As filed with the Securities and Exchange Commission on June 29, 2018August 9, 2021

Registration Statement No. 333-           

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-3

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

 

BRAINSTORM CELL

THERAPEUTICS INC.


(Exact name of registrant as specified in its charter)

Delaware20-7273918
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification Number)

1325 Avenue of Americas, 28th Floor
New York, NY 10019
(201) 488-0460

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Chaim Lebovits
Chief Executive Officer
c/o Brainstorm Cell Therapeutics Inc.
1325 Avenue of Americas, 28th Floor
New York, NY 10019
(201) 488-0460
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

 

 

 

Delaware
(State or other jurisdiction of incorporation or organization)Copy to:

 

20-7273918Christopher J. Denn, Esq.
(I.R.S. Employer Identification No.)Jesse Nevarez, Esq.
Goodwin Procter LLP
100 Northern Avenue
Boston, Massachusetts 02210
(617) 570-1000

1745 Broadway, 17th Floor
New York, NY 10019
(201) 488-0460

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

 

 

 

Chaim Lebovits

President and Chief Executive Officer

c/o Brainstorm Cell Therapeutics Inc.

1745 Broadway, 17th Floor

New York, NY 10019

(201) 488-0460

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

Copies to:

Thomas B. Rosedale, Esq.

BRL Law Group LLC

425 Boylston Street, 3rd Floor

Boston, MA 02116

(617) 399-6931 (telephone number)

(617) 399-6930 (facsimile number)

As soon as practicableFrom time to time after the effective date of this registration statement.

(Approximatestatement becomes effective. (Approximate date of commencement of proposed sale to public)the public)

 

If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.¨

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 other than securities offered only in connection with dividend or interest reinvestment plans, check the following box.x

 

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

 

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

 

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.¨

 

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.¨

 

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

 

Large accelerated filer¨Accelerated filer¨
Non-accelerated filer¨  (Do not check if a smaller reporting company)xSmaller reporting companyx
  Emerging growth company¨

 

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

 

CALCULATION OF REGISTRATION FEE

 

Title of Each Class of
Securities to be Registered
 Amount
to be
Registered
  Proposed
Maximum
Offering Price
Per Share
  Proposed
Maximum
Aggregate
Offering Price
  Amount of
Registration Fee
 
Common Stock, $.00005 par value per Share (1)  2,458,201  $3.94(2) $9,685,311.94  $1,205.82 
Title of each class of securities to
be registered
 Amount to be
Registered(1)
  Proposed
Maximum
Offering Price
Per Unit(2)
  Proposed Maximum
Aggregate
Offering Price(3)
  Amount of
Registration Fee
 
Common Stock, par value $0.00005 per share                
Debt Securities                
Warrants                
Units(4)                
Common Stock, par value $0.00005 per share                
Total $200,000,000   N/A  $200,000,000  $21,820(5)

 

(1)PursuantThe amount to Rule 416be registered consists of up to $200,000,000 of an indeterminate amount of the securities of each identified class as may from time to time be offered hereunder at indeterminate prices, along with an indeterminate number of securities that may be issued upon exercise, settlement, exchange or conversion of securities offered or sold hereunder. Separate consideration may or may not be received for securities that are issuable upon conversion, exercise or exchange of other securities. Any securities registered hereunder may be sold separately or as units with the other securities registered hereunder.

(2)The proposed maximum aggregate offering price per unit will be determined from time to time by the Registrant in connection with the sale and issuance by the Registrant of the securities registered hereunder and is not specified as to each class of security pursuant to General Instruction II.D. of Form S-3 under the Securities Act, this registration statement also covers such indeterminate number of additional shares of Common Stock as may be issuable with respect to the shares being registered hereunder as a result of any stock splits, stock dividends or similar transactions.Act.

(2)(3)Estimated solely for the purpose of calculating the registration fee and based on the average of the high and low prices of the Common Stock on the Nasdaq Capital Market on June 28, 2018 in accordance withpursuant to Rule 457(c)457(o) under the Securities ActAct. No separate consideration will be received for (i) common stock or other securities of 1933.the registrant that may be issued upon conversion of, or in exchange for, convertible or exchangeable debt securities registered hereby or (ii) common stock, debt securities or units that may be issued upon exercise of warrants registered hereby, as the case may be.

(4)Each unit will be issued under a unit agreement and will represent an interest in two or more securities, which may or may not be separable from one another.

(5)Calculated pursuant to Rule 457(o) under the Securities Act.

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with SectionTHE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) of the Securities Act ofOF THE SECURITIES ACT OF 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to said SectionAS AMENDED, OR UNTIL THIS REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION ACTING PURSUANT TO SAID SECTION 8(a), may determine.MAY DETERMINE.

 

 

 

 

 

 

Subject to Completion, Dated June 29, 2018EXPLANATORY NOTE

 

This registration statement contains:

a base prospectus which covers the offering, issuance and sale by us of the securities identified above from time to time in one or more offerings with a total value of up to $200,000,000; and

a distribution agreement prospectus covering the offering, issuance and sale by us of up to a maximum aggregate offering price of $100,000,000 of our common stock that may be issued and sold from time to time under the Amended and Restated Distribution Agreement, or the Distribution Agreement, entered into with SVB Leerink LLC and Raymond James & Associates, Inc.

The base prospectus immediately follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The specific terms of the securities to be issued and sold under the Distribution Agreement are specified in the distribution agreement prospectus that immediately follows the base prospectus. The $100,000,000 of common stock that may be offered, issued and sold under the distribution agreement prospectus is included in the $200,000,000 of securities that may be offered, issued and sold by us under the base prospectus. Upon termination of the Distribution Agreement with SVB Leerink LLC and Raymond James & Associates, Inc., any portion of the $100,000,000 included in the distribution agreement prospectus that is not sold pursuant to the Distribution Agreement will be available for sale in other offerings pursuant to the base prospectus and a corresponding prospectus supplement, and if no shares are sold under the Distribution Agreement, the full $200,000,000 of securities may be sold in other offerings by us pursuant to the base prospectus and a corresponding prospectus supplement.

The information in this prospectus is not complete and may be changed. These securitiesWe may not be soldsell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it iswe are not soliciting an offeroffers to buy these securities in any statejurisdiction where the offer or sale is not permitted.

Subject to completion, dated August 9, 2021

 

PROSPECTUS

 

BRAINSTORM CELL THERAPEUTICS INC.

2,458,201 Shares of

$200,000,000

Common Stock

This prospectus relates to the resale by certain of our stockholders and warrantholders, which we refer to as “Selling Securityholders” of up to 2,458,201 shares of common stock that are issuable on exercise of the warrants that were acquired pursuant to a warrant exercise agreement (the “New Warrants”).Debt
Securities

Warrants
Units

 

We will not receive any proceedsmay offer and sell from time to time up to $200,000,000 in aggregate principal amount of our common stock, debt securities, warrants and/or units in one or more offerings. This prospectus describes the salegeneral terms of these securities although weand the general manner in which these securities will receivebe offered. We will provide the exercise price for any warrants that are exercised. We are registeringspecific terms of these securities for resale byin one or more supplements to this prospectus. The prospectus supplements will also describe the Selling Securityholders, but that does not necessarily mean that they will sell any of the securities. Anyspecific manner in which these securities sold by the Selling Securityholders will be offered at marketand may also supplement, update or privately negotiated prices.amend information contained in this document. You should read this prospectus and any applicable prospectus supplement or amendment carefully before you invest in our securities.

 

We may offer these securities in amounts, at prices and on terms determined at the time of offering. The exercise price ofsecurities may be sold directly to you, through agents, or through underwriters and dealers. If agents, underwriters or dealers are used to sell the New Warrants is $9.00 per share. The New Warrants are currently exercisablesecurities, we will name them and expire on December 31, 2020. Holders of the warrants may currently purchase one share of common stock for each warrant exercised. The exercise price and number of shares of common stock issuable upon exercise of the warrants is subject to further adjustmentdescribe their compensation in certain circumstances.a prospectus supplement.

 

Our common stock is tradedlisted on theThe Nasdaq Capital Market under the symbol “BCLI”.“BCLI.” On June 28, 2018,August 6, 2021, the last reported salesclosing price for our common stock, as reported on The Nasdaq Capital Market was $3.96 per share.

 

Investing in our common stocksecurities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginningsignificant risks. See “Risk Factors on page 63 of this prospectus (and any accompanying prospectus supplement) and under similar headings in any amendments or supplementsthe documents incorporated by reference in this prospectus for a discussion of the factors you should carefully consider before deciding to this prospectus.purchase these securities.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

 

The date of this prospectus is               _______________, 2018., 2021

 

 

 

 

TABLE OF CONTENTS

Table of Contents
 
 Page
ABOUT THIS PROSPECTUS SUMMARY1
ABOUT THE COMPANY42
RISK FACTORS6
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS73
USE OF PROCEEDS74
SELLING SECURITYHOLDERSDILUTION5
DESCRIPTION OF CAPITAL STOCK76
DESCRIPTION OF DEBT SECURITIES8
DESCRIPTION OF WARRANTS14
DESCRIPTION OF UNITS15
PLAN OF DISTRIBUTION816
LEGAL MATTERS1017
EXPERTS1018
WHERE YOU CAN FIND MORE INFORMATION1019
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE20
SIGNATURES10II-6
SIGNATURES AND POWER OF ATTORNEYII-7

 

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ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, using a “shelf” registration process. Under this shelf registration process, we may from time to time sell any combination of the securities described in this prospectus in one or more offerings for an aggregate of up to $200,000,000.

This prospectus provides you with a general description of the securities we may offer. Each time we offer securities under this prospectus, we will provide one or more prospectus supplements that will contain specific information about the terms of the offering. We may also authorize one or more free writing prospectuses to be provided to you that may contain material information relating to these offerings. Each prospectus supplement and any related free writing prospectus may also add, update or change information contained in this prospectus or the documents incorporated by reference into this prospectus. You should read both this prospectus and the accompanying prospectus supplement and any related free writing prospectus together with the additional information described under the heading “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” before you invest in our securities.

 

You should rely only on the information contained in or incorporated by reference in this documentprospectus, any accompanying prospectus supplement or to which we have referred you.in any related free writing prospectus filed by us with the SEC. We have not authorized anyone to provide you with information that is different.different or additional information. This document may only be used where it is legalprospectus and any accompanying prospectus supplement do not constitute an offer to sell these securities. Theor the solicitation of an offer to buy any securities other than the securities described in any accompanying prospectus supplement or an offer to sell or the solicitation of an offer to buy such securities in any circumstances in which such offer or solicitation is unlawful. You should assume that the information containedappearing in this documentprospectus, any prospectus supplement, the documents incorporated by reference and any related free writing prospectus is accurate only as of their respective dates. Our business, financial condition, results of operations and prospects may only be accurate on the date of this document.have changed materially since those dates.

 

As used herein,Unless the context suggests otherwise, all references in this prospectus to “us,” “our,” “Brainstorm,” “we,” “us,” “our” or the “Company” refersand similar designations refer to Brainstorm Cell Therapeutics Inc. and, allwhere appropriate, our subsidiaries. We use various trademarks and trade names in our business, including without limitation our corporate name and logo. All other trademarks or trade names referred to in this prospectus are the property of its consolidated subsidiaries.their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

 

PROSPECTUS SUMMARYSPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This summary highlights important features of this offeringprospectus and the information included or incorporated by reference in this prospectus. This summary does notprospectus include, and any prospectus supplement or free writing prospectus may contain, all“forward-looking statements” within the meaning of the information that you should consider before investing in our common stock. You should read the entire prospectus carefully, especially the risksSection 27A of investing in our common stock discussed under “Risk Factors.”

Company Overview

Brainstorm Cell Therapeutics Inc. is a biotechnology company committed to bring innovative Central Nervous System (“CNS”) adult stem cell therapies to the market to improve the lives of patients with debilitating neurodegenerative diseases. As a leader in CNS regenerative cellular medicines, Brainstorm is leveraging NurOwn®, its proprietary autologous mesenchymal stem cell platform technology, a strong and expanded IP portfolio, as well as manufacturing and commercialization capabilities, to address growing unmet medical needs across a broad range of neurodegenerative disorders, such as Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou Gehrig’s disease), Multiple Sclerosis (“MS”), Parkinson’s disease (“PD”) and Autism Spectrum Disorders (“ASD”).  The NurOwn® proprietary technology is fully licensed to and developed by Brainstorm Cell Therapeutics Ltd., our wholly-owned subsidiary (the “Israeli Subsidiary”).

NurOwn® technology is based on an innovative manufacturing protocol, which induces the differentiation of bone marrow-derived mesenchymal stem cells (“MSC”) into cells capable of releasing high levels of multiple neurotrophic factors (“MSC-NTF” cells) for neuroprotection while maintaining the immunodulatory effects of MSC cells. These factors are known to be critical for the growth, survival and differentiation of neurons, they include: glial-derived neurotrophic factor (“GDNF”); brain-derived neurotrophic factor (“BDNF”); vascular endothelial growth factor (“VEGF”); and hepatocyte growth factor (“HGF”).  GDNF is one of the most potent survival factors known for peripheral neurons. VEGF and HGF have been demonstrated to have important neuro-protective effects in ALS and in other neurodegenerative diseases.  

