Form 10-Q ATHERSYS, INC / NEW For: Mar 31

Form 10-Q ATHERSYS, INC / NEW For: Mar 31

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May 6, 2016 6:11 AM EDT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2016

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission file number: 001-33876

Athersys, Inc.

(Exact name of registrant as specified in its charter)


Delaware		20-4864095
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

3201 Carnegie Avenue, Cleveland, Ohio		44115-2634
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (216) 431-9900

Former name, former address and former fiscal year, if changed since last report: Not Applicable

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act): Yes ¨ No x

The number of outstanding shares of the registrant’s common stock, $0.001 par value, as of May 2, 2016 was 84,364,555.

ATHERSYS, INC.

TABLE OF CONTENTS


PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements			1

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			12

ITEM 3. Quantitative and Qualitative Disclosures About Market Risk			21

ITEM 4. Controls and Procedures			21

PART II. OTHER INFORMATION

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds			22

ITEM 6. Exhibits			22

SIGNATURES			23

EXHIBIT INDEX			24

PART I. FINANCIAL INFORMATION

Item 1.

Financial Statements.

Athersys, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)


	March 31,			December 31,
	2016			2015
Assets
Current assets:
Cash and cash equivalents	$	30,414		$	23,027
Accounts receivables		706			361
Prepaid expenses and other		426			429

Total current assets		31,546			23,817
Equipment, net		1,253			1,135
Deferred tax assets		184			177

Total assets	$	32,983		$	25,129

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,274		$	2,702
Accrued compensation and related benefits		515			1,024
Accrued clinical trial costs		443			82
Accrued expenses		489			513
Deferred revenue		—			245
Note payable		—			190

Total current liabilities		4,721			4,756
Warrant liabilities		2,830			649
Stockholders’ equity:
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at March 31, 2016 and December 31, 2015		—			—
Common stock, $0.001 par value; 150,000,000 shares authorized, and 84,114,555 and 83,720,154 shares issued at March 31, 2016 and December 31, 2015, respectively, and 84,090,729 and 83,720,154 shares outstanding at March 31, 2016 and December 31, 2015, respectively		84			84
Additional paid-in capital		323,540			322,582
Accumulated deficit		(298,192	)		(302,942	)

Total stockholders’ equity		25,432			19,724

Total liabilities and stockholders’ equity	$	32,983		$	25,129

See accompanying notes to unaudited condensed consolidated financial statements.

Athersys, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(In thousands, except share and per share data)

(Unaudited)


	Three months ended March 31,
	2016			2015
Revenues
Contract revenue	$	15,124		$	106
Grant revenue		334			625

Total revenues		15,458			731
Costs and expenses
Research and development		6,664			5,668
General and administrative		2,014			1,886
Depreciation		68			70

Total costs and expenses		8,746			7,624

Income (loss) from operations		6,712			(6,893	)
Expense from change in fair value of warrants, net		(2,181	)		(5,604	)
Other income, net		210			15

Income (loss) before income taxes		4,741			(12,482	)
Income tax benefit		9			—

Net income (loss) and comprehensive income (loss)	$	4,750		$	(12,482	)

Net income (loss) per share - Basic and Diluted	$	0.06		$	(0.16	)
Weighted average shares outstanding - Basic		83,781,114			79,180,697
Weighted average shares outstanding - Diluted		83,865,607			79,180,697

See accompanying notes to unaudited condensed consolidated financial statements.

Athersys, Inc.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)


	Three months ended March 31,
	2016			2015
Operating activities
Net income (loss)	$	4,750		$	(12,482	)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation		68			70
Income from forgiveness of note payable		(190	)		—
Stock-based compensation		707			751
Change in fair value of warrant liabilities and other		2,174			5,605
Changes in operating assets and liabilities:
Accounts receivable		(345	)		(2,143	)
Prepaid expenses and other assets		3			41
Accounts payable and accrued expenses		400			(678	)
Deferred revenue		(245	)		9,952

Net cash provided by operating activities		7,322			1,116
Investing activities
Purchases of equipment		(186	)		(63	)

Net cash used in investing activities		(186	)		(63	)
Financing activities
Proceeds from issuance of common stock, net		424			7,606
Purchase of treasury stock		(173	)		(257	)
Proceeds from exercise of warrants		—			976

Net cash provided by financing activities		251			8,325
Increase in cash and cash equivalents		7,387			9,378
Cash and cash equivalents at beginning of the period		23,027			26,127

Cash and cash equivalents at end of the period	$	30,414		$	35,505

See accompanying notes to unaudited condensed consolidated financial statements.

Athersys, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

Three-Month Periods Ended March 31, 2016 and 2015

1. Background and Basis of Presentation

We are an international biotechnology company that is focused primarily in the field of regenerative medicine and operate in one business segment. Our operations consist primarily of research and product development activities.

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included below in this Quarterly Report on Form 10-Q.

2. Recently Issued Accounting Standards

In November 2015, the Financial Accounting Standards Board (“FASB”) issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which amends the existing guidance to require that deferred income tax liabilities and assets be classified as noncurrent in a classified balance sheet and eliminates the prior guidance, which required an entity to separate deferred tax liabilities and assets into a current amount and a noncurrent amount in a classified balance sheet. The amendments in this ASU are effective for financial statements for annual periods and interim periods within those annual periods beginning after December 15, 2016, with early adoption permitted, and the new guidance can be applied either prospectively to all deferred tax liabilities and assets or retrospectively to all periods presented. We have adopted this ASU in the first quarter of 2016 on a prospective basis and, therefore, the adoption did not impact prior period financial statements.

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 requires an entity to recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, the amendment provides five steps that an entity should apply when recognizing revenue. The amendment also specifies the accounting of some costs to obtain or fulfill a contract with a customer and expands the disclosure requirements around contracts with customers. An entity can either adopt this amendment retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the update recognized at the date of initial application. In August 2015, the FASB issued ASU 2015-14, which delays the effective date by one year, making the new standard effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after December 15, 2016. We are in the process of evaluating, but have not determined, the impact that the adoption of ASU 2014-09 will have on our consolidated financial statements.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and, if so, to provide related footnote disclosures. ASU 2014-15 provides a definition of the term “substantial doubt” and requires an assessment for a period of one year after the date that the financial statements are issued or available to be issued. Management will also be required to evaluate and disclose whether it has plans to alleviate that doubt. The guidance is effective for the annual periods ending after December 15, 2016 and interim periods thereafter with early adoption permitted. We will adopt ASU 2014-15 as required and are evaluating the impact the new guidance will have on our year-end disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires lessees to put most leases on their balance sheets, but recognize expenses on their income statements in a manner similar to current accounting practice. Under the guidance, lessees initially recognize a lease liability for the obligation to make lease payments and a right-of-use (“ROU”) asset for the right to use the underlying asset for the lease term. The lease liability is measured at the present value of the lease payments over the lease term. The ROU asset is measured at the lease liability amount, adjusted for lease prepayments, lease incentives received and the lessee’s initial direct costs. The guidance is effective for the annual periods beginning after December 15, 2018 and interim periods thereafter, with early adoption permitted. We are in the process of evaluating the impact the new guidance will have on our financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting, which involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Under the new standard, income tax benefits and deficiencies are to be recognized as income tax expense or benefit in the income statement and the tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity should also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits should be classified along with other income tax cash flows as an operating activity. In regards to forfeitures, the entity may make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures when they occur. This ASU is effective for fiscal years beginning after December 15, 2016 including interim periods within that reporting period, with early adoption permitted, provided that all amendments are adopted in the same period. We are currently evaluating the impact the adoption of ASU 2016-09 will have on its financial statements.

3. Net Income (Loss) per Share

Basic and diluted net income (loss) per share have been computed using the weighted-average number of shares of common stock outstanding during the period. The table below reconciles the net income (loss) and the number of shares used to calculate basic and diluted net income (loss) per share for the three-month periods ended March 31, 2016 and 2015, in thousands, except share and per share data.


	Three months ended March 31,
	2016		2015
Numerator:
Net income (loss) attributable to common stockholders - Basic and Diluted	$	4,750	$	(12,482	)

Denominator:
Weighted-average shares outstanding - Basic		83,781,114		79,180,697
Potentially dilutive common shares outstanding:
Stock-based awards		84,493		—

Weighted-average shares used to calculate diluted net income (loss) per share		83,865,607		79,180,697

Basic and Diluted earnings (loss) per share	$	0.06	$	(0.16	)

We have outstanding stock-based awards and warrants that are not used in the calculation of diluted net income (loss) per share because to do so would be antidilutive. The following instruments were excluded from the calculation of diluted net income (loss) per share because their effects would be antidilutive:


	Three months ended March 31,
	2016		2015
Stock-based awards		7,593,940		8,014,773
Warrants		3,554,893		8,364,893

Total		11,148,833		16,379,666

4. Financial Instruments

Fair Value Measurements

We classify the inputs used to measure fair value into the following hierarchy:


Level 1		Unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2		Unadjusted quoted prices in active markets for similar assets or liabilities, or unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are observable for the asset or liability.

Level 3		Unobservable inputs for the asset or liability.

The following table provides a summary of the financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 (in thousands):


			Fair Value Measurements at March 31, 2016 Using
Description	Balance as of March 31, 2016		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Warrant liabilities	$	2,830	$	—	$	—	$	2,830

We review and reassess the fair value hierarchy classifications on a quarterly basis. Changes from one quarter to the next related to the observability of inputs in a fair value measurement may result in a reclassification between fair value hierarchy levels. There were no reclassifications for all periods presented.

The estimated fair value of warrants accounted for as liabilities, representing a level 3 fair value measure, was determined on the issuance date and subsequently marked to market at each financial reporting date.

We use the Black-Scholes valuation model to value the warrant liabilities at fair value. The fair value is estimated using the expected volatility based on our historical volatility. The fair value of the warrants is determined using probability weighted-average assumptions, when appropriate. The following inputs were used at March 31, 2016:


	Expected Volatility	Risk-Free Interest Rate	Expected Life
Warrants with one year or less remaining term	78.58% – 95.67%	0.21% – 0.59%	0.29 – 0.95 year

A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrants is as follows (in thousands):


	Three months ended
	March 31, 2016
Balance January 1, 2016	$	649
Loss included in expense from change in fair value of warrants		2,181

Balance March 31, 2016	$	2,830

Financing Arrangement

In 2012, we entered into an arrangement with the Global Cardiovascular Innovation Center and the Cleveland Clinic Foundation in which we received $166,000 in the form of a forgivable loan to fund certain preclinical work. Interest on the loan accrued at a fixed rate of 4.25% per annum and was added to the outstanding principal, and the loan carried an expiration date of March 31, 2016. In January 2016, the $190,000 loan (including accrued interest) was forgiven according to its terms based on the achievement of certain milestones and the forgiveness was recognized as other income in the consolidated statement of operations and comprehensive income (loss).

5. Collaborations and Revenue Recognition

Healios

On January 8, 2016, we entered into a license agreement (“Healios Agreement”) with Healios K.K. (“Healios”) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan, and to provide Healios with access to Athersys’ proprietary MAPC technology for use in Healios’ “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the Healios Agreement, Healios also obtained a right, at their option, to expand the scope of the collaboration to include the exclusive rights to develop and commercialize MultiStem for the treatment of two additional indications in Japan, which include acute respiratory distress syndrome (“ARDS”) and another indication in the orthopedic area, and to include all indications for the “organ bud” program. Healios will develop and commercialize the MultiStem product in Japan, and we will provide the manufactured product to Healios.

Under the terms of the Healios Agreement, we received a nonrefundable, up-front cash payment of $15 million from Healios, the majority of which was received in January 2016. If Healios exercises their option to expand the collaboration, we will be entitled to receive a cash payment of $10 million. Healios may exercise its option to expand the collaboration prior to certain milestone dates that are expected to occur within the next two years.

For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones aggregating up to $225 million. Such amounts are non-refundable and non-creditable towards future royalties or any other payment due from Healios. We will also receive tiered royalties on net product sales, starting in the low double-digits and increasing incrementally into the high teens, depending on net sales levels. Additionally, we will receive payments for product supplied to Healios for ischemic stroke.

If Healios exercises the option to expand the collaboration to include ARDS and another indication in the orthopedic area, we would be entitled to receive royalties from product sales and success-based development, regulatory approval and sales milestones, as well as payments for product supply related to the additional indications covered by the option.

For the “organ bud” product, we are entitled to receive a fractional royalty percentage on net sales of the “organ bud” products and will receive payments for manufactured product supplied to Healios under a manufacturing supply agreement. Additionally, we have a right of first negotiation for commercialization of an “organ bud” product in North America, with such right expiring on the later of (i) the date five years from the effective date of the Healios Agreement and (ii) 30 days after authorization to initiate clinical studies on an “organ bud” product under the first investigational new drug application or equivalent in Japan, North America or the European Union.

The Healios Agreement will expire automatically when there are no remaining intellectual property rights subject to the license. Additionally, Healios may terminate the Healios Agreement under certain circumstances, including for material breach and without cause upon advance written notice. We may terminate the Healios Agreement if there is an uncured material breach of the agreement by Healios. In the event that Healios does not move the program forward, the development and commercialization rights would revert to us.

To determine the appropriate accounting for the license agreement, we evaluated the Healios Agreement and related facts and circumstances, focusing in particular on the rights and obligations of the arrangement. We have determined that our obligations under the Healios Agreement represent multiple deliverables. For deliverables with standalone value, our policy is to account for these as separate units of accounting. We allocate the overall consideration of the arrangement that is fixed and determinable, excluding consideration that is contingent upon future deliverables, to the separate units of accounting based on estimated selling prices (as defined in ASC 605-25) of each deliverable.

Given Healios’ ability to sublicense under the Healios Agreement and its ability to conduct the ongoing development efforts, we concluded that the license had stand-alone value at the inception of the arrangement and would be treated as a separate unit of accounting, noting that there was no general right of return associated with the license. Further, the preclinical and clinical manufacturing services and certain near-term regulatory advisory services that will be provided to Healios under the Healios Agreement had been determined to have stand-alone value and considered separate units of accounting.

We were unable to establish vendor-specific objective evidence of selling price or third-party evidence for either the license or the services, and thus, instead, allocated the arrangement consideration between the license and the services based on their relative selling prices using best estimate of selling price (“BESP”). We developed the BESP of the license using a probability weighted, discounted cash flow analysis using the income approach, taking into consideration market assumptions including the estimated development and commercialization timeline, data regarding patient population, discount rate related to our industry, and probability of success using market data for both our industry and therapeutic field. We estimated the BESP of the manufacturing services and certain near-term regulatory advisory services using actual historical experience and best estimates of the cost of obtaining these services at arm’s length from a third-party provider, including an estimated mark-up. As a result of this analysis, we allocated $15 million to the license, which represents the amount of consideration that is allocable pursuant to the relative selling price and is not contingent upon delivery of additional items under the Healios Agreement. The license was delivered and recognized as revenue in January 2016.

Other contingent deliverables that were not accounted for at the inception of the arrangement, and will not be accounted for until the contingency is resolved, included the potential expansion of the collaboration to include additional indications, and the milestones that are not substantive since they are dependent on the activities of Healios. Further, the arrangement contemplates our providing manufacturing services for commercial product supply, the terms of which are not defined and are to be agreed upon in the future under a separate supply agreement.

Upon the removal of the contingencies associated with each of the potential contingent deliverables, including the expansion fee, milestone payments and / or commercial product supply, we will reevaluate the overall arrangement, including the estimated selling prices and the allocation of the overall consideration of the arrangement.

Chugai

In October 2015, we and Chugai Pharmaceutical Co. Ltd. (“Chugai”) agreed to terminate the License Agreement (the “Chugai Agreement”), dated February 28, 2015, between the parties, as a result of an inability to reach an agreement on the modification of the financial terms of the Chugai Agreement and on the development strategy, as proposed by Chugai, of our MultiStem^® cell therapy for the treatment of ischemic stroke in Japan. Pursuant to the terms of the Chugai Agreement, upon termination, we regained all rights for developing our stem cell technologies and products for ischemic stroke in Japan, and Chugai no longer has any license rights or options with respect to our technologies and products. Neither we nor Chugai have any further obligations to each other.

Under the Chugai Agreement, we received a non-refundable, up-front cash payment of $10 million from Chugai, of which approximately $2.0 million was temporarily withheld by Japan taxing authorities and was refunded in September 2015. The $10 million upfront payment from Chugai was recorded as deferred revenue since we had concluded that the license grant did not have standalone value (as defined in ASC 605-25) at the inception of the arrangement. In connection with the termination and the parties having no further obligations under the Chugai Agreement, we recognized the $10 million upfront payment from Chugai as revenue in October 2015.

RTI Surgical, Inc.

In 2010, we entered into an agreement with RTI Surgical, Inc. (“RTI”) to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market on an exclusive basis. Under the terms of the agreement, we received a non-refundable license fee in installments and performed certain services that were concluded in 2012, and we are eligible to receive cash payments upon the successful achievement of certain commercial milestones. We evaluated the nature of the events triggering these contingent payments and concluded that these events are substantive and that revenue will be recognized in the period in which each underlying triggering event occurs. No milestone revenue has been recognized to date. In addition, we began receiving in 2014 tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single digits and increasing into the mid-teens. Any royalties may be subject to a reduction if third-party payments for intellectual property rights are necessary or commercially desirable to permit the manufacture or sale of the product.

6. Stock-based Compensation

We have two incentive plans that authorized an aggregate of 11,500,000 shares of common stock for awards to employees, directors and consultants. These equity incentive plans authorize the issuance of equity-based compensation in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock-based awards. As of March 31, 2016, a total of 2,983,302 shares of common stock have been issued under our equity incentive plans.

As of March 31, 2016, a total of 339,111 shares were available for issuance under our equity compensation plans and stock-based awards to purchase 8,177,587 shares of common stock were outstanding. For the three-month periods ended March 31, 2016 and 2015, stock-based compensation expense was approximately $707,000 and $751,000, respectively. At March 31, 2016, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $3.5 million, which is expected to be recognized by the end of 2020 using the straight-line method.

