Massachusetts (State or other jurisdiction of incorporation or organization) | | | 83-1895370 (I.R.S. Employer Identification No.) |
Large accelerated filer ☐ | | | Accelerated filer ☐ |
Non-accelerated filer ☐ | | | Smaller reporting company ☒ |
| | Emerging growth company ☒ |
• | the timing, investment and associated activities involved in developing, obtaining regulatory approval for, launching and commercializing our product candidates, including CY6463; |
• | the coronavirus (“COVID-19”) pandemic affecting our clinical trials and other operating activities; |
• | our relationships with third parties, collaborators and our employees; |
• | our ability to execute our strategic priorities; |
• | our ability to finance our operations and business initiatives; |
• | the impact on our business of workforce and expense reduction initiatives; |
• | our plans with respect to the development, manufacture or sale of our product candidates and the associated timing thereof, including the design and results of pre-clinical and clinical studies; |
• | the safety profile and related adverse events of our product candidates; |
• | the efficacy and perceived therapeutic benefits of our product candidates, their potential indications and their market potential; |
• | U.S. and non-U.S. regulatory requirements for our product candidates, including any post-approval development and regulatory requirements, and the ability of our product candidates to meet such requirements; |
• | our ability to attract and retain employees needed to execute our business plans and strategies and our ability to manage the impact of any loss of key employees; |
• | our ability to obtain and maintain intellectual property protection for our product candidates and the strength thereof; |
• | our future financial performance, revenues, expense levels, payments, cash flows, profitability, tax obligations, capital raising and liquidity sources, real estate needs and concentration of voting control, as well as the timing and drivers thereof, and internal control over financial reporting; |
• | our ability to compete with other companies that are or may be developing or selling products that are competitive with our product candidates; |
• | the impact of government regulation in the life sciences industry, particularly with respect to healthcare reform; |
• | potential indemnification liabilities we may owe to Ironwood after the Separation (as defined below); and |
• | trends and challenges in the markets for our potential products. |
• | Praliciguat is an orally administered, once-daily systemic sGC stimulator that was evaluated in two Phase 2 proof-of-concept studies for adult participants with diabetic nephropathy (“DN”) and heart failure with preserved ejection fraction (“HFpEF”). We released topline results from these studies in October 2019. On June 3, 2021, we entered into a license agreement with Akebia Therapeutics, Inc. (“Akebia”) relating to the exclusive worldwide license to Akebia of our rights to the development, manufacture, medical affairs and commercialization of pharmaceutical products containing the pharmaceutical compound praliciguat and other related products and forms thereof enumerated in such agreement. |
• | Olinciguat is an orally administered, once-daily, vascular sGC stimulator that was evaluated in a Phase 2 study of participants with sickle cell disease. We released topline results from this study in October 2020. |
• | We also have discovery and pre-clinical phase programs with organ-targeted sGC stimulators. |
• | We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. |
• | We have incurred significant losses and have never generated revenue from product sales; we anticipate that we will continue to incur significant losses for the foreseeable future and may never be profitable. |
• | We will need to raise additional funding to advance our product candidates, which may not be available on acceptable terms, or at all, and may dilute existing shareholders or restrict our operations. |
• | Our approach to the discovery and development of our product candidates may never lead to marketable products. |
• | We may encounter substantial delays in our clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities in the development of CY6463. |
• | The COVID-19 pandemic continues to disrupt our business, including our clinical development activities. |
• | We could encounter difficulties in enrolling participants in our clinical studies, which could delay or prevent progress of our product candidates. |
• | The FDA regulatory approval process is lengthy, time-consuming and inherently unpredictable. We may be unable to obtain regulatory approval for our product candidates and unable to generate product revenue. |
• | Our product candidates may cause side effects that may result in label restrictions. |
• | We may have to change our nonclinical or clinical study protocols due to regulatory reasons or unanticipated events, which could result in increased costs to us and could delay our development timeline. |
• | We may enter into a collaboration or license arrangement in the future that ultimately is not successful. |