Our approach to the treatment of neurodegenerative diseases with autologous adult stem cells includes a multi-step process that includes: harvesting of undifferentiated stem cells from the patient’s own bone marrow; processing of cells at the manufacturing site and cryopreservation to enable multiple treatments from a single bone marrow sample; and intrathecal (“IT”) injection of MSC-NTF cells into the same patient by standard lumbar puncture. This procedure does not require hospitalization and has been shown to be safe and well tolerated in multiple CNS clinical trials to date.  The ongoing US Phase 3 ALS study is evaluating the therapeutic potential of repeated dosing (every 2 months).  The proprietary technology and manufacturing processing of NurOwn® (MSC-NTF cells) for clinical use is conducted in full compliance with current Good Manufacturing Practice (“cGMP”).

The NurOwn® Transplantation Process includes: 

·Bone marrow aspiration from patient;
·Isolation and propagation of the mesenchymal stem cells (MSC);
·Cryopreservation of MSC;
·Thawing and differentiation of the MSC into neurotrophic-factor secreting (MSC-NTF; NurOwn®) cells; and
·Autologous transplantation into the patient’s cerebrospinal fluid by IT injection (lumbar puncture).

The ability to induce differentiation of autologous adult mesenchymal stem cells into MSC-NTF cells before transplantation is unique to NurOwn®, making it the first-of-its-kind for the treatment of neurodegenerative diseases.

The specialized MSC-NTF cells secrete multiple neurotrophic factors that may lead to:

·Protection of existing motor neurons;
·Promotion of motor neuron repair; and
·Re-establishment of functional nerve-muscle interaction.

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The NurOwn® approach is autologous, using the patient’s own bone-marrow derived stem cells for “self-transplantation”. In autologous transplantation, there is no risk of rejection or introduction of donor antigens and no need for treatment with immunosuppressive agents, which can cause severe and/or long-term side effects. In addition, the use of adult stem cells is free of ethical controversies associated with the use of embryonic-derived stem cells in some countries.

NurOwn® is currently in a Phase 3 late stage clinical development program for the treatment of ALS. It has been granted Fast Track designation by the U.S. Food and Drug Administration (“FDA”) for this indication, and has been granted Orphan Status, which provides the potential for an extended period of exclusivity, in both the United States and in Europe. We have completed two early stage clinical trials of NurOwn® in patients with ALS at the Hadassah Medical Center (“Hadassah”) in Jerusalem as well as a Phase 2 double-blind, placebo-controlled, clinical study at three prestigious US medical centers, all highly experienced in the management and investigation of ALS.

We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 1745 Broadway, 17th Floor, New York, NY 10019, and our telephone number is (201) 488-0460. We maintain a website at http://www.brainstorm-cell.com. The information on our website is not incorporated by reference into this prospectus and should not be considered to be part of this prospectus.

The Transactions

Warrant Exercise Agreement

On June 6, 2018, we entered into a Warrant Exercise Agreement (the “Warrant Exercise Agreement”) with certain holders (the “Selling Securityholders”) of warrants (the “2015 Warrants”) to purchase Company common stock, $0.00005 par value per share (“Common Stock”), which 2015 Warrants were originally issued in the Company’s January 8, 2015 private placement. Pursuant to the Warrant Exercise Agreement, the Selling Securityholders exercised their 2015 Warrants for a total of 2,458,201 shares of Common Stock (the “Exercised Shares”) at an amended exercise price of $5.00 per share. The warrant exercises generated gross cash proceeds to the Company of $12,291,005.00. For each 2015 Warrant exercised, the Company issued 1 new warrant to the Selling Securityholders to purchase an equal number of unregistered shares of Common Stock, at an exercise price of $9.00, with an expiration date of December 31, 2020 (the “New Warrants”). Certain Holders of New Warrants also entered into a Share Cap Agreement with the Company, whereby the Holders agreed to a 6-month delay (from the date of issuance) in exercisability of any shares at or in excess of the 20% limitation on the size of the entire transaction contained in Nasdaq Listing Rule 5635(d).

The Warrant Exercise Agreement also requires that to the extent that a Holder’s exercise of 2015 Warrants would result in such Holder exceeding the Beneficial Ownership Limitation (as defined in the 2015 Warrants), such excess warrant shares shall be held in abeyance for the benefit of such Warrant Holder until such time as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation.

The Selling Securityholders agreed that, subject to limited exceptions, for the 90 days following the date of the Warrant Exercise Agreement (the “Restricted Period”), neither the Company nor any Subsidiary will issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock, without the prior written consent of all of the Selling Securityholders of the warrant shares. The Company also agreed that during the time the New Warrants are unexercised, the Company will not enter into any agreements with any holder of 2015 Warrants with more favorable terms, without the consent of the Selling Securityholders of a majority of the warrant shares then exercisable under all outstanding Warrant Exercise Agreements.

The Company also agreed to file this registration statement covering the resale of the additional shares of Common Stock underlying the New Warrants. The New Warrants have not been registered under the Securities Act of 1933, as amended, (the Securities Act), or state securities laws. The Exercised Shares have been registered for resale on the Company’s registration statement on Form S-3 (File No. 333-201704). The issuance of the Exercised Shares and New Warrants was exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act, and Rule 506 of Regulation D promulgated under the Securities Act. 

Under the Warrant Exercise Agreement, the Company agreed that we would file a resale registration statement for the Common Stock underlying the New Warrants within 30 days following the signingSection 21E of the Warrant Exercise Agreement. We agreed to have the registration statement declared effective within 120 days following the signing of the agreement and to use commercially reasonable efforts to keep the registration statement effective until all securities covered by the registration statement have been sold or may be sold without restriction under Rule 144 under the SecuritiesExchange Act. If the Company does not comply with the registration rights provisions in the Warrant Exercise Agreement, the Selling Securityholders will have the option of cashless exercise of the New Warrants as their sole remedy.

The Company and the Selling Securityholders also entered into Leak-Out Agreements (the “Leak-Out Agreement”) pursuant to which neither Selling Securityholders nor certain of their affiliates would collectively sell, dispose of or otherwise transfer, directly or indirectly, on any day on which the Nasdaq Capital Market is open for trading during the Restricted Period (any such date, a “Date of Determination”), shares of the Company’s Common Stock in an amount more than an aggregate 30% of the trading volume of Common Stock as reported by Bloomberg, LP for the applicable Date of Determination.

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We are registering the shares of Common Stock underlying the New Warrants in order to fulfill our contractual obligations to the Selling Securityholders contained in the Warrant Exercise Agreement. Registration of the shares of Common Stock covered by this prospectus does not necessarily mean that all or any portion of such shares will be offered for sale by the Selling Securityholders.

Offering by Selling Securityholders

We are registering the following securities issued in connection with the transactions as described above under “The Transactions”:

·For resale by the Selling Securityholders, 2,458,201 shares of Common Stock issuable upon exercise of the New Warrants that were acquired pursuant to the Warrant Exercise Agreement.

As of the date of this prospectus, each warrant is exercisable to purchase one share of Common Stock. The exercise price and number of shares of Common Stock issuable upon exercise of the warrants are subject to further adjustment in certain circumstances.

The exercise price of the New Warrants is $9.00 per share. The New Warrants are currently exercisable and expire on December 31, 2020. There is a possibility that the warrants will never be exercised when in-the-money or otherwise, and that warrant holders will never receive shares or payment of cash in settlement of the warrants. 

Common stock outstanding:20,669,528 shares as of June 6, 2018.
Use of proceeds:We will not receive any of the proceeds from the sale of the securities being registered on behalf of the Selling Securityholders hereunder. We will receive the exercise price upon the exercise of any Warrant. To the extent we receive cash upon any exercise of the Warrants, we expect to use that cash for general corporate and working capital purposes.  
Market Symbol:Our Common Stock is quoted on the Nasdaq Capital Market under the symbol “BCLI”.
Risk Factors:Investing in our securities involves substantial risks. You should carefully review and consider the “Risk Factors” section of this prospectus beginning on page 6 for a discussion of factors to consider before deciding to invest in our securities.

We will bear the expenses of registering these securities. The Selling Securityholders will pay the cost of any brokerage commissions and discounts, and all expenses incurred by them in connection with the resale of the securities. See “Plan of Distribution.”

We had 20,669,528 shares of Common Stock outstanding as of June 6, 2018, which includes 1,558,202 shares issued in connection with the exercises of 2015 Warrants and excludes:

·907,620 shares of Common Stock issuable upon exercise of outstanding stock options, at a weighted average exercise price of $2.5312 per share, under our equity incentive plans;
·957,709 additional shares of Common Stock reserved for future issuance under our equity incentive plans; and
·4,585,534 shares of Common Stock issuable upon exercise of outstanding warrants with exercise prices ranging from $1.005 per share to $9.00 per share.

Except as otherwise indicated herein, all informationAny forward-looking statements presented in this prospectus, assumes or gives effectwhich management may make orally or in writing from time to no exercise of the New Warrants.

RISK FACTORS

Investing in our securities involves significant risks. Please see the risk factors under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, as revised or supplemented by our Quarterly Reports on Form 10-Q filed with the SEC since the filing of our most recent Annual Report on Form 10-K, each of which are on file with the SEC and are incorporated by reference in this prospectus. Before making an investment decision, you should carefully consider these risks as well as other information we include or incorporate by reference in this prospectus and any prospectus supplement. The risks and uncertainties we have described are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business operations.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and each prospectus supplement includes and incorporates forward-looking statements within the meaning of the federal securities laws. These forward-looking statementstime, are based on management’s beliefs and assumptions. In addition, other written or oral statements that constitute forward-looking statements are based on current expectations, estimates and projections about the industry and markets in which we operate and statements may beassumptions made by, and information currently available to, management. All statements, other than statements of historical facts, contained or on our behalf. Wordsincorporated by reference in this prospectus are forward-looking statements. In some cases you can identify such as“forward-looking statements” by the use of words like “may,” “will,” “should,” “could,” “expects,” “hopes,” “anticipates,” “believes,” “intends,” “plans,” “projects,” “targets,” “goals,” “estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of any of these terms or similar words and expressions are intended to identify such forward-looking statements.words. These statements, are not guarantees of future performancedescriptions, forecasts and projections constitute “forward-looking statements,” and as such involve certainknown and unknown risks, uncertainties, and assumptions that are difficult to predict. There are a number of importantother factors that couldmay cause our actual results, levels of activity, performance and achievements to differbe materially different from those indicatedany results, levels of activity, performance and achievements expressed or implied by any such forward-looking“forward-looking statements. Forward-looking statements” These risks and uncertainties include, but are not limited to statements about potential future business operations and performance, including statements regarding the market potential for treatment of neurodegenerative disorders suchour need to raise additional capital, our ability to continue as ALS, the sufficiency of our existing capital resources for continuing operations in 2018, the safety and clinical effectivenessa going concern, regulatory approval of our NurOwn® technology,treatment candidate, the success of our product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of our NurOwn® and its related clinical development, andtreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, our ability to develop collaborationsmanufacture and partnershipscommercialize our NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, our ability to supportprotect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, disruptions in our business plan. Thesedue to the COVID-19 outbreak, including our clinical development activities.

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Any forward-looking statements contained or incorporated by reference in this prospectus reflect our current views with respect to future events as of the date of this prospectusor to our future financial performance and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any accompanying prospectus supplement and are based on assumptions and subject to risks and uncertainties.future results, performance or achievements expressed or implied by these forward-looking statements. See “Risk Factors” for more information. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this prospectus and any accompanying prospectus supplement and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this prospectus and any accompanying prospectus supplement. We anticipate that subsequent events and developments will cause our views to change. We have included important factors in the cautionary statements included or incorporated in this prospectus and any accompanying prospectus supplement, particularly under the heading “Risk Factors,” that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger,mergers, dispositions, joint ventures or investments we may undertake. We qualify all of ourmake or enter into. Except as required by law, we assume no obligation to update or revise these forward-looking statements by these cautionary statements.for any reason, whether as a result of new information, future events or otherwise.

 

USE OF PROCEEDSABOUT THE COMPANY

Our Business

Brainstorm Cell Therapeutics Inc. is a leading biotechnology company committed to the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases including: Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou Gehrig’s disease); Progressive Multiple Sclerosis (“PMS”); Alzheimer's disease (AD); and other neurodegenerative diseases. NurOwn®, our proprietary platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs), modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function.

NurOwn® has been evaluated in a Phase 3 ALS and a Phase 2 PMS clinical trial. We announced top-line data from our Phase 3 ALS trial on November 17, 2020. On March 24, 2021, we announced positive topline data from our Phase 2 trial evaluating three repeated administrations of NurOwn®, each given 2 months apart, as a treatment for PMS. On June 24, 2020, we announced a new clinical program focused on the development of NurOwn® as a treatment for AD. We are currently evaluating next steps based on emerging scientific insights and the rapidly changing regulatory landscape for AD following the recent FDA decision on Aducanumab.

Our wholly-owned Israeli subsidiary, Brainstorm Cell Therapeutics Ltd. (“Israeli Subsidiary”), holds exclusive rights to commercialize NurOwn® technology through a licensing agreement with Ramot (“Ramot”), the technology transfer company of Tel Aviv University, Israel. Our Israeli Subsidiary was granted approval by the Israeli Ministry of Health (“MoH”) to treat ALS patients with NurOwn® under the Hospital Exemption Pathway (“HE”).

NurOwn® has a strong and comprehensive intellectual property portfolio and was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug status by the FDA and the European Medicines Agency (EMA) for ALS.