7. Issuance of Common Stock and Warrants

Aspire Capital

In November 2011, we entered into an equity purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”), which provided that Aspire Capital was committed to purchase up to an aggregate of $20.0 million of shares of our common stock over a two-year term, subject to our election to sell any such shares. As of September 2013, we had sold all the remaining shares that were available under the equity facility, which was due to expire. In October 2013, we terminated the expiring 2011 equity purchase agreement and entered into a new 2013 equity purchase agreement with Aspire Capital to purchase up to an aggregate of $25.0 million of shares of our common stock over a new two-year period. The terms of the 2013 equity facility were similar to the previous arrangement. Upon the 2013 equity facility’s expiration, in December 2015, we entered into a new 2015 equity purchase agreement with Aspire Capital to purchase up to an aggregate of $30.0 million of shares of our common stock over a new three-year period. The terms of the 2015 equity facility are similar to the previous arrangements, and we issued 250,000 shares of our common stock to Aspire Capital as a commitment fee in December 2015, which are accounted for as a cost of the offering, and filed a registration statement for the resale of 16,600,000 shares of common stock in connection with the new equity facility.

In the first quarter of 2016, we sold 200,000 shares to Aspire Capital Fund, LLC (“Aspire Capital”) under our equity purchase agreement at an average price of $2.14 per share, generating aggregate proceeds of $0.4 million.

Warrants

As of March 31, 2016, we had the following outstanding warrants to purchase shares of common stock:


Number of Underlying Shares		Exercise Price		Expiration
	2,054,893	$	1.01	March 14, 2017
	1,500,000	$	4.50	July 15, 2016

	3,554,893

No warrants were exercised during the three months ended March 31, 2016.

8. Warrant Liabilities

We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. Registered common stock warrants that could require cash settlement are accounted for as liabilities. We classify these warrant liabilities on the consolidated balance sheet as a non-current liability. The warrant liabilities are revalued at fair value at each balance sheet date subsequent to the initial issuance. Changes in the fair market value of the warrant are reflected in the consolidated statement of operations as income (expense) from change in fair value of warrants.

The warrants we issued in the January 2014 registered direct offering contain a provision for a cash payment in the event that the shares are not delivered to the holder within two trading days. The cash payment equals $10 per day per $2,000 of warrant shares for each day late. The warrants we issued in the March 2012 private placement contain a provision for net cash settlement in the event that there is a fundamental transaction (e.g., merger, sale of substantially all assets, tender offer, or share exchange).

If a fundamental transaction occurs in which the consideration issued consists of all cash or stock in a non-public company, then the warrant holder has the option to receive cash equal to a Black Scholes value of the remaining unexercised portion of the warrant. Further, the March 2012 warrants include price protection in the event we sell stock below the exercise price, as defined.

The warrants have been classified as liabilities, as opposed to equity, due to the potential adjustment to the exercise price that could result upon late delivery of the shares or potential cash settlement upon the occurrence of certain events as described above, and are recorded at their fair values at each balance sheet date.

9. Income Taxes

We have U.S. federal net operating loss and research and development tax credit carryforwards, as well as state and city net operating loss carryforwards, which may be used to reduce future taxable income and tax liabilities. We also have foreign net operating loss and tax credit carryforwards, and the foreign net operating losses do not expire. Substantially all of our deferred tax assets have been fully offset by a valuation allowance due to our cumulative losses.

As a result of our October 2012 equity offering, the utilization of our net operating loss and tax credit carryforwards generated prior to October 2012 is substantially limited under Section 382 of the Internal Revenue Code. U.S. federal net operating loss carryforwards, research and development tax credits, and state and local net operating loss carryforwards generated after October 2012, as well as foreign net operating loss carryforwards and foreign tax credits, are not subject to annual limitations. We recognize refundable tax benefits related to research and development credits associated with our foreign subsidiary.

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

This discussion and analysis should be read in conjunction with our unaudited financial statements and notes thereto included in this Quarterly Report on Form 10-Q and the audited financial statement and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015. Operating results are not necessarily indicative of results that may occur in future periods.

Overview and Recent Developments

We are an international biotechnology company that is focused primarily in the field of regenerative medicine. Our MultiStem^® cell therapy is currently being evaluated in multiple clinical trials. Our current clinical development programs are focused on treating neurological conditions, cardiovascular disease, inflammatory and immune disorders, and other conditions. We are also applying our pharmaceutical discovery capabilities to identify and develop small molecule compounds with potential applications in indications such as obesity, related metabolic conditions and certain neurological conditions.

Current Programs

To date, we have advanced several MultiStem cell therapy programs to the clinical development stage, including the following:

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Ischemic Stroke: We completed our Phase 2 study of MultiStem treatment of subjects suffering a moderate to severe ischemic stroke. In April 2015, we announced the interim results from the clinical study, and in February 2016, we announced the one-year follow-up data from the study. Our double blind, placebo-controlled, randomized trial was conducted at 33 leading stroke centers across the United States and the United Kingdom, or UK. In the study, we treated patients one to two days after a stroke. Published studies suggest that approximately 90% of ischemic stroke patients reach the hospital within 24 hours. By contrast, the current standard of care, thrombolytic tPA, must be administered within 3 to 4.5 hours after a stroke, limiting the proportion of patients receiving such treatment to less than 10% of ischemic stroke patients. Patients were assessed at 90 days and one-year in accordance with three well validated and commonly utilized clinical rating scales that are used to assess recovery. These include the Modified Rankin Score, or mRS (which is a scale from 0 to 6, with a score of 0 reflecting no patient disability and 6 indicating death), assessing overall disability; the NIH Stroke Scale, or NIHSS, which assesses neurological and motor skill deficit (a scale from 0 to 42, with a score of 0 reflecting no disability, and 42 reflecting maximum disability in every category) assessing neurological and motor skill deficits; and the Barthel Index, or BI, (a 100 point index, with a score of 100 representing the best possible score) evaluating the patient’s ability to engage in activities of daily living.

The interim results following the 90-day patient evaluation demonstrate favorable tolerability and safety for MultiStem, consistent with prior studies. With respect to the primary and component secondary endpoints for the intent-to-treat population, the MultiStem treatment did not show a meaningful difference at 90 days compared to placebo. However, MultiStem treatment was associated with lower rates of mortality and life threatening adverse events, infections and pulmonary events, and also a reduction in hospitalization. Furthermore, a higher proportion of patients receiving MultiStem achieved an “Excellent Outcome,” meaning complete or nearly full recovery, which is defined clinically as the patient achieving excellent recovery in each of the three clinical rating scales, as evidenced by patients achieving a score of mRS £1, NIHSS £1 and BI ³95. Achievement of an Excellent Outcome is important because it means that a patient has substantially improved in each of the three clinical rating scales used to assess patient improvement and has regained the ability to live and function independently with a high quality of life. Among all subjects who received MultiStem treatment, 15.4% of patients achieved an Excellent Outcome, compared to 6.6% of patients who received placebo (p=0.10). Importantly, by one year, there was a significant difference between the groups with 23.1% of MultiStem subjects having an Excellent Outcome compared to 8.2% of placebo subjects (p=0.02).

In addition, analyses show that patients who received MultiStem treatment earlier (24 to 36 hours post-stroke) in the study’s treatment window had better recovery in comparison to placebo. For example, at 90 days post-stroke, patients who were treated with MultiStem within 24 to 36 hours of the stroke (i.e. consistent with our original study design) had much better outcomes compared to placebo patients as measured by recovery in each of the key secondary endpoints: mRS £ 2, NIHSS D ³75% and BI ³95. Specifically, 41.9% of the MultiStem-treated patients achieved good or excellent recovery in all three clinical scales, compared to only 24.6% of all patients receiving placebo, a difference of 17.3% (p = 0.08). Additionally, MultiStem subjects had a significantly lower rate of secondary infections than placebo subjects (16.1% v. 47.5%, p<0.01) and of average initial hospital days (6.8 v. 9.8, p=0.02). At one year, such early-treated MultiStem patients had a significantly higher rate of Excellent Outcome than all placebo subjects (29.0% v. 8.2%, p<0.01).

Furthermore, we evaluated the recovery at 90 days of patients who received treatment with MultiStem within 24 to 36 hours post stroke versus all patients receiving placebo, excluding in both groups patients who received both tPA and mechanical reperfusion (and who were excluded in the original trial design). In this post-hoc analysis, patients in the MultiStem group were more than two times as likely as the placebo group to achieve global recovery based on the Global Test Statistic – the primary endpoint (p=0.06), demonstrated substantially better performance in the three component secondary endpoints, and also exhibited accelerated improvement in comparison to patients receiving placebo. These MultiStem-treated patients were also much more likely to achieve recovery in each of the key secondary endpoints, with 44.4% of these patients achieving such recovery on all three scales, compared to just 17.3% for the placebo group, a difference of 27.1% (p < 0.01). Additionally, these MultiStem patients achieved significantly higher rates of Excellent Outcome (p=0.03), and patients in the MultiStem group showed improvement on the Cochran-Mantel-Haenszel “shift” analysis (p=0.03), which compares performance for the patient groups across the spectrum of mRS outcomes. Hospitalization duration was significantly reduced for the MultiStem-treated patients (35% lower than the average for placebo patients) and the average intensive care unit stay was also meaningfully reduced. One-year follow-up data demonstrates that MultiStem-treated subjects, on average, continued to improve relative to placebo with significant differences in Excellent Outcome (29.6% v. 5.8%, p<0.01), the “shift” analysis (p=0.04) and Barthel Index (67.7% v. 38.5%, p=0.02).

Analysis of biomarker data obtained from samples of study subjects indicated that MultiStem treatment reduces post-stroke inflammation compared to placebo, and it appears that this effect is more pronounced for subjects receiving MultiStem within 36 hours post-stroke. This effect is consistent with our hypothesis regarding mechanisms of action and related preclinical data, and with the clinical data suggesting faster recovery for MultiStem-treated patients.

If the MultiStem therapy is proven effective in a registrational study, this would represent a substantial increase in the time window for treatment for ischemic stroke victims, which currently is limited to several hours. Further analyses are being undertaken, and we are actively preparing for the next stage of clinical development of this program and are engaged in discussions with the Pharmaceuticals and Medical Devices Agency in Japan in conjunction with our development partner Healios, as well as with the U.S. Food and Drug Administration, or FDA, and other regulators.

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Acute Myocardial Infarction: We recently initiated a Phase 2 clinical study in the United States for the administration of MultiStem cell therapy to patients that have suffered an acute myocardial infarction, or AMI. We previously evaluated the administration of MultiStem to patients that suffered an AMI in a Phase 1 clinical study. The results of this study demonstrated a favorable safety profile and encouraging signs of improvement in heart function among patients that exhibited severely compromised heart function prior to treatment. This data was published in a leading peer reviewed scientific journal, and one-year follow-up data suggested that the benefit observed was sustained over time. We were awarded a grant for up to $2.8 million in funding to support the advancement of this clinical program, and we are currently enrolling patients in our Phase 2 clinical study, evaluating the safety and efficacy of MultiStem treatment in subjects who have a non-ST elevated myocardial infarction. The study is double-blind, sham-controlled and is being conducted at leading cardiovascular centers in the United States.

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Acute Respiratory Distress Syndrome: We have also initiated a clinical study for the treatment of acute respiratory distress syndrome, or ARDS, in the UK and in the United States. In 2015, we were awarded a grant from Innovate UK for up to approximately £2.0 million in support of a Phase 2a clinical study evaluating the administration of MultiStem cell therapy to ARDS patients. ARDS is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, or other trauma and represents a major cause of morbidity and mortality in the critical care setting. The medical need for a safe and effective treatment of ARDS is significant due to its high mortality rate, and it annually affects approximately 400,000 to 500,000 patients in Europe, the United States and Japan, together. The Phase 2a clinical trial is currently enrolling patients.

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Hematopoietic Stem Cell Transplant / GvHD: We completed a Phase 1 clinical study of the administration of MultiStem cell therapy to patients suffering from leukemia or certain other blood-borne cancers in which patients undergo radiation therapy and then receive a hematopoietic stem cell transplant. Such patients are at significant risk for serious complications, including graft-versus-host disease, or GvHD, an imbalance of immune system function caused by transplanted cells that trigger an attack against various tissues and organs in the patient. Data from the study demonstrated the safety of MultiStem cell therapy in this indication and suggested that the treatment may have a beneficial effect in reducing the incidence and severity of GvHD, as well as providing other benefits. We were granted orphan drug designation by the FDA and the European Medicines Agency, or EMA, for MultiStem treatment in the prevention of GvHD. In February 2015, the MultiStem product was granted Fast Track designation by the FDA for prophylaxis therapy against GvHD following hematopoietic cell transplantation. Subsequently, our registration study design received a positive opinion from the EMA through the Protocol Assessment/Scientific Advice procedure. Furthermore, in December 2015, the proposed registration study received Special Protocol Assessment designation from the FDA, meaning that the trial is adequately designed to support a biologics license application, or BLA, submission for registration if it is successful. Currently, we are staging this program for future registration-directed development dependent on the achievement of certain business development and financial objectives.

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Inflammatory Bowel Disease: MultiStem therapy has been evaluated in a Phase 2 clinical study involving administration of MultiStem to patients suffering from ulcerative colitis, or UC, the most common form of inflammatory bowel disease, or IBD, which was conducted by a collaborative partner, Pfizer Inc. Overall, the study results released in 2014 were disappointing, in that a single administration of MultiStem to a patient population with longstanding, chronic advanced disease failed to show a meaningful clinical effect at the eight-week evaluation period. Despite not showing a significant improvement compared to placebo in the primary efficacy endpoints, the MultiStem therapy demonstrated favorable safety and tolerability in the eight weeks following treatment. Furthermore, at four weeks, patients getting MultiStem treatment had a significantly higher proportion of rectal bleeding responders than placebo patients, suggesting the possibility of a transient effect from the single MultiStem dose. Subsequent analyses suggest that MultiStem treatment has an impact on relevant biomarkers shortly after treatment compared to placebo, suggesting the possibility of improved benefit from a different treatment regime. Taking these results into account and following an internal portfolio review of its IBD programs, Pfizer determined that it would not invest further in this program as required by the collaboration and notified us of its decision to terminate the license agreement effective in the third quarter of 2015. In connection with the termination, all rights to the program reverted to us, and we are free to use preclinical and clinical data for development in this area and in other areas, including immunology and inflammatory conditions.

We are also conducting or supporting clinical activity in other areas, such as solid organ transplant, which is an investigator-initiated study being conducted at a leading transplant center in Europe. We are also engaged in the preparation stages for translational and clinical studies in other targeted areas.

We are actively engaged in multiple process development initiatives intended to enable increased manufacturing scale, reduce production costs, and enhance process controls and product quality, among other things. These initiatives and investment are meant to improve our ability to meet potential commercial demand in the event of eventual regulatory approval.

In addition to our current and anticipated clinical development activities, we are engaged in preclinical development and evaluation of MultiStem therapy in other neurological, cardiovascular and inflammatory and immune disease areas, as well as certain other indications. We conduct such work both through our own internal research efforts and through a broad global network of collaborators. We are routinely in discussions with third parties about collaborating in the development of MultiStem therapy for various programs and may enter into one or more business partnerships to advance these programs over time.

In January 2016, we entered into a license agreement with Healios K.K., or Healios, to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan, and to provide Healios with access to our proprietary MAPC, for use in Healios’ proprietary “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the agreement, Healios also obtained a right to expand the scope of the collaboration to include the exclusive rights to develop and commercialize MultiStem for the treatment of two additional indications in Japan, which include ARDS and another indication in the orthopedic area, as well as all indications for the organ bud program. Healios will develop and commercialize the MultiStem product in Japan, and we will provide the manufactured product to Healios.

We had entered into a similar arrangement with Chugai Pharmaceuticals Co., Ltd., or Chugai, early in 2015 for the development and commercialization of MultiStem therapy for stroke in Japan, but we terminated the license agreement in October 2015 when the parties were unable to reach an agreement on a potential modification of the financial terms of the agreement and on the development strategy in Japan as proposed by Chugai following the initial results from our Phase 2 clinical study.

We also have a collaboration with RTI Surgical, Inc., or RTI, for the development of products for certain orthopedic applications using our stem cell technologies in the bone graft substitutes market, we have been earning royalty revenue from product sales since 2014 and may receive other payments upon the successful achievement of certain commercial milestones.

Financial

In connection with our January 2016 license agreement with Healios, we received an up-front cash payment of $15 million from Healios, and the collaboration can be expanded at Healios’ election. If Healios expands the collaboration, we will be entitled to receive an additional cash payment of $10 million. Healios may exercise its option to expand the collaboration prior to certain milestone dates that are expected to occur within the next two years.

For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones aggregating up to $225 million. We will also receive tiered royalties on net product sales, starting in the low double digits and increasing incrementally into the high teens, depending on net sales levels. Additionally, we will receive payments for product supplied to Healios under a manufacturing supply agreement.

If Healios exercises the option to expand the collaboration to include ARDS and another indication in the orthopedic area, we would be entitled to receive royalties from product sales and success-based development, regulatory approval and sales milestones, and payments for product supply for the additional indications, as well as a fractional royalty percentage on net sales of the organ bud products.

In October 2015, we and Chugai agreed to terminate our 2015 license agreement as a result of an inability to reach an agreement on the modification of the financial terms of the agreement and on the development strategy of our MultiStem cell therapy for the treatment of ischemic stroke in Japan. We retained the $10 million up-front cash payment from Chugai that we received in 2015, which was recognized in full in October 2015 in connection with the termination of the collaboration. We regained all rights for developing its stem cell technologies and products for ischemic stroke in Japan, and Chugai no longer has any license rights or options with respect to our technologies and products. Neither we nor Chugai have any further obligations to each other.

We have in place an equity purchase agreement with Aspire Capital Fund, LLC, or Aspire Capital, which provides us the ability to sell shares to Aspire Capital from time-to-time, as appropriate. Under our facility that was renewed in December 2015, we can elect to sell to Aspire Capital up to an additional $30 million of shares of common stock under the agreement. During the quarter ended March 31, 2016, 200,000 shares were sold under the Aspire equity purchase agreement at an average price of $2.14.

In February 2015, we were awarded a grant from Innovate UK in support or a Phase 2a clinical study evaluating the administration of MultiStem cell therapy to ARDS patients. The grant is expected to provide up to approximately £2.0 million in support over the course of the study, which will be conducted at leading clinical sites in the UK in conjunction with Catapult, a not-for-profit center focused on the development of the UK cell therapy industry.

Results of Operations

Since our inception, our revenues have consisted of license fees, contract revenues and milestone payments from our collaborators, and grant proceeds primarily from federal, state and foundation grants. We have derived no revenue from the commercial sale of therapeutic products to date, but we receive royalties on commercial sales by a licensee of products using our technologies. Research and development expenses consist primarily of external clinical and preclinical study fees, manufacturing costs, salaries and related personnel costs, legal expenses resulting from intellectual property prosecution processes, facility costs, and laboratory supply and reagent costs. We expense research and development costs as they are incurred. We expect to continue to make significant investments in research and development to enhance our technologies, advance clinical trials of our product candidates, expand our regulatory affairs and product development capabilities, conduct preclinical studies of our product and manufacture our product candidates. General and administrative expenses consist primarily of salaries and related personnel costs, professional fees and other corporate expenses. We expect to continue to incur substantial losses through at least the next several years.