• | We rely, and expect that we will continue to rely, on third parties to conduct nonclinical or clinical studies and to manufacture drug supplies for our product candidates. If these third parties do not execute successfully, our business could be substantially harmed. |
• | We share confidential information with third-party vendors, including trade secrets and know-how, which increases the possibility that our confidential information will be misappropriated or disclosed. |
• | We may be unable to adequately protect our proprietary technologies, or obtain and maintain issued patents that are sufficient to protect our product candidates. |
• | We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts. |
• | We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property. |
• | We may not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection. |
• | We may not be able to obtain additional protection under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) and similar foreign legislation by extending the patent terms and obtaining data exclusivity for our product candidates. |
• | We may be subject to damages resulting from claims that we or our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers. |
• | If the market opportunities for our product candidates are smaller than we estimate, our revenue and ability to achieve profitability may be harmed. |
• | Even if we obtain regulatory approval for our product candidates, they may not achieve broad market acceptance by patients, physicians and healthcare payors, which would limit our revenue |
• | We may fail to comply with healthcare and other regulations and could face substantial penalties. |
• | Our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours. |
• | The impact of healthcare reform and other governmental and private payor initiatives may harm our business. |
• | Our prospects for success depend on our ability to retain our management team and to attract, retain and motivate qualified personnel. |
• | We may need to expand our organization and we may experience difficulties in managing growth of our employee base. |
• | We face potential product liability exposure, and, if claims are brought against us, we may incur substantial liability. |
• | We could fail to maintain proper and effective internal controls and our ability to produce accurate and timely financial statements could be impaired. |
• | Our internal computer systems, or those of our third-party CROs, CMOs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product candidates' development programs. |
• | If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur. |
• | We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act (the “FCPA”) and other worldwide anti-bribery laws. |
• | Our rights under the intellectual property license agreement with Ironwood could be challenged. |
• | Our historical financial information is not necessarily representative of the results that we would have achieved as a separate, publicly traded company and should not be relied upon as an indicator of our future results. |
• | We may be required to make payments to indemnify Ironwood for certain liabilities in connection with the separation. |
• | We have limited trading history and a relatively low-volume trading market for our shares and our market price of our common stock may fluctuate widely. |
• | Our common stock market price is particularly volatile and we expect it to be more volatile than that of a seasoned issuer. |
• | We may not attract securities or industry analysts to initiate or maintain coverage of our stock; analysts may publish negative reports or change their recommendations regarding our stock adversely and our stock price and trading volume could decline. |
• | We have adopted anti-takeover provisions in our restated articles of organization and amended and restated bylaws and are subject to provisions of Massachusetts law that may frustrate any attempt to remove or replace our current board of directors or to effect a change of control or other business combination involving our company. |
• | the FDA or other regulatory bodies may not authorize us or our investigators to commence planned clinical studies, or require that we suspend ongoing clinical studies through imposition of clinical holds; |
• | negative results from our ongoing studies or other industry studies involving product candidates modulating the same or similar mechanism of action; |
• | delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to considerable negotiation and may vary significantly among different CROs and study sites; |
• | inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical studies, for example delays in the manufacturing of sufficient supply of finished drug product; |
• | difficulties obtaining EC or IRB approval(s) to conduct a clinical study at a prospective site or sites; |
• | challenges in recruiting and enrolling participants in clinical studies, the proximity of participants to study sites, eligibility criteria for the clinical study, the nature of the clinical study protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical study programs for similar indications; |
• | severe or unexpected drug-related side effects experienced by participants in a clinical study; |
• | the presence of unanticipated metabolites in participants in a clinical study may require considerable nonclinical and clinical assessment; |