Implications of Being a Smaller Reporting Company

 

We willare a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended. We may continue to be a smaller reporting company after this offering if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

Corporate Information

We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 1325 Avenue of Americas, 28th Floor, New York, NY 10019, and our telephone number is (201) 488-0460. We also maintain an office in Petach Tikva, Israel. We maintain a website at http://www.brainstorm-cell.comNo portion of our website is incorporated by reference into this prospectus and you should not receiveconsider any proceeds from the resaleinformation on, or that can be accessed through, our website as part of this prospectus. Our common stock trades on The Nasdaq Capital Market under the symbol “BCLI”.

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RISK FACTORS

Investing in our securities involves significant risks. You should carefully consider the risks and uncertainties described in this prospectus and any accompanying prospectus supplement or in any related free writing prospectus, and the risk factors set forth in our filings with the SEC that are incorporated by reference herein, including the selling stockholder subjectrisk factors in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and any of our subsequent filings with the SEC, before making an investment decision pursuant to this prospectus. The Selling Securityholders will receiveprospectus and any accompanying prospectus supplement relating to a specific offering.

Our business, financial condition and results of operations could be materially and adversely affected by any or all of these risks or by additional risks and uncertainties not presently known to us or that we currently deem immaterial that may adversely affect us in the future.

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USE OF PROCEEDS

We intend to use the net proceeds from the sale of any sharessecurities offered under this prospectus. The Selling Securityholders will pay any underwriting discounts and commissions and expenses incurred by the Selling Securityholders for brokerage, accounting, tax, legal services or any other expenses incurred by the Selling Securityholders in disposing of these shares. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares covered by this prospectus.

We may receive gross proceeds of up to $22,123,809 from the exercise of the warrants. We currently intend to use the estimated net proceeds from the sale of these securitiesprospectus for general corporate purposes whichunless the applicable prospectus supplement provides otherwise. General corporate purposes may include research and development costs, sales and marketing costs, clinical studies, manufacturing development, the following:

·the research, development and clinical trials for our treatments;

·pursuing growth initiatives;

·capital expenditures;

·working capital; and

·any other purpose that we may specify in any prospectus supplement.

acquisition or licensing of other businesses or technologies, repayment and refinancing of debt, working capital and capital expenditures. We may temporarily invest the net proceeds in a variety of capital preservation instruments, including short-term, investment grade, interest bearing instruments and U.S. government securities, until they are used for their stated purpose. We have not yet determined the amount of net proceeds to be used specifically for anysuch purposes. As a result, management will retain broad discretion over the allocation of net proceeds.

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DILUTION

If there is a material dilution of the foregoing purposes. Accordingly, our management will have significant discretion and flexibility in applying the net proceedspurchasers’ equity interest from the exercisesale of common equity securities offered under this prospectus, we will set forth in any prospectus supplement the following information regarding any such material dilution of the warrants. Pending any use,equity interests of purchasers purchasing securities in an offering under this prospectus:

·the net tangible book value per share of our equity securities before and after the offering;

·the amount of the increase in such net tangible book value per share attributable to the cash payments made by the purchasers in the offering; and

·the amount of the immediate dilution from the public offering price which will be absorbed by such purchasers.

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DESCRIPTION OF CAPITAL STOCK

The following description of our capital stock is intended as described above, we intenda summary only. This description is based upon, and is qualified by reference to, invest the net proceeds in high-quality, short-term, interest-bearing securities. Our plans to use the estimated net proceeds from the exerciseour amended and restated certificate of incorporation, or certificate of incorporation, our amended and restated bylaws, or bylaws, and applicable provisions of the warrantsDelaware General Corporation Law. This summary is not intended to be a complete description of our capital stock. You should read our certificate of incorporation and bylaws for the provisions that are important to you.

General

Our authorized capital stock consists of 100,000,000 shares of common stock, par value $0.00005 per share.

As of the date of this prospectus, 36,318,561 shares of our common stock were outstanding and held by 32 stockholders of record.

Common Stock

The holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The holders of our common stock do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds legally available for that purpose. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.

In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities. All outstanding shares of common stock are fully paid and nonassessable.

Exchange Listing

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

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is American Stock Transfer & Trust Co LLC. The transfer agent and registrar’s address is 6201 15th Avenue, Brooklyn, New York 11219, and its telephone number is (877) 248-6417.

Anti-Takeover Effects of our Certificate of Incorporation and Bylaws and Delaware Law

Our certificate of incorporation and bylaws include a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board of directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.

Board Composition and Filling Vacancies

Our bylaws provide that directors may be removed with or without cause at an annual meeting or at a special meeting called for that purpose, by a majority vote of the shares then entitled to vote at an election of directors. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative vote of a majority of our directors then in office even if less than a quorum. The limitations on removal of directors, together with the treatment of vacancies, has the effect of making it more difficult for stockholders to change the composition of our board of directors.

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Meetings of Stockholders

Our certificate of incorporation provide that the President, the Chairman of the Board, if any, or any two members of the board of directors, or by the Secretary or any other officer upon the written request of one or more stockholders holding of record at least a majority of the outstanding shares of stock of the corporation entitled to vote at such meeting may call special meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our bylaws limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.

Amendment to Certificate of Incorporation and Bylaws

Any amendment of our certificate of incorporation must first be approved by a majority of our board of directors and must thereafter be approved by the affirmative vote of the holders of a majority of the outstanding shares of our common stock. Our bylaws may be amended by the affirmative vote of a majority of the directors present at any regular or special meeting of the board of directors at which a quorum is present; and may also be amended by the affirmative vote of the holders of a majority of the shares of our capital stock issued and outstanding and entitled to vote at any regular meeting of stockholders, or at any special meeting of stockholders provided notice of such alteration, amendment, repeal or adoption of new by-laws shall have been stated in the notice of such special meeting.

Section 203 of the Delaware General Corporation Law

We are subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:

·before the stockholder became interested, our board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

·upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting

·stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances, but not the outstanding voting stock owned by the interested stockholder; or

·at or after the time the stockholder became interested, the business combination was approved by our board of directors and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a business combination to include:

·any merger or consolidation involving the corporation and the interested stockholder;

·any sale, transfer, lease, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;

·subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

·subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; and

·the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.

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DESCRIPTION OF DEBT SECURITIES

We may offer debt securities which may be senior or subordinated. We refer to senior debt securities and subordinated debt securities collectively as debt securities. Each series of debt securities may have different terms. The following description summarizes the general terms and provisions of the debt securities. We will describe the specific terms of the debt securities and the extent, if they do,any, to which the general provisions summarized below apply to any series of debt securities in the prospectus supplement relating to the series and any applicable free writing prospectus that we will update this informationauthorize to be delivered.

We may issue senior debt securities from time to time, in one or more series under a senior indenture to be entered into between us and a senior trustee to be named in a prospectus supplement, which we refer to as the senior trustee. We may issue subordinated debt securities from time to time, in one or more series, under a subordinated indenture to be entered into between us and a subordinated trustee to be named in a prospectus supplement, which we refer to as the subordinated trustee. The forms of senior indenture and subordinated indenture are filed as exhibits to the registration statement of which this prospectus forms a part. Together, the senior indenture and the subordinated indenture are referred to as the indentures and, together, the senior trustee and the subordinated trustee are referred to as the trustees. This prospectus briefly outlines some of the provisions of the indentures. The following summary of the material provisions of the indentures is qualified in its entirety by the provisions of the indentures, including definitions of certain terms used in the indentures. Wherever we refer to particular sections or defined terms of the indentures, those sections or defined terms are incorporated by reference in this prospectus or the applicable prospectus supplement. You should review the indentures that are filed as exhibits to the registration statement of which this prospectus forms a part for additional information. As used in this prospectus, the term “debt securities” includes the debt securities being offered by this prospectus and all other debt securities issued by us under the indentures.

 

SELLING SECURITYHOLDERSGeneral

 

Below is informationThe indentures:

·do not limit the amount of debt securities that we may issue;

·allow us to issue debt securities in one or more series;

·do not require us to issue all of the debt securities of a series at the same time; and

·allow us to reopen a series to issue additional debt securities without the consent of the holders of the debt securities of such series.

Unless otherwise provided in the applicable prospectus supplement, the senior debt securities will be unsubordinated obligations and will rank equally with all of our other unsecured and unsubordinated indebtedness. Payments on the subordinated debt securities will be subordinated to the prior payment in full of all of our senior indebtedness, as described under “Subordination” and in the applicable prospectus supplement.

Each indenture provides that we may, but need not, designate more than one trustee under an indenture. Any trustee under an indenture may resign or be removed and a successor trustee may be appointed to act with respect to the beneficial ownershipseries of ourdebt securities administered by the Selling Securityholdersresigning or removed trustee. If two or more persons are acting as trustee with respect to different series of June 6, 2018, based on information supplied to usdebt securities, each trustee shall be a trustee of a trust under the applicable indenture separate and apart from the trust administered by the Selling Securityholders. When we refer to the “Selling Securityholders”any other trustee. Except as otherwise indicated in this prospectus, we mean the holders listed belowany action described in this prospectus to be taken by each trustee may be taken by each trustee with respect to, and their pledgees, donees, transferees or other successors in interest. Except as described below, the Selling Securityholders do not have, or have had, any position, office or other material relationship with us or any of our affiliates beyond their investment in, or receipt of, our securities. Beneficial ownership has been determined in accordance with the rules of the SEC, and includes voting or investment poweronly with respect to, the securities. Our registrationone or more series of thesedebt securities does not necessarily mean thatfor which it is trustee under the Selling Securityholdersapplicable indenture.

The prospectus supplement for each offering will sell any or all ofprovide the securities covered by this prospectus.following terms, where applicable:

 

·the title of the debt securities and whether they are senior or subordinated;

·any limit upon the aggregate principal amount of the debt securities of that series;

·the date or dates on which the principal of the debt securities of the series is payable;

·the price at which the debt securities will be issued, expressed as a percentage of the principal and, if other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof or, if applicable, the portion of the principal amount of such debt securities that is convertible into another security of ours or the method by which any such portion shall be determined;

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·the rate or rates at which the debt securities of the series shall bear interest or the manner of calculation of such rate or rates, if any;

·the date or dates from which interest will accrue, the interest payment dates on which such interest will be payable or the manner of determination of such interest payment dates, the place(s) of payment, and the record date for the determination of holders to whom interest is payable on any such interest payment dates or the manner of determination of such record dates;

·the right, if any, to extend the interest payment periods and the duration of such extension;

·the period or periods within which, the price or prices at which and the terms and conditions upon which debt securities of the series may be redeemed, converted or exchanged, in whole or in part;

·our obligation, if any, to redeem or purchase debt securities of the series pursuant to any sinking fund, mandatory redemption, or analogous provisions (including payments made in cash in satisfaction of future sinking fund obligations) or at the option of a holder thereof and the period or periods within which, the price or prices at which, and the terms and conditions upon which, debt securities of the series shall be redeemed or purchased, in whole or in part, pursuant to such obligation;

·the form of the debt securities of the series including the form of the Certificate of Authentication for such series;

·if other than minimum denominations of one thousand U.S. dollars ($1,000) or any integral multiple of $1,000 thereof, the denominations in which the debt securities of the series shall be issuable;

·whether the debt securities of the series shall be issued in whole or in part in the form of a global debt security or global debt securities; the terms and conditions, if any, upon which such global debt security or global debt securities may be exchanged in whole or in part for other individual debt securities; and the depositary for such global debt security or global debt securities;

·whether the debt securities will be convertible into or exchangeable for common stock or other securities of ours or any other Person and, if so, the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, and the applicable conversion or exchange period;

·any additional or alternative events of default to those set forth in the indenture;

·any additional or alternative covenants to those set forth in the indenture;

·the currency or currencies including composite currencies, in which payment of the principal of (and premium, if any) and interest, if any, on such debt securities shall be payable (if other than the currency of the United States of America), which unless otherwise specified shall be the currency of the United States of America as at the time of payment is legal tender for payment of public or private debts;

·if the principal of (and premium, if any), or interest,, if any, on such debt securities is to be payable, at our election or at the election of any holder thereof, in a coin or currency other than that in which such debt securities are stated to be payable, then the period or periods within which, and the terms and conditions upon which, such election may be made;

·whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made;

·the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes;

·additional or alternative provisions, if any, related to defeasance and discharge of the offered debt securities than those set forth in the indenture;

·the applicability of any guarantees;

·any restrictions on transfer, sale or assignment of the debt securities of the series; and

·any other terms of the debt securities (which may supplement, modify or delete any provision of the indenture insofar as it applies to such series).

We may issue debt securities that provide for less than the entire principal amount thereof to be payable upon declaration of acceleration of the maturity of the debt securities. We refer to any such debt securities throughout this prospectus as “original issue discount securities.”

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We are registering 2,458,201 shares of Common Stock underlyingwill provide you with more information in the warrants, issuedapplicable prospectus supplement regarding any deletions, modifications, or additions to the Selling Securityholdersevents of default or covenants that are described below, including any addition of a covenant or other provision providing event risk or similar protection.

Payment

Unless otherwise provided in the applicable prospectus supplement, the principal of, and any premium or make-whole amount, and interest on, any series of the debt securities will be payable by mailing a check to the address of the person entitled to it as it appears in the applicable register for resale from timethe debt securities or by wire transfer of funds to time bythat person at an account maintained within the Selling Securityholders identified in this prospectus.United States.

All monies that we pay to a paying agent or a trustee for the payment of the principal of, and any premium, or interest on, any debt security will be repaid to us if unclaimed at the end of two years after the obligation underlying payment becomes due and payable. After funds have been returned to us, the holder of the debt security may look only to us for payment, without payment of interest for the period which we hold the funds.