Three Months Ended March 31, 2016 and 2015

Revenues. Revenues increased to $15.5 million for the three months ended March 31, 2016 from $731,000 in the comparable period in 2015. We received an upfront license fee from our Healios collaboration, which resulted in the recognition of $15.0 million of contract revenue during the quarter ended March 31, 2016. Grant revenue may fluctuate from period to period based on the timing of grant-related activities and the award and expiration of new grants.

Research and Development Expenses. Research and development expenses increased to $6.7 million for the three months ended March 31, 2016 from $5.7 million for the comparable period in 2015. The $1.0 million increase is primarily associated with increased clinical and preclinical development costs of $858,000, increased legal and professional fees of $173,000 and an increase in research supplies of $154,000. These increases were partially offset by a decrease in sponsored research costs of $75,000 and a decrease in stock-based compensation of $83,000. The increase in our clinical and preclinical costs is primarily due to increased product manufacturing costs and increased clinical trial costs during the three-month period. The increase in legal fees resulted from additional expenses associated with patent prosecution, national filings, and interparty proceedings and related filings.

The increase in research supplies was due to an increase in internal process development activities. We expect our research and development expenses to increase in 2016 as compared to 2015 related to our clinical and process development activities. Other than external expenses for our clinical and preclinical programs, we do not track our research expenses by project; rather, we track such expenses by the type of cost incurred.

General and Administrative Expenses. General and administrative expenses were relatively consistent at $2.0 million for the three months ended March 31, 2016 and $1.9 million in the comparable period in 2015. We expect our general and administrative expenses to remain relatively consistent in 2016 as compared to 2015.

Depreciation. Depreciation expense was relatively consistent at $68,000 for the three months ended March 31, 2016 and $70,000 in the comparable period in 2015. We expect our depreciation to increase in 2016 as compared to 2015 related to planned equipment purchases for our process development activities.

Expense from Change in Fair Value of Warrants. Expense of $2.2 million was recognized during the three months ended March 31, 2016 for the market value change in our warrant liabilities, compared to $5.6 million in the comparable period in 2015, reflecting primarily changes in our stock price.

Other Income, net. Other income, net, generally includes net foreign currency gains and losses, and net interest income and expense. However, in the three-month period ended March 31, 2016, we recognized other income of $190,000 from a loan (including interest) that was forgiven.

Income Tax Benefit. The income tax benefit in 2016 represents refundable foreign tax credits.

Liquidity and Capital Resources

Our sources of liquidity include our cash balances and any available-for-sale securities. At March 31, 2016, we had $30.4 million in cash and cash equivalents. We have primarily financed our operations through business collaborations, grant funding and equity financings. We conduct all of our operations through our subsidiary, ABT Holding Company. Consequently, our ability to fund our operations depends on ABT Holding Company’s financial condition and its ability to make dividend payments or other cash distributions to us. There are no restrictions such as government regulations or material contractual arrangements that restrict the ability of ABT Holding Company to make dividend and other payments to us.

We incurred losses since inception of operations in 1995 and had an accumulated deficit of $298 million at March 31, 2016. Our losses have resulted principally from costs incurred in research and development, clinical and preclinical product development, acquisition and licensing costs, and general and administrative costs associated with our operations. We used the financing proceeds from equity and debt offerings and other sources of capital to develop our technologies, to discover and develop therapeutic product candidates, develop business collaborations and to acquire certain technologies and assets.

We have an equity purchase agreement with Aspire Capital, whereby Aspire Capital is committed to purchase up to an aggregate of $30.0 million of shares of our common stock over a three-year period ending in January 2019, subject to our election to sell any such shares. Under the agreement, we have the right to sell shares, subject to certain volume limitations and a minimum floor price, at a modest discount to the prevailing market price. During the three-month period ended March 31, 2016, we generated net proceeds aggregating $424,000 from sales of our common stock to Aspire Capital at an average price per share of $2.14.

Healios may exercise its option to expand the collaboration prior to certain milestone dates that are expected to occur within the next two years. For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones aggregating up to $225 million. We will also receive tiered royalties on net product sales, starting in the low double digits and increasing incrementally into the high teens, depending on net sales levels. Additionally, we will receive payments for product supplied to Healios under a manufacturing supply agreement.

If Healios exercises the option to expand to collaboration, we would be entitled to receive royalties from product sales and success-based development, regulatory approval and sales milestones, and payments for product supply for the additional indications, as well as a fractional royalty percentage on net sales of the organ bud products.

In connection with our license agreement with Chugai that was terminated in October 2015, we received an up-front cash payment of $10 million in 2015 and were entitled to receive a potential near-term payment of $7 million tied to the results of our ongoing Phase 2 clinical trial in ischemic stroke. We terminated the license agreement when the parties were unable to reach an agreement on the potential modification of the financial terms of the agreement and on the development strategy in Japan. We retained the $10 million up-front cash payment from Chugai and regained all rights for developing our stem cell technologies and products for ischemic stroke in Japan, and Chugai no longer has any license rights or options with respect to our technologies and products. Neither we nor Chugai have any further obligations to each other.

Under the terms of our RTI agreement, we are eligible to receive cash payments aggregating up to $35.5 million upon the successful achievement of certain commercial milestones, though there can be no assurance that such milestones will be achieved, and no milestone payments have been received as of March 31, 2016. In addition, we are entitled to receive tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single digits and increasing into the mid-teens, and we began receiving royalty payments in 2014.

We are obligated to pay the University of Minnesota a sublicense fee or a royalty based on worldwide commercial sales of licensed products if covered by a valid licensed patent. The low single-digit royalty rate may be reduced if third-party payments for intellectual property rights are necessary or commercially desirable to permit the manufacture or sale of the product. As of March 31, 2016, we have paid no royalties to the University of Minnesota and have paid sublicense fees from time-to-time in connection with our collaborations.

In 2012, we entered into an arrangement with the Global Cardiovascular Innovation Center and the Cleveland Clinic Foundation in which we were entitled to proceeds of up to $500,000 in the form of a forgivable loan to fund certain preclinical work. Interest on the loan accrued at a fixed rate of 4.25% per annum and was added to the outstanding principal, and the loan carried an expiration date of March 31, 2016. In January 2016, the loan and accrued interest, which amounted to approximately $190,000 at January 28, 2016, was forgiven according to its terms based on the achievement of certain milestones.

In 2015, we were awarded a grant from Innovate UK in support of a Phase 2a clinical study evaluating the administration of MultiStem cell therapy to ARDS patients. The grant is expected to provide up to approximately £2.0 million (approximately $2.9 million based on the current exchange rate) in support over the course of the study, which will be conducted at leading clinical sites in the UK in conjunction with Catapult, a not-for-profit center focused on the development of the UK cell therapy industry.

We will require substantial additional funding in order to continue our research and product development programs, including preclinical evaluation and clinical trials of our product candidates and manufacturing process development. At March 31, 2016, we had available cash and cash equivalents of $30.4 million, and we intend to meet our short-term liquidity needs with available cash. Over the longer term, we will make use of available cash, but will have to continue to generate additional funding to meet our needs, through business development, achievement of milestones under our collaborations, and grant-funding opportunities.

Additionally, we may raise capital from time to time through our equity purchase agreement with Aspire Capital, subject to its volume and price limitations. We also manage our cash by deferring certain discretionary costs and staging certain development costs to extend our operational runway, as needed. Over time, we may consider the sale of additional equity securities, or possibly borrowing from financing institutions.

Our capital requirements over time depend on a number of factors, including progress in our clinical development programs, our clinical and preclinical pipeline of additional opportunities and their stage of development, additional external costs such as payments to contract research organizations and contract manufacturing organizations, additional personnel costs and the costs in filing and prosecuting patent applications and enforcing patent claims. The availability of funds impacts our ability to advance multiple clinical programs concurrently, and any shortfall in funding could result in our having to delay or curtail research and development efforts. Further, these requirements may change at any time due to technological advances, business development activity or competition from other companies. We cannot assure you that adequate funding will be available to us or, if available, that it will be available on acceptable terms.

We expect to continue to incur substantial losses through at least the next several years and may incur losses in subsequent periods. The amount and timing of our future losses are highly uncertain. Our ability to achieve and thereafter sustain profitability will be dependent upon, among other things, successfully developing, commercializing and obtaining regulatory approval or clearances for our technologies and products resulting from these technologies.

Cash Flow Analysis

Net cash provided by operating activities was $7.3 million for the three months ended March 31, 2016, and $1.1 million for the three months ended March 31, 2015, reflecting the $14.8 million of cash received from Healios in January 2016 (noting that $245,000 was received from Healios in December 2015 in connection with a letter of intent) and the $10 million of cash received from Chugai in the first quarter of 2015, and the use of cash in funding preclinical and clinical development activities. Net cash used in operating activities has fluctuated significantly on a quarter-to-quarter basis over the past few years primarily due to the receipt of collaboration fees and payment of specific clinical trial costs, such as clinical manufacturing campaigns, contract research organization costs, and manufacturing process development projects. We expect the cash use for operating activities to increase in 2016 as compared to 2015 due to our planned clinical and process development activities.

Net cash used by investing activities was $186,000 and $63,000 for the three months ended March 31, 2016 and 2015, respectively, representing purchases of equipment supporting our operations. We expect our 2016 annual capital equipment expenditures to be higher than 2015 in support of our manufacturing process development activities.

Financing activities provided cash of $251,000 for the three months ended March 31, 2016 related primarily to equity sales to Aspire Capital. Financing activities provided cash of $8.3 million for the three months ended March 31, 2015 related primarily to equity sales to Aspire Capital and the exercise of common stock warrants.

Investors in certain of our equity offerings have received warrants to purchase shares of our common stock, of which warrants to purchase an aggregate of 3.6 million shares remain outstanding at March 31, 2016 with a weighted average exercise price of $2.48 per share. The exercise of warrants could provide us with cash proceeds.

We have no off-balance sheet arrangements.

Critical Accounting Policies and Management Estimates

The Securities and Exchange Commission, or SEC, defines critical accounting policies as those that are, in management’s view, important to the portrayal of our financial condition and results of operations and demanding of management’s judgment. Our discussion and analysis of financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates on experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates. A description of these accounting policies and estimates is included in Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2015. There have been no material changes in our accounting policies and estimates as described in our Annual Report. For additional information regarding our accounting policies, see Note B to the Consolidated Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2015.

Cautionary Note on Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, 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. These forward-looking statements appear in a number of places in this Quarterly Report on Form 10-Q.

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 human therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks 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.

Other important factors to consider in evaluating our forward-looking statements include:

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our ability to raise capital to fund our operations;

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the timing and nature of results from our MultiStem clinical trials;

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

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

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uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of stroke, AMI, and ARDS, and the prevention of GvHD and other disease indications;

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changes in external market factors;

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changes in our industry’s overall performance;

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changes in our business strategy;

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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;

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

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our ability to meet milestones and earn royalties under our collaboration agreements, including in connection with our collaboration with Healios;

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our collaborators’ ability to continue to fulfill their obligations under the terms of our collaboration agreement;

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the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in the United States, Europe and Japan;

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

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changes in productivity and reliability of suppliers; and

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

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. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as 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.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

Our exposure to interest rate risk is related to our investment portfolio and our borrowings. Fixed rate investments and borrowings may have their fair market value adversely impacted from changes in interest rates. Due in part to these factors, our future investment income may fall short of expectations. Further, we may suffer losses in investment principal if we are forced to sell securities that have declined in market value due to changes in interest rates. When appropriate based on interest rates, we invest our excess cash primarily in debt instruments of the United States government and its agencies and corporate debt securities, and as of March 31, 2016, we had no investments. We have been investing conservatively due to the current economic conditions and have prioritized liquidity and the preservation of principal in lieu of potentially higher returns. As a result, we experienced no losses on the principal of our investments.

We enter into loan arrangements with financial institutions when needed and when available to us. At March 31, 2016, we had no borrowings outstanding.

Item 4.

Controls and Procedures.

Disclosure controls and procedures

Our management, under the supervision of and with the participation of our Chief Executive Officer and our Senior Vice President of Finance, has evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as of the end of the period covered by this quarterly report on Form 10-Q. Based upon this evaluation, our Chief Executive Officer and Senior Vice President of Finance have concluded that, as of the end of the period covered by this quarterly report on Form 10-Q, our disclosure controls and procedures were effective.

Changes in internal control over financial reporting

During the first quarter of 2016, there has been no change in our internal control over financial reporting (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

During the quarter ended March 31, 2016, we sold an aggregate of 200,000 shares of common stock to Aspire Capital at an average purchase price of $2.14 per share. Each issuance of these unregistered shares qualifies as an exempt transaction pursuant to Section 4(2) of the Securities Act of 1933. Each issuance qualified for exemption under Section 4(2) of the Securities Act of 1933 because none involved a public offering. Each offering was not a public offering due to the number of persons involved, the manner of the issuance and the number of securities issued. In addition, in each case Aspire Capital had the necessary investment intent.

Item 6.

Exhibits.


Exhibit No.		Description

10.1*		License Agreement by and between ABT Holding Company and Healios K.K., dated as of January 8, 2016.

31.1		Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification of Laura K. Campbell, Senior Vice President of Finance, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1		Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer, and Laura Campbell, Senior Vice President, Finance, pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		XBRL Taxonomy Extension Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

*	Confidential treatment requested as to certain portions, which portions have been filed separately with the SEC.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


						ATHERSYS, INC.

Date: May 5, 2016						/s/ Gil Van Bokkelen
						Gil Van Bokkelen
						Chairman and Chief Executive Officer
						(principal executive officer authorized to sign on behalf of the registrant)

						/s/ Laura K. Campbell
						Laura K. Campbell
						Senior Vice President of Finance
						(principal financial and accounting officer authorized to sign on behalf of the registrant)

EXHIBIT INDEX


Exhibit No.		Description

10.1*		License Agreement by and between ABT Holding Company and Healios K.K., dated as of January 8, 2016.

31.1		Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification of Laura K. Campbell, Senior Vice President of Finance, pursuant to SEC Rules 13a-14(a) and 15d-14(a) adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1		Certification of Gil Van Bokkelen, Chairman and Chief Executive Officer, and Laura Campbell, Senior Vice President of Finance, pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		XBRL Taxonomy Extension Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

*	Confidential treatment requested as to certain portions, which portions have been filed separately with the SEC.

EXHIBIT 10.1

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE REDACTED PORTIONS OF THIS EXHIBIT, AND SUCH CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

LICENSE AGREEMENT

This License Agreement (this “Agreement”), dated as of January 8, 2016 (the “Effective Date”), is made and entered into between ABT Holding Company (“ATHX”), a Delaware corporation having its principal place of business at 3201 Carnegie Avenue, Cleveland, OH 44115 and wholly-owned subsidiary of Athersys, Inc. (“Athersys”), and Healios, K.K. (“Healios”), a Japanese company having its principal place of business at World Trade Center Bldg. 15F, 2-4-1 Hamamatsucho, Minato-ku, Tokyo 105-6115 Japan. ATHX and Healios may be referred to individually as a “Party” and collectively as the “Parties”.

ATHX and Healios hereby agree as follows:

SECTION 1

DEFINITIONS.

Capitalized terms used in this Agreement shall have the meaning ascribed to them in the preamble or recitals above, this Section 1, or the following Sections of this Agreement.

1.1 The term “Affiliate” shall mean, with respect to a Party, a corporation or other legal entity, directly or indirectly, controlling, controlled by or under common control with such Party. For purpose of this definition, the term “control” and, with correlative meanings, the terms “controlled by” and “under common control with”, as used with respect to any corporation or other entity, means (a) direct or indirect ownership of fifty percent (50%) or more of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such corporation or other entity or (b) the power to direct or cause the direction of the management or policies of such corporation or other entity, whether through the ownership of voting securities by contract or otherwise.

1.2 The term “ARDS/[*] Field” shall mean the treatment of acute respiratory distress syndrome (“ARDS”) or [*].

1.3 The term “ARDS/[*] Product” shall mean any product for the ARDS/[*] Field in the Territory.

1.4 The term “ATHX MAPC Background Patents” shall mean any (a) patents and patent applications that are owned or controlled by ATHX or any of its Affiliates as of the Effective Date and are pending or issued in the Territory, (b) pre-grant forms claiming priority to of any of the foregoing, including provisionals, converted provisionals, divisionals, continuations (in whole or in part), (c) all patents issuing from any of the foregoing, and (d) all post-grant forms of any of the foregoing, including extensions, in each case (a) – (d),

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

that, if issued, would be infringed, but for the license granted under Section 2.3, by use in the Organ Bud Field. ATHX MAPC Background Patents owned or controlled by ATHX as of the Effective Date include the patents listed in Schedule 1.

1.5 The term “ATHX MultiStem Background Know-How” shall mean Know-How that is owned or controlled by ATHX or its Affiliates as of the Effective Date, in each case, that is specifically related to Products in the Primary Field or to development, distribution, promotion, marketing, manufacture, use, import, offer for sale, or sale of Products in the Primary Field.

1.6 The term “ATHX MultiStem Background Patents” shall mean any (a) patents and patent applications that are owned or controlled by ATHX or any of its Affiliates as of the Effective Date and are pending or issued in the Territory, (b) pre-grant forms claiming priority to of any of the foregoing, including provisionals, converted provisionals, divisionals, continuations (in whole or in part), (c) all patents issuing from any of the foregoing, and (d) all post-grant forms of any of the foregoing, including extensions, in each case, that (if issued) would be infringed, but for the license granted under Sections 2.1 or 2.2 by the manufacture, development, distribution, promotion, marketing, use, import, offer for sale or sale of Products in the Primary Field. ATHX MultiStem Background Patents owned or controlled by ATHX as of the Effective Date include the patents as listed in Schedule 2.

1.7 The term “Conditional Approval” shall mean approval under the Japanese Pharmaceuticals and Medical Devices Act (PMDA) enacted November 2014 for a Product that allows time-limited marketing approval for use of the Product.

1.8 The term “Cost of Supply” shall mean [*].

1.9 The term “Foreground IP” shall mean, with respect to a Party, (a) any and all non-public, proprietary technical information, know-how, trade secret, data, test results, knowledge, techniques, discoveries, inventions, specifications, designs, regulatory filings, and other information (whether or not patentable) and (b) any intellectual property rights thereon (except trademarks), including patent and patent application issuing or filed for based thereon and copyright; in each case under clause (a) and (b), that is specifically related to a Product or to the manufacture, development, distribution, promotion, marketing, use, import, offer for sale or sale of a Product and that is first owned or controlled on or after the Effective Date by such Party or any of its Affiliates.

