athx20231103

S-1 1 athx20231103_s1.htm FORM S-1 athx20231103_s1.htm

As filed with the Securities and Exchange Commission on November 9, 2023

Registration No. 333-__________

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

ATHERSYS, INC.

(Exact name of registrant as specified in its charter)

Delaware	2834	20-4864095
(State or jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
incorporation or organization)	Classification Code Number)	Identification No.)

3201 Carnegie Avenue

Cleveland, Ohio 44115-2634

Phone: (216) 431-9900

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Daniel A. Camardo

Chief Executive Officer

Athersys, Inc.

3201 Carnegie Avenue

Cleveland, Ohio 44115-2634

Phone: (216) 431-9900

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Faith L. Charles

Thompson Hine LLP

300 Madison Avenue, 27th Floor

New York, New York 10017-6232

Phone: (212) 344-5680

Fax: (212) 344-6101

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

	Page
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS	ii
ABOUT THIS PROSPECTUS	1
SUMMARY	2
RISK FACTORS	3
USE OF PROCEEDS	5
DIVIDEND POLICY	5
DESCRIPTION OF SECURITIES	6
SELLING STOCKHOLDERS	7
PLAN OF DISTRIBUTION	8
LEGAL MATTERS	11
EXPERTS	11
WHERE YOU CAN FIND MORE INFORMATION	11
INFORMATION WE INCORPORATE BY REFERENCE	12

	●	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 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;

	●	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;

	●	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, contaminations, 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;

	●	our ability to maintain quotation of our common stock on the OTC Pink;

	●	our ability to identify, evaluate, and complete any strategic alternative that yields value for our stockholders; 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.

Common Stock Offered by the Selling Stockholders:		We are registering the resale by the Selling Stockholders named in this prospectus, or their permitted transferees, up to 76,249,080 shares of common stock consisting of (i) 56,249,080 shares of common stock that are issuable upon the exercise the Inducement Warrants issued by us to the Selling Stockholders in a private placement of the Inducement Warrants which closed on October 16, 2023 pursuant the Inducement Letter, and (ii) 20,000,000 shares of common stock that are issuable upon exercise of the October 30, 2023 Warrants issued by the Company on October 30, 2023 pursuant to the Letter Agreement.

Plan of Distribution:		The Selling Stockholders will determine when and how it will sell the common stock offered in this prospectus, as described in “Plan of Distribution” section of this prospectus.

Use of Proceeds:		We will not receive any proceeds from the sale of shares of our common stock by the Selling Stockholders.

Risk Factors:		Before investing in our securities, you should carefully read and consider the information set forth in the “Risk Factors” section of this prospectus and under similar headings in any amendments or supplements to this prospectus and the documents incorporated herein by reference.

OTC Pink symbol:		ATHX

	(1)	Assumes the sale of all shares of common stock offered pursuant to this prospectus. Such number (i) 2,505,358 shares of common stock known by us to be held by such Selling Stockholder as of the date of this prospectus; (ii) 5,022,000 shares of common stock that are held in abeyance until the Selling Stockholder notifies us that the issuance of such shares would not result in the Selling Stockholder beneficially owning in excess of 4.99% of our common stock and (iii) 3,370,000 shares of common stock issuable upon exercise of warrants exercisable within 60 days of November 8, 2023.

	(2)	Such percentage assumes total shares issued and outstanding after the offering is 137,967,895, which number includes 5,022,000 shares of common stock that are held in abeyance until the Selling Stockholder notifies us that the issuance of such shares would not result in the Selling Stockholder beneficially owning in excess of 4.99% of our common stock. Such percentage also includes, for purposes of beneficial ownership, 3,370,000 shares of common stock issuable upon exercise of warrants exercisable within 60 days of November 8, 2023.

	(3)	The securities are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”), and may be deemed to be beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Stockholder from exercising that portion of the warrants that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

	(4)	Includes (i) 2,505,358 shares of common stock known by us to be held by such Selling Stockholder as of the date of this prospectus; (ii) 5,022,000 shares of common stock that are held in abeyance until the Selling Stockholder notifies us that the issuance of such shares would not result in the Selling Stockholder beneficially owning in excess of 4.99% of our common stock; (iii) 3,370,000 shares of common stock issuable upon exercise of warrants exercisable within 60 days of November 8, 2023; and (iv) the shares of common stock that are being registered hereunder that are issuable upon exercise of the Subject Warrants, in each case without giving effect to any beneficial ownership limitations that may exist on such warrants.

	●	through underwriters or dealers for resale to the public or to investors;

	●	directly to one or more purchasers;

	●	through agents;

	●	in “at the market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an existing trading market on an exchange or otherwise;

	●	in block trades;

	●	through public or privately negotiated transactions; or

	●	any other method permitted pursuant to applicable law.