Merger, Consolidation or Sale of Assets

 

The informationindentures provide that we may, without the consent of the holders of any outstanding debt securities, (i) consolidate with, (ii) sell, lease or convey all or substantially all of our assets to, or (iii) merge with or into, any other entity provided that:

·either we are the continuing entity, or the successor entity, if other than us, assumes the obligations (a) to pay the principal of, and any premium, and interest on, all of the debt securities and (b) to duly perform and observe all of the covenants and conditions contained in the applicable indenture; and in the event the debt securities are convertible into or exchangeable for common stock or other securities of ours, such successor entity will, by such supplemental indenture, make provision so that the holders of debt securities of that series shall thereafter be entitled to receive upon conversion or exchange of such debt securities the number of securities or property to which a holder of the number of common stock or other securities of ours deliverable upon conversion or exchange of those debt securities would have been entitled had such conversion or exchange occurred immediately prior to such consolidation, merger, sale, conveyance, transfer or other disposition; and

·an officers’ certificate and legal opinion covering such conditions are delivered to each applicable trustee.

Events of Default, Notice and Waiver

Unless the applicable prospectus supplement states otherwise, when we refer to “events of default” as defined in the indentures with respect to any series of debt securities, we mean:

·default in the payment of any installment of interest on any debt security of such series continuing for 90 days unless such date has been extended or deferred;

·default in the payment of principal of, or any premium on, any debt security of such series when due and payable unless such date has been extended or deferred;

·default in the performance or breach of any covenant or warranty in the debt securities or in the indenture by us continuing for 90 days after written notice described below;

·bankruptcy, insolvency or reorganization, or court appointment of a receiver, liquidator or trustee of us; and

·any other event of default provided with respect to a particular series of debt securities.

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If an event of default (other than an event of default described in the fourth bullet point above) occurs and is continuing with respect to debt securities of any series outstanding, then the applicable trustee or the holders of 25% or more in principal amount of the debt securities of that series will have the right to declare the principal amount of, and accrued interest on, all the debt securities of that series to be due and payable. If an event of default described in the fourth bullet point above occurs, the principal amount of, and accrued interest on, all the debt securities of that series will automatically become and will be immediately due and payable without any declaration or other act on the part of the trustee or the holders of the debt securities. However, at any time after such a declaration of acceleration has been made, but before a judgment or decree for payment of the money due has been obtained by the applicable trustee, the holders of at least a majority in principal amount of outstanding debt securities of such series or of all debt securities then outstanding under the applicable indenture may rescind and annul such declaration and its consequences if:

·we have deposited with the applicable trustee all required payments of the principal, any premium, interest and, to the extent permitted by law, interest on overdue installment of interest, plus applicable fees, expenses, disbursements and advances of the applicable trustee; and

·all events of default, other than the non-payment of accelerated principal, or a specified portion thereof, and any premium, have been cured or waived.

·The indentures provide that holders of debt securities of any series may not institute any proceedings, judicial or otherwise, with respect to such indenture or for any remedy under the indenture, unless the trustee fails to act for a period of 90 days after the trustee has received a written request to institute proceedings in respect of an event of default from the holders of 25% or more in principal amount of the outstanding debt securities of such series, as well as an offer of indemnity reasonably satisfactory to the trustee. However, this provision will not prevent any holder of debt securities from instituting suit for the enforcement of payment of the principal of, and any premium, and interest on, such debt securities at the respective due dates thereof.

·The indentures provide that, subject to provisions in each indenture relating to its duties in the case of a default, a trustee has no obligation to exercise any of its rights or powers at the request or direction of any holders of any series of debt securities then outstanding under the indenture, unless the holders have offered to the trustee reasonable security or indemnity. The holders of at least a majority in principal amount of the outstanding debt securities of any series or of all debt securities then outstanding under an indenture shall have the right to direct the time, method and place of conducting any proceeding for any remedy available to the applicable trustee, or of exercising any trust or power conferred upon such trustee. However, a trustee may refuse to follow any direction which:

·is in conflict with any law or the applicable indenture;

·may involve the trustee in personal liability; or

·may be unduly prejudicial to the holders of debt securities of the series not joining the proceeding.

Within 120 days after the close of each fiscal year, we will be required to deliver to each trustee a certificate, signed by one of our several specified officers, stating whether or not that officer has knowledge of any default under the applicable indenture. If the officer has knowledge of any default, the notice must specify the nature and status of the default.

Modification of the Indentures

Subject to certain exceptions, the indentures may be amended with the consent of the holders of a majority in aggregate principal amount of the outstanding debt securities of all series affected by such amendment (including consents obtained in connection with a tender offer or exchange for the debt securities of such series).We and the applicable trustee may make modifications and amendments of an indenture without the consent of any holder of debt securities for any of the following purposes:

·to cure any ambiguity, defect, or inconsistency in the applicable indenture or in the Securities of any series;

·to comply with the covenant described above under “Merger, Consolidation or Sale of Assets”;

·to provide for uncertificated debt securities in addition to or in place of certificated debt securities;

·to add events of default for the benefit of the holders of all or any series of debt securities;

·to add the covenants, restrictions, conditions or provisions relating to us for the benefit of the holders of all or any series of debt securities (and if such covenants, restrictions, conditions or provisions are to be for the benefit of less than all series of debt securities, stating that such covenants, restrictions, conditions or provisions are expressly being included solely for the benefit of such series), to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default, or to surrender any right or power in the applicable indenture conferred upon us;

·to add to, delete from, or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication, and delivery of debt securities, as set forth in the applicable indenture;

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·to make any change that does not adversely affect the rights of any holder of notes under the applicable indenture in any material respect;

·to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided in the applicable indenture, to establish the form of any certifications required to be furnished pursuant to the terms of the applicable indenture or any series of debt securities under the applicable indenture, or to add to the rights of the holders of any series of debt securities;

·to evidence and provide for the acceptance of appointment under the applicable indenture by a successor trustee or to appoint a separate trustee with respect to any series;

·to comply with any requirements of the SEC or any successor in connection with the qualification of the indenture under the Trust Indenture Act of 1939, as amended, or the Trust Indenture Act; or

·to conform the applicable indenture to this “Description of Debt Securities” or any other similarly titled section in any prospectus supplement or other offering document relating to a series of debt securities.

Subordination

Payment by us of the principal of, premium, if any, and interest on any series of subordinated debt securities issued under the subordinated indenture will be subordinated to the extent set forth in an indenture supplemental to the subordinated indenture relating to such series.

Discharge, Defeasance and Covenant Defeasance

Unless otherwise provided in the applicable prospectus supplement, the indentures allow us to discharge our obligations to holders of any series of debt securities issued under any indenture when:

·either (i) all securities of such series have already been delivered to the applicable trustee for cancellation; or (ii) all securities of such series have not already been delivered to the applicable trustee for cancellation but (a) have become due and payable, (b) will become due and payable within one year, or (c) if redeemable at our option, are to be redeemed within one year, and we have irrevocably deposited with the applicable trustee, in trust, funds in such currency or currencies, or governmental obligations in an amount sufficient to pay the entire indebtedness on such debt securities in respect of principal and any premium, and interest to the date of such deposit if such debt securities have become due and payable or, if they have not, to the stated maturity or redemption date; or

·we have paid or caused to be paid all other sums payable.

Unless otherwise provided in the applicable prospectus supplement, the indentures provide that, upon our irrevocable deposit with the applicable trustee, in trust, of an amount, in such currency or currencies in which such debt securities are payable at stated maturity, or government obligations, or both, applicable to such debt securities, which through the scheduled payment of principal and interest in accordance with their terms will provide money in an amount sufficient to pay the principal of, and any premium or make-whole amount, and interest on, such debt securities, and any mandatory sinking fund or analogous payments thereon, on the scheduled due dates therefor, the issuing company shall be released from its obligations with respect to such debt securities under the applicable indenture or, if provided in the applicable prospectus supplement, its obligations with respect to any other covenant, and any omission to comply with such obligations shall not constitute an event of default with respect to such debt securities.

The applicable prospectus supplement may further describe the provisions, if any, permitting such defeasance or covenant defeasance, including any modifications to the provisions described above, with respect to the debt securities of or within a particular series.

 12

Conversion Rights

The terms and conditions, if any, upon which the debt securities are convertible into common stock or other securities of ours will be set forth in the following table regardingapplicable prospectus supplement. The terms will include whether the beneficial ownership after resaledebt securities are convertible into shares of common stock or other securities assumesof ours, the conversion price, or manner of calculation thereof, the conversion period, provisions as to whether conversion will be at the issuing company’s option or the option of the holders, the events requiring an adjustment of the conversion price and provisions affecting conversion in the event of the redemption of the debt securities and any restrictions on conversion.

Governing Law

The indentures and the debt securities will be governed by and construed in accordance with the laws of the State of New York, except to the extent that the Selling SecurityholderTrust Indenture Act is applicable.

 13

DESCRIPTION OF WARRANTS

We may issue warrants to purchase debt securities or common stock. We may offer warrants separately or together with one or more additional warrants, debt securities or common stock, or any combination of those securities in the form of units, as described in the applicable prospectus supplement. If we issue warrants as part of a unit, the accompanying prospectus supplement will purchasespecify whether those warrants may be separated from the maximum number of shares of Common Stock provided for byother securities in the warrants and will sell allunit prior to the expiration date of the shareswarrants. The applicable prospectus supplement will also describe the following terms of Common Stock owned by that Selling Securityholder covered by this prospectus. There is no assurance that any of the warrants will be exercised.

  Securities Beneficially Owned Prior to the Offering  Securities Offered Hereby  Securities Beneficially Owned After this Offering  Percentage of Common Stock Owned After this Offering 
Name Common Stock  Warrants  Common Stock  Common Stock underlying Warrants  Common Stock  Warrants    
Sabby Healthcare Master Fund, Ltd.  127,299   1,000,000      1,000,000   472,948(1)     2.3 
Sabby Volatility Warrant Master Fund, Ltd.  0   899,999      899,999   414,428(1)     2.0 
AIGH Investment Partners LP  0   400,001      400,001   383,757      1.9 
Dr. Joshua A. Hirsch  0   20,001      20,001   20,001      * 
Maxim Partners LLC (2)  0   122,200      38,200   38,200   84,000   * 
Warberg WF V LP  0   300,000      100,000   100,000   200,000(3)  1.5 

* Less than 1%warrants:

 

(1)·Asthe specific designation and aggregate number of, June 21, 2018.and the offering price at which we will issue, the warrants;

(2)·Asthe currency or currency units in which the offering price, if any, and the exercise price are payable;

·the date on which the right to exercise the warrants will begin and the date on which that right will expire or, if you may not continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise the warrants;

·whether the warrants are to be sold separately or with other securities as parts of closeunits;

·whether the warrants will be issued in definitive or global form or in any combination of business on June 6, 2018 Maxim Partners LLC held 84,000 unexercised warrants initially issued June 19, 2014, which expire on June 19, 2019. Maxim Group LLC,these forms, although, in any case, the form of a broker-dealer and affiliate of Maxim Partners LLC, was retained as Financial Advisor on behalfwarrant included in a unit will correspond to the form of the Companyunit and of any security included in connection with the Warrant Exercise Agreement.that unit;

(3)·Asany applicable material U.S. federal income tax consequences;

·the identity of closethe warrant agent for the warrants and of businessany other depositaries, execution or paying agents, transfer agents, registrars or other agents;

·the proposed listing, if any, of the warrants or any securities purchasable upon exercise of the warrants on June 6, 2018 Warberg WF V LP held 200,000 unexercisedany securities exchange;

·the designation and terms of any equity securities purchasable upon exercise of the warrants;

·the designation, aggregate principal amount, currency and terms of any debt securities that may be purchased upon exercise of the warrants;

·if applicable, the designation and terms of the debt securities or common stock with which the warrants initiallyare issued and, the number of warrants issued with each security;

·if applicable, the date from and after which any warrants issued as part of a unit and the related debt securities or common stock will be separately transferable;

·the number of shares of common stock purchasable upon exercise of a warrant and the price at which those shares may be purchased;

·if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;

·information with respect to book-entry procedures, if any;

·the antidilution provisions of, and other provisions for changes to or adjustment in the Company’s January 8, 2015 private placement, which expired unexercised on June 19, 2018.exercise price of, the warrants, if any;

·any redemption or call provisions; and

·any additional terms of the warrants, including terms, procedures and limitations relating to the exchange or exercise of the warrants.

 

Specific warrant agreements will contain additional important terms and provisions and will be incorporated by reference as an exhibit to the registration statement of which this prospectus forms a part.

 14

PLANDESCRIPTION OF DISTRIBUTIONUNITS

The following description, together with the additional information that we include in any applicable prospectus supplements and in any related free writing prospectuses, summarizes the material terms and provisions of the units that we may offer under this prospectus. While the terms we have summarized below will apply generally to any units that we may offer under this prospectus, we will describe the particular terms of any series of units in more detail in the applicable prospectus supplement. The terms of any units offered under a prospectus supplement may differ from the terms described below.

We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that we file with the SEC, the form of unit agreement that describes the terms of the series of units we are offering, and any supplemental agreements, before the issuance of the related series of units. The following summaries of material terms and provisions of the units are subject to, and qualified in their entirety by reference to, all the provisions of the unit agreement and any supplemental agreements applicable to a particular series of units. We urge you to read the applicable prospectus supplements related to the particular series of units that we may offer under this prospectus, as well as any related free writing prospectuses and the complete unit agreement and any supplemental agreements that contain the terms of the units.