1.10 The term “Full Approval” shall mean final marketing approval for sale and distribution of an approved Product.

1.11 The term “Ischemic Stroke Field” shall mean the treatment of ischemic stroke in humans.

1.12 The term “Ischemic Stroke Product” shall mean any product within the Ischemic Stroke Field for the Territory.

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

1.13 The term “Know-How” shall mean any and all non-public, proprietary technical information, know-how, data, test results, knowledge, techniques, discoveries, inventions, specifications, designs, regulatory filings, and other information (whether or not patentable).

1.14 The term “Laws” shall mean all applicable laws, statutes, regulations, rules, ordinance, order, decree, ruling or binding position or guideline of any governmental authority having jurisdiction over the subject act(s) or matter(s).

1.15 The term “LOI” shall mean that Letter of Intent dated 15 October 2015 by and between the Parties.

1.16 The term “MAPC” shall mean any multipotent adult progenitor cell described in ATHX MAPC Background Patents.

1.17 The term “Net Sales” shall mean, with respect to each Product, the total gross sales of such products sold by Healios, its Affiliate or their respective direct or indirect sublicensee under the license or sublicense of this Agreement, for arm’s length sales to any non-Affiliated third party in the Territory, less the following deductions: trade and cash discounts, sales and excise taxes, rebates and return of goods. The foregoing shall be booked or calculated in accordance with Generally Accepted Accounting Principles (GAAP) or International Financial Reporting Standard (IFRS) each as consistently applied by the selling entity. For clarification, if the product once sold by Healios, its Affiliate or their sublicensee, for arm’s length sales to any non-Affiliated third party in the Territory is recalled, such sales shall be deducted from the Net Sales.

1.18 [Section no longer used.]

1.19 The term “Organ Bud Field” shall mean (a) as of the Effective Date, the treatment of liver disease or dysfunction in humans by implant of certain liver cell precursors (such organ tissue cell precursors known as “organ buds”) (“First Indication”) and (b) shall be expanded to include the treatment of other organ diseases or dysfunctions in humans by implant of organ buds if and only if the option to expand the Field is exercised by Healios in accordance with SECTION 4.

1.20 The term “Organ Bud Product” shall mean a product that is used for organ bud transplantation in humans in the Organ Bud Field and that is generated at least in part using MAPC.

1.21 The term “Organ Bud Product Net Sales” shall mean [*].

1.22 The term “Other Improvements” shall mean with respect to a Party, (a) any and all non-public, proprietary technical information, know-how, trade secret, data, test results, knowledge, techniques, discoveries, inventions, specifications, designs, regulatory filings, and other information (whether or not patentable) and (b) any intellectual property rights

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

thereon (except trademarks), including patent and patent application issuing or filed for based thereon and copyright; in each case under clause (a) and (b), that result from activities conducted in accordance with this Agreement and that are not otherwise Foreground IP. Other Improvements include all such things that result from the research, development, manufacture or use of MAPC made by or for Athersys, its Affiliates or their respective licensees or that are covered by any claim within the ATHX MAPC Background Patents.

1.23 The term “Primary Field” shall mean (a) as of the Effective Date, the Ischemic Stroke Field and (b) shall be expanded to include the ARDS/[*] Field if and only if the option to expand the Primary Field is exercised by Healios in accordance with SECTION 4.

1.24 The term “Product” shall mean (a) as of the Effective Date, any Ischemic Stroke Product and (b) shall be expanded to include any ARDS/[*] Product if and only if the option to expand the Primary Field is exercised by Healios in accordance with SECTION 4.

1.25 The term “Termination of this Agreement” shall mean any expiration of this Agreement under SECTION 12 or termination of this Agreement for any reason under SECTION 13.

1.26 The term “Territory” shall mean Japan.

1.27 The term “Trademark” shall mean any trademark owned by ATHX and licensed to Healios under this Agreement for the Product in the Territory for the Field.

SECTION 2

LICENSE OF BACKGROUND IP.

2.1 Subject to the terms and conditions of this Agreement, ATHX grants to Healios, under the ATHX MultiStem Background Patents and ATHX MultiStem Background Know-How (collectively “ATHX MultiStem Background IP”), an exclusive, non-transferable and non-assignable (except as provided pursuant to Section 19.6) license to research, develop, use, distribute, promote, market, offer for sale, sell and import Products in the Territory solely for and in the Primary Field. The foregoing license includes the right to sublicense (a) without consent of ATHX, to Affiliates of Healios and to contractors engaged by Healios or its Affiliate to develop (including to conduct clinical trials) and distribute, promote, market, offer for sale, sell and import Products in the Primary Field in the Territory and for such purpose and (b) only with the advance, written consent of ATHX, which will not be unreasonably withheld, to all other non-Affiliates of Healios or for any other purpose. The foregoing rights to import are limited to the import of Products supplied by ATHX or its Affiliate unless and until the license is granted under Section 2.2.

2.2 Subject to the terms and conditions of this Agreement, ATHX will grant to Healios under the ATHX MultiStem Background IP, a non-exclusive, non-transferable and non-assignable (except as provided pursuant to Section 19.6) license to make and have made Products worldwide solely for import into the Territory for use in the Primary Field in the Territory, upon and after any of the following events occurs:

(a) ATHX does not supply the Products to Healios at the pricing set forth in Section 10.4 or otherwise acceptable to Healios, as further provided in Section 10.5;

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

(b) ATHX fails to supply all or a material part of the amount of the Product reasonably requested by Healios by any delivery date in a binding purchase order and fails to supply the shortfall within a reasonable period from the delivery date;

(d) At least 30 days before ATHX voluntarily files a petition for commencement of insolvency proceedings including, without limitation, bankruptcy, liquidation and reorganization (collectively referred to as “Insolvency Proceeding”); or

(e) Prior to a court of competent jurisdiction issues (i) an order of relief in an Insolvency Proceeding with ATHX as the debtor or (ii) an order of commencement of an involuntary Insolvency Proceeding against ATHX and after such proceeding is not dismissed within 45 days after such commencement.

2.3 ATHX represents and warrants that, to the best of its knowledge as of the Effective Date, the ATHX MultiStem Background Patents for the Primary Field in the Territory are as specified in Schedule 2. ATHX shall update Schedule 2 to reflect the current state of ATHX MultiStem Background Patents in the Territory and send to Healios the updated Schedule 2 as of each anniversary of the Effective Date within a 30 day period from the anniversary.

2.4 Subject to the terms and conditions of this Agreement, ATHX grants to Healios, under the ATHX MAPC Background Patents, an exclusive, worldwide, non-transferable and non-assignable (except as provided pursuant to Section 19.6) license to use MAPC provided by ATHX or its Affiliate to Healios to research, develop, distribute, promote, market, make, have made, use, import, offer for sale, and sell Organ Bud Products in the Organ Bud Field. The foregoing license includes the right to sublicense (a) without consent of ATHX, to Affiliates of Healios and to contractors engaged by Healios or its Affiliate to research, develop (including to conduct clinical trials) and distribute, promote, market, offer for sale, and sell Organ Bud Products in the Organ Bud Field and for such purpose and (b) only with the advance, written consent of ATHX, which will not be unreasonably withheld, to all other non-Affiliates of Healios or for any other purpose. ATHX hereby consents to Healios granting a sublicense to Yokohama City University under the foregoing rights to research and develop Organ Bud Products in the Organ Bud Field.

2.5 As between the Parties, ATHX is and shall remain the sole owner of all ATHX MultiStem Background Patents and ATHX MAPC Background Patents, and ATHX shall be responsible for preparation, filing, prosecution, maintenance of all such ATHX MultiStem Background Patents and ATHX MAPC Background Patents in its sole discretion and at its sole cost and expense.

SECTION 3

FOREGROUND IP AND OTHER IMPROVEMENTS.

3.1 Subject to the terms and conditions of this Agreement, ATHX shall grant, and hereby grants immediately upon the existence of any Foreground IP of ATHX, to Healios an exclusive, non-transferable and non-assignable (except as provided pursuant to Section 19.6)

CONFIDENTIAL

license under the Foreground IP of ATHX to research, develop, use, distribute, promote, market, offer for sale, sell and import Products in the Territory solely for and in the Primary Field. The foregoing license includes the right to sublicense (a) without consent of ATHX, to Affiliates of Healios and to contractors engaged by Healios or its Affiliate to develop (including to conduct clinical trials) and distribute, promote, market, offer for sale, sell and import Products in the Primary Field in the Territory and for such purpose and (b) only with the advance, written consent of ATHX, which will not be unreasonably withheld, to all other non-Affiliates of Healios or for any other purpose. The foregoing rights to import are limited to the import of Products supplied by ATHX or its Affiliate unless and until the license is granted under Section 3.2.

3.2 Subject to the terms and conditions of this Agreement, ATHX will grant to Healios under the Foreground IP of ATHX, a non-exclusive, non-transferable and non-assignable (except as provided pursuant to Section 19.6) license to make and have made Products worldwide solely for import into the Territory for use in the Primary Field in the Territory, upon and after occurrence of any of the events described in clauses (a) – (e) of Section 2.2.

3.3 Subject to the terms and conditions of this Agreement, Healios shall grant, and hereby grants immediately upon the existence of any Foreground IP of Healios, to ATHX a non-exclusive, non-transferable and non-assignable (except as provided pursuant to Section 19.6) license, under the Foreground IP of Healios, with the right to grant sublicenses, to research, develop, make, have made, use, distribute, promote, market, offer for sale, sell and import Products outside the Primary Field or Territory.

3.4 Unless constrained by the agreement with any licensee of ATHX or its Affiliate, ATHX will make reasonable efforts to consult with and enable Healios to use non-clinical/clinical data, information regarding CMC, the record of discussions and meetings with regulatory agencies, and test results of the Product generated by ATHX, its Affiliate or a licensee of ATHX of the Product outside the Territory as reasonably necessary for Healios’ obtaining approval of the Product in the Primary Field in the Territory including, but not limited to, filing applications for approval. Unless constrained by the agreement with any sublicensee of Healios or its Affiliate, Healios will make reasonable efforts to consult with and enable ATHX, its Affiliates, and their licensees to use non-clinical/clinical data, information regarding CMC, the record of discussions and meetings with regulatory agencies, and test results of the Product generated by Healios, its Affiliate and their sublicensee in the Primary Field in the Territory as reasonably necessary for ATHX’s, its Affiliates’ and their licensees’ filing applications for approval of the Product outside of the Territory.

3.5 At least once per calendar year, each Party shall disclose in writing to the JSC and the other Party a general description of all new Foreground IP relating to the Primary Field and generated by such Party or any of its Affiliates since the last time reported. If a Party recognizes that any Foreground IP created by a Party and not previously disclosed to the other Party is reasonably likely to have a material impact on the activities contemplated by this Agreement, then such Party shall promptly notify the JSC and other Party of such Foreground IP. Each Party shall provide further, more detailed disclosures of any such Foreground IP as reasonably requested by the other Party or the JSC from time to time.

CONFIDENTIAL

3.6 Inventorship of Foreground IP and Other Improvements, whether or not patentable, shall be determined in accordance with U.S. patent laws. Authorship of Foreground IP and Other Improvements shall be determined in accordance with U.S. copyright laws.

3.7 As between the Parties, ownership of Foreground IP shall be determined as follows:

(a) ATHX shall solely own all Foreground IP for which one or more director(s), officer(s), employee(s), agent(s), representative(s), consultant(s), or independent contractor(s) of ATHX or any of its Affiliates is/are the only inventor(s) or author(s), as applicable (“Representative(s)”);

(b) Healios shall solely own all Foreground IP for which one or more Representative(s) of Healios or any of its Affiliates is/are the only inventor(s) or author(s), as applicable; and

(c) ATHX shall solely own all Foreground IP for which one or more Representative(s) of ATHX or any of its Affiliates together with one or more Representative(s) of Healios are joint inventor(s) or author(s), as applicable;

in each such case, subject to (i) the licenses granted in such Foreground IP in this SECTION 3 and (ii) Healios shall not grant any license or otherwise permit any Person to use, access or exploit any of the Foreground IP of Healios for any purpose (a) within the Territory outside of the Primary Field or (b) outside of the Territory other than for the manufacture and supply of Products to Healios for use within the Territory in the Primary Field.

3.8 ATHX shall be responsible for preparation, filing, prosecution, maintenance of all such Foreground IP of ATHX in its sole discretion and at its sole cost and expense.

3.9 Healios shall be responsible for preparation, filing, prosecution, maintenance of all such Foreground IP of Healios in its sole discretion and at its sole cost and expense.

3.10 As between the Parties, ownership of Other Improvements shall be determined consistent with inventorship, or authorship, as applicable. As between the Parties, unless otherwise mutually agreed by the Parties, ATHX shall be responsible for preparation, filing, prosecution, maintenance of all patent applications and patents that claim Other Improvements owned jointly by ATHX and Healios after obtaining a consent on the documents to be filed at the patent office from Healios, and the cost and expense of all such activities will be shared equally by the Parties. Except as provided in the preceding sentence, each of the Parties may exploit jointly-owned Other Improvements, including any issued patents granted thereon, independently of, and without accounting to, the other joint owner (subject to any applicable underlying rights of either Party that may be required to exploit such joint ownership rights).

CONFIDENTIAL

SECTION 4

OPTION TO EXPAND THE FIELDS.

4.1 After payment of the upfront license fee provided in Section 7.1, Healios shall have the right, conditioned upon payment of a one-time fee of $10,000,000 US Dollars (“Expansion Fee”) to expand (a) the Primary Field in the Territory to include the ARDS/[*] Field and (b) the Organ Bud Field to include all indications other than the First Indication.

4.2 To exercise its option to expand the Primary Field and the Organ Bud Field, Healios must provide notice together with the payment of the Expansion Fee to be received byATHX no later than the later of 5 P.M. Eastern Standard Time (New York) on the later of: (a) December 31, 2016 or (b) 30 days after the date upon which ATHX has provided to Healios the initial results of the ATHX study of ARDS using the ATHX MultiStem Background Patents or ATHX MultiStem Background Know How.

4.3 ATHX shall update the ATHX MultiStem Background Patents provided on Schedule 2 and the ATHX MAPC Background Patents provided on Schedule 1 upon such expansion of the Primary Field and Organ Bud Field in accordance with this SECTION 4 to show the then-current state of the patents and patent applications that are applicable to such fields after such expansion.

SECTION 5

ATHX RIGHT OF FIRST NEGOTIATION.

5.1 ATHX shall have the first right regarding commercialization of an Organ Bud Product for an indication in the Organ Bud Field in North America, as mutually agreed upon by the Parties, as provided in this SECTION 5. Such right shall exist during the period that starts on the Effective Date and ends upon the later of (a) 5 years after the Effective Date and (b) 30 days after authorization to initiate clinical studies of an Organ Bud Product under the first investigational new drug application or equivalent thereto in Japan, North America or the European Union.

5.2 During the period described in Section 5.1, before Healios starts to negotiate with any third party to grant a (sub)license for the commercialization of an Organ Bud Product in North America for the First Indication or an alternative indication as may be mutually agreed by the Parties, Healios shall first offer ATHX to grant a (sub)license under all Healios intellectual property regarding such Organ Bud Product and collaborate for the commercialization. Within a 60 day period, ATHX and Healios will negotiate the terms of a definitive agreement regarding the commercialization of such Organ Bud Product for such indication in North America and use their respective good faith efforts to enter into a definitive agreement. If, despite each Party’s good faith efforts, the Parties are not able to reach agreement, Healios shall be free to negotiate and execute an agreement with the third party.

SECTION 6

TRADEMARK.

6.1 ATHX shall select the Trademark in accordance with Laws in the Territory and taking into account advice from relevant authorities. The Trademark shall be property of ATHX.

6.2 As between the Parties, ATHX shall have the right to register and maintain the Trademark for the Product at the competent authority in the Territory including the Japan Patent Office. ATHX shall be the party to file application of and maintain the registration of Trademark and to defend the registration against any third party’s challenge including,

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

without limitation, filing of invalidation trial. ATHX shall be responsible for the costs and fees incurred in relation to filing application of, maintaining and defending the registration of the Trademark. Healios will cooperate with ATHX with respect to all such activities as reasonably requested by ATHX from time to time, including by providing such testimony, documents, samples or other materials required to prove use of the Trademark in the Territory. The reasonable out-of-pocket costs and fees incurred by Healios in connection with such cooperation shall be reimbursed by ATHX.

6.3 As between the Parties, ATHX shall have the right to enforce the Trademark against infringements or other violations thereof, shall be responsible for all costs and fees incurred in relation to such activity, and shall be entitled to retain all awards or damages in connection with such activities. Healios shall promptly notify ATHX of any known infringements or other violations of the Trademark in the Territory.

6.4 Subject to the terms and conditions of this Agreement, ATHX hereby grants to Healios and its Affiliate an exclusive, non-transferable and non-assignable license, with the right to sublicense with prior written notice to ATHX, to use the Trademark to develop, distribute, promote, market, offer for sale, sell, and import Product in the Primary Field in the Territory.

6.5 Healios shall and shall cause its Affiliate and its and their respective sublicensee to only distribute, promote, market, offer for sale, and sell Product in the Primary Field in the Territory using the Trademark. Furthermore, upon and after notice by ATHX, Healios shall refer to Product in its regulatory filings for the Primary Field in the Territory using the Trademark.

6.6 All goodwill of the Trademark generated through use of it by Healios, its Affiliate and its and their respective sublicensee will inure to the sole benefit of ATHX. Healios shall not, and shall cause its Affiliate and their respective sublicensee not to (a) use, register or apply to register the Trademark, an variant of it, any mark including it or any variant of it, or any mark confusingly similar to the Trademark or (b) do or permit to be done any act that impairs, prejudices, dilutes or infringes ATHX’s rights in the Trademark.

6.7 Healios shall and shall cause its Affiliate and its and their respective sublicensee to only use the Trademark in the form approved by ATHX from time to time, provided that the approval shall not be unreasonably withheld. Healios shall provide to ATHX samples of use of the Trademark as reasonably requested by ATHX from time to time. Healios, its Affiliate or their sublicensee may seek the foregoing approval from ATHX, which approval shall not be unreasonably withheld or delayed, for use of the Trademark in combination with any mark indicating (i) Healios, its Affiliate or their sublicensee, including, without limitation, corporate identity of Healios, its Affiliate or their sublicensee or (ii) any brand controlled or owned by Healios, its Affiliate or their sublicensee.

SECTION 7

PAYMENTS.