• | we may decide, or regulatory authorities may require us, to conduct additional clinical studies or abandon product development programs; |
• | delays in validating, or inability to validate, any endpoints utilized in a clinical study; |
• | the FDA or other regulatory bodies may disagree with our clinical study design and our interpretation of data from clinical studies, or may change the requirements for approval even after it has reviewed and commented on the design for our clinical studies; |
• | reports from nonclinical or clinical testing of other competing candidates that raise safety or efficacy concerns; and |
• | difficulties retaining participants who have enrolled in a clinical study but may be prone to withdraw due to rigors of the clinical studies, lack of efficacy, side effects, personal issues, or loss of interest. |
• | failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols; |
• | inspection of the clinical study operations or study sites by the FDA or other regulatory authorities that reveals deficiencies or violations that require us to undertake corrective action, including in response to the imposition of a clinical hold; |
• | unforeseen safety issues, including any that could be identified in our ongoing studies, adverse side effects or lack of effectiveness; |
• | changes in government regulations or administrative actions; |
• | problems with clinical supply materials; and |
• | lack of adequate funding to continue clinical studies. |
• | partners have significant discretion in determining the efforts and resources that they will apply to collaborations; |
• | a partner with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; |
• | partners may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; |
• | collaboration and license arrangements may be terminated, and, if terminated, this may result in a need for additional capital to pursue further development or commercialization of the applicable current or future product candidates; |
• | partners may own or co-own intellectual property covering products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; |
• | disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaboration or license arrangements; and |
• | a partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. |
• | the efficacy and safety of our approved product candidates as demonstrated in clinical trials; |
• | the clinical indications and labeling claims for our product candidates that are approved; |
• | limitations or warnings contained in the labeling approved for our product candidates by the FDA or other applicable regulatory authorities; |
• | any restrictions on the use of our products together with other medications or restrictions on the use of our products in certain types of patients; |
• | the prevalence and severity of any adverse effects associated with our product candidates; |
• | the size of the target patient population, and the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
• | the safety, efficacy, cost and other potential advantages of our approved product candidates compared to other available therapies; |
• | our ability to generate cost effectiveness data that supports a profitable price; |
• | our ability to obtain sufficient reimbursement and pricing by third-party payors and government authorities; |
• | the willingness of patients to pay out-of-pocket in the absence of sufficient payor coverage; |
• | the effectiveness of our sales and marketing strategies; or |
• | publicity concerning our products or competing products and treatments. |
• | federal healthcare program anti-kickback laws, which prohibit, among other things, persons from offering, soliciting, receiving or providing remuneration, directly or indirectly, as an inducement or reward for their past, current or potential future prescribing, purchase, use, recommending for use, referral, formulary placement, or dispensing of our products; |
• | the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; |
• | the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug product and medical device research, development, and marketing, prohibits manufacturers from marketing or promoting such products prior to approval; and |
• | state law equivalents of the above federal laws, such as anti-kickback laws, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. |
• | our customers’ ability to obtain reimbursement for our product candidates outside the United States; |
• | our ability to gain reimbursement in foreign markets at a price that is profitable; |
• | our inability to directly control commercial activities because we are relying on third parties; |
• | the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; |
• | different medical practices and customs in foreign countries affecting acceptance in the marketplace; |
• | import or export licensing requirements; |
• | longer accounts receivable collection times; |
• | longer lead times for shipping; |
• | language barriers for technical training; |
• | reduced protection of intellectual property rights in some foreign countries; |
• | the existence of additional potentially relevant third-party intellectual property rights; |
• | foreign currency exchange rate fluctuations; and |
• | the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute. |
