
The following table sets forth potential shares that were considered anti-dilutive for the years ended December 31, 2023 and 2022:
+Added: Preferred Stock
Stock Options
−Removed: There was no provision for income taxes for the years ended December 31, 2022, and 2021, due to the Company’s operating losses and a full valuation allowance on deferred tax assets.
+Added: There was no provision for income taxes for the years ended December 31, 2023, and 2022, due to the Company’s operating losses and a full valuation allowance on deferred tax assets.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
10 unchanged sentences
Permanent differences
−Removed: PPP loan forgiveness
Change in valuation allowance
7 unchanged sentences
Share-based compensation
−Removed: Operating lease - liability
Property and equipment
20 unchanged sentences
State credits begin to expire in 2022 and continue through 2034 .
−Removed: The Company’s ability to use its operating loss carryforwards and tax credits to offset future taxable income could be subject to restrictions under Section 382 of the U.S.
−Removed: Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”).
+Added: The Company’s ability to use its operating loss carryforwards and tax credits to offset future taxable income could be subject to restrictions under Section 382 of the U.S.
+Added: Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”).
These potential restrictions may limit the future use of the operating loss carryforwards and tax credits if certain ownership changes described in the Internal Revenue Code occur.
−Removed: Changes in stock ownership may occur that would create these limitations on the Company’s use of the operating loss carryforwards and tax credits.
+Added: Changes in stock ownership may occur that would create these limitations on the Company’s use of the operating loss carryforwards and tax credits.
In such a situation, the Company may be required to pay income taxes, even though significant operating loss carryforwards and tax credits exist.
The Company has not as yet conducted a study of its research and development credit carry forwards.
−Removed: This study may result in an adjustment to the Company’s research and development credit carryforwards;
+Added: This study may result in an adjustment to the Company’s research and development credit carryforwards;
however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position.
−Removed: A full valuation allowance has been provided against the Company’s research and development credits, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance.
+Added: A full valuation allowance has been provided against the Company’s research and development credits, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance.
Thus, there would be no impact to the consolidated balance sheets or statements of operations if an adjustment were required.
9 unchanged sentences
The Company's contributions to the plan are at the sole discretion of the board of directors.
−Removed: Currently, the Company provides a matching contribution of 75 % of the employee’s contributions, up to $ 6,000 annually.
+Added: Currently, the Company provides a matching contribution of 75 % of the employee’s contributions, up to $ 6,000 annually.
Included in compensation expense is approximately $ 0.1 million and $ 0.2 million related to the defined contribution 401(k) Savings Plan for the years ended December 31, 2023 and 2022 , respectively.
Workforce Reduction
−Removed: 2022 Workforce Reduction
+Added: Workforce Reductions
On October 6, 2022, the Company began a reduction of its current workforce by thirteen (13) full-time employees to align its resources with its current priorities of focusing on a mitochondrial disease-focused strategy.
The workforce reduction was completed in the fourth quarter of 2022.
−Removed: The Company recorded total costs related to the 2022 Workforce Reduction were approximately $ 1.3 million, including a de minimis amount of stock-based compensation from the modification of certain share-based equity awards.
+Added: The Company recorded total costs related to the 2022 Workforce Reduction of approximately $ 1.3 million, including a de minimis amount of stock-based compensation from the modification of certain share-based equity awards.
+Added: The Company had further reductions of workforce in 2023 in connection with the sale of the Transferred Assets to Tisento and change to the Company’s strategy.
+Added: The Company recorded total costs of approximately $ 0.6 million related to the reduction in workforce during 2023.
The following table summarizes the accrued liabilities activity recorded in connection with the reduction in workforce for the year ended December 31, 2023 (in thousands):
−Removed: 2022 workforce reduction
+Added: Workforce reductions
License Agreement
Akebia License Agreement
−Removed: On June 3, 2021, the Company and Akebia entered into a License Agreement (the “Akebia License Agreement”) relating to the exclusive worldwide license by the Company to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing the pharmaceutical compound known as praliciguat and other related products and forms thereof enumerated in the
−Removed: License Agreement (collectively, the “Products”).
+Added: On June 3, 2021, the Company and Akebia entered into a License Agreement (the “Akebia License Agreement”) relating to the exclusive worldwide license by the Company to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing the pharmaceutical compound known as praliciguat and other related products and forms thereof enumerated in the License Agreement (collectively, the “Products”).
Pursuant to the Akebia License Agreement, Akebia will be responsible for all future research, development, regulatory, and commercialization activities for the Products.
−Removed: Akebia paid a $ 3.0 million up-front payment to the Company upon signing of the License Agreement and the Company is eligible to receive additional milestone cash payments of up to $ 12.0 million upon initiation of a Phase 2 clinical trial.
−Removed: Further milestone cash payments by Akebia are scheduled in the Akebia License Agreement based on the initiation of Phase 3 clinical trials in the U.S.
−Removed: for Products for first and second indication, for FDA approvals, for approvals in certain other major markets, and for certain sales milestones.
+Added: Akebia paid a $ 3.0 million up-front payment to the Company upon signing of the License Agreement and the Company is eligible to receive additional milestone cash payments of up to $ 585 million in total potential future development, regulatory, and commercialization milestone payments for praliciguat.
In addition to these cash milestone payments, Akebia will pay the Company tiered royalty payments on net sales in certain major markets at percentages ranging from the mid-single digits to the high-teens, subject to certain reductions and offsets.
7 unchanged sentences
Akebia Supply Agreement
−Removed: On August 3, 2021, the Company and Akebia entered into a Supply Agreement (the “Supply Agreement”) relating to the manufacturing by the Company of the Initial Supply of the Drug Product and placebo ("Initial Supply") for Akebia's use pursuant to the Akebia License Agreement.
+Added: On August 3, 2021, the Company and Akebia entered into a Supply Agreement (the “Supply Agreement”) relating to the manufacturing by the Company of the Initial Supply of the Drug Product and placebo ("Initial Supply") for Akebia's use pursuant to the Akebia License Agreement.
Akebia will pay the Company for the manufacturing costs at mutually agreed upon rates.
2 unchanged sentences
The manufacturing of the Initial Supply by the Company represents a single performance obligation and consideration related to the manufacturing costs will be recognized over time as costs are incurred.
−Removed: The Company recorded approximately $ 0.3 million and approximately $ 0.3 million, respectively, for the years ended December 31, 2022 and 2021 , as revenue from the Supply Agreement.
+Added: The Company recorded a de minimis amount and approximately $ 0.3 million, respectively, for the years ended December 31, 2023 and 2022 , as revenue from the Supply Agreement.
Grant Revenue
In August 2021, the Company was approved to receive funding from the PTC Grant for the Phase 2 study of CNS sGC stimulation in AD with vascular features.
−Removed: The granting period is July 1, 2021, to December 31, 2022, and the Company will receive an award of up to $ 2 million.
+Added: The granting period is July 1, 2021, to December 31, 2022, and the Company received an award of $ 2.0 million.
The Company determined that this transaction is non-reciprocal as there is not considered to be a commensurate value exchanged with the Alzheimer's Association as the funding provider.
3 unchanged sentences
The Company incurred approximately $ 0.1 million and approximately $ 0.6 million of allowable expenses and recognized a corresponding amount of grant revenue for the years ended December 31, 2023 and 2022 .
−Removed: Subsequent Events
+Added: Subseq uent Events
The Company has evaluated all events and transactions that occurred after the balance sheet date through the date the consolidated financial statements were issued and determined that there were no such events requiring recognition or disclosure in the consolidated financial statements.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.