7.1 Healios shall pay to ATHX an upfront licensee fee of $15,000,000.00 US Dollars, less a credit of the “LOI Fee” in the amount of $245,424.29 US Dollars (representing the payment of ¥29,500,000 JPY paid by Healios under the LOI), for a total of $14,754,575.71.

CONFIDENTIAL

7.2 ATHX will issue an invoice for payment of the upfront licensee fee within 30 days of the Effective Date and Healios will make the payment within 15 days of the receipt of the invoice.

7.3 As partial consideration for the rights granted, Healios shall pay to ATHX the following for the Ischemic Stroke Field (“Ischemic Stroke Development Milestone Payments”), which shall be non-refundable, non-creditable towards future royalties or any other payments due from Healios under this Agreement:

[*].

7.4 As a partial consideration for the rights granted, and in addition to the milestones provided in Section 7.3, Healios shall pay to ATHX each of the following sales milestone payments upon first achievement of the corresponding Net Sales of Ischemic Stroke Products provided in Table 7.4 (“Ischemic Stroke Sales Milestone Payments”), which shall be non-refundable, non-creditable towards future royalties or any other payments due from Healios under this Agreement and shall be due within 45 days from the end of the calendar quarter in which the milestone is achieved:

Table 7.4 – Ischemic Stroke Sales Milestone Payments


*[]**	[*	]

[*]	[*	]

[*]	[*	]

[*]	[*	]

7.5 After expansion of the Primary Field to include the ARDS/[*] Field in accordance with SECTION 4, Healios shall pay to ATHX, in addition to the milestone payments under Section 7.3 and 7.4, the following (“ARDS/[*] Development Milestone Payments”), which shall be non-refundable, non-creditable towards future royalties or any other payments due from Healios under this Agreement:

[*]

7.6 After expansion of the Primary Field to include the ARDS/[*] Field in accordance with SECTION 4, Healios shall pay to ATHX the following sales milestone payments upon first achievement of the Net Sales of ARDS/[*] Products provided in Table 7.6 (“ARDS/[*] Sales Milestone Payments”), which shall be non-refundable, non-creditable towards future royalties or any other payments due from Healios under this Agreement and shall be due within 45 days from the end of the calendar quarter in which the milestone is achieved:

Table 7.6 – ARDS/[*] Sales Milestone Payments


[*]	[*	]

[*]	[*	]

[*]	[*	]

[*]	[*	]

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

7.7 Healios shall notify ATHX of the occurrence of each of the milestones provided in Sections 7.3, 7.4, 7.5, or 7.6 within 30 days of each such occurrence. ATHX will provide an invoice for any such payment promptly after request by Healios, but the date of such invoice will have no effect on the due date for the payment.

7.8 As partial consideration for the rights granted, and in addition to any payments due under Sections 7.1 –7.7, Healios shall pay to ATHX royalties on the portion of Net Sales of Products in a calendar year at the rates set forth in Table 7.8 below:

Table 7.8 – Royalty Rates


Net Sales of Products	Royalty Rate

[*]		[*	]

[*]		[*	]

[*]		[*	]

[*]		[*	]

[*]		[*	]

The foregoing rates will be applied on an incremental basis throughout a calendar year. For example, [*].

7.9 As partial consideration for the rights granted, and in addition to any payments due under Sections 7.1 - 7.8, Healios shall pay to ATHX a royalty of [*] of Organ Bud Product Net Sales.

7.10 Payment of the amounts due under Sections 7.8 and 7.9 shall be made in US Dollars within 60 days from the end of each calendar quarter. To calculate the amount due in US Dollars, Healios shall convert the amount of Net Sales of Products from JPY to US Dollars using the currency conversion published by the Wall Street Journal, Eastern Edition, and based upon the average conversion rate for the calendar quarter being reported.

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

7.11 All amounts required to be paid by Healios under this Agreement shall be paid in US Dollars even if the calculation of such amount is not based upon US Dollars.

7.12 Any payments made by a Party pursuant to this Agreement shall not be reduced on account of any Taxes unless required by applicable law. ATHX shall be responsible for paying any and all Taxes (other than withholding taxes required to be paid by Healios under applicable law, except to the extent that ATHX does not provide any requested IRS documentation) levied on account of, or measured in whole or in part by reference to, any payments it receives hereunder. Healios shall deduct or withhold from any such payments to ATHX any Taxes that Healios is required to deduct or withhold under applicable law. Notwithstanding the foregoing, if ATHX is entitled under any applicable Tax treaty to a reduction in the rate of, or the elimination of, applicable withholding Tax, it may deliver to Healios or the appropriate governmental authority (with the assistance of Healios to the extent that such assistance is reasonably required and is requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Healios of its obligation to withhold Tax, and Healios shall apply the reduced rate of withholding, or dispense with withholding, as the case may be, provided that Healios has received evidence, in a form reasonably satisfactory to Healios, of ATHX’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least 10 days prior to the time that the payments are due. If, in accordance with the foregoing, Healios withholds any amount, it shall (a) timely remit to ATHX the balance of such payment excluding the withheld tax; (b) timely remit the full amount withheld to the proper governmental authority; and (c) send to ATHX written proof of remittance of the full amount withheld within 30 days following remittance.

SECTION 8

DEVELOPMENT OF PRODUCTS.

8.1 Healios shall be responsible to file applications for and to obtain and hold Conditional Approvals and Full Approvals for the Products in the Territory, as well as application for NHI Price listings for the Products in the Territory. Healios shall be the responsible Party for funding and conducting all clinical studies for the Products in the Territory. ATHX, at its discretion upon the request of Healios, will consult with and provide information and advice to Healios to support Healios’ regulatory and development activities within the Primary Field.

8.2 ATHX remains responsible to file applications for approval and to obtain and hold all regulatory approvals for Products in the Primary Field outside the Territory, at its discretion. In the event of international studies that involve the Primary Field sponsored by ATHX or any of its third party licensees of the ATHX MultiStem Background IP, Healios may elect to participate in such study as a joint participant therein provided that such participation is in compliance with all Laws and, to the extent necessary, is permitted by such third party licensee(s). If Healios participates in any such study(ies), then Healios shall be responsible for all of the direct costs associated with the study(ies) in the Territory, as well as a reasonable allocation of all of the indirect and overhead costs associated with the study based upon the % of patients in the Territory as part of the overall study(ies) or such other allocation as may be mutually agreed by the Parties.

8.3 If Healios elect to participate in international studies under the Section 8.2, the Parties shall, to their respective best efforts, coordinate international regulatory, development and reimbursement strategies for Products in the Primary Field. Each Party shall have final responsibility for its respective territory.

CONFIDENTIAL

SECTION 9

JOINT STEERING COMMITTEE.

9.1 In order to develop, to file applications for and to obtain and hold Conditional Approvals and Full Approvals for the Products in the Territory as smoothly and expeditiously as possible, as well as to distribute, to promote, to market and to sell the Products in the Territory as efficiently as possible, ATHX and Healios shall establish a Joint Steering Committee (the “JSC”) as a body for discussion and decision about all important courses of action to take in due course after the Effective Date.

9.2 Agenda of the JSC will cover the following:

(a) Determination of an overall development plan of Products in the Territory and the life cycle management such as commencement and/or discontinuance of development of such Products in the Territory;

(b) Reporting and review of the progress of the development plan of Products in the Territory, and revision, if necessary, of such plan;

(c) Reporting and review of the application strategy for the approval of the Products in the Territory and the strategy for filing of application thereof and for the NHI Price listings;

(d) Reporting strategy on marketing, promotion plans, the sales record and post marketing study of Products in the Territory; and

(e) Any other important matters related to development, marketing or sale of Products in the Territory for the purpose of achieving smooth and maximum penetration of Products in the Territory.

9.3 The JSC shall consist of [*]. Such representatives shall be at a senior management level, and may be changed by either Party appointing them. A chairperson of the JSC shall be appointed by Healios from its representatives.

9.4 The meetings of the JSC shall be held once a year as an ordinary meeting and at any time upon reasonable request from either Party as an extraordinary meeting for any urgent matters. The JSC shall be held face to face or by telephone/video conference; provided, however, for the reason of urgency or convenience, with respect to agenda and content the JSC may also make decisions in writing (or by electromagnetic records) if all members of the JSC have agreed in advance in writing.

9.5 In the case of failure to form unanimity in the JSC, [*] subject to Section 9.6.

9.6 When a decision of JSC is reasonably expected to have a material effect on ATHX’s development, reimbursement, pricing or commercialization outside the Primary Field or the Territory, the chairperson of the JSC shall fairly and reasonably consider the material effect of such a decision. When either Party is dissatisfied with the judgment, the Party may submit such dispute to mediation in accordance with the mediation rules of the International Chamber of Commerce. The place of mediation shall be Tokyo. The language to be used in the mediation shall be English. If the Parties cannot agree upon the course of action to be taken as a result of such mediation, either Party may submit the dispute for final resolution by arbitration pursuant to Section 19.2. Unless and until such dispute is finally resolved by such arbitration or the Parties otherwise mutual agree as to the action to be taken (or not taken) regarding the disputed subject, the judgment shall have no effect and neither Party may take such action (or refrain from taking such action) that was the subject of such judgment.

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

SECTION 10

SUPPLY OF PRODUCTS AND MAPC.

10.1 Subject to the terms and conditions of this SECTION 10, ATHX or its Affiliate, itself or through competent third party manufacturer(s) (“Third Party Manufacturer(s)”) shall supply to Healios, and Healios shall order and purchase from ATHX or its Affiliate, (a) all of the Products reasonably required for the Primary Field in the Territory and (b) all of the MAPC reasonably required for use in the research and development of Organ Bud Products in the Organ Bud Field.

10.2 The Products delivered by or for ATHX or its Affiliate shall be manufactured in accordance with all Laws and shall be delivered in finished form required for use in the Primary Field in the Territory. The MAPC delivered by or for ATHX or its Affiliate shall be manufactured in accordance with all Laws, and shall be provided in forms suitable for research and development of Organ Bud Products in the Organ Bud Field, as such forms may be mutually agreed.

10.3 In addition to the payments due under SECTION 7, as partial consideration for the rights granted Healios will pay to ATHX or its Affiliate for MAPC supplied to Healios under this Agreement [*].

10.4 In addition to the payments due under SECTION 7, as partial consideration for the rights granted Healios will pay to ATHX or its Affiliate for Products supplied to Healios under this Agreement will be as follows:

[*].

10.5 ATHX and its Affiliates will use commercially reasonable efforts to be able to supply the Products pursuant to Section 10.4(a) to Healios for use in the Primary Field in the Territory [*], then the sole and exclusive remedy of Healios will be that ATHX will grant to Healios the licenses set forth in Section 2.2 and 3.2 to make and have made such Products so affected anywhere in the world solely for import into the Territory for use in the Primary Field in the Territory.

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

10.6 ATHX and its Affiliates shall deliver Products and MAPC Ex-Works (Incoterms 2010) at the location of ATHX, its Affiliate or their respective Third Party Manufacturer, as may be designated by ATHX from time to time.

10.7 All payments under this SECTION 10 shall be invoiced and paid in US Dollars within 30 days from the date Healios receives the invoice from ATHX or its Affiliates.

10.8 Healios shall have the right to audit manufacturing facilities of ATHX, its Affiliates and the Third Party Manufacturer(s) that are making the Products or MAPC for delivery to Healios under this Agreement for compliance with Laws. ATHX shall permit Healios to conduct the audit upon reasonable advance notice, during normal business hours, in a manner that does not interfere with normal operations, and subject to all on-site rules and regulations for visitors, and ATHX shall cooperate with Healios in the audit. ATHX shall ensure that its contracts with the Third Party Manufacturer(s) allow such audits of Third Party Manufacturer(s).

10.9 Healios shall have the right to verify the [*] for Products and MAPC through independent accountants or auditors. ATHX shall permit the independent accountants or auditors to conduct such verification upon reasonable advance notice, during normal business hours, in a manner that does not interfere with normal operations, and subject to all on-site rules and regulations for visitors, and ATHX shall cooperate with Healios and the independent accountant s or auditors in the verification. ATHX shall make and keep records necessary for calculation of such [*] and allow the independent accounts or auditors to access and examine the records in the verification. ATHX and Healios will discuss to decide the number of independent accountants or auditors to access and examine the records in the verification. ATHX may require the independent accountants or auditors to enter into a confidentiality agreement with ATHX before undertaking any such verification, provided that the independent accountants or auditors may disclose and report the results of the verification, including, the information concerning [*], to Healios.

10.10 ATHX, its Affiliate or their Third Party Manufacturer shall provide certificates of analysis to Healios for all the Products supplied under this Agreement. Upon reasonable request from Healios, ATHX shall provide Healios with any documents that are related to the manufacturing and supply of the Products to Healios under this Agreement and that are reasonably necessary for Healios to prepare or submit its regulatory filings in relation to the Products in the Primary Field in the Territory. Upon reasonable request from Healios, ATHX shall provide Healios with any documents that are related to the manufacturing and supply of MAPC to Healios under this Agreement and that are reasonably necessary for Healios to prepare or submit its regulatory filings in relation to the Organ Bud Products in the Organ Bud Field.

10.11 ATHX may consider establishing manufacturing in the Territory to supply Products for use in the Primary Field in the Territory. If requested by ATHX, the Parties will work together to establish a suitable approach to facilitate this goal.

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

SECTION 11

TECH TRANSFER.

11.1 When any of the events described in clauses (a) to (e) in Section 2.2 occurs, if requested by Healios, ATHX shall promptly begin to provide and transfer to Healios or its Affiliate any and all data, information, know-how or technology required for manufacturing the Products for the Primary Field for the Territory and support Healios so that Healios may make or have made such Products for the Primary Field for the Territory (collectively “Manufacturing Information”). Manufacturing Information shall include, without limitation, any confidential manufacturing dossier such as all specifications, SOPs and testing reports. Manufacturing Information shall cover any and all information that ATHX provides to at least one of the Third Party Manufacturer(s) of the subject Product during all or part of the term of this Agreement. If requested by Healios, ATHX will use commercially reasonable efforts to facilitate an arrangement between Healios and a Third Party Manufacturer that ATHX retains for the manufacturing of Product provided to Healios, so that [*]. Such transfer of Manufacturing Information (the “Tech Transfer”) shall be deemed completed if Healios becomes ready to manufacture or have manufactured the subject Product for the requirement in the Territory.

11.2 Notwithstanding Section 11.1 above, any of the events described in clauses (a) or (b) in Section 2.2 occurs, Healios may provide ATHX with notice thereof and its intent to exercise its rights under Section 11.1. If ATHX demonstrates within 30 days after receipt of such notice that ATHX is able to supply Healios with the subject Product for the Primary Field in the Territory [*], then Healios may not exercise such rights. If ATHX fails to so demonstrate, Healios may exercise such rights. In response to exercise of such rights by Healios upon or after ATHX’s failure to so demonstrate under this Section 11.2, ATHX shall assume the obligations as set forth in Section 11.1.

11.3 The Parties shall make their reasonable efforts, and shall reasonably cooperate with each other, so that the Tech Transfer may be completed as soon as reasonably possible after any of (a) to (e) in Section 2.1 occurs.

11.4 ATHX shall be responsible for the costs of ATHX and its Affiliates in connection with the Tech Transfer described in Section 11.1. Healios shall be responsible for the costs of Healios and its Affiliates in connection with the Tech Transfer described in Section 11.1 and any associated costs of Healios’ designated third party manufacturer, if applicable, [*].

11.5 If, at any time after Healios has exercised its right to manufacture the subject Product pursuant to Section 11.1 and before or after the Tech Transfer is completed, ATHX reasonably demonstrates that it is able to supply Healios with the subject Product for the Primary Field in the Territory [*], then Healios will purchase a reasonable proportion of its requirements of the subject Product from ATHX on a non-exclusive basis, taking into

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

account the nature and extent of Healios’ fixed manufacturing investment and third party purchase commitments and price competitiveness of ATHX, for so long as ATHX continues to demonstrate its ability to supply [*].

SECTION 12

TERM AND EXPIRATION.

This Agreement shall become effective on the Effective Date and remain in full force and effect until no intellectual property rights remain in any of the ATHX MultiStem Background IP, Foreground IP of ATHX, and ATHX MAPC Background Patents, unless terminated earlier pursuant to SECTION 13.

SECTION 13

TERMINATION; EFFECTS OF TERMINATION OF THIS AGREEMENT.

13.1 Healios may terminate this Agreement without cause with 6 months prior written notice to ATHX.

13.2 Healios may terminate this Agreement immediately by notice to ATHX in the event that ATHX is in material breach of this Agreement and fails to rectify such breach within 60 days of written notice of such breach from Healios.

13.3 ATHX may terminate this Agreement, in its entirety or in part with respect to any Product, Organ Bud Product, Ischemic Stroke Field, ARDS/[*] Field or Organ Bud Field, immediately by notice to Healios in the event Healios is in material breach of this Agreement and fails to rectify such breach within 60 days of written notice of such breach from ATHX. Without limiting the foregoing, Healios’ failure to pay any of the amounts due under SECTION 7 when due is a material breach of this Agreement.

13.4 Upon Termination of this Agreement for any reason:

(a) the provisions in Sections 1, 2.5, 3.3, 3.6-3.10, 7.10-7.12, 13.4-13.7, 15, 16, 18.6, and 19 shall survive Termination of this Agreement if and as applicable; and

(b) all obligations accruing prior to Termination of this Agreement shall remain due and owed in accordance with their respective terms.

13.5 Upon Termination of this Agreement by Healios pursuant to Section 13.1 or by ATHX pursuant to Section 13.3, Healios will work in good faith with ATHX to promptly (i) transfer to ATHX ownership of all investigator’s brochures, regulatory filings and regulatory approvals for the Product in the Primary Field in the Territory; (ii) deliver to ATHX all clinical data and information in Healios’ possession or control relating to Products, including for clarity manufacturing data, if any, in the same form in which Healios maintains such data,

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

(iii) deliver to ATHX, in the same form in which Healios maintains such items, copies of all reports, records, regulatory correspondence and other materials in Healios’ possession or control relating to the clinical development of Product in the Primary Field in the Territory.

13.6 Upon Termination of this Agreement by Healios pursuant to Sections 13.1 or 13.2, Healios may continue to sell the then-current finished goods inventory of Product in its stock as of the effective date of termination even after termination, subject to any of its obligations under SECTION 7 that result from such sales.