• | our historical combined financial data prior to the Separation does not reflect the Separation; |
• | our historical financial data prior to the Separation reflects expense allocations for certain business and support functions that are provided on a centralized basis within Ironwood, such as expenses for |
• | a relatively low-volume trading market for our shares of common stock may result, which could cause trades of small blocks of shares to have a significant impact on the price of our shares of common stock; |
• | results and timing of nonclinical studies and clinical studies of our product candidates; |
• | the commercial performance of our products, if approved, as well as the costs associated with such activities; |
• | results of clinical studies of our competitors’ products; |
• | failure to adequately protect our trade secrets; |
• | our inability to raise additional capital and the terms on which we raise it; |
• | commencement or termination of any strategic partnership or licensing arrangement; |
• | regulatory developments with respect to our products or our competitors’ products, including any developments, litigation or public concern about the safety of such products; |
• | announcements concerning product development results, including clinical trial results, the introduction of new products or intellectual property rights of us or others; |
• | actual or anticipated fluctuations in our financial condition and our quarterly and annual operating results; |
• | deviations in our operating results from any guidance we may provide or the estimates of securities analysts; |
• | additions and departures of key personnel; |
• | the passage of legislation or other regulatory developments affecting us or our industry; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | sales of our common stock by us, our insiders or our other shareholders; |
• | strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; |
• | announcement or expectation of additional financing efforts; |
• | publication of research reports by securities analysts about us or our competitors or our industry and speculation regarding our company or our stock price in the financial or scientific press or in online investor communities; |
• | changes in market conditions in the pharmaceutical and biotechnology sector; and |
• | changes in general market and economic conditions. |
• | the number of shares constituting each class or series; |
• | voting rights; |
• | rights and terms of redemption, including sinking fund provisions; |
• | dividend rights and rates; |
• | terms concerning the distribution of assets; |
• | conversion or exchange terms; |
• | redemption prices and terms; and |
• | liquidation preferences. |
• | the title and stated value of the preferred stock; |
• | the number of shares of the preferred stock offered, the liquidation preference per share and the offering price of the preferred stock; |
• | the dividend rate(s), period(s) or payment date(s) or method(s) of calculation applicable to the preferred stock; |
• | whether dividends are cumulative or non-cumulative and, if cumulative, the date from which dividends on the preferred stock will accumulate; |
• | our right, if any, to defer payment of dividends and the maximum length of any such deferral period; |
• | the procedures for auction and remarketing, if any, for the preferred stock; |
• | the provisions for a sinking fund, if any, for the preferred stock; |
• | the provision for redemption, if applicable, of the preferred stock; |
• | any listing of the preferred stock on any securities exchange; |
• | the terms and conditions, if applicable, upon which the preferred stock will be convertible into common stock, including the conversion price or manner of calculation and conversion period; |
• | voting rights, if any, of the preferred stock; |
• | whether interests in the preferred stock will be represented by depositary shares; |
• | a discussion of any material or special United States federal income tax considerations applicable to the preferred stock; |
• | the relative ranking and preferences of the preferred stock as to dividend rights and rights upon the liquidation, dissolution or winding up of our affairs; |
• | any limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the class or series of preferred stock as to dividend rights and rights upon the liquidation, dissolution or winding up of our affairs; and |
• | any other specific terms, preferences, rights, limitations or restrictions of the preferred stock. |
• | Action by written consent; special meetings of shareholders. Our restated articles of organization provide that shareholder action can be taken only at an annual or special meeting of shareholders or by the unanimous written consent of all shareholders in lieu of such a meeting. Our restated articles of organization and amended and restated bylaws also provide that, except as otherwise required by law, special meetings of the shareholders can only be called pursuant to a resolution adopted by a majority of our board of directors or holders of at least 40% of our then outstanding common stock. Except as described above, shareholders are not permitted to call a special meeting or to require our board of directors to call a special meeting. |