General

We may issue units comprised of shares of common stock, debt securities, warrants and units in any combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time or at any time before a specified date.

We will describe in the applicable prospectus supplement the terms of the series of units, including:

·designation and terms of the units, including whether and under what circumstances the securities comprising the units may be held or transferred separately;

·any provisions of the governing unit agreement that differ from those described below; and

·any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.

The provisions described in this section, as well as those described under “Description of Capital Stock,” “Description of Debt Securities” and “Description of Warrants,” will apply to each unit and to the common stock, debt securities and warrants included in each unit, respectively.

Issuance in Series

We may issue units in such amounts and in such numerous distinct series as we determine.

Enforceability of Rights by Holders of Units

 

Each Selling Securityholderunit agent will act solely as our agent under the applicable unit agreement and will not assume any obligation or relationship of agency or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series of units. A unit agent will have no duty or responsibility in case of any default by us under the applicable unit agreement or unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit may, without the consent of the securitiesrelated unit agent or the holder of any other unit, enforce by appropriate legal action its rights as holder under any security included in the unit.

Title

We, the unit agent and any of their pledgees, assigneesits agents, may treat the registered holder of any unit certificate as an absolute owner of the units evidenced by that certificate for any purpose and successors-in-interestas the person entitled to exercise the rights attaching to the units so requested, despite any notice to the contrary.

 15

PLAN OF DISTRIBUTION

We may from time to time, sell any or all of their securities covered hereby on the principal Trading Market or any other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A Selling Securityholder may usethrough any one or more of the following methods when selling securities:from time to time:

 

·ordinary brokerage transactions and transactionsto or through underwriters, brokers or dealers;

·through agents;

·directly to one or more other purchasers in negotiated sales or competitively bid transactions;

·through a block trade in which the broker-dealer solicits purchasers;

·broker or dealer engaged to handle the block trades in which the broker-dealertrade will attempt to sell the securities as agent, but may position and resell a portion of the block as principal to facilitate the transaction; or

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

·an exchange distribution in accordance with the rules of the applicable exchange;

·privately negotiated transactions;

·settlement of short sales;

8

·in transactions through broker-dealers that agree with the Selling Securityholders to sell a specified number of such securities at a stipulated price per security;

·through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

·a combination of any suchof the above methods of sale; or

·any other method permitted pursuant to applicable law.sale.

 

The Selling SecurityholdersWe may also selldirectly solicit offers to purchase securities, under Rule 144or agents may be designated to solicit such offers. We will, in the prospectus supplement relating to such offering, name any agent that could be viewed as an underwriter under the Securities Act and describe any commissions that we must pay. Any such agent will be acting on a best efforts basis for the period of its appointment or, if available, rather than under this prospectus.indicated in the applicable prospectus supplement, on a firm commitment basis. This prospectus may be used in connection with any offering of our securities through any of these methods or other methods described in the applicable prospectus supplement.

 

Broker-dealers engaged byThe distribution of the Selling Securityholderssecurities may arrange for other brokers-dealersbe effected from time to participatetime in sales. Broker-dealers may receive commissionsone or discountsmore transactions:

·at a fixed price, or prices, which may be changed from time to time;

·at market prices prevailing at the time of sale;

·at prices related to such prevailing market prices; or

·at negotiated prices.

Each prospectus supplement will describe the Selling Securityholders (or, ifmethod of distribution of the securities and any broker-dealer acts as agent forapplicable restrictions.

The prospectus supplement with respect to the purchaser of securities from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and inparticular series will describe the caseterms of a principal transaction a markup or markdown in compliance with FINRA IM-2440.the offering of the securities, including the following:

 

·the name of the agent or any underwriters;

In connection with

·the public offering or purchase price;

·any discounts and commissions to be allowed or paid to the agent or underwriters;

·all other items constituting underwriting compensation;

·any discounts and commissions to be allowed or paid to dealers; and

·any exchanges on which the securities will be listed.

If any underwriters or agents are utilized in the sale of the securities or interests therein, the Selling Securityholders mayin respect of which this prospectus is delivered, we will enter into hedging transactions with broker-dealersan underwriting agreement or other financial institutions, which mayagreement with them at the time of sale to them, and we will set forth in turn engagethe prospectus supplement relating to such offering the names of the underwriters or agents and the terms of the related agreement with them.

If a dealer is utilized in short salesthe sale of the securities in respect of which the course of hedging the positions they assume. The Selling Securityholders may alsoprospectus is delivered, we will sell securities short and deliver thesesuch securities to close out their short positions, or loan or pledgethe dealer, as principal. The dealer may then resell such securities to the public at varying prices to be determined by such dealer at the time of resale.

If we offer securities in a subscription rights offering to our existing security holders, we may enter into a standby underwriting agreement with dealers, acting as standby underwriters. We may pay the standby underwriters a commitment fee for the securities they commit to broker-dealers that in turn may sell these securities. The Selling Securityholders may alsopurchase on a standby basis. If we do not enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the deliverya standby underwriting arrangement, we may retain a dealer-manager to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).manage a subscription rights offering for us.

 

The Selling SecurityholdersAgents, underwriters, dealers and any broker-dealers or agents that are involved in selling the securitiesother persons may be deemedentitled under agreements which they may enter into with us to be “underwriters” within the meaning ofindemnification by us against certain civil liabilities, including liabilities under the Securities Act, in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissionscustomers of, engage in transactions with or discounts under the Securities Act. Each Selling Securityholder has informed the Company that they acquired the securitiesperform services for us in the ordinary course of business and that they do not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities. The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the securities.business.

 

Because Selling Securityholders may be deemed to be “underwriters” within the meaning of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act including Rule 172 thereunder. In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144 rather than under this prospectus. The Selling Securityholders have advised us that there is no underwriter or coordinating broker acting in connection with the proposed sale of the resale securities by the Selling Securityholders.

We agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Securityholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the Common Stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Securityholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of securities of the Common Stock by the Selling Securityholders or any other person. We will make copies of this prospectus available to the Selling Securityholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

 9 16 

 

 

LEGAL MATTERSIf so indicated in the applicable prospectus supplement, we will authorize underwriters or other persons acting as our agents to solicit offers by certain institutions to purchase securities from us pursuant to delayed delivery contracts providing for payment and delivery on the date stated in the prospectus supplement. Each contract will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts shall not be less nor more than, the respective amounts stated in the prospectus supplement. Institutions with whom the contracts, when authorized, may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational and charitable institutions and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts will not be subject to any conditions except that:

·the purchase by an institution of the securities covered under that contract shall not at the time of delivery be prohibited under the laws of the jurisdiction to which that institution is subject; and

·if the securities are also being sold to underwriters acting as principals for their own account, the underwriters shall have purchased such securities not sold for delayed delivery. The underwriters and other persons acting as our agents will not have any responsibility in respect of the validity or performance of delayed delivery contracts.

Certain agents, underwriters and dealers, and their associates and affiliates may be customers of, have borrowing relationships with, engage in other transactions with, or perform services, including investment banking services, for us or one or more of our respective affiliates in the ordinary course of business.

 

ValidityIn order to facilitate the offering of the securities, offeredany underwriters may engage in transactions that stabilize, maintain or otherwise affect the price of the securities or any other securities the prices of which may be used to determine payments on such securities. Specifically, any underwriters may overallot in connection with the offering, creating a short position for their own accounts. In addition, to cover overallotments or to stabilize the price of the securities or of any such other securities, the underwriters may bid for, and purchase, the securities or any such other securities in the open market. Finally, in any offering of the securities through a syndicate of underwriters, the underwriting syndicate may reclaim selling concessions allowed to an underwriter or a dealer for distributing the securities in the offering if the syndicate repurchases previously distributed securities in transactions to cover syndicate short positions, in stabilization transactions or otherwise. Any of these activities may stabilize or maintain the market price of the securities above independent market levels. Any such underwriters are not required to engage in these activities and may end any of these activities at any time.

Under Rule 15c6-1 of the Exchange Act, trades in the secondary market generally are required to settle in two business days, unless the parties to any such trade expressly agree otherwise. The applicable prospectus supplement may provide that the original issue date for your securities may be more than two scheduled business days after the trade date for your securities. Accordingly, in such a case, if you wish to trade securities on any date prior to the third business day before the original issue date for your securities, you will be required, by virtue of the fact that your securities initially are expected to settle in more than two scheduled business days after the trade date for your securities, to make alternative settlement arrangements to prevent a failed settlement.

The securities may be new issues of securities and may have no established trading market. The securities may or may not be listed on a national securities exchange. We can make no assurance as to the liquidity of or the existence of trading markets for any of the securities.

In compliance with the guidelines of the Financial Industry Regulatory Authority, or FINRA, the aggregate maximum discount, commission or agency fees or other items constituting underwriting compensation to be received by any FINRA member or independent broker-dealer will not exceed 8% of the proceeds from any offering pursuant to this prospectus and any applicable prospectus supplement.

LEGAL MATTERS

Unless the applicable prospectus supplement indicates otherwise, the validity of the securities in respect of which this prospectus is being delivered will be passed upon for us by BRL Law Group LLC, Boston, Massachusetts.  As of June 29, 2018, Thomas B. Rosedale, the Managing Member of BRL Law Group LLC, beneficially and of record owns 69,090 shares of our common stock.Goodwin Procter LLP.

 

 17

EXPERTS

 

The consolidated financial statements of Brainstorm Cell Therapeutics Inc. as of December 31, 2020 and 2019 and for each of the years in the two-year period ended December 31, 2017 and 2016,2020 incorporated in this prospectusProspectus by reference from the Company’s Brainstorm Cell Therapeutics Inc. Annual Report on Form 10-K filed on March 8, 2018 for the year ended December 31, 2017,2020 have been audited by Brightman Almagor Zohar & Co., a member ofFirm in the Deloitte Touche Tohmatsu Limited,Global Network, an independent registered public accounting firm, as stated in their report (which report expresses an unqualified opinion on the financial statements and includes an explanatory paragraph regarding the Company’s ability to continue as a going concern), which isthereon, incorporated herein by reference, and hashave been so incorporated in this Prospectus and Registration Statement in reliance upon such report and upon the reportauthority of such firm given upon their authority as experts in accounting and auditing.

 

 18

WHERE YOU CAN FIND MORE INFORMATION

 

We file annual, quarterly and specialcurrent reports, proxy statements and other information with the SEC. TheseOur SEC filings contain important information that does not appear in this prospectus. For further information about us, you may read and copy any reports, statements and otherare available to the public over the Internet at the SEC’s website at www.sec.gov. Copies of certain information filed by us atwith the SEC’s Public Reference Room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549-0102. You may obtain further information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. Our SEC filings are also available on the SEC Internet siteour website at http://www.sec.gov, which contains reports, proxywww.brainstorm-cell.com. Our website is not a part of this prospectus and information statements, and other information regarding issuers that file electronically with the SEC.is not incorporated by reference in this prospectus.

 

This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission. TheSEC. This prospectus omits some information contained in the registration statement contains morein accordance with SEC rules and regulations. You should review the information thanand exhibits in the registration statement for further information on us and the securities we are offering. Statements in this prospectus regarding usconcerning any document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive and our Common Stock, including certain exhibits and schedules.are qualified by reference to these filings. You should review the complete document to evaluate these statements. You can obtain a copy of the registration statement from the Securities and Exchange CommissionSEC at the address listed above or from the SEC’s Internet site.website.

 

Our Internet address is www.brainstorm-cell.com.  The information on our Internet website is not incorporated by reference in this prospectus or any prospectus supplement.

 19

 

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

 

The Securities and Exchange Commission requiresSEC allows us to “incorporateincorporate by reference” into this prospectus certainreference much of the information we file with them,the SEC, which means that we can disclose important information to you by referring you to those publicly available documents. The information that we incorporate herein by reference in this prospectus is considered to be part of this prospectus.

Because we are incorporating by reference future filings with the SEC, this prospectus is continually updated and those future filings may modify or supersede some of the information included or incorporated in this prospectus. This means that you must look at all of the SEC filings that we file later withincorporate by reference to determine if any of the Securities and Exchange Commission automatically will update and supersede such information. We incorporate hereinstatements in this prospectus or in any document previously incorporated by reference have been modified or superseded. This prospectus incorporates by reference the documents listed below and any future filings we make with the Securities and Exchange CommissionSEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, prioras amended, or the Exchange Act (in each case, other than those documents or the portions of those documents not deemed to be filed) between the terminationdate of the initial registration statement and the effectiveness of the registration statement and following the effectiveness of the registration statement until the offering of the securities covered by this prospectus, as amended:under the registration statement is terminated or completed:

 

(1)Our Annual Report on Form 10-K for the fiscal year ended December 31, 2017;2020, which was filed with the SEC on February 4, 2021;

 

(2)Our Quarterly ReportReports on Form 10-Q for the quarterquarters ended March 31, 2018;2021, and June 30, 2021, which were filed with the SEC on April 26, 2021, and August 5, 2021, respectively;

 

(3)Our Current Reports on Form 8-K filed on January 4, 2018, February 5, 2018May 28, 2021; and June 7, 2018 (but, in each case, excluding information furnished but not filed therein);

 

(4)All of our filings pursuant to the Exchange Act after the date of filing the initial registration statement and prior to the effectiveness of the registration statement; and

(5)The description of our common stock contained in our Registration Statement on Form 8-A filed on September 24, 2014, including any amendments or reports filed for the purpose of updating such description.

 

We incorporate by reference any future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act between the date of this prospectus and the termination of the offering.