13.7 Upon Termination of this Agreement pursuant to SECTION 12 because no intellectual property rights remain in any of the ATHX MultiStem Background IP, Foreground IP of ATHX, and ATHX MAPC Background Patents, SECTION 6 shall remain in full force and effect; provided, however, that the license granted to Healios under Section 6.4 shall be royalty-bearing and shall terminate automatically without further action by either Party at such time that neither Healios nor any of its Affiliates or permitted sublicensees have used the Trademark in the Territory for the sale of Products for a continuous period of 1 year. The applicable royalty rate for such license shall be calculated based upon the total Net Sales of Products in a calendar year, or any partial calendar year, as appropriate, as set forth in Table 13.7 below:

Table 13.7 – Post-Term Trademark Royalty Rates


Total Net Sales of Products in the Calendar Year	Royalty Rate

[*]		[*	]

[*]		[*	]

[*]		[*	]

[*]		[*	]

[*]		[*	]

[*]

All royalties due under this Section shall be paid in accordance with and subject to Sections 7.11 and 7.11 (as if they were payments due pursuant to Section 7.8). The payment of the amounts due under this Section 13.7 shall be made in US Dollars within 60 days from the end of each calendar year. To calculate the amount due in US Dollars, Healios shall convert the amount of Net Sales of Products from JPY to US Dollars using the currency conversion published by the Wall Street Journal, Eastern Edition, and based upon the average conversion rate for the calendar year being reported. To determine the royalty rate applicable to Net Sales for a partial calendar year (such as for the period starting on Termination of this Agreement and ending at the end of the calendar year in which that occurs), [*].

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

SECTION 14

PHARMACOVIGILANCE AND DILIGENCE.

14.1 In accordance with any Laws, ATHX shall monitor and evaluate any and all adverse or undesirable events in relation to the Product arising in preclinical trials, clinical trials and post-marketing surveillance that ATHX is involved with independently of (i) the causation between prevention or treatment with the Product and the event and (ii) the characteristics of the event. If such event occurs, ATHX shall report such event required to be reported under Laws to an authority in charge in accordance with the Laws within time allowed for the report, and forward the information of such event within the shortest delay and no later than one week after becoming aware of the event.

14.2 In response to a request of Healios in relation to the event as set forth in Section 14.1, ATHX shall provide an answer in writing within one week.

14.3 The Parties shall discuss and put in place a written agreement for exchanging adverse event and other safety and pharmacovigilance information relating to the Product prior to the initiation of clinical activity by Healios.

14.4 Healios shall use commercially reasonable efforts to develop and achieve approval for the Ischemic Stroke Products in the Ischemic Stroke Field in the Territory, and, upon exercise of the option to expand such Primary Field in accordance with SECTION 4, the ARDS/[*] Products in the ARDS/[*]Field. Following any such approval, Healios shall use commercially reasonable efforts to commercialize such Products in the Primary Field throughout the Territory. Without limiting the foregoing, if Healios [*], such failure shall constitute a breach of this Section and a material breach of this Agreement subject to termination under Section 13.3. In any such event, ATHX may elect to terminate this Agreement in its entirety or in part only with respect to the particular subset of Products that are the subject of the breach.

SECTION 15

CONFIDENTIALITY.

15.1 “Confidential Information” means (a) terms of this Agreement (but not its mere existence) and (b) any and all proprietary information disclosed by one Party (“Discloser”) to the other Party (“Recipient”) under this Agreement or the MCDA, whether orally, visually, electronically such as by email or in an electric file, or in writing, which (i) if disclosed in writing or other tangible form, is clearly designated as being confidential by a mark with the word “Confidential” or a similar warning, or (ii) if disclosed orally, visually or in other non-tangible form, is disclosed as confidential at the time of disclosure, reduced to a written document describing such information and the place and date of such disclosure and provided to Recipient with a mark with the word “Confidential” or a similar warning within 30 days from the date of disclosure; provided, however, that the Confidential Information does not include information that falls under any of the following categories, which shall be proved by Recipient:

(a) Information which is publicly known at the time of disclosure by Discloser or information which becomes publicly known with no fault of Recipient after disclosure by Discloser;

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

(b) Information which is already in the possession of Recipient on or before disclosure by Discloser;

(c) Information which Recipient duly obtains from a third party who is not under any obligation to maintain the confidentiality of such information;

(d) Information which Recipient has independently developed or obtained without the benefit of information disclosed by Disclosure; or

(e) Information for which the Recipient obtains from the Discloser a prior written approval for disclosure.

15.2 Except as otherwise provided in this SECTION 15, Recipient shall hold and maintain Confidential Information in strict confidence, and shall not disclose to any third party Confidential Information without a prior written approval of Discloser and Recipient shall use Confidential Information solely for the purpose of this Agreement (“Purpose”). Notwithstanding the foregoing, Recipient may disclose Confidential Information to its directors, statutory auditors, officers, employees and agents and those of its Affiliate (collectively referred to as “Staff”) when its Staff needs to know the Confidential Information for the Purpose. Recipient shall make its Staff comply with the obligations as set forth in this SECTION 15, whether during the period in which the Staff has positions in Recipient or after the Staffs leave Recipient and shall be fully liable to Discloser for their breach of such terms as if such breach was by Recipient.

15.3 Recipient may disclose Confidential Information to its and its Affiliates’ licensees or sublicensees, as applicable, and its and their respective bankers, accountants, counsels, consultants and independent contractors (the “Outside Staff”) who need to know the Confidential Information for the Purpose or their professional duties in connection with the rights or obligations of Recipient under this Agreement, provided that Recipient shall cause the Outside Staff to be bound by no less stringent terms than those set forth in SECTION 15 (applied mutatis mutandis) and shall be fully liable to Discloser for their breach of such terms as if such breach was by Recipient.

15.4 Recipient shall manage Confidential Information with the same degree of care as it would manage its own confidential information but always with no less stringent degree of care than a reasonable care.

15.5 In the case where Recipient is required to disclose Confidential Information by any administrative or judicial organization (including the ICC for mediation or arbitration under this Agreement) or under any Law, including without limitation regulations and rules of stock exchange and, in response to the request, discloses the Confidential Information, such disclosure does not fall into any breach of the obligations as set forth in this SECTION 15. In such case, Recipient shall notify Discloser of such disclosure in advance (if an advance notice is impossible or difficult, promptly after such disclosure) and make reasonable efforts to minimize the scope of such disclosure.

CONFIDENTIAL

15.6 Within 60 days after Termination of this Agreement, Recipient shall promptly return to Discloser returnable materials in which Confidential Information (including reproduced/replicated Confidential Information) is recorded, or, as instructed by Discloser, destroy such materials and (ii) delete Confidential Information recorded in unreturnable materials (including that provided via email or as an attached file thereof and recorded in a hard disk drive); provided, however, that (a) digital backup files automatically generated by Recipient’s customary electronic data processing system may be retained and properly stored as confidential files for the sole purpose of backup and will be deleted in accordance with its retention policy and (b) ATHX may retain all information transferred from Healios to ATHX pursuant to Section 13.5 all of which shall thereafter be the Confidential Information of ATHX for which Healios is deemed the Recipient (notwithstanding that Healios may have first disclosed such information to ATHX) and with respect to which the exceptions in Sections 15.1(a)-(d) do not apply.

15.7 The obligations set forth in SECTION 15 shall be effective for 20 years from Termination of this Agreement.

SECTION 16

INDEMNIFICATION.

16.1 Each Party (“Indemnifying Party”) shall protect, defend, indemnify and hold the other Party (“Indemnified Party”), its Affiliate and its and their respective Staff and Outside Staff (collectively, the “Indemnitees”) harmless from and against any and all actual or threatened claims or lawsuits by any third party and all associated liabilities, losses, damages (whether or not “punitive” in nature), fees, expenses, costs, claims, demands, fines and penalties, including the burden and expense of defending against all third party claims and regulatory actions, amounts paid in settlement thereof (including interest), and reasonable attorneys’ fees and disbursements of counsel (“Liabilities”), arising out of or based upon (i) any misrepresentation or breach by the Indemnifying Party of any representation or warranty in this Agreement or (ii) any breach by the Indemnifying Party of any of the provisions of this Agreement; except in each case to the extent that any of the Liabilities are caused by or attributable to (x) negligence or willful misconduct of any of the Indemnitees, (y) any misrepresentation or breach by the Indemnified Party of any representation or warranty in this Agreement, or (z) any breach by the Indemnified Party of any of the provisions of this Agreement or any act (or omission) of an Indemnitee that if performed (or not performed) by the Indemnified Party would be a breach of any provision of this Agreement. The foregoing indemnification is conditional upon (a) the Indemnified Party shall notify the Indemnifying Party of any claim or demand for Liabilities promptly after it receives or notices the same, (b) Indemnified Party cooperating with Indemnifying Party in the defense of Indemnifying Party, and if requested, giving full control of defense to the Indemnifying Party and (c) Indemnified Party not compromising or settling such claim or demand without the prior written consent of the Indemnifying Party.

SECTION 17

INFRINGEMENT AND CHALLENGE OF RIGHTS.

17.1 When either Party (the “Notifying Party”) becomes aware of any actual or threatened infringement of the ATHX MultiStem Background IP, the Trademark or Foreground IP of ATHX by any third party in the Territory (the “Infringement by Third Party”), the Notifying Party shall promptly notify the other Party of the detailed conduct of the Infringement by Third Party and the name of the third party to the extent that the Notifying Party knows.

CONFIDENTIAL

17.2 Infringement by Third Party will be addressed as follows:

(a) Subject to Section 17.2(b), Healios shall have the right, but not the obligation, to attempt to stop Infringement by Third Party of the ATHX MultiStem Background IP, the Trademark or Foreground IP of ATHX in the Primary Field in the Territory, including through negotiation and litigation at its cost, to the extent that the Infringement by Third Party is related to a product(s) competing with any product in the Primary Field that is sold by Healios, its Affiliate or their sublicensee. ATHX shall provide Healios with any assistance in connection with the Healios’ activities to attempt to stop such Infringement by Third Party as reasonably requested by Healios, including by ATHX joining as a party to any such litigation or filing a joint action with Healios if Healios desires to seek an injunction against the Third Party and ATHX’s participation as a party in such litigation is required to obtain such injunction. Any recoveries resulting from such efforts will be allocated in the following priority: (i) first, in reimbursing Healios’ out of pocket expenses (including counsel fees and expenses) in undertaking such activities, (ii) second in reimbursing ATHX’s out of pocket expenses (including counsel fees and expenses) in assisting with such activities, and (iii) third, the remainder (if any) to be retained by Healios but reported as Net Sales and paid to ATHX thereon under SECTION 7. No settlement, stipulated judgment or other voluntary final disposition of litigation under this Section 17.2(a) may be undertaken by Healios without the consent of ATHX if such settlement, stipulated judgment or other voluntary final disposition would require ATHX to be subject to an injunction, admit wrong-doing, make a monetary payment or would otherwise materially adversely affect ATHX’ rights under this Agreement or any of the ATHX MultiStem Background IP, the Trademark or Foreground IP of ATHX.

(b) If Healios fails, pursuant to Section 17.2(a) to bring an action with respect to, or to terminate, the Infringement by Third Party before the earlier of (i) 180 days following the notice of alleged infringement; and (ii) 10 days before the time limit, if any, set forth in the Laws for the filing of such actions, then ATHX shall have the right, but not the obligation, to attempt to stop such infringement, including through litigation. Healios will provide ATHX with any assistance in connection with ATHX’s activities to attempt to stop Infringement by Third Party as reasonably requested by ATHX, and ATHX shall be responsible for all of the out-of-pocket costs and expenses (including counsel fees) in relation to the assistance, regardless of whether any recoveries are obtained. Any recoveries resulting from such action will be retained by ATHX. ATHX may not enter into settlements, stipulated judgments or other arrangements respecting such infringement without the prior written consent of Healios if such settlement, stipulated judgment or other arrangement would require Healios to be subject to an injunction, admit wrong-doing, make a monetary payment or would otherwise conflict with the exclusive rights granted to Healios under this Agreement.

(c) The Parties will consult with each other with respect to potential strategies for stopping the Infringement by Third Party without litigation and during litigation. Each Party will cooperate with the other Party in its efforts to stop the Infringement

CONFIDENTIAL

by Third Party as reasonably requested, including by joining in any such litigation as a party or participating in any such litigation as a sole party to the extent required by any Laws in the Territory.

17.3 When any third party takes any action to invalidate or to have declared unenforceable any of the ATHX MultiStem Background IP, the Trademark or Foreground IP of ATHX in any manner, including filing an invalidation trial or an opposition or as an invalidation defense, a counterclaim, declaratory judgment or other response to an allegation made by Healios or ATHX under Section 17.2, ATHX shall have the sole right to defend against, and shall take at its sole expense commercially reasonable actions to defend against, the third party’s actions or claims. In response to a request of ATHX, Healios shall provide all reasonable assistance to ATHX in connection with ATHX’s actions above. ATHX shall be responsible for all of the out-of-pocket costs and expenses reasonably incurred by Healios in connection with such assistance requested by ATHX.

17.4 When (a) either (i) any conduct under the license or the sublicense by Healios, its Affiliate or its permitted sublicensee constitutes a material risk of being deemed an infringement of any right, title or interest of any intellectual property of any third party (“Infringement of Third Party’s Right”) or (ii) any third party threatens or initiates legal actions alleging Infringement of Third Party’s Right in connection with any conduct under such license or the sublicense by Healios or its permitted sublicensee, and (b) such risk, threat or litigation is based upon the Product as supplied by ATHX, its Affiliate or a Third Party Manufacturer to Healios under this Agreement or a supply agreement contemplated hereby (“Supplied Product”) or upon the manufacturing method as transferred by ATHX to Healios pursuant to Section 11.1 to make Product for use in the Primary Field in the Territory (“Transferred Method”), then (c) if requested by Healios and subject to Section 17.5, ATHX shall [*]. ATHX shall be responsible for all of ATHX’s and its Affiliates’ costs and expenses incurred in the actions above, including, if and as applicable, (A) payments under any agreement entered between ATHX or its Affiliate, on the one hand, and the third party, on the other hand, (B) any costs and expenses of ATHX and its Affiliates for legal procedures against the third party, including the attorneys’ fees of ATHX and its Affiliates, and (C) any costs and expenses of ATHX’s and its Affiliates’ associated with their respective negotiations with the third party. Healios shall cooperate with ATHX and its Affiliates in connection with the actions above and be responsible for all of Healios’ and its Affiliates’ costs and expenses incurred in the actions above.

17.5 Notwithstanding Section 17.4, ATHX shall have no obligation thereunder:

(a) when the Supplied Product as supplied by ATHX or the Third Party Manufacturer(s) has been modified in a manner not specifically directed in writing by ATHX and without such modification exploitation of the Product would not be deemed a material risk of infringement;

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

(b) when the Transferred Method has been modified in a manner not specifically directed in writing by ATHX and without such modification exploitation of the Transferred Method would not be deemed a material risk of infringement;

(c) when the Supplied Product or the Transferred Method is exploited for any application outside of the Primary Field, outside of the Territory or in any other manner that is not licensed or that would be a breach of this Agreement;

(d) when the Supplied Product is exploited in combination with anything not provided or specifically directed in writing by ATHX and exploitation of the Product alone, as supplied by ATHX or the Third Party Manufacturer(s), would not be deemed a material risk of infringement;

(e) when the Transferred Method is exploited in combination with anything not provided or specifically directed in writing by ATHX and exploitation of the Transferred Method alone would not be deemed a material risk of infringement;

(f) for any use or methods of treatment developed by Healios; or

(g) any Liabilities incurred by Healios, its Affiliates or their respective sublicensees.

SECTION 18

REPRESENTATION AND WARRANTIES; DISCLAIMER.

18.1 Each of ATHX and Healios represents and warrants that it is duly organized and exists in good standing under the Laws of the jurisdiction in which it is organized, has the power to own its property and to carry on its business as now being conducted.

18.2 Each of ATHX and Healios represents and warrants that it has the corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder, including, without limitation, to grant the license as set forth in this Agreement, without consent of any third party and without breach of any agreements with or obligations to any third party.

18.3 Each of ATHX and Healios represents and warrants that it is not currently a party to and will not enter into agreement with an obligation to a third party inconsistent, incompatible, or conflicting with its obligations under this Agreement.

18.4 ATHX represents and warrants that, to its knowledge as of the Effective Date, the issued patents of ATHX MultiStem Background Patents in the Primary Field in the Territory and the ATHX MAPC Background Patents are valid and enforceable.

18.5 ATHX represents and warrants that, to its knowledge as of the Effective Date, the information disclosed to Healios in the course of discussion and negotiation with Healios in relation to this Agreement is true in all material respects.

18.6 EXCEPT AS PROVIDED EXPRESSLY IN THIS SECTION 18 AND IN SECTION 2.3, NEITHER ATHX NOR HEALIOS MAKES ANY REPRESENTATIONS OR WARRANTIES UNDER THIS AGREEMENT WHATSOEVER, AND EACH OF ATHX AND HEALIOS HEREBY DISCLAIMS ALL OTHER SUCH POTENTIAL WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES OF

CONFIDENTIAL

MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, AGAINST INFRINGEMENT, AND THOSE ARISING THROUGH COURSE OF DEALING OR TRADE OR OTHERWISE.

SECTION 19

MISCELLANEOUS.

19.1 This Agreement shall be governed by and construed under the Laws of State of New York without regard to its choice of law principles.

19.2 All disputes arising out of or relating to this Agreement shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by 3 arbitrators appointed in accordance with the said Rules. The Emergency Arbitrator Provisions shall not apply. The seat of the arbitration shall be Tokyo. The language to be used in the arbitration shall be English. The award rendered by arbitration shall be final and binding upon both Parties and judgment upon the award may be entered into in any court having jurisdiction for enforcement thereof. The Parties shall treat all matters relating to the arbitration, including, but not limited to, the existence of the arbitration, all documents produced by one Party in the arbitration, or the award rendered by the arbitration as Confidential Information.

19.3 All rights and licenses of Healios or its Affiliate under this Agreement except those for Trademark are and shall be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any counterparts in other jurisdictions, licenses of rights to “intellectual property” as defined in Section 101 of the U.S. Bankruptcy Code, to the extent that the U.S. Bankruptcy Code or any counterparts in other jurisdictions is applicable to the rights and license. Healios may retain and exercise all of its rights and elections under the U.S. Bankruptcy Code or any counterparts in other jurisdictions.

19.4 The licenses granted by either Party under its respective intellectual property in this Agreement are limited to those specifically and expressly set forth in Sections 2.1, 2.2, 2.4, 3.1, 3.2, 3.3, and 6.4. Nothing in this Agreement does or will be construed to grant to a Party any rights in any intellectual property rights not expressly granted, in each case whether by implication, estoppel or otherwise, and neither Party will exploit or grant sublicenses in any of the intellectual property rights licensed to it outside of the scope expressly licensed to it under this Agreement. All rights not specifically granted by a Party are reserved by such Party.