• | Advance notice procedures. Our amended and restated bylaws establish an advance notice procedure for shareholder proposals to be brought before an annual meeting of our shareholders, including proposed nominations of persons for election to the board of directors. Shareholders at an annual meeting are |
• | Proxy Access. Our amended and restated bylaws provides that a shareholder or a group of shareholders meeting certain conditions may nominate candidates for election as a director at an annual meeting of our shareholders using “proxy access” provisions. These provisions allow one or more shareholders (up to 20, collectively), owning at least 3% of our outstanding common stock continuously for at least three years, to nominate for election to our board of directors and to be included in our proxy materials up to the greater of two individuals or 20% of our board of directors, subject to the provisions to be included in our amended and restated bylaws, including the provision of timely written notice to our Secretary. |
• | Number of directors and filling vacancies; election of directors. Our restated articles of organization provide that the number of directors is established by the board of directors. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative vote of a majority of our directors then in office. The ability of our board of directors to increase the number of directors and fill any vacancies may make it more difficult for our shareholders to change the composition of our board of directors. Our amended and restated bylaws provide that a majority of the votes properly cast for the election of a director shall effect such election unless there are more nominees than directorships, in which case a plurality standard shall apply. |
• | Authorized but unissued shares. Our authorized but unissued shares of common stock and preferred stock are available for future issuance without shareholder approval. These additional shares may be utilized for a variety of corporate purposes, including future public offerings to raise additional capital, corporate acquisitions and employee benefit plans. The existence of authorized but unissued shares of common stock and preferred stock could render more difficult or discourage an attempt to obtain control of a majority of our common stock by means of a proxy contest, tender offer, merger or otherwise. |
• | Board authority to issue preferred stock. Our restated articles of organization provide that upon the affirmative vote of a majority of the total number of directors then in office, our board of directors, without shareholder approval, may issue shares of preferred stock with voting and conversion rights which could adversely affect the holders of shares of our common stock and the market value of our common stock. Under certain circumstances, the issuance of shares of preferred stock may render more difficult or tend to discourage a merger, tender offer or proxy contest, the assumption of control by a holder of a large block of our securities or the removal of incumbent management. |
• | Exclusive forum. Our restated articles of organization will require, to the fullest extent permitted by law, that derivative actions brought in the name of Cyclerion, actions against our directors, officers and employees for breach of a fiduciary duty and other similar actions may be brought only in specified courts in the Commonwealth of Massachusetts. Although we believe this provision benefits us by providing increased consistency in the application of Massachusetts law in the types of lawsuits to which it applies, the provision may have the effect of discouraging lawsuits against our directors and officers. See “Risk Factors — Our restated articles of organization designate the state and federal courts located within the Commonwealth of Massachusetts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our shareholders, which could discourage lawsuits against us and our directors and officers.” |
Name of Selling Stockholder | | | Shares of Common Stock Beneficially Owned Prior to the Offering(1)(2) | | | Shares of Common Stock Being Offered Hereby | | | Shares of Common Stock Beneficially Owned After Completion of the Offering(4) | |||
| Number | | | Number | | | Number | | | Percent(3) | ||
Entities Associated with EcoR1 Capital, LLC(5) | | | 2,888,327 | | | 1,282,051 | | | 1,606,276 | | | 4.0% |
Invus Public Equities, L.P.(6) | | | 2,768,069 | | | 961,538 | | | 1,806,531 | | | 4.5% |
Lincoln Park Capital Fund, LLC(7) | | | 750,000 | | | 650,000 | | | 100,000 | | | * |
MFN Partners, LP(8) | | | 3,389,215 | | | 961,538 | | | 2,427,677 | | | 6.0% |
Polaris Partners VIII, L.P.(9) | | | 697,313 | | | 92,831 | | | 604,482 | | | 1.5% |
Polaris Entrepreneurs’ Fund VIII, L.P.(10) | | | 24,957 | | | 3,322 | | | 21,635 | | | * |
Slate Path Master Fund LP(11) | | | 7,157,601 | | | 961,538 | | | 6,196,063 | | | 15.3% |
Peter M. Hecht(12) | | | 3,596,668 | | | 823,170 | | | 2,773,498 | | | 6.6% |
* | Less than 1% |
(1) | Beneficial ownership is determined in accordance with Rule 13d-3 under the Exchange Act. |
(2) | Ownership prior to the offering consists of shares directly owned by the selling stockholder. |
(3) | Calculated based on 40,420,909 shares of our common stock outstanding on June 7, 2021. |