Notwithstanding the foregoing, unless specifically stated to the contrary, information that we furnish (and that is not deemed “filed” with the SEC) under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits under Item 9.01, is not incorporated by reference into this prospectus or the registration statement of which this prospectus is a part.

Any statement contained in a document that is incorporated by reference will be modified or superseded for all purposes to the extent that a statement contained in this prospectus, or in any other document that is subsequently filed with the SEC and incorporated by reference into this prospectus, modifies or is contrary to that previous statement. Any statement so modified or superseded will not be deemed a part of this prospectus, except as so modified or superseded. Since information that we later file with the SEC will update and supersede previously incorporated information, you should look at all of the SEC filings that we incorporate by reference to determine if any of the statements in this prospectus or in any documents previously incorporated by reference have been modified or superseded.

Upon request, we will provide, without charge, to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, a copy of the documents incorporated by reference into this prospectus but not delivered therewith. You may request orally or in writing, a copy of these filings, (includingand any exhibits to such filings that we have specifically incorporated by reference as an exhibit in such filings),this prospectus, at no cost by contacting our executive officeswriting or telephoning us at the following address:

Brainstorm Cell Therapeutics Inc.
1745 Broadway, 17th 1325 Avenue of Americas, 28th Floor,

New York, NY 10019,
Attention: Chief Executive Officer
Officer; telephone: (201) 488-0460488-0460.

 

 10 20 

 

 

You may also access these documents, free of charge on the SEC’s website at www.sec.gov or on our website at www.brainstorm-cell.com. Information contained on our website is not incorporated by reference into this prospectus and you should not consider any information on, or that can be accessed from, our website as part of this prospectus.

This prospectus is part of a registration statement we filed with the SEC. We have incorporated exhibits into this registration statement. You should read the exhibits carefully for provisions that may be important to you. You should rely only on the information contained in this prospectus, including information incorporated by reference as described above, or any prospectus supplement or that we have specifically referred you to.provided in this prospectus. We have not authorized anyone else to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this prospectus or any prospectus supplementin the documents incorporated by reference is accurate as of any date other than the date on the front of this prospectus or those documents.

 21

 

$200,000,000

Common Stock

Debt Securities

Warrants

Units

PROSPECTUS

              , 2021

We have not authorized any dealer, salesperson or other person to give any information or represent anything not contained in this prospectus. You must not rely on any unauthorized information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus does not offer to sell any securities in any jurisdiction where it is unlawful. Neither the delivery of this prospectus, nor any sale made hereunder, shall create any implication that the information in this prospectus is correct after the date hereof.

 22

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to completion, dated August 9, 2021

PROSPECTUS

$100,000,000

 

Common Stock

This prospectus and any accompanying prospectus relate to the offer and sale from time to time of shares of our common stock, par value $0.00005 per share, having an aggregate offering price of up to $100,000,000. Shares of our common stock to which this prospectus relates may be offered over a period of time and from time to time through SVB Leerink LLC and Raymond James & Associates, Inc., as our distribution agents, which we refer to as our Distribution Agents, for sale to the public in accordance with the terms of an Amended and Restated Distribution Agreement, or the Distribution Agreement, we have entered into with the Distribution Agents. Sales of shares of our common stock, if any, may be made in transactions that are deemed to be “at-the-market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act, including sales made directly on or through the Nasdaq Capital Market, sales made to or through a market maker other than on an exchange, in transactions at market prices prevailing at the time of sale or at prices related to such market prices, or any other method permitted by law. Under the terms of the Distribution Agreement, we may also sell our common stock to either of the Distribution Agents as principals for their own accounts at prices agreed upon at the time of sale. If we sell our common stock to the Distribution Agents as principals, we will enter into a separate terms agreement with the Distribution Agents. The Distribution Agents are not required to sell any specific dollar amount or number of securities, but will act as the Distribution Agents using commercially reasonable efforts consistent with their normal trading and sales practice, on mutually agreed upon terms between us and the Distribution Agents. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.

We may offer and sell up to an additional $100,000,000 of common stock through the Distribution Agents pursuant to this prospectus. Our common stock is listed on the Nasdaq Capital Market under the symbol “BCLI.” On August 6, 2021, the last reported sale price of our common stock on the Nasdaq Capital Market was $3.96 per share.

We will pay the Distribution Agents a commission rate equal to 3.0% of the gross sales price of all shares sold by them as the Distribution Agents under the Distribution Agreement. In connection with the sale of our common stock on our behalf, the Distribution Agents will be deemed to be “underwriters” within the meaning of the Securities Act and the compensation of the Distribution Agents will be deemed to be underwriting commissions. We have also agreed to provide rights of indemnification and contribution to the Distribution Agents with respect to certain liabilities, including liabilities under the Securities Act.

Investing in our common stock involves a high degree of risk. Before deciding whether to invest in our common stock, you should review carefully the risks and uncertainties that are described in the “Risk Factors” section beginning on page S-5 of this prospectus, and in the documents incorporated by reference herein, including our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as the risks and uncertainties described in the other documents incorporated herein by reference.

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

SVB LeerinkRaymond James

The date of this prospectus is                                     , 2021.

TABLE OF CONTENTS

ABOUT THIS PROSPECTUSS-1
PROSPECTUS SUMMARYS-3
THE OFFERINGS-4
RISK FACTORSS-5
CAUTIONARY STATEMENT ON FORWARD-LOOKING STATEMENTSS-8
USE OF PROCEEDSS-9
DIVIDEND POLICYS-10
DILUTIONS-11
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS TO NON-U.S. HOLDERSS-13
DESCRIPTION OF CAPITAL STOCKS-17
PLAN OF DISTRIBUTIONS-20
LEGAL MATTERSS-22
EXPERTSS-23
WHERE YOU CAN FIND MORE INFORMATIONS-24
INCORPORATION BY REFERENCES-25

S-i

We are responsible for the information contained and incorporated by reference in this prospectus, in the accompanying prospectus, and in any related free writing prospectus we prepare or authorize. We have not authorized anyone to give you any other information, and we take no responsibility for any other information that others may give you. If you are in a jurisdiction where offers to sell, or solicitations of offers to purchase, the securities offered by this documentation are unlawful, or if you are a person to whom it is unlawful to direct these types of activities, then the offer presented in this document does not extend to you. The information contained in this document speaks only as of the date of this document, unless the information specifically indicates that another date applies. Our business, financial condition, results of operations and prospects may have changed since those dates.

ABOUT THIS PROSPECTUS

This prospectus is part of a shelf registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC. We may offer shares of our common stock having an aggregate offering price of up to $100,000,000 from time to time under this prospectus and the accompanying prospectus at prices and on terms to be determined by market conditions at the time of the offering.

If the information contained in this prospectus differs or varies from the information contained in any document incorporated by reference is accurate as of anyherein that was filed with the SEC before the date other than its filing date. You should not consider this prospectus to be an offer or solicitation relating to the securities in any jurisdiction in which such an offer or solicitation relating to the securities is not authorized. Furthermore, you should not consider this prospectus to be an offer or solicitation relating to the securities if the person making the offer or solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or solicitation.

Any statement contained in a document incorporated or deemed to be incorporated herein by reference will be deemed to be modified or superseded for purposes of this prospectus, toyou should rely on the extent thatinformation set forth in this prospectus. If any statement in one of these documents is inconsistent with a statement contained herein or any otherin another document having a later date (for example, a subsequently filed document that is deemed to be incorporated herein by reference in this prospectus), the statement in the document having the later date modifies or supersedes the earlier statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

 

You should rely only on the information contained or incorporated by reference in this prospectus. We have not, and the distribution agents have not, authorized anyone to provide you with information that is in addition to or different from that contained or incorporated by reference in this prospectus or contained in any permitted free writing prospectuses we may authorize for use in connection with this offering. We and the distribution agents take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may provide.

The information contained in this prospectus and the documents incorporated by reference herein is accurate only as of their respective dates, regardless of the time of delivery of any such document or the time of any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since those dates. It is important for you to read and consider all information contained or incorporated by reference in this prospectus in making your investment decision. You should read this prospectus, as well as the documents incorporated by reference herein, the additional information described under the section titled “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference” in this prospectus and any free writing prospectus that we may authorize for use in connection with this offering, before investing in our common stock.

We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference in this prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.

 11S-1 

 

 

PART IIWe use various trademarks and trade names in our business, including without limitation our corporate name and logo. All other trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. This prospectus and the documents incorporated by reference herein also contain estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where such offers and sales are permitted. The distribution of this prospectus and the offering of our common stock in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of our common stock and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.

Unless the context suggests otherwise, all references in this prospectus and any free writing prospectus to “us,” “our,” “Brainstorm,” “we,” the “Company” and similar designations refer to Brainstorm Cell Therapeutics Inc. and, where appropriate, our subsidiaries.

S-2

PROSPECTUS SUMMARY

This summary highlights selected information about us and this offering and does not contain all of the information that you should consider before investing in our common stock. Before investing in our common stock, you should carefully read the information contained and incorporated by reference in this prospectus, including the section titled “Risk Factors” and the financial statements and accompanying notes.

Our Business

Brainstorm Cell Therapeutics Inc. is a leading biotechnology company committed to the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases including: Amyotrophic Lateral Sclerosis (“ALS”, also known as Lou Gehrig’s disease); Progressive Multiple Sclerosis (“PMS”); Alzheimer's disease (AD); and other neurodegenerative diseases. NurOwn®, our proprietary platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs), modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function.

NurOwn® has been evaluated in a Phase 3 ALS and a Phase 2 PMS clinical trial. We announced top-line data from our Phase 3 ALS trial on November 17, 2020. On March 24, 2021, we announced positive topline data from our Phase 2 trial evaluating three repeated administrations of NurOwn®, each given 2 months apart, as a treatment for PMS. On June 24, 2020, we announced a new clinical program focused on the development of NurOwn® as a treatment for AD. We are currently evaluating next steps based on emerging scientific insights and the rapidly changing regulatory landscape for AD following the recent FDA decision on Aducanumab.

Our wholly-owned Israeli subsidiary, Brainstorm Cell Therapeutics Ltd. (“Israeli Subsidiary”), holds exclusive rights to commercialize NurOwn® technology through a licensing agreement with Ramot (“Ramot”), the technology transfer company of Tel Aviv University, Israel. Our Israeli Subsidiary was granted approval by the Israeli Ministry of Health (“MoH”) to treat ALS patients with NurOwn® under the Hospital Exemption Pathway (“HE”).

NurOwn® has a strong and comprehensive intellectual property portfolio and was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug status by the FDA and the European Medicines Agency (EMA) for ALS.

Implications of Being a Smaller Reporting Company

We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended. We may continue to be a smaller reporting company after this offering if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year and the market value of our shares held by non-affiliates is less than $700 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

Corporate Information

We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 1325 Avenue of Americas, 28th Floor, New York, NY 10019, and our telephone number is (201) 488-0460. We also maintain an office in Petach Tikva, Israel. We maintain a website at http://www.brainstorm-cell.comNo portion of our website is incorporated by reference into this prospectus and you should not consider any information on, or that can be accessed through, our website as part of this prospectus. Our common stock trades on The Nasdaq Capital Market under the symbol “BCLI”.

S-3

THE OFFERING

Common stock offered by us:Shares of our common stock having an aggregate offering price of up to $100,000,000.

Common stock to be outstanding after this offering:Up to 61,571,086 (as more fully described in the notes following this table), assuming sales of 25,252,525 shares of our common stock in this offering at an offering price of $3.96 per share, which was the last reported sale price of our common stock on The Nasdaq Capital Market on August 6, 2021. The actual number of shares issued will vary depending on the sales prices under this offering.

Manner of offering:“At the market offering” that may be made from time to time on The Nasdaq Capital Market or other existing trading market for our common stock through our distribution agents, SVB Leerink LLC and Raymond James & Associates, Inc., or the Distribution Agents, and such other sales as agreed upon by us and the Distribution Agents. See “Plan of Distribution” on page S-20 of this prospectus.

Use of proceeds:We intend to use the net proceeds from the sale of our common stock in this offering to advance our clinical programs and for working capital and general corporate purposes.  See “Use of Proceeds” on page S-9 of this prospectus.

Risk factors:Investing in our common stock involves risks. See “Risk Factors” beginning on page S-5 of this prospectus and under similar headings in the documents incorporated by reference herein for a discussion of the factors you should carefully consider before deciding to invest in our common stock.

Nasdaq Capital Market symbol:“BCLI”

All information in this prospectus related to the number of shares of our common stock to be outstanding immediately after this offering is based on 36,318,561 shares of our common stock outstanding as of June 30, 2021. The number of shares outstanding as of June 30, 2021, excludes:

·1,391,485 shares of common stock issuable upon the exercise of share options outstanding as of June 30, 2021, at a weighted average exercise price of $4.6349 per share;

·3,366,666 shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2021, at a weighted average exercise price of $5.7371 per share; and

·3,393,413 shares of common stock reserved for future issuance under our equity incentive plans as of June 30, 2021.

Unless otherwise stated, all information contained in this prospectus assumes no exercise of stock options after June 30, 2021, and reflects an assumed public offering price of $3.96, which was the last reported sale price of our common stock on The Nasdaq Capital Market August 6, 2021.