19.5 NEITHER ATHX NOR HEALIOS WILL BE LIABLE UNDER THIS AGREEMENT FOR ANY SPECIAL, PUNITIVE, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT DAMAGES OF ANY TYPE OR NATURE, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE OR OTHERWISE, INCLUDING LOSS OF PROFITS OR REVENUES, EXCEPT (A) TO THE EXTENT ANY SUCH DAMAGES ARE PAYABLE TO THIRD PARTIES IN CONNECTION WITH A INDEMNIFICATION OBLIGATION HEREUNDER, (B) FOR WILLFUL BREACH OR BREACH RESULTED FROM BAD FAITH OF ANY PROVISION OF THIS AGREEMENT, (C) FOR EXPLOITATION OF ANY OF THE INTELLECTUAL PROPERTY RIGHTS LICENSED UNDER THIS AGREEMENT OUTSIDE OF THE SCOPE LICENSED, OR (D) BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 20.

CONFIDENTIAL

19.6 Neither this Agreement nor any rights or obligations of any Party to this Agreement may be assigned or otherwise transferred by such Party without the consent of the other Party, except that a Party may assign this Agreement, without such consent, to an Affiliate or to a purchaser of or successor in interest to substantially all of that Party’s business or assets to which this Agreement pertains, through merger, sale of assets and/or sale of stock or ownership interest, consolidation or name change. Any permitted assignee shall assume all obligations of its assignor under this Agreement and provide notice of such assignment to the other Party promptly after such assignment. Any purported assignment in violation of this Section is void.

19.7 This Agreement may be executed in counterparts, each of which, when executed, are deemed to be an original and all of which together constitute one and the same document.

19.8 This Agreement together with its Exhibit(s) sets forth the entire agreement and understanding between the Parties as to the subject matter hereof and supersedes all agreements or understandings, verbal or written, made between ATHX, Healios and their respective Affiliates with respect to the subject matter hereof, including that certain Mutual Confidential Disclosure Agreement between the Parties dated 16 October 2014 (“MCDA”) and the LOI (including the “Option Agreement” contemplated thereby); provided, however, that all information disclosed by one Party, any of its, or its or their respective Staff or Outside Staff to the other Party, any of its Affiliates, or its or their respective Staff or Outside Staff prior to the Effective Date pursuant to the MCDA will be deemed to have been disclosed pursuant to this Agreement. None of the terms of this Agreement may be amended, supplemented or modified except in writing signed by the Parties.

19.9 Headings in this Agreement are included herein for reference only and shall not affect in any way the meaning or interpretation of this Agreement.

19.10 All notices, consents, approvals, requests or other communications required hereunder given by one Party to the other Party shall be in writing and made by (i) registered or certified air mail, postage prepaid and return receipt requested, (ii) facsimile, (iii) internationally recognized express overnight courier or (iv) delivered personally to the following addresses of the respective Parties:


If to ATHX:		ABT Holding Company
		3201 Carnegie Avenue
		Cleveland, OH 44115
		Attention: President
		Facsimile: +1.216.361.9495

with a copy to:		Jones Day
		12265 El Camino Real, Suite 200
		San Diego, CA 92130
		Attention: Thomas A. Briggs
		Facsimile: +1.858.314.1150

If to Healios:		Healios, K.K.
		World Trade Center Bldg. 15F
		2-4-1 Hamamatsucho,

CONFIDENTIAL


		Minato-ku, Tokyo, 135-6115 Japan
		Attention: President
		Tadahisa ‘Hardy” Kagimoto,
		Facsimile: +81.3.3434.7231

with a copy to:		Healios, K.K. Kobe Research Institute
		Attention: Hiroyuki Mizuo
		1-5-2 Minatojima-Minamimachi
		Chuo-ku, Kobe, Hyogo 650-0047 Japan
		Facsimile: +81.78.306.2154

Notices hereunder are deemed to be effective (i) upon receipt when made by registered or certified air mail, (ii) upon receipt when sent by facsimile, provided that the sender retains a written confirmation of the successful transmittal, (iii) upon receipt when made by internationally recognized express overnight courier, or (iv) upon delivery if personally delivered. A Party may change its address listed above by sending notice to the other Party.

19.11 The relationship between ATHX and Healios is that of independent contractors. Nothing in this Agreement shall be constructed to create a relationship of employer and employee, partner, joint venture, or principal and agent.

19.12 The invalidity or unenforceability of any term or provision in this Agreement shall not affect the validity or enforceability of any other term or provision hereof. If any of the terms or provisions of this Agreement are in conflict with any applicable law or regulation, such term(s) or provision(s) shall be deemed inoperative to the extent they may conflict therewith and shall be deemed to be modified to confirm with such law and regulation.

19.13 Any right of one Party hereto to the other Party may not be or is not deemed waived except by an instrument in writing signed by the party having such right. All rights, remedies, undertakings, obligations and agreements contained in this Agreement are cumulative and none of them are a limitation of any other remedy, right, undertaking, obligation or agreement.

[Remainder of page intentionally blank]

CONFIDENTIAL

IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be executed by their duly authorized officers upon the date set out below.


ABT Holding Company		Healios, K.K.

/s/ Gil Van Bokkelen		/s/ Tadahisa “Hardy” Kagimoto
Title:	Chairman & CEO	Title:	President

GUARANTEE BY ATHERSYS, INC.

Athersys, Inc. hereby irrevocably guarantees the performance of all of ATHX’s obligations under this Agreement.


Athersys, Inc.

/s/ Gil Van Bokkelen
Title:		Chairman & CEO

CONFIDENTIAL

Schedule 1

ATHX MAPC Patents in the Territory

[*]

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

CONFIDENTIAL

Schedule 2

ATHX MultiStem Patents in the Territory

[*]

*	Confidential treatment has been requested for the redacted portions of this exhibit, and such confidential portions have been omitted and filed separately with the Securities and Exchange Commission.

EXHIBIT 31.1

CERTIFICATIONS

I, Gil Van Bokkelen, certify that:

I have reviewed this quarterly report on Form 10-Q of Athersys, Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

May 5, 2016

/s/ Gil Van Bokkelen

Gil Van Bokkelen

Chief Executive Officer and Chairman of the Board of Directors

EXHIBIT 31.2

CERTIFICATIONS

I, Laura K. Campbell, certify that:

I have reviewed this quarterly report on Form 10-Q of Athersys, Inc.;

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

May 5, 2016

/s/ Laura K. Campbell

Laura K. Campbell

Senior Vice President of Finance

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Athersys, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to such officer’s knowledge:

(1)	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of the dates and for the periods expressed in the Report.

Date: May 5, 2016


/s/ Gil Van Bokkelen
Name:		Gil Van Bokkelen
Title:		Chairman and Chief Executive Officer

/s/ Laura K. Campbell
Name:		Laura K. Campbell
Title:		Senior Vice President of Finance

The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2016	May. 02, 2016
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2016
Document Fiscal Year Focus	2016
Document Fiscal Period Focus	Q1
Trading Symbol	ATHX
Entity Registrant Name	ATHERSYS, INC / NEW
Entity Central Index Key	0001368148
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Common Stock, Shares Outstanding		84,364,555

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents	$ 30,414	$ 23,027
Accounts receivables	706	361
Prepaid expenses and other	426	429
Total current assets	31,546	23,817
Equipment, net	1,253	1,135
Deferred tax assets	184	177
Total assets	32,983	25,129
Current liabilities:
Accounts payable	3,274	2,702
Accrued compensation and related benefits	515	1,024
Accrued clinical trial costs	443	82
Accrued expenses	489	513
Deferred revenue		245
Note payable		190
Total current liabilities	4,721	4,756
Warrant liabilities	$ 2,830	$ 649
Stockholders' equity:
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at March 31, 2016 and December 31, 2015
Common stock, $0.001 par value; 150,000,000 shares authorized, and 84,114,555 and 83,720,154 shares issued at March 31, 2016 and December 31, 2015, respectively, and 84,090,729 and 83,720,154 shares outstanding at March 31, 2016 and December 31, 2015, respectively	$ 84	$ 84
Additional paid-in capital	323,540	322,582
Accumulated deficit	(298,192)	(302,942)
Total stockholders' equity	25,432	19,724
Total liabilities and stockholders' equity	$ 32,983	$ 25,129

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2016	Dec. 31, 2015
Statement of Financial Position [Abstract]
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	84,114,555	83,720,154
Common stock, shares outstanding	84,090,729	83,720,154

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Revenues
Contract revenue	$ 15,124	$ 106
Grant revenue	334	625
Total revenues	15,458	731
Costs and expenses
Research and development	6,664	5,668
General and administrative	2,014	1,886
Depreciation	68	70
Total costs and expenses	8,746	7,624
Income (loss) from operations	6,712	(6,893)
Expense from change in fair value of warrants, net	(2,181)	(5,604)
Other income, net	210	15
Income (loss) before income taxes	4,741	(12,482)
Income tax benefit	9
Net income (loss) and comprehensive income (loss)	$ 4,750	$ (12,482)
Net income (loss) per share - Basic and Diluted	$ 0.06	$ (0.16)
Weighted average shares outstanding - Basic	83,781,114	79,180,697
Weighted average shares outstanding - Diluted	83,865,607	79,180,697

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Operating activities
Net income (loss)	$ 4,750	$ (12,482)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation	68	70
Income from forgiveness of note payable	(190)
Stock-based compensation	707	751
Change in fair value of warrant liabilities and other	2,174	5,605
Changes in operating assets and liabilities:
Accounts receivable	(345)	(2,143)
Prepaid expenses and other assets	3	41
Accounts payable and accrued expenses	400	(678)
Deferred revenue	(245)	9,952
Net cash provided by operating activities	7,322	1,116
Investing activities
Purchases of equipment	(186)	(63)
Net cash used in investing activities	(186)	(63)
Financing activities
Proceeds from issuance of common stock, net	424	7,606
Purchase of treasury stock	(173)	(257)
Proceeds from exercise of warrants		976
Net cash provided by financing activities	251	8,325
Increase in cash and cash equivalents	7,387	9,378
Cash and cash equivalents at beginning of the period	23,027	26,127
Cash and cash equivalents at end of the period	$ 30,414	$ 35,505

Background and Basis of Presentation	3 Months Ended
Background and Basis of Presentation	Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Background and Basis of Presentation	1. Background and Basis of Presentation We are an international biotechnology company that is focused primarily in the field of regenerative medicine and operate in one business segment. Our operations consist primarily of research and product development activities. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included below in this Quarterly Report on Form 10-Q.

Recently Issued Accounting Standards	3 Months Ended
Recently Issued Accounting Standards	Mar. 31, 2016
Accounting Changes and Error Corrections [Abstract]
Recently Issued Accounting Standards	2. Recently Issued Accounting Standards In November 2015, the Financial Accounting Standards Board (“FASB”) issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which amends the existing guidance to require that deferred income tax liabilities and assets be classified as noncurrent in a classified balance sheet and eliminates the prior guidance, which required an entity to separate deferred tax liabilities and assets into a current amount and a noncurrent amount in a classified balance sheet. The amendments in this ASU are effective for financial statements for annual periods and interim periods within those annual periods beginning after December 15, 2016, with early adoption permitted, and the new guidance can be applied either prospectively to all deferred tax liabilities and assets or retrospectively to all periods presented. We have adopted this ASU in the first quarter of 2016 on a prospective basis and, therefore, the adoption did not impact prior period financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 requires an entity to recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, the amendment provides five steps that an entity should apply when recognizing revenue. The amendment also specifies the accounting of some costs to obtain or fulfill a contract with a customer and expands the disclosure requirements around contracts with customers. An entity can either adopt this amendment retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the update recognized at the date of initial application. In August 2015, the FASB issued ASU 2015-14, which delays the effective date by one year, making the new standard effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after December 15, 2016. We are in the process of evaluating, but have not determined, the impact that the adoption of ASU 2014-09 will have on our consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and, if so, to provide related footnote disclosures. ASU 2014-15 provides a definition of the term “substantial doubt” and requires an assessment for a period of one year after the date that the financial statements are issued or available to be issued. Management will also be required to evaluate and disclose whether it has plans to alleviate that doubt. The guidance is effective for the annual periods ending after December 15, 2016 and interim periods thereafter with early adoption permitted. We will adopt ASU 2014-15 as required and are evaluating the impact the new guidance will have on our year-end disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires lessees to put most leases on their balance sheets, but recognize expenses on their income statements in a manner similar to current accounting practice. Under the guidance, lessees initially recognize a lease liability for the obligation to make lease payments and a right-of-use (“ROU”) asset for the right to use the underlying asset for the lease term. The lease liability is measured at the present value of the lease payments over the lease term. The ROU asset is measured at the lease liability amount, adjusted for lease prepayments, lease incentives received and the lessee’s initial direct costs. The guidance is effective for the annual periods beginning after December 15, 2018 and interim periods thereafter, with early adoption permitted. We are in the process of evaluating the impact the new guidance will have on our financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting, which involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Under the new standard, income tax benefits and deficiencies are to be recognized as income tax expense or benefit in the income statement and the tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity should also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits should be classified along with other income tax cash flows as an operating activity. In regards to forfeitures, the entity may make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures when they occur. This ASU is effective for fiscal years beginning after December 15, 2016 including interim periods within that reporting period, with early adoption permitted, provided that all amendments are adopted in the same period. We are currently evaluating the impact the adoption of ASU 2016-09 will have on its financial statements.

Net Income (Loss) per Share

3 Months Ended

Mar. 31, 2016

Earnings Per Share [Abstract]

Net Income (Loss) per Share

3. Net Income (Loss) per Share


	Three months ended March 31,
	2016		2015
Numerator:
Net income (loss) attributable to common stockholders - Basic and Diluted	$	4,750	$	(12,482	)

Denominator:
Weighted-average shares outstanding - Basic		83,781,114		79,180,697
Potentially dilutive common shares outstanding:
Stock-based awards		84,493		—

Weighted-average shares used to calculate diluted net income (loss) per share		83,865,607		79,180,697

Basic and Diluted earnings (loss) per share	$	0.06	$	(0.16	)


	Three months ended March 31,
	2016		2015
Stock-based awards		7,593,940		8,014,773
Warrants		3,554,893		8,364,893

Total		11,148,833		16,379,666

Financial Instruments

3 Months Ended

Mar. 31, 2016

Investments, All Other Investments [Abstract]

Financial Instruments

4. Financial Instruments

Fair Value Measurements

We classify the inputs used to measure fair value into the following hierarchy:


Level 1		Unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2		Unadjusted quoted prices in active markets for similar assets or liabilities, or unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are observable for the asset or liability.

Level 3		Unobservable inputs for the asset or liability.

The following table provides a summary of the financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 (in thousands):


			Fair Value Measurements at March 31, 2016 Using
Description	Balance as of March 31, 2016		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Warrant liabilities	$	2,830	$	—	$	—	$	2,830


	Expected Volatility	Risk-Free Interest Rate	Expected Life
Warrants with one year or less remaining term	78.58% – 95.67%	0.21% – 0.59%	0.29 – 0.95 year

A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrants is as follows (in thousands):


	Three months ended
	March 31, 2016
Balance January 1, 2016	$	649
Loss included in expense from change in fair value of warrants		2,181