(4) | No selling stockholder is obligated to sell all or any portion of the shares of our common stock shown as offered by it. Accordingly, we cannot estimate the actual number or percentage of shares of our common stock that will be held by any selling stockholder upon completion of this offering. However, for purposes of this table, we have assumed that all shares of common stock being registered under the registration statement of which this prospectus forms a part are sold in this offering, and that no selling stockholder acquires additional shares of our common stock after the date of this prospectus and prior to completion of this offering. |
(5) | Consists of 364,763 shares held by EcoR1 Capital Fund, L.P. and 2,523,564 shares held by EcoR1 Capital Fund Qualified, L.P. (“the EcoR1 Funds”) which are managed by EcoR1 Capital, LLC (“EcoR1”). Oleg Nodelman, the manager of EcoR1, has shared voting control and investment discretion over the securities reported herein that are held by the EcoR1 Funds. As a result, Mr. Nodelman may be deemed to have beneficial ownership of the securities that are held by the EcoR1 Funds. The address of EcoR1 is 357 Tehama Street #3, San Francisco, CA 94103. |
(6) | Invus Public Equities, L.P. (“Invus PE”) directly holds 2,768,069 shares. Invus Public Equities Advisors, LLC (“Invus PE Advisors”) controls Invus PE, as its general partner and accordingly, may be deemed to beneficially own the shares held by Invus PE. Artal Treasury Limited (“Artal Treasury”) controls Invus PE Advisors, as its managing member and accordingly, may be deemed to beneficially own the shares held by Invus PE. In addition, Invus, L.P. directly holds 11,053 shares. Invus Advisors LLC (“Invus Advisors”) controls Invus, L.P., as its general partner and accordingly, may be deemed to beneficially own the shares held by Invus, L.P. Artal International S.C.A. (“Artal International”) (i) through its Geneva branch, is the sole stockholder of Artal Treasury and may be deemed to beneficially own the 2,768,069 shares that Artal Treasury may be deemed to beneficially own, and (ii) as the |
(7) | Joshua Scheinfeld and Jonathan Cope, the principals of Lincoln Park Capital Fund, LLC (“Lincoln Park”) are deemed to be beneficial owners of all the shares owned by Lincoln Park. Messers. Scheinfeld and Cope have shared voting and dispositive power. |
(8) | The general partner of MFN Partners, LP (“MFN Partnership”) is MFN Partners GP, LLC (“MFN GP”). MFN Partners Management, LP (“MFN Management”) acts as investment adviser to the MFN Partnership. The general partner of MFN Management is MFN Partners Management, LLC (“MFN LLC”). Farhad Nanji and Michael F. DeMichele are the managing members of MFN GP and MFN LLC, and collectively make voting and investment decisions with respect to shares held by the MFN Partnership. The address of each of the foregoing is 222 Berkeley Street, 13th Floor, Boston, MA 02116. |
(9) | Polaris Partners VIII, L.P. (“PP VIII”) directly holds 697,313 shares. Polaris Partners GP VIII, L.L.C. (“PPG VIII”) is the general partner of PP VIII. PPG VIII may be deemed to have sole voting and dispositive power with respect to the shares owned by PP VIII. David Barrett, Brian Chee, Amir Nashat and Bryce Youngren are the managing members of PPG VIII (collectively, the “Polaris VIII Managing Members”), and Terrance McGuire, a member of our board of directors, is an interest holder of PPG VIII. Each of the Polaris VIII Managing Members and Mr. McGuire, in their respective capacities with respect to PPG VIII, may be deemed to share voting and dispositive power with respect to the shares held by PP VIII. |
(10) | Polaris Entrepreneurs’ Fund VIII, L.P. (“PEF VIII”) directly holds 24,957 shares. PPG VIII is also the general partner of PEF VIII. PPG VIII may be deemed to have sole voting and dispositive power with respect to the shares owned by PEF VIII. Each of the Polaris VIII Managing Members and Mr. McGuire, in their respective capacities with respect to PPG VIII, may be deemed to share voting and dispositive power with respect to the shares held by PEF VIII. |
(11) | Slate Path Capital LP (the “Investment Manager”), a Delaware limited partnership, acts as the investment manager of Slate Path Master Fund LP. Mr. David Greenspan serves as the managing member of Jades GP, LLC, a Delaware limited liability company, and the general partner of the Investment Manager. Each of Slate Path Master Fund LP, the Investment Manager, Jades GP, LLC and Mr. David Greenspan expressly disclaims beneficial ownership of these securities. |
(12) | Includes 1,548,970 shares of common stock issuable to Dr. Hecht upon the exercise of options that are exercisable within 60 days following June 7, 2021. |
• | on any national securities exchange or over-the-counter market on which the shares of common stock may be listed or quoted at the time of sale; |
• | in the over-the-counter market; |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which a broker-dealer may attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer, as principal, and a subsequent resale by the broker-dealer for its account; |
• | in “at the market” offerings to or through market makers into an existing market for the shares; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | short sales; |
