424B3 1 athx20230607_424b3.htm FORM 424B3 athx20230427c_s3a.htm

Filed Pursuant to Rule 424(b)(3)

Registration No 333-271106

 

Prospectus

 

11,029,090 Shares

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Common Stock

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This prospectus relates to the issuance by us of up to 11,029,090 shares of common stock that are issuable upon the exercise of our outstanding warrants, or the “Warrants”. Warrants to purchase 1,920,000 shares of common stock were issued on August 15, 2022, and are exercisable at a price per share of $0.96. Warrants to purchase 9,109,090 shares of common stock were issued on November 9, 2022, and are exercisable at a price per share of $1.10.

 

Investing in common stock involves risk. Please read carefully the section entitled Risk Factors beginning on page 1 of this prospectus.

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Our common stock is listed on The NASDAQ Capital Market under the symbol “ATHX.” On April 27, 2023, the closing price of our common stock on The NASDAQ Capital Market was $0.83 per share.

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Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 

The date of this prospectus is May 10, 2023.

 

 

 

TABLE OF CONTENTS

 

 

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About This Prospectus

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Where You Can Find More Information

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Information We Incorporate By Reference

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The Company

1

Corporate Information

1

Risk Factors

1

Disclosure Regarding Forward-Looking Statements

1

Use of Proceeds

3

Description of Capital Stock

3

Plan of Distribution

4

Legal Matters

4

Experts

4

 

 

 

About This Prospectus

 

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or the SEC. This prospectus relates to up to 11,029,090 shares of our common stock that we may issue upon exercise of the Warrants.

 

You should read this prospectus together with additional information under the heading “Where You Can Find More Information” and “Information We Incorporate By Reference.” We have not authorized anyone to provide you with different information from the information contained or incorporated by reference in this prospectus or in any free writing prospectus that we may provide you. You should not assume that the information contained in this prospectus, any document incorporated by reference or any free writing prospectus is accurate as of any date, other than the date mentioned on the cover page of these documents. We are not making offers to sell our common stock in any jurisdiction in which an offer or solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make an offer or solicitation.

 

References in this prospectus to the terms “we,” “us” or “the Company” or other similar terms mean Athersys, Inc. and its consolidated subsidiaries, unless we state otherwise or the context indicates otherwise.

 

Where You Can Find More Information

 

We are subject to the informational reporting requirements of the Securities Exchange Act of 1934, or the “Exchange Act.” We file reports, proxy statements and other information with the SEC. Our SEC filings are available over the Internet at the SEC’s website at http://www.sec.gov. We make available, free of charge, on our website at http://www.athersys.com, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports and statements as soon as reasonably practicable after they are filed with the SEC. The contents of our website are not part of this prospectus, and the reference to our website does not constitute incorporation by reference into this prospectus of the information contained on or through that site, other than documents we file with the SEC that are specifically incorporated by reference into this prospectus.

 

Information We Incorporate By Reference

 

The SEC allows us to “incorporate by reference” into this prospectus the information in documents we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be a part of this prospectus, and information that we file later with the SEC will automatically update and supersede this information. Any statement contained in any document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in or omitted from this prospectus or any accompanying prospectus supplement, or in any other subsequently filed document, which also is or is deemed to be incorporated by reference herein, modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

 

We incorporate by reference the documents listed below and any future documents that we file with the SEC (excluding any portion of such documents that are furnished and not filed with the SEC) under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act (1) after the date of the initial filing of the registration statement of which this prospectus forms a part prior to the effectiveness of the registration statement and (2) after the date of this prospectus until the offering of the securities is terminated:

 

 

our Annual Report on Form 10-K for the year ended December 31, 2022;

 

 

our Current Reports on Form 8-K filed on January 5, 2023January 25, 2023April 14, 2023 and April 18, 2023; and

 

 

the description of our common stock set forth in the registration statement on Form 8-A filed on  December 6, 2007, as updated by Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 24, 2022, and all amendments and reports filed for the purpose of updating that description.

 

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We will not, however, incorporate by reference in this prospectus any documents or portions thereof that are not deemed “filed” with the SEC, including any information furnished pursuant to Item 2.02 or Item 7.01 of our current reports on Form 8-K unless, and except to the extent, specified in such current reports.

 

We will provide you with a copy of any of these filings (other than an exhibit to these filings, unless the exhibit is specifically incorporated by reference into the filing requested) at no cost, if you submit a request to us by writing or telephoning us at the following address and telephone number:

 

Athersys, Inc.