S-4

RISK FACTORS

An investment in our common stock involves a high degree of risk. Before you invest in our common stock, you should carefully consider the risk factors set forth below, those risk factors related to us and our business described in “Item 1A. Risk Factors” in Part I of our most recent Annual Report on Form 10-K, as amended, our most recent Quarterly Report on Form 10-Q, any subsequently filed Quarterly Reports on Form 10-Q and any subsequently filed Current Reports on Form 8-K, which are incorporated herein by reference, and those risk factors that may be included in any applicable prospectus supplement, together with all of the other information included in this prospectus, any accompanying prospectus supplement and the documents we incorporate by reference, in evaluating an investment in our common stock. If any of the risks discussed in the foregoing documents were to occur, our business, financial condition, results of operations and cash flows could be materially adversely affected. Please read “Special Note Regarding Forward-Looking Statements.”

Risks Relating to this Offering and an Investment in Our Common Stock

The number of shares of our common stock available for future sale could adversely affect the market price of our common stock.

We cannot predict whether future issuances of shares of our common stock or the availability of shares for resale in the open market will decrease the market price per share of our common stock. We may sell shares of our common stock under this prospectus with an aggregate gross offering price of up to $100,000,000. We may also sell additional shares of our common stock in the future under additional prospectus supplements which will accompany this prospectus or in other offerings or other acquisitions we may undertake. Sales of substantial amounts of shares of our common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our common stock.

Our management will have broad discretion as to the use of proceeds from this offering. You may not agree with the manner in which we use the proceeds and our use of those proceeds may not yield a favorable return on investment.

We intend to use the net proceeds of this offering to advance the Company’s clinical programs and for working capital and general corporate purposes. We have not designated the amount of net proceeds we will use for any particular purpose and our management will retain broad discretion to allocate the net proceeds of this offering. The net proceeds may be applied in ways with which some investors in this offering may not agree. Moreover, our management may use the net proceeds for corporate purposes that may not increase our market value or make us more profitable. In addition, it may take us some time to effectively deploy the net proceeds from this offering. Until the net proceeds are effectively deployed, our return on equity and earnings per share may be negatively impacted. Management’s failure to use the net proceeds of this offering effectively could have an adverse effect on our business, financial condition and results of operations.

Share ownership by our officers and directors and certain agreements may make it more difficult for third parties to acquire us or effectuate a change of control that might be viewed favorably by other stockholders.

As of June 30, 2021, our executive officers and directors beneficially owned, directly or indirectly, in the aggregate, approximately 21% of our common stock. As a result, if our executive officers and directors were to oppose a third party’s acquisition proposal for, or a change in control of, the Company, our executive officers and directors may have sufficient voting power to be able to block or at least delay such an acquisition or change in control from taking place, even if other stockholders would support such a sale or change of control. In addition, a number of our executive officers have change of control agreements which could increase the costs and, therefore, lessen the attractiveness of an acquisition of the Company to a potential acquiring party.

S-5

We may sell additional shares of common stock in the future which could result in dilution to our stockholders.

As of June 30, 2021, a total of approximately 63.7 million authorized but unissued shares of our common stock are available for future sale and issuance by action of our board of directors alone, including sales of up to $100,000,000 in value of shares of our common stock under this prospectus. Accordingly, if we were to sell additional shares in the future, our stockholders could suffer dilution in their investment in their shares of our common stock and in their percentage ownership of the Company.

We may issue additional equity securities, or engage in other transactions which could dilute our book value or affect the priority of our common stock, which may adversely affect the market price of our common stock.

Our board of directors may determine from time to time to raise additional capital by issuing additional shares of our common stock or other securities. In addition, we may issue additional securities in connection with future acquisitions we may make. We are not restricted from issuing additional shares of common stock, including securities that are convertible into or exchangeable for, or that represent the right to receive, common stock. We cannot predict or estimate the amount, timing, or nature of any future offerings or issuances of additional stock in connection with acquisitions, or the prices at which such offerings may be affected. Such offerings could be dilutive to common stockholders. New investors also may have rights, preferences and privileges that are senior to, and that adversely affect, our then-current common stockholders. Additionally, if we raise additional capital by making additional offerings of debt or securities, upon liquidation of the Company, holders of our debt securities, and lenders with respect to other borrowings, will receive distributions of our available assets prior to the holders of our common stock. Additional equity offerings may dilute the holdings of our existing stockholders or reduce the market price of our common stock, or both. Holders of our common stock are not entitled to preemptive rights or other protections against dilution.

The regulatory approval process of NurOwn® for ALS is subject to risks and uncertainties.

While we continue to assess the regulatory strategy for advancing NurOwn® towards potential approval in ALS, the regulatory approval process for ALS is subject to significant uncertainty based on the FDA’s position that the data from our randomized Phase 3 controlled clinical trial comparing NurOwn® to placebo does not support a Biologic License Application (BLA). Notwithstanding the FDA’s position, the Company can still choose to submit a BLA and we will consider pursuing this option or other evolving regulatory pathways, as appropriate. If after submitting a BLA the FDA continues to assert that additional data is necessary, complying with any additional requests for information from the FDA, or designing and conducting any new clinical trial will be time-consuming, expensive, and may delay or prevent our ability to continue to study and develop NurOwn®, or result in a change in our regulatory strategy. If we are unable to adequately address recommendations, concerns, requests, or objections of the FDA in a timely manner or at all, we could be delayed or prevented from seeking approval of NurOwn® as a treatment for ALS or for any intended use.

A failure to maintain effective internal control over financial reporting could have a material adverse effect on our business and stock prices.

Although we are not required to obtain or include in our annual reports on Form 10-K an attestation report from our independent registered accountants with respect to the effectiveness of our internal control over financial reporting, like all other public companies, our Chief Executive Officer and our Chief Financial Officer are required, annually, to assess, and disclose their findings in our annual reports on Form 10-K with respect to, the effectiveness of our internal control over financial reporting in a manner that meets the requirements of Section 404(a) of the Sarbanes-Oxley Act. The rules governing the standards that must be met for our Chief Executive and Chief Financial Officers to assess and report on the effectiveness of our internal control over financial reporting are complex and require significant documentation, testing and possible remediation, which could significantly increase our operating expenses.

Additionally, if we are unable to maintain the effectiveness of our internal control over financial reporting in the future, we may be unable to report our financial results accurately and on a timely basis. In such an event, investors and clients may lose confidence in the accuracy and completeness of our financial statements, as a result of which our liquidity, access to capital markets, and perceptions of our creditworthiness could be adversely affected and the market prices of our common stock could decline. In addition, we could become subject to investigations by the Nasdaq Capital Market, the SEC or other regulatory authorities, which could require us to expend additional financial and management resources. As a result, an inability to maintain the effectiveness of our internal control over financial reporting in the future could have a material adverse effect on our business, financial condition, results of operations and prospects.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

S-6

The shares of our common stock offered under this prospectus and any accompanying supplement may be sold in "at-the-market" offerings, and investors who buy shares at different times will likely pay different prices.

Investors who purchase shares under this prospectus and any accompanying prospectus supplement at different times will likely pay different prices, and so may experience different outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing, prices, and numbers of shares sold, and to determine the minimum sales price for shares sold. Investors may experience declines in the value of their shares as a result of share sales made in connection with "at-the-market" offerings at prices lower than the prices they paid.

The actual number of shares we will issue under the distribution agreement, at any one time or in total, is uncertain.

Subject to certain limitations in the Distribution Agreement and compliance with applicable law, we and the Distribution Agents may mutually agree to sell shares of our common stock under a transaction acceptance at any time throughout the term of the Distribution Agreement. The number of shares that are sold by the Distribution Agents after agreement on the terms of the transaction acceptance will fluctuate based on the market price of the shares of our common stock during the sales period and limits we set with the Distribution Agents. Because the price per share of each share sold will fluctuate based on the market price of our shares of common stock during the sales period, it is not possible to predict the number of shares that will ultimately be issued.

We do not anticipate paying any cash dividends on our common stock in the foreseeable future. As a result, you will need to sell your shares of common stock to receive any income or realize a return on your investment.

To date, we have not paid any cash dividends on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. We cannot assure you that we would, at any time, generate sufficient surplus cash that would be available for distribution to the holders of our common stock as a dividend.

Changes in tax law could adversely affect our business and financial condition.

The rules dealing with U.S. federal, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department.  Changes to tax laws (which changes may have retroactive application) could adversely affect us or holders of our common stock.  In recent years, many such changes have been made and changes are likely to continue to occur in the future.  Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations.  We urge investors to consult with their legal and tax advisers regarding the implications of potential changes in tax laws on an investment in our common stock.

S-7

CAUTIONARY STATEMENT ON FORWARD-LOOKING STATEMENTS

This prospectus and the information incorporated by reference in this prospectus include, and any prospectus supplement or free writing prospectus may contain, “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Any forward-looking statements presented in this prospectus, or which management may make orally or in writing from time to time, are based on management’s beliefs and assumptions made by, and information currently available to, management. All statements, other than statements of historical facts, contained or incorporated by reference in this prospectus are forward-looking statements. In some cases you can identify such “forward-looking statements” by the use of words like “may,” “will,” “should,” “could,” “expects,” “hopes,” “anticipates,” “believes,” “intends,” “plans,” “projects,” “targets,” “goals,” “estimates,” “predicts,” “likely,” “potential,” or “continue” or the negative of any of these terms or similar words. These statements, descriptions, forecasts and projections constitute “forward-looking statements,” and as such involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance and achievements to be materially different from any results, levels of activity, performance and achievements expressed or implied by any such “forward-looking statements.” These risks and uncertainties include, but are not limited to our need to raise additional capital, our ability to continue as a going concern, regulatory approval of our NurOwn® treatment candidate, the success of our product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of our NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, our ability to manufacture and commercialize our NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, our ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, disruptions in our business due to the COVID-19 outbreak, including our clinical development activities.

Any forward-looking statements contained or incorporated by reference in this prospectus reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. See “Risk Factors” for more information. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or enter into. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information, future events or otherwise.

S-8

USE OF PROCEEDS

We may issue and sell shares of our common stock having aggregate sale proceeds of up to $100,000,000 from time to time. The amount of proceeds from this offering will depend upon the number of shares of our common stock sold and the market price at which they are sold. There can be no assurance that we will be able to sell any shares under or fully utilize the Distribution Agreement with the Distribution Agents as a source of financing. Because there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time.

We intend to use the proceeds of this offering to fund our operations, which includes, but is not limited to advancing the Company’s clinical programs, commercial production of the investigational therapeutic NurOwn® (whether for ALS or other indications), regulatory, pre-marketing and commercialization preparation activities of NurOwn® for ALS, working capital and general corporate purposes. Our expected use of the net proceeds from this offering is based upon our present plans and business condition. As of the date of this prospectus, we cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual use of proceeds will vary depending on numerous factors, including the factors described under the heading “Risk Factors” beginning on page S-5 and under the heading “Risk Factors” in the prospectus accompanying this prospectus and our other SEC filings. As a result, management will retain broad discretion over the allocation of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds.

S-9

DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock. We intend to retain all of our future earnings, if any, to finance the growth and development of our business. We do not intend to pay cash dividends to our stockholders in the foreseeable future.

S-10

DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share of our common stock in this offering and the as adjusted net tangible book value per share of our common stock immediately after this offering. The net tangible book value of our common stock as of June 30, 2021, was approximately $30.2 million, or approximately $0.83 per share of common stock based upon 36,318,561 shares outstanding. Net tangible book value per share is equal to our total tangible assets, less our total liabilities, divided by the total number of shares of common stock outstanding as of June 30, 2021.

Net tangible book value dilution per share to investors participating in this offering represents the difference between the amount per share paid by purchasers of shares of common stock in this offering and the as adjusted net tangible book value per share of our common stock immediately after this offering. After giving effect to the sale of 25,252,525 shares of common stock in this offering at an assumed public offering price of $3.96 per share, the last reported sale price of our common stock on The Nasdaq Capital Market on August 6, 2021, and after deducting sales commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of June 30, 2021, would have been approximately $127.1 million, or approximately $2.06 per share of common stock. This represents an immediate increase in as adjusted net tangible book value of $1.23 per share to our existing stockholders and an immediate dilution in net tangible book value of $1.77 per share to investors participating in this offering at the assumed public offering price.

Dilution per share to new investors is determined by subtracting as adjusted net tangible book value per share after this offering from the assumed public offering price per share paid by new investors. The following table illustrates this per share dilution to new investors:

Assumed public offering price per share    $3.96 
Historical net tangible book value per share as of June 30, 2021 $0.83     
Increase in net tangible book value per share attributable to the offering  1.23     
As adjusted net tangible book value per share after giving effect to this offering    $2.06 
Dilution in net tangible book value per share to investors participating in this offering    $1.77 

The table above assumes for illustrative purposes that an aggregate of $100.0 million in shares of our common stock are sold at a price of $3.96 per share, the last reported sale price of our common stock on The Nasdaq Capital Market on August 6, 2021. The shares sold in this offering, if any, will be sold from time to time at various prices. An increase of $1.00 per share in the price at which the shares are sold from the assumed offering price of $4.96 per share shown in the table above, assuming all of our common stock in the aggregate amount of $100.0 million is sold at that price, would result in an adjusted net tangible book value per share after the offering to $2.25 per share and would increase the dilution in net tangible book value per share to investors participating in this offering to $2.56 per share, after deducting sales commissions and estimated offering expenses payable by us. A decrease of $1.00 per share in the price at which the shares are sold from the assumed offering price of $2.96 per share shown in the table above, assuming all of our common stock in the aggregate amount of $100.0 million is sold at that price, would result in an adjusted net tangible book value per share after the offering to $1.81 per share and would decrease the dilution in net tangible book value per share to investors participating in this offering to $1.06 per share, after deducting sales commissions and estimated offering expenses payable by us.