• | sales pursuant to Rule 144; |
• | broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share; |
• | in transactions otherwise than on such exchanges or in the over-the-counter market; |
• | through a combination of any such methods; or |
• | through any other method permitted under applicable law. |
• | enter into transactions involving short sales of the shares by broker-dealers in the course of hedging the positions they assume with selling stockholder; |
• | sell shares short itself and deliver the shares registered hereby to settle such short sales or to close out stock loans incurred in connection with their short positions; |
• | write call options, put options or other derivative instruments (including exchange-traded options or privately negotiated options) with respect to the shares, or which they settle through delivery of the shares; |
• | enter into option transactions or other types of transactions that require the selling stockholders to deliver shares to a broker, dealer or other financial institution, who may then resell or transfer the shares under this prospectus; or |
• | lend or pledge the shares to a broker, dealer or other financial institution, which may sell the shares under this prospectus. |
• | our annual report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 25, 2021; |
• | our quarterly reports on Form 10-Q for the quarters ended March 31, 2021, filed with the SEC on April 30, 2021; |
• | our current reports on Form 8-K filed with the SEC on March 18, 2021, March 19, 2021, April 26, 2021 (only with respect to Item 5.02 thereof), May 4, 2021 and June 4, 2021; and |
• | our definitive proxy statement on Schedule 14A filed with the SEC on April 28, 2021. |
Item 14. | Other Expenses of Issuance and Distribution. |
| | Amount to be paid | |
SEC registration fee | | | $2,780 |
Legal fees and expenses | | | 25,000 |
Accounting fees and expenses | | | 7,500 |
Miscellaneous | | | 4,720 |
Total | | | $40,000 |
Item 15. | Indemnification of Directors and Officers. |
Item 16. | Exhibits. |
Item 17. | Undertakings. |
(1) | The undersigned registrant hereby undertakes: |
a. | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
i. | To include any prospectus required by Section 10(a)(3) of the Securities Act; |
ii. | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated |
iii. | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
b. | That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; and |
c. | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
d. | That, for the purpose of determining liability under the Securities Act to any purchaser: |
i. | Each prospectus filed by a registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
ii. | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(2) | The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(3) | The undersigned registrant hereby undertakes that: |
i. | For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance on |
ii. | For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(4) | The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the SEC under Section 305(b)(2) of the Trust Indenture Act. |
(5) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the undersigned registrant, pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the undersigned registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
Exhibit Number | | | Description of Exhibit |
| | Separation Agreement, dated March 30, 2019, by and between Ironwood Pharmaceuticals, Inc. and Cyclerion Therapeutics, Inc. (incorporated by reference to Exhibit 2.1 to Current Report on Form 8-K filed on April 2, 2019 (File No. 001-38787)). | |
| | Restated Articles of Organization of Cyclerion Therapeutics, Inc. (incorporated by reference to Exhibit 4.1 to Registration Statement on Form S-8 filed on March 29, 2019) (File No. 333-230615)). | |
| | Amended and Restated Bylaws of Cyclerion Therapeutics, Inc. (incorporated by reference to Exhibit 4.2 to Registration Statement on Form S-8 filed on March 29, 2019) (File No. 333-230615)). | |
| | Opinion of Foley Hoag LLP. | |
| | Common Stock Purchase Agreement, dated as of June 3, 2021, by and between Cyclerion Therapeutics, Inc. and the Investors named therein. | |
| | Consent of Ernst & Young LLP. | |
| | Consent of Foley Hoag LLP (included as part of Exhibit 5.1). | |
| | Power of Attorney (included in the signature page to this registration statement). |
* | Previously filed. |
| | CYCLERION THERAPEUTICS, INC. | ||||
| | | | |||
| | By: | | | /s/ Anjeza Gjino | |
| | | | Anjeza Gjino Chief Financial Officer |
Signature | | | Title |
| | ||
* | | | Chief Executive Officer (Principal Executive Officer) |
Peter M. Hecht | | ||
| | ||
/s/ Anjeza Gjino | | | Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
Anjeza Gjino | | ||
| | ||
* | | | Director |
Kevin Churchwell | | ||
| | ||
* | | | Director |
George Conrades | | ||
| | ||
* | | | Director |
Errol De Souza | | ||
| | ||
* | | | Director |
Marsha Fanucci | | ||
| | ||
* | | | Director |
Ole Isacson | | ||
| | ||
* | | | Director |
Stephanie Lovell | | ||
| | ||
* | | | Director |
Terrance McGuire | | ||
| | ||
* | | | Director |
Michael Mendelsohn | |
*By: | | | /s/ Anjeza Gjino | | | |
| | Anjeza Gjino Attorney-in-Fact | | |