3201 Carnegie Avenue
Cleveland, Ohio 44115-2634
(216) 431-9900
Attn: Secretary

 

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The Company

 

 

We are a biotechnology company that is focused primarily in the field of regenerative medicine. Our MultiStem® (invimestrocel) cell therapy, a patented and proprietary allogeneic stem cell product candidate, is our lead platform product and is currently in clinical development in several therapeutic and geographic areas. Our most advanced program is an ongoing Phase 3 clinical trial for the treatment of ischemic stroke. Our current clinical development programs are focused on treating neurological conditions, inflammatory and immune disorders, certain pulmonary conditions, cardiovascular disease and other conditions where the current standard of care is limited or inadequate for many patients, particularly in the critical care segment.

 

Corporate Information

 

We were incorporated in Delaware and our headquarters are located at 3201 Carnegie Avenue, Cleveland, Ohio 44115. Our telephone number is (216) 431-9900. Our website is http://www.athersys.com. The information accessible on or through our website is not part of this prospectus, other than the documents that we file with the SEC that are specifically incorporated by reference into this prospectus.

 

Risk Factors

 

Investing in our common stock involves risk. Prior to making a decision about investing in our common stock, you should carefully consider the risk factors discussed under the heading “Risk Factors” in our most recent annual report on Form 10-K, which is incorporated herein by reference and may be amended, supplemented or superseded from time to time by other reports we file with the SEC in the future. If any of these risks actually occurs, our business, results of operations and financial condition could suffer. In that case, the trading price of our common stock could decline, and you could lose all or a part of your investment.

 

Disclosure Regarding Forward-Looking Statements

 

This prospectus, including the documents incorporated by reference, contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the timing of initiation of new clinical sites and patient enrollment in our clinical trials, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “suggest,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations.

 

In addition, a number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements:

 

 

 

our ability to raise capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, on terms acceptable to us or at all, and to continue as a going concern

 

 

our ability to successfully resolve the payment issues with our primary contract manufacturer and gain access to our clinical product;

 

 

our collaborators’ ability and willingness to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies;

 

 

the possibility of unfavorable results from ongoing and additional clinical trials involving MultiStem;

 

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the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in an early stage clinical trial may not be predictive of results in later stage or large scale clinical trials;

 

 

our ability to regain compliance with the requirement to maintain a minimum market value of listed securities of $35 million as set forth in Nasdaq Listing Rule 5550(b)(2);

 

 

the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke;

 

 

our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios;

 

 

the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of ARDS induced by COVID-19 and other pathogens, and the MATRICS-1 clinical trial being conducted with The University of Texas Health Science Center at Houston evaluating the treatment of patients with serious traumatic injuries;

 

 

the availability of product sufficient to meet commercial demand shortly following any approval;

 

 

the possibility of delays in, adverse results of, and excessive costs of the development process;

 

 

our ability to successfully initiate and complete clinical trials of our product candidates;

 

 

the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contamination, operational restrictions due to COVID-19 or other public health emergencies, labor constraints, regulatory issues or other factors that could negatively impact our trials and the trials of our collaborators;

 

 

uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for neurological, inflammatory and immune, cardiovascular and other critical care indications;

 

 

changes in external market factors;

 

 

changes in our industry’s overall performance;

 

 

changes in our business strategy;

 

 

our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development;

 

 

our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies;

 

 

the success of our efforts to enter into new strategic partnerships and advance our programs;

 

 

our possible inability to execute our strategy due to changes in our industry or the economy generally;

 

 

changes in productivity and reliability of suppliers;

 

 

the success of our competitors and the emergence of new competitors; and

 

 

the risks described in our Annual Report on Form 10-K for the year ended December 31, 2022, under Item 1A, “Risk Factors.” and our other filings with the SEC.

 

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Any forward-looking statement you read in this prospectus or any document incorporated by reference reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, operating results, growth strategy and liquidity. Although we currently believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee our future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements because such statements speak only as of the date when made. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law. You are advised, however, to consult any further disclosures we make on related subjects in our reports on Forms 10-Q, 8-K and 10-K furnished to the SEC. You should understand that it is not possible to predict or identify all risk factors. Consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.

 

Any document incorporated by reference or any prospectus supplement may also contain statistical data and estimates we obtained from industry publications and reports generated by third parties. Although we believe that the publications and reports are reliable, we have not independently verified their data.

 

Use of Proceeds

 

If the Warrants are exercised in full for cash, we would receive gross proceeds of approximately $11.9 million. There can be no assurance, however, that the holders of the Warrants will elect to exercise any or all of such Warrants.