	●	on any national securities exchange or quotation service on which our common stock may be listed or quoted at the time of sale or in the over-the-counter market;

	●	in transactions other than on a national securities exchange or quotation service or in the over-the-counter market;

	●	in block transactions in which the broker or dealer so engaged will attempt to sell the shares of common stock as agent but may position and resell a portion of the block as principal to facilitate the transaction, or in crosses, in which the same broker acts as an agent on both sides of the trade;

	●	in ordinary brokerage transactions in which the broker-dealer solicits purchasers;

	●	through purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

	●	through the writing of options, convertible securities or other contracts or agreements to be satisfied by the delivery of shares of common stock;

	●	through short sales;

	●	through privately negotiated transactions;

	●	through an exchange distribution in accordance with the rules of the applicable exchange;

	●	through broker-dealers who may agree with any Selling Stockholder to sell a specified number of its shares at a stipulated price per share;

	●	through the lending of such securities;

	●	by pledge to secure debts and other obligations or on foreclosure of a pledge;

	●	through the distribution of such securities by any Selling Stockholder to its stockholders;

	●	through a combination of any of the above methods; or

	●	through any other method permitted pursuant to applicable law.

	●	our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on April 3, 2023;

	●	our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as filed with the SEC on May 15, 2023, and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as filed with the SEC on August 16, 2023;

	●	our Current Reports on Form 8-K and/or amendments thereto (other than any portions thereof deemed furnished and not filed), as filed with the SEC on January 5, 2023, January 25, 2023, April 14, 2023, April 18, 2023, May 23, 2023, June 28, 2023, July 5, 2023, July 14, 2023, July 31, 2023, August 8, 2023, August 10, 2023, August 11, 2023, August 18, 2023, September 11, 2023, September 19, 2023, October 2, 2023, October 3, 2023, October 11, 2023, October 12, 2023, October 18, 2023, and October 30, 2023;

	●	our Definitive Proxy Statement on Schedule 14A, as filed with the SEC on August 17, 2023; and

	●	the description of our common stock set forth in the registration statement on Form 8-A filed with the SEC 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.

	Amount
SEC registration fee	$	304
Accountant’s fees and expenses		25,000
Legal fees and expenses		15,000
Miscellaneous fees and expenses		1,000
Total Expense	$	41,304

	●	for any breach of their duty of loyalty to the company or its stockholders;

	●	for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;

	●	for unlawful payment of dividend or unlawful stock repurchase or redemption, as provided under Section 174 of the General Corporation Law of the State of Delaware (the “DGCL”); or

	●	for any transaction from which the director derived an improper personal benefit.

	ATHERSYS, INC.

	By:	/s/ Daniel A. Camardo
	Name:	Daniel A. Camardo
	Title:	Chief Executive Officer

Signatures		Title
/s/ Daniel A. Camardo		Chief Executive Officer and Director (Principal Executive Officer)
Daniel A. Camardo

/s/ Kasey Rosado		Interim Chief Financial Officer
Kasey Rosado		(Principal Financial and Accounting Officer)

/s/ Jane Wasman
Jane Wasman		Chair of the Board of Directors

/s/ Joseph Nolan
Joseph Nolan		Director

/s/ Jack L. Wyszomierski
Jack L. Wyszomierski		Director

/s/ Neema Mayhugh
Neema Mayhugh		Director

	●	On October 30, 2023, we entered into the Letter Agreement with the Holder (as defined below). Pursuant to the Letter Agreement, we issued the October 30, 2023 Warrants exercisable for an aggregate of 20,000,000 shares at a price of $0.01 per share in consideration of the Holder’s agreement to (i) reduce the subsequent equity sale restriction period provided by the Inducement Letter and any periods limiting the Company’s ability to enter into variable rate transactions provided by any other agreements with the Holder, and (ii) vote all shares of its common stock (if any) in accordance with the recommendations of our board of directors upon the occurrence of a Fundamental Transaction (as defined in the October 30, 2023 Warrants) if a stockholder vote is required for such Fundamental Transaction.

	●	On October 11, 2023, we entered into the Inducement Letter with a holder (the “Holder”) of certain existing warrants (the “Existing Warrants”) exercisable for an aggregate of 28,124,590 shares of our common stock. Pursuant to the Inducement Letter, and in consideration of the holder’s exercising in full the Existing Warrants at a reduced exercise price of $0.1395 per share, we issued the Inducement Warrants exercisable for an aggregate of 56,249,180 shares at a price of $0.1395 per share. On October 30, 2023, we entered into an amendment to the Inducement Warrants, reducing the exercise price from $0.1395 to $0.01 per share. We engaged A.G.P./Alliance Global Partners (“A.G.P.”) to act as our financial advisor in connection with this transaction for a fee of $275,000.

	●	On May 17, 2023, we entered into a Forbearance, Restructuring and Settlement Agreement with a supplier, pursuant to which we issued a convertible promissory note to the supplier in the principal amount of $15.0 million (the “Note”). Subject to a beneficial ownership limitation of 19.99% of our outstanding common stock and any shareholder approval requirements, the supplier may elect, at its sole discretion, to convert any outstanding principal and interest on the Note into shares of our common stock at a conversion price of $1.30 per share.