Balance March 31, 2016	$	2,830

Financing Arrangement

Collaborations and Revenue Recognition	3 Months Ended
Collaborations and Revenue Recognition	Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Collaborations and Revenue Recognition	5. Collaborations and Revenue Recognition Healios On January 8, 2016, we entered into a license agreement (“Healios Agreement”) with Healios K.K. (“Healios”) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan, and to provide Healios with access to Athersys’ proprietary MAPC technology for use in Healios’ “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the Healios Agreement, Healios also obtained a right, at their option, to expand the scope of the collaboration to include the exclusive rights to develop and commercialize MultiStem for the treatment of two additional indications in Japan, which include acute respiratory distress syndrome (“ARDS”) and another indication in the orthopedic area, and to include all indications for the “organ bud” program. Healios will develop and commercialize the MultiStem product in Japan, and we will provide the manufactured product to Healios. Under the terms of the Healios Agreement, we received a nonrefundable, up-front cash payment of $15 million from Healios, the majority of which was received in January 2016. If Healios exercises their option to expand the collaboration, we will be entitled to receive a cash payment of $10 million. Healios may exercise its option to expand the collaboration prior to certain milestone dates that are expected to occur within the next two years. For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones aggregating up to $225 million. Such amounts are non-refundable and non-creditable towards future royalties or any other payment due from Healios. We will also receive tiered royalties on net product sales, starting in the low double-digits and increasing incrementally into the high teens, depending on net sales levels. Additionally, we will receive payments for product supplied to Healios for ischemic stroke. If Healios exercises the option to expand the collaboration to include ARDS and another indication in the orthopedic area, we would be entitled to receive royalties from product sales and success-based development, regulatory approval and sales milestones, as well as payments for product supply related to the additional indications covered by the option. For the “organ bud” product, we are entitled to receive a fractional royalty percentage on net sales of the “organ bud” products and will receive payments for manufactured product supplied to Healios under a manufacturing supply agreement. Additionally, we have a right of first negotiation for commercialization of an “organ bud” product in North America, with such right expiring on the later of (i) the date five years from the effective date of the Healios Agreement and (ii) 30 days after authorization to initiate clinical studies on an “organ bud” product under the first investigational new drug application or equivalent in Japan, North America or the European Union. The Healios Agreement will expire automatically when there are no remaining intellectual property rights subject to the license. Additionally, Healios may terminate the Healios Agreement under certain circumstances, including for material breach and without cause upon advance written notice. We may terminate the Healios Agreement if there is an uncured material breach of the agreement by Healios. In the event that Healios does not move the program forward, the development and commercialization rights would revert to us. To determine the appropriate accounting for the license agreement, we evaluated the Healios Agreement and related facts and circumstances, focusing in particular on the rights and obligations of the arrangement. We have determined that our obligations under the Healios Agreement represent multiple deliverables. For deliverables with standalone value, our policy is to account for these as separate units of accounting. We allocate the overall consideration of the arrangement that is fixed and determinable, excluding consideration that is contingent upon future deliverables, to the separate units of accounting based on estimated selling prices (as defined in ASC 605-25) of each deliverable. Given Healios’ ability to sublicense under the Healios Agreement and its ability to conduct the ongoing development efforts, we concluded that the license had stand-alone value at the inception of the arrangement and would be treated as a separate unit of accounting, noting that there was no general right of return associated with the license. Further, the preclinical and clinical manufacturing services and certain near-term regulatory advisory services that will be provided to Healios under the Healios Agreement had been determined to have stand-alone value and considered separate units of accounting. We were unable to establish vendor-specific objective evidence of selling price or third-party evidence for either the license or the services, and thus, instead, allocated the arrangement consideration between the license and the services based on their relative selling prices using best estimate of selling price (“BESP”). We developed the BESP of the license using a probability weighted, discounted cash flow analysis using the income approach, taking into consideration market assumptions including the estimated development and commercialization timeline, data regarding patient population, discount rate related to our industry, and probability of success using market data for both our industry and therapeutic field. We estimated the BESP of the manufacturing services and certain near-term regulatory advisory services using actual historical experience and best estimates of the cost of obtaining these services at arm’s length from a third-party provider, including an estimated mark-up. As a result of this analysis, we allocated $15 million to the license, which represents the amount of consideration that is allocable pursuant to the relative selling price and is not contingent upon delivery of additional items under the Healios Agreement. The license was delivered and recognized as revenue in January 2016 Other contingent deliverables that were not accounted for at the inception of the arrangement, and will not be accounted for until the contingency is resolved, included the potential expansion of the collaboration to include additional indications, and the milestones that are not substantive since they are dependent on the activities of Healios. Further, the arrangement contemplates our providing manufacturing services for commercial product supply, the terms of which are not defined and are to be agreed upon in the future under a separate supply agreement. Upon the removal of the contingencies associated with each of the potential contingent deliverables, including the expansion fee, milestone payments and / or commercial product supply, we will reevaluate the overall arrangement, including the estimated selling prices and the allocation of the overall consideration of the arrangement. Chugai In October 2015, we and Chugai Pharmaceutical Co. Ltd. (“Chugai”) agreed to terminate the License Agreement (the “Chugai Agreement”), dated February 28, 2015, between the parties, as a result of an inability to reach an agreement on the modification of the financial terms of the Chugai Agreement and on the development strategy, as proposed by Chugai, of our MultiStem^® cell therapy for the treatment of ischemic stroke in Japan. Pursuant to the terms of the Chugai Agreement, upon termination, we regained all rights for developing our stem cell technologies and products for ischemic stroke in Japan, and Chugai no longer has any license rights or options with respect to our technologies and products. Neither we nor Chugai have any further obligations to each other. Under the Chugai Agreement, we received a non-refundable, up-front cash payment of $10 million from Chugai, of which approximately $2.0 million was temporarily withheld by Japan taxing authorities and was refunded in September 2015. The $10 million upfront payment from Chugai was recorded as deferred revenue since we had concluded that the license grant did not have standalone value (as defined in ASC 605-25) at the inception of the arrangement. In connection with the termination and the parties having no further obligations under the Chugai Agreement, we recognized the $10 million upfront payment from Chugai as revenue in October 2015. RTI Surgical, Inc. In 2010, we entered into an agreement with RTI Surgical, Inc. (“RTI”) to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market on an exclusive basis. Under the terms of the agreement, we received a non-refundable license fee in installments and performed certain services that were concluded in 2012, and we are eligible to receive cash payments upon the successful achievement of certain commercial milestones. We evaluated the nature of the events triggering these contingent payments and concluded that these events are substantive and that revenue will be recognized in the period in which each underlying triggering event occurs. No milestone revenue has been recognized to date. In addition, we began receiving in 2014 tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single digits and increasing into the mid-teens. Any royalties may be subject to a reduction if third-party payments for intellectual property rights are necessary or commercially desirable to permit the manufacture or sale of the product.

Stock-based Compensation	3 Months Ended
Stock-based Compensation	Mar. 31, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-based Compensation	6. Stock-based Compensation We have two incentive plans that authorized an aggregate of 11,500,000 shares of common stock for awards to employees, directors and consultants. These equity incentive plans authorize the issuance of equity-based compensation in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock-based awards. As of March 31, 2016, a total of 2,983,302 shares of common stock have been issued under our equity incentive plans. As of March 31, 2016, a total of 339,111 shares were available for issuance under our equity compensation plans and stock-based awards to purchase 8,177,587 shares of common stock were outstanding. For the three-month periods ended March 31, 2016 and 2015, stock-based compensation expense was approximately $707,000 and $751,000, respectively. At March 31, 2016, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $3.5 million, which is expected to be recognized by the end of 2020 using the straight-line method.

Issuance of Common Stock and Warrants

3 Months Ended

Mar. 31, 2016

Equity [Abstract]

Issuance of Common Stock and Warrants

7. Issuance of Common Stock and Warrants

Aspire Capital

Warrants

As of March 31, 2016, we had the following outstanding warrants to purchase shares of common stock:


Number of Underlying Shares		Exercise Price		Expiration
	2,054,893	$	1.01	March 14, 2017
	1,500,000	$	4.50	July 15, 2016

	3,554,893

No warrants were exercised during the three months ended March 31, 2016.

Warrant Liabilities	3 Months Ended
Warrant Liabilities	Mar. 31, 2016
Text Block [Abstract]
Warrant Liabilities	8. Warrant Liabilities We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. Registered common stock warrants that could require cash settlement are accounted for as liabilities. We classify these warrant liabilities on the consolidated balance sheet as a non-current liability. The warrant liabilities are revalued at fair value at each balance sheet date subsequent to the initial issuance. Changes in the fair market value of the warrant are reflected in the consolidated statement of operations as income (expense) from change in fair value of warrants. The warrants we issued in the January 2014 registered direct offering contain a provision for a cash payment in the event that the shares are not delivered to the holder within two trading days. The cash payment equals $10 per day per $2,000 of warrant shares for each day late. The warrants we issued in the March 2012 private placement contain a provision for net cash settlement in the event that there is a fundamental transaction (e.g., merger, sale of substantially all assets, tender offer, or share exchange). If a fundamental transaction occurs in which the consideration issued consists of all cash or stock in a non-public company, then the warrant holder has the option to receive cash equal to a Black Scholes value of the remaining unexercised portion of the warrant. Further, the March 2012 warrants include price protection in the event we sell stock below the exercise price, as defined. The warrants have been classified as liabilities, as opposed to equity, due to the potential adjustment to the exercise price that could result upon late delivery of the shares or potential cash settlement upon the occurrence of certain events as described above, and are recorded at their fair values at each balance sheet date.

Income Taxes	3 Months Ended
Income Taxes	Mar. 31, 2016
Income Tax Disclosure [Abstract]
Income Taxes	9. Income Taxes We have U.S. federal net operating loss and research and development tax credit carryforwards, as well as state and city net operating loss carryforwards, which may be used to reduce future taxable income and tax liabilities. We also have foreign net operating loss and tax credit carryforwards, and the foreign net operating losses do not expire. Substantially all of our deferred tax assets have been fully offset by a valuation allowance due to our cumulative losses. As a result of our October 2012 equity offering, the utilization of our net operating loss and tax credit carryforwards generated prior to October 2012 is substantially limited under Section 382 of the Internal Revenue Code. U.S. federal net operating loss carryforwards, research and development tax credits, and state and local net operating loss carryforwards generated after October 2012, as well as foreign net operating loss carryforwards and foreign tax credits, are not subject to annual limitations. We recognize refundable tax benefits related to research and development credits associated with our foreign subsidiary.

Recently Issued Accounting Standards (Policies)	3 Months Ended
Recently Issued Accounting Standards (Policies)	Mar. 31, 2016
Accounting Changes and Error Corrections [Abstract]
Recently Issued Accounting Standards	Recently Issued Accounting Standards In November 2015, the Financial Accounting Standards Board (“FASB”) issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which amends the existing guidance to require that deferred income tax liabilities and assets be classified as noncurrent in a classified balance sheet and eliminates the prior guidance, which required an entity to separate deferred tax liabilities and assets into a current amount and a noncurrent amount in a classified balance sheet. The amendments in this ASU are effective for financial statements for annual periods and interim periods within those annual periods beginning after December 15, 2016, with early adoption permitted, and the new guidance can be applied either prospectively to all deferred tax liabilities and assets or retrospectively to all periods presented. We have adopted this ASU in the first quarter of 2016 on a prospective basis and, therefore, the adoption did not impact prior period financial statements. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 requires an entity to recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, the amendment provides five steps that an entity should apply when recognizing revenue. The amendment also specifies the accounting of some costs to obtain or fulfill a contract with a customer and expands the disclosure requirements around contracts with customers. An entity can either adopt this amendment retrospectively to each prior reporting period presented or retrospectively with the cumulative effect of initially applying the update recognized at the date of initial application. In August 2015, the FASB issued ASU 2015-14, which delays the effective date by one year, making the new standard effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is permitted for annual reporting periods beginning after December 15, 2016. We are in the process of evaluating, but have not determined, the impact that the adoption of ASU 2014-09 will have on our consolidated financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and, if so, to provide related footnote disclosures. ASU 2014-15 provides a definition of the term “substantial doubt” and requires an assessment for a period of one year after the date that the financial statements are issued or available to be issued. Management will also be required to evaluate and disclose whether it has plans to alleviate that doubt. The guidance is effective for the annual periods ending after December 15, 2016 and interim periods thereafter with early adoption permitted. We will adopt ASU 2014-15 as required and are evaluating the impact the new guidance will have on our year-end disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which requires lessees to put most leases on their balance sheets, but recognize expenses on their income statements in a manner similar to current accounting practice. Under the guidance, lessees initially recognize a lease liability for the obligation to make lease payments and a right-of-use (“ROU”) asset for the right to use the underlying asset for the lease term. The lease liability is measured at the present value of the lease payments over the lease term. The ROU asset is measured at the lease liability amount, adjusted for lease prepayments, lease incentives received and the lessee’s initial direct costs. The guidance is effective for the annual periods beginning after December 15, 2018 and interim periods thereafter, with early adoption permitted. We are in the process of evaluating the impact the new guidance will have on our financial statements. In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting, which involves several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. Under the new standard, income tax benefits and deficiencies are to be recognized as income tax expense or benefit in the income statement and the tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity should also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits should be classified along with other income tax cash flows as an operating activity. In regards to forfeitures, the entity may make an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures when they occur. This ASU is effective for fiscal years beginning after December 15, 2016 including interim periods within that reporting period, with early adoption permitted, provided that all amendments are adopted in the same period. We are currently evaluating the impact the adoption of ASU 2016-09 will have on its financial statements.

Net Income (Loss) per Share (Tables)

3 Months Ended

Mar. 31, 2016

Earnings Per Share [Abstract]

Net Income (Loss) and Number of Shares Used to Calculate Basic and Diluted Net Income (Loss) Per Share

The table below reconciles the net income (loss) and the number of shares used to calculate basic and diluted net income (loss) per share for the three-month periods ended March 31, 2016 and 2015, in thousands, except share and per share data.


	Three months ended March 31,
	2016		2015
Numerator:
Net income (loss) attributable to common stockholders - Basic and Diluted	$	4,750	$	(12,482	)

Denominator:
Weighted-average shares outstanding - Basic		83,781,114		79,180,697
Potentially dilutive common shares outstanding:
Stock-based awards		84,493		—

Weighted-average shares used to calculate diluted net income (loss) per share		83,865,607		79,180,697

Basic and Diluted earnings (loss) per share	$	0.06	$	(0.16	)

Instruments Excluded from Calculation of Diluted Net Income (Loss) Per Share

The following instruments were excluded from the calculation of diluted net income (loss) per share because their effects would be antidilutive:


	Three months ended March 31,
	2016		2015
Stock-based awards		7,593,940		8,014,773
Warrants		3,554,893		8,364,893

Total		11,148,833		16,379,666

Financial Instruments (Tables)

3 Months Ended

Mar. 31, 2016

Investments, All Other Investments [Abstract]

Summary of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis

The following table provides a summary of the financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2016 (in thousands):


			Fair Value Measurements at March 31, 2016 Using
Description	Balance as of March 31, 2016		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Warrant liabilities	$	2,830	$	—	$	—	$	2,830

Fair Value of Warrants Based on Historical Volatilities

The following inputs were used at March 31, 2016:


	Expected Volatility	Risk-Free Interest Rate	Expected Life
Warrants with one year or less remaining term	78.58% – 95.67%	0.21% – 0.59%	0.29 – 0.95 year

Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrants

A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrants is as follows (in thousands):


	Three months ended
	March 31, 2016
Balance January 1, 2016	$	649
Loss included in expense from change in fair value of warrants		2,181

Balance March 31, 2016	$	2,830

Issuance of Common Stock and Warrants (Tables)

3 Months Ended

Mar. 31, 2016

Equity [Abstract]

Outstanding Warrants to Purchase Shares of Common Stock

As of March 31, 2016, we had the following outstanding warrants to purchase shares of common stock:


Number of Underlying Shares		Exercise Price		Expiration
	2,054,893	$	1.01	March 14, 2017
	1,500,000	$	4.50	July 15, 2016

	3,554,893

Background and Basis of Presentation - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2016 Segment
Accounting Policies [Abstract]
Number of business segments	1

Net Income (Loss) per Share - Net Income (Loss) and Number of Shares Used to Calculate Basic and Diluted Net Income (Loss) Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Numerator:
Net income (loss) attributable to common stockholders - Basic and Diluted	$ 4,750	$ (12,482)
Denominator:
Weighted-average shares outstanding - Basic	83,781,114	79,180,697
Potentially dilutive common shares outstanding:
Stock-based awards	84,493
Weighted-average shares used to calculate diluted net income (loss) per share	83,865,607	79,180,697
Basic and Diluted earnings (loss) per share	$ 0.06	$ (0.16)

Net Income (Loss) per Share - Instruments Excluded from Calculation of Diluted Net Income (Loss) Per Share (Detail) - shares	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	11,148,833	16,379,666
Stock-Based Awards [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	7,593,940	8,014,773
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total	3,554,893	8,364,893

Financial Instruments - Summary of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrant liabilities	$ 2,830	$ 649
Fair Value Measurements, Recurring Basis [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrant liabilities	2,830
Fair Value Measurements, Recurring Basis [Member] \| Significant Unobservable Inputs (Level 3) [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Warrant liabilities	$ 2,830

Financial Instruments - Fair Value of Warrants Based on Historical Volatilities (Detail) - Warrants With One Year or Less Remaining Term [Member]	3 Months Ended
	Mar. 31, 2016
Minimum [Member]
Class of Warrant or Right [Line Items]
Expected Volatility	78.58%
Risk-Free Interest Rate	0.21%
Expected Life	3 months 15 days
Maximum [Member]
Class of Warrant or Right [Line Items]
Expected Volatility	95.67%
Risk-Free Interest Rate	0.59%
Expected Life	11 months 12 days

Financial Instruments - Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrants (Detail) - Outstanding Warrants [Member] $ in Thousands	3 Months Ended
	Mar. 31, 2016 USD ($)
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items]
Beginning Balance	$ 649
Loss included in expense from change in fair value of warrants	2,181
Ending Balance	$ 2,830

Financial Instruments - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2016	Jan. 31, 2016	Dec. 31, 2012
Fair Value Disclosures [Abstract]
Forgivable loan			$ 166,000
Interest on forgivable loan			4.25%
Non current note payable		$ 190,000
Forgivable loan, expiration date	Mar. 31, 2016

Collaborations and Revenue Recognition - Additional Information (Detail) - USD ($)	1 Months Ended		3 Months Ended
	Jan. 31, 2016	Sep. 30, 2015	Mar. 31, 2016	Oct. 31, 2015	Feb. 28, 2015
RTI Surgical Inc [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Commercial milestone revenue			$ 0
Healios License Agreement [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Up-front cash payment received			15,000,000
Potential near-term payment received			$ 10,000,000
Collaborative expansion period			2 years
License revenue	$ 15,000,000
Healios License Agreement [Member] \| Regulatory and Sales Milestones [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Commercial milestone revenue			$ 225,000,000
Chugai Collaboration [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Up-front cash payment received		$ 10,000,000		$ 10,000,000	$ 10,000,000
National Tax Agency, Japan [Member] \| Chugai Collaboration [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cash withheld by tax authorities refunded		$ 2,000,000

Stock-Based Compensation - Additional Information (Detail) $ in Thousands	3 Months Ended
	Mar. 31, 2016 USD ($) Plans shares	Mar. 31, 2015 USD ($)
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Number of incentive plans \| Plans	2
Common stock authorized for equity incentive plans	11,500,000
Common stock shares issued	2,983,302
Shares available for issuance	339,111
Shares of common stock outstanding	8,177,587
Stock-based compensation expense \| $	$ 707	$ 751
Total unrecognized estimated compensation cost \| $	$ 3,500

Issuance of Common Stock and Warrants - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended		3 Months Ended
	Oct. 31, 2013	Nov. 30, 2011	Mar. 31, 2016	Dec. 31, 2015
Class of Warrant or Right [Line Items]
Warrants exercised			0
Aspire [Member]
Class of Warrant or Right [Line Items]
Equity purchase agreement, value	$ 25.0	$ 20.0	$ 30.0
Equity purchase agreement, term	2 years	2 years	3 years
Common stock issued as commitment fees				250,000
Common stock registered for resale			16,600,000
Aspire [Member] \| Common Stock [Member]
Class of Warrant or Right [Line Items]
Issuance of common stock, new issues			200,000
Sale of additional shares at an average price			$ 2.14
Issuance of common stock, new issues			$ 0.4

Issuance of Common Stock and Warrants - Outstanding Warrants to Purchase Shares of Common Stock (Detail)	3 Months Ended
	Mar. 31, 2016 $ / shares shares
Class of Warrant or Right [Line Items]
Number of Underlying Shares	3,554,893
March 14, 2017 [Member]
Class of Warrant or Right [Line Items]
Number of Underlying Shares	2,054,893
Exercise Price \| $ / shares	$ 1.01
Expiration	Mar. 14, 2017
July 15, 2016 [Member]
Class of Warrant or Right [Line Items]
Number of Underlying Shares	1,500,000
Exercise Price \| $ / shares	$ 4.50
Expiration	Jul. 15, 2016

Warrant Liabilities - Additional Information (Detail)	3 Months Ended
Warrant Liabilities - Additional Information (Detail)	Mar. 31, 2016 USD ($)
Equity [Abstract]
Terms of issuance of warrant demanding cash payments	The warrants we issued in the January 2014 registered direct offering contain a provision for a cash payment in the event that the shares are not delivered to the holder within two trading days. The cash payment equals $10 per day per $2,000 of warrant shares for each day late.
Number of trading days to deliver shares under warrants provision	2 days
Value of warrants considered for cash payment for late delivery of shares	$ 2,000
Cash payment per day for warrants shares not delivered as per provision	$ 10

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