 

We expect to use the proceeds from the issuance of common stock upon the exercise of any Warrants for general corporate purposes, including, but not limited to, research and development costs, payment obligations and capital expenditures. Pending any specific application, we may initially invest funds in U.S. government obligations.

 

Description of Capital Stock

 

We are authorized to issue 600,000,000 shares of common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share.

 

Common Stock

 

This section describes the general terms and provisions of our common stock. For more detailed information, you should refer to our Certificate of Incorporation and Bylaws, copies of which have been filed with the SEC. These documents are also incorporated by reference into the registration statement of which this prospectus forms a part.

 

Holders of shares of our common stock will be entitled to receive dividends if and when declared by the board of directors from funds legally available therefor, and, upon liquidation, dissolution or winding-up of our company, will be entitled to share ratably in all assets remaining after payment of liabilities. The holders of shares of our common stock will not have any preemptive rights, but will be entitled to one vote for each share of common stock held of record. Stockholders will not have the right to cumulate their votes for the election of directors. The shares of our common stock offered hereby, when issued, will be fully paid and nonassessable.

 

Preferred Stock

 

This section describes the general terms and provisions of our preferred stock. For more detailed information, you should refer to our Certificate of Incorporation and Bylaws, copies of which have been filed with the SEC. These documents are also incorporated by reference into the registration statement of which this prospectus forms a part.

 

Our board of directors is authorized, without action by our stockholders, to designate and issue up to 10,000,000 shares of preferred stock, par value $0.001 per share, in one or more series. The board of directors can fix the rights, preferences and privileges of the shares of each series and any of its qualifications, limitations or restrictions. Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of our common stock. The issuance of preferred stock, while providing flexibility in connection with possible future financings, acquisitions and other corporate purposes could, under certain circumstances, have the effect of delaying, deferring or preventing a change in control of us and could adversely affect the market price of our common stock. We do not have any shares of preferred stock outstanding, and we have no current plans to issue any preferred stock.

 

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Transfer Agent and Registrar

 

We have appointed Computershare Investor Services as the transfer agent and registrar for our common stock.

 

Listing

 

Our common stock is listed on The Nasdaq Capital Market under the symbol “ATHX.”

 

Plan of Distribution

 

On August 17, 2022, we issued and sold, in a registered direct offering, (i) an aggregate of 1,200,000 shares of common stock, (ii) pre-funded warrants exercisable for an aggregate of 720,000 shares of common stock and (iii) Warrants exercisable for an aggregate of 1,920,000 shares of common stock, in combinations of one share of common stock or one pre-funded warrant and one Warrant for a combined purchase price of $6.25 (less $0.0025 for any pre-funded warrant). Each Warrant initially was exercisable for one share of common stock at a price per share of $6.385 during the period ending February 17, 2030. On April 17, 2023, the exercise price of these Warrants were reduced to $0.96 per share, and the exercise period was extended to April 17, 2030.

 

On November 10, 2022, we issued and sold, in a public offering, (i) an aggregate of 3,927,275 shares of common stock, (ii) pre-funded warrants exercisable for an aggregate of 1,077,270 shares of common stock and (iii) Warrants exercisable for an aggregate of 10,009,090 shares of common stock, in combinations of one share of common stock or one pre-funded warrant and two Warrants for a combined purchase price of $1.10 (less $0.0001 for any pre-funded warrant). Each Warrant is exercisable for one share of common stock at a price per share of $1.10 for a period ending November 10, 2027. In 2023, holders of Warrants exercisable for 900,000 shares of common stock in the aggregate exercised their Warrants on a cashless basis.

 

Upon exercise of any Warrants, either for cash or on a cashless basis, we will issue the holders of the Warrants shares of common stock pursuant to this prospectus.

 

Legal Matters

 

Jones Day will pass upon the validity of the securities being offered hereby.

 

Experts

 

The consolidated financial statements of Athersys, Inc. appearing in Athersys, Inc.’s Annual Report (Form 10-K) for the year ended December 31, 2022 have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon (which contains an explanatory paragraph describing conditions that raise substantial doubt about the Company’s ability to continue as a going concern as described in Note B to the consolidated financial statements) included therein, and incorporated herein by reference. Such financial statements are, and audited financial statements to be included in subsequently filed documents will be, incorporated herein in reliance upon the report of Ernst & Young LLP pertaining to such financial statements (to the extent covered by consents filed with the Securities and Exchange Commission) given on the authority of such firm as experts in accounting and auditing.

 

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