	●	On April 18, 2023, we entered into a securities purchase agreement with certain accredited investors, pursuant to which we offered and sold shares of our common stock and pre-funded warrants, in a registered direct offering, for an aggregate offering price of approximately $3.6 million. We paid A.G.P., the placement agent for the offering, a cash fee equal to 6.5% of the aggregate gross proceeds received from the offering. In a concurrent private placement, we issued warrants exercisable for an aggregate of 3,685,000 shares of our common stock.

	●	On April 18, 2023, we amended (i) common stock purchase warrants exercisable for an aggregate of 1,920,000 shares of our common stock that we issued to an accredited investor on September 22, 2022 (the “September Warrants”), and (ii) common stock purchase warrants exercisable for an aggregate of 2,000,000 shares that we issued to an accredited investor on August 17, 2022, as amended on September 22, 2022 (the “August Warrants”). The September Warrants and the August Warrants were issued in a concurrent private placement in connection with a registered direct offering of our securities under that securities purchase agreement, dated August 15, 2022, as amended on September 22, 2022, for an aggregate offering price of approximately $12 million. We paid A.G.P., the placement agent for the offering, a cash fee equal to 7.0% of the aggregate gross proceeds received from the offering.

	●	On August 15, 2022, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain accredited investors, pursuant to which we offered and sold common stock purchase warrants, in a registered direct offering, exercisable for an aggregate of 1,920,000 shares of our common stock at a price of $6.3850 per share. On September 22, 2022, we entered into an amendment to the Purchase Agreement, which, among other things, reduced the standstill period and curtailed the term and amount of the right of participation under the Purchase Agreement. As an inducement to such investors’ entering the Purchase Agreement amendment, we issued to each investor new warrants exercisable for an aggregate of 2,000,000 shares of our common stock at a price of $6.3850 per share.

	●	On May 12, 2022, we entered into a common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”), pursuant to which Aspire Capital committed to purchase from us up to an aggregate of $100 million of shares of our common stock, subject to the terms and conditions specified in such common stock purchase agreement, over the 24-month term of the common stock purchase agreement. On July 6, 2022, Aspire Capital delivered notice to us, terminating such common stock purchase agreement, effective immediately. From May 12, 2022 through the date of termination, the Company sold 274,800 shares of its common stock under such common stock purchase agreement, generating proceeds of $1,859,529.

	●	On June 24, 2021, we entered into a common stock purchase agreement with Aspire Capital, pursuant to which Aspire Capital committed to purchase from us up to an aggregate of $100 million of shares of our common stock, subject to the terms and conditions specified in such common stock purchase agreement, over the 36-month term of the common stock purchase agreement. From June 24, 2021 through June 23, 2022, the Company sold 1,600,000 shares of its common stock under such common stock purchase agreement, generating proceeds of $31,068,740.

	●	On November 5, 2019, we entered into a common stock purchase agreement with Aspire Capital, pursuant to which Aspire Capital committed to purchase from us up to an aggregate of $100 million of shares of our common stock, subject to the terms and conditions specified in such common stock purchase agreement, over the 36-month term of the common stock purchase agreement. From July 1, 2020 through August 11, 2021, the Company sold 1,186,000 shares of its common stock under such common stock purchase agreement, generating proceeds of $54,828,034.

Exhibit Number		Description
3.1		Certificate of Incorporation of Athersys, Inc., as amended as of June 20, 2013 (incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q (Commission No. 001-33876) filed with the SEC on August 13, 2013).

3.2		Certificate of Amendment to Certificate of Incorporation of Athersys, Inc., as amended as of June 7, 2017 (incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017 (Commission No. 001-33876) filed with the SEC on August 9, 2017).

3.3		Certificate of Amendment to Certificate of Incorporation of Athersys, Inc., as amended, effective as of June 16, 2021 (incorporated by reference to Exhibit 3.3 to our Registration Statement on Form S-3 (Commission No. 333-257409) filed with the Commission on June 25, 2021).

3.4		Certificate of Amendment to Certificate of Incorporation of Athersys, Inc., as amended as of August 26, 2022 (incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on August 29, 2022).

3.5		Bylaws of Athersys, Inc., as amended and restated as of March 13, 2019 (incorporated by reference to Exhibit 3.1 to our Quarterly Report on Form 10-Q (Commission No. 001-33876) filed with the Commission on May 8, 2019).

4.1		Reference is made to Exhibits 3.1 through 3.5.

4.2		Form of Series A Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on October 12, 2023).

4.3		Form of Inducement Letter (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on October 12, 2023).

4.4		Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on October 30, 2023).

4.5		Form of Letter Agreement (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on October 30, 2023).

4.6		Amendment to Series A Common Stock Purchase Warrants (incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K (Commission No. 001-33876) filed with the Commission on October 30, 2023).

5.1*		Opinion of Thompson Hine LLP.

23.1*		Consent of Thompson Hine LLP (included in Exhibit 5.1 to this Registration Statement).

23.2*		Consent of Independent Registered Public Accounting Firm.

24.1*		Power of Attorney (included on signature page).

107*		Filing Fee Table.

SEC Form S-1 filed by Athersys Inc.