The information discussed above is illustrative only and will adjust based on the actual price at which our shares of common stock are sold.

The table and discussion above are based on 36,318,561 shares of common stock outstanding as of June 30, 2021, and excludes:

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·1,391,485 shares of common stock issuable upon the exercise of share options outstanding as of June 30, 2021, at a weighted average exercise price of $4.6349 per share;

·3,366,666 shares of common stock issuable upon the exercise of warrants outstanding as of June 30, 2021, at a weighted average exercise price of $5.7371 per share; and

·3,393,413 shares of common stock reserved for future issuance under our equity incentive plans as of June 30, 2021.

To the extent that any options are exercised, new options are issued under our equity incentive plans or we otherwise issue additional shares of common stock in the future (including shares issued in connection with acquisitions), there will be further dilution to new investors.

In addition, we may choose to raise additional capital due to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

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MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS FOR NON-U.S. HOLDERS

The following discussion is a summary of certain material U.S. federal income tax considerations applicable to non-U.S. holders (as defined below) with respect to their ownership and disposition of shares of our common stock issued pursuant to this offering. For purposes of this discussion, a non-U.S. holder means a beneficial owner of our common stock that is for U.S. federal income tax purposes:

a non-resident alien individual;

a foreign corporation or any other foreign organization taxable as a corporation for U.S. federal income tax purposes; or

a foreign estate or trust, the income of which is not subject to U.S. federal income tax on a net income basis.

This discussion does not address the tax treatment of partnerships or other entities or arrangements that are treated as pass-through entities for U.S. federal income tax purposes or persons that hold their common stock through partnerships or other pass-through entities. A partner in a partnership or an investor in any other pass-through entity that will hold our common stock should consult his, her or its tax advisor regarding the tax consequences of acquiring, holding and disposing of our common stock through a partnership or other pass-through entity, as applicable.

This discussion is based on current provisions of the U.S. Internal Revenue Code of 1986, as amended, or the Code, existing and proposed U.S. Treasury Regulations promulgated thereunder, current administrative rulings and judicial decisions, all as in effect as of the date of this prospectus and all of which are subject to change or to differing interpretation, possibly with retroactive effect. Any such change or differing interpretation could alter the tax consequences to non-U.S. holders described in this prospectus. There can be no assurance that the Internal Revenue Service, or the IRS, will not challenge one or more of the tax consequences described herein. We assume in this discussion that each non-U.S. holder holds shares of our common stock as a capital asset within the meaning of Section 1221 of the Code, which is generally property held for investment.

This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder’s individual circumstances nor does it address any U.S. state, local or non-U.S. tax considerations, the alternative minimum tax, the rules regarding qualified small business stock within the meaning of Section 1202 of the Code, the Medicare tax on net investment income, any tax treaties or any other aspect of any U.S. federal tax other than income taxes (including, for example, estate taxes). This discussion also does not consider any specific facts or circumstances that may apply to a non-U.S. holder and does not address the special tax rules applicable to particular non-U.S. holders, such as:

insurance companies;

tax-exempt or governmental organizations;

financial institutions;

brokers or dealers in securities;

regulated investment companies;

pension plans;

“controlled foreign corporations,” “passive foreign investment companies,” and corporations that accumulate earnings to avoid U.S. federal income tax;

“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by qualified foreign pension funds;

partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and partners and investors therein);

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persons deemed to sell our common stock under the constructive sale provisions of the Code;

persons that hold our common stock as part of a straddle, hedge, conversion transaction, synthetic security or other integrated investment;

persons subject to special tax accounting rules as a result of any item of gross income with respect to our common stock being taken into account in an applicable financial statement under Section 451(b) of the Code;

persons who have elected to mark securities to market;

persons who hold or receive our common stock pursuant to the exercise of any employee stock option or otherwise as compensation; and

U.S. expatriates.

This discussion is for general information only and is not tax advice. Accordingly, all prospective non-U.S. holders of our common stock should consult their tax advisors with respect to the U.S. federal, state, local and non-U.S. tax consequences of the purchase, ownership and disposition of our common stock, including the consequences of any proposed changes in appliable laws.

Distributions on Our Common Stock

As described in the “Dividend Policy” section above, we do not intend to pay any cash dividends on our common stock in the foreseeable future. Distributions, if any, on our common stock generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such holder’s tax basis in the common stock. Any remaining excess will be treated as capital gain, subject to the tax treatment described below in “—Gain on Sale or Other Taxable Disposition of Our Common Stock.” Any such distributions will also be subject to the discussions below under the sections titled “—Backup Withholding and Information Reporting” and “—FATCA.”

Subject to the discussion in the following two paragraphs in this section, dividends paid to a non-U.S. holder generally will be subject to withholding of U.S. federal income tax at a 30% rate or such reduced rate specified by an applicable income tax treaty between the United States and such holder’s country of residence. If we are unable to determine, at a time reasonably close to the date of payment of a distribution on our common stock, what portion, if any, of the distribution will constitute a dividend, then we may withhold U.S. federal income tax on the basis of assuming that the full amount of the distribution will be a dividend. If we or another withholding agent apply over-withholding, a non-U.S. holder may be entitled to a refund or credit of any excess tax withheld by timely filing an appropriate claim with the IRS.

Dividends that are treated as effectively connected with a trade or business conducted by a non-U.S. holder within the United States and, if an applicable income tax treaty so provides, that are attributable to a permanent establishment or a fixed base maintained by the non-U.S. holder within the United States, are generally exempt from the 30% withholding tax if the non-U.S. holder satisfies applicable certification and disclosure requirements. To obtain this exemption, a non-U.S. holder must generally provide us with a properly executed original IRS Form W- 8ECI properly certifying such exemption. However, such U.S. effectively connected income, net of specified deductions and credits, is taxed at the same graduated U.S. federal income tax rates applicable to United States persons (as defined in the Code). Any U.S. effectively connected income received by a non-U.S. holder that is a corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or such reduced rate specified by an applicable income tax treaty between the United States and such holder’s country of residence.

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A non-U.S. holder of our common stock who claims the benefit of an applicable income tax treaty between the United States and such holder’s country of residence generally will be required to provide a properly executed IRS Form W-8BEN or W-8BEN-E (or other applicable or successor form) to the applicable withholding agent and satisfy applicable certification and other requirements. Any documentation provided to an applicable withholding agent may need to be updated in certain circumstances. The certification requirements described above may require a non-U.S. holder to provide its U.S. taxpayer identification number. Non-U.S. holders are urged to consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty. A non-U.S. holder that is eligible for a reduced rate of U.S. withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim with the IRS.

Gain on Sale or Other Taxable Disposition of Our Common Stock

Subject to the discussions below under “—Backup Withholding and Information Reporting” and “—FATCA,” a non-U.S. holder generally will not be subject to any U.S. federal income or withholding tax on any gain realized upon such holder’s sale or other taxable disposition of shares of our common stock unless:

the gain is effectively connected with the non-U.S. holder’s conduct of a U.S. trade or business and, if an applicable income tax treaty so provides, is attributable to a permanent establishment or a fixed base maintained by such non-U.S. holder in the United States, in which case the non-U.S. holder generally will be taxed on a net income basis at the graduated U.S. federal income tax rates applicable to United States persons (as defined in the Code) and, if the non-U.S. holder is a foreign corporation, the branch profits tax described above in “—Distributions on Our Common Stock” also may apply;

the non-U.S. holder is a nonresident alien individual who is present in the United States for a period or periods aggregating 183 days or more in the taxable year of the disposition and certain other conditions are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence) on the net gain derived from the disposition, which may be offset by certain U.S. source capital losses of the non-U.S. holder, if any (even though the individual is not considered a resident of the United States), provided that the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses; or

we are, or have been, at any time during the five-year period preceding such sale or other taxable disposition (or the non-U.S. holder’s holding period, if shorter) a U.S. real property holding corporation (as defined in the Code), unless our common stock is regularly traded on an established securities market and the non-U.S. holder holds no more than 5% of our outstanding common stock, directly or indirectly, actually or constructively, during the shorter of the 5-year period ending on the date of the disposition or the period that the non-U.S. holder held our common stock. If we are or were a U.S. real property holding corporation during the relevant period and the foregoing 5% exception does not apply, the non-U.S. holder generally will be taxed on its net gain derived from the disposition at the graduated U.S. federal income tax rates applicable to United States persons (as defined in the Code). If we are a U.S. real property holding corporation and our common stock is not regularly traded on an established securities market, a non-U.S. holder’s proceeds received on the disposition of shares will also generally be subject to withholding at a rate of 15%. Generally, a corporation is a U.S. real property holding corporation only if the fair market value of its U.S. real property interests (as defined in the Code) equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its other assets used or held for use in a trade or business. Although there can be no assurance, we do not believe that we are, or have been, a U.S. real property holding corporation for U.S. federal income tax purposes, or that we are likely to become one in the future. No assurance can be provided that our common stock will be regularly traded on an established securities market for purposes of the rules described above. Non-U.S. holders should consult their tax advisors with respect to the application of the foregoing rules to their ownership and disposition of our common stock.

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Backup Withholding and Information Reporting

We (or the applicable paying agent) must report annually to the IRS and to each non-U.S. holder the gross amount of the distributions on our common stock paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. holders may have to comply with specific certification procedures to establish that the holder is not a “United States person” (as defined in Section 7701(a)(30) of the Code) in order to avoid backup withholding at the applicable rate with respect to dividends on our common stock. Dividends paid to non-U.S. holders subject to withholding of U.S. federal income tax, as described above in “—Distributions on Our Common Stock,” generally will be exempt from U.S. backup withholding if the non-U.S. holders establish an exemption by properly certifying their non-U.S. status on an IRS Form W-8BEN or W-8BEN-E (or other applicable or successor form).

Information reporting and backup withholding will generally apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outside the United States through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Non-U.S. holders should consult their tax advisors regarding the application of the information reporting and backup withholding rules to them. Copies of information returns may be made available to the tax authorities of the country in which the non-U.S. holder resides or is incorporated under the provisions of a specific treaty or agreement. Any documentation provided to an applicable withholding agent may need to be updated in certain circumstances. Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder can be refunded or credited against the non-U.S. holder’s U.S. federal income tax liability, if any, provided that an appropriate claim is filed with the IRS in a timely manner.

FATCA

The Foreign Account Tax Compliance Act, or FATCA, generally imposes a U.S. federal withholding tax at a rate of 30% on payments of dividends on, or subject to the discussion of certain proposed U.S. Treasury regulations below, gross proceeds from the sale or other disposition of, our common stock paid to a foreign entity unless (i) if the foreign entity is a “foreign financial institution,” such foreign entity undertakes certain due diligence, reporting, withholding, and certification obligations, (ii) if the foreign entity is not a “foreign financial institution,” such foreign entity either certifies it does not have any substantial U.S. owners or furnishes identifying information regarding each substantial U.S. owner and such entity meets certain other specified requirements, or (iii) the foreign entity is otherwise exempt under FATCA. However, proposed regulations, if finalized in their present form, would eliminate the federal withholding tax of 30% applicable to the gross proceeds of a sale or other disposition of our common stock. Taxpayers (including withholding agents) are permitted to rely on the proposed regulations until final regulations are issued. Under certain circumstances, a non-U.S. holder may be eligible for refunds or credits of this withholding tax. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this paragraph. Non-U.S. holders should consult their tax advisors regarding the possible implications of this legislation on their investment in our common stock and the entities through which they hold our common stock, including, without limitation, the process and deadlines for meeting the applicable requirements to prevent the imposition of the 30% withholding tax under FATCA.

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DESCRIPTION OF CAPITAL STOCK

The following description of our capital stock is intended as a summary only. This description is based upon, and is qualified by reference to, our amended and restated certificate of incorporation, or certificate of incorporation, our amended and restated bylaws, or bylaws, and applicable provisions of the Delaware General Corporation Law. This summary is not intended to be a complete description of our capital stock. You should read our certificate of incorporation and bylaws for the provisions that are important to you.

General

Our authorized capital stock consists of 100,000,000 shares of common stock, par value $0.00005 per share.

As of the date of this prospectus, 36,318,561 shares of our common stock were outstanding and held by 32 stockholders of record.

Common Stock

The holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of the stockholders. The holders of our common stock do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any dividends declared by our board of directors out of funds legally available for that purpose. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.

In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in all assets remaining after payment of all debts and other liabilities. All outstanding shares of common stock are fully paid and nonassessable.

Exchange Listing

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

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is American Stock Transfer & Trust Co LLC. The transfer agent and registrar’s address is 6201 15th Avenue, Brooklyn, New York 11219, and its telephone number is (877) 248-6417.

Anti-Takeover Effects of our Certificate of Incorporation and Bylaws and Delaware Law

Our certificate of incorporation and bylaws include a number of provisions that may have the effect of delaying, deferring or preventing another party from acquiring control of us and encouraging persons considering unsolicited tender offers or other unilateral takeover proposals to negotiate with our board of directors rather than pursue non-negotiated takeover attempts. These provisions include the items described below.

Board Composition and Filling Vacancies

Our bylaws provide that directors may be removed with or without cause at an annual meeting or at a special meeting called for that purpose, by a majority vote of the shares then entitled to vote at an election of directors. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative vote of a majority of our directors then in office even if less than a quorum. The limitations on removal of directors, together with the treatment of vacancies, has the effect of making it more difficult for stockholders to change the composition of our board of directors.

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Meetings of Stockholders

Our certificate of incorporation provide that the President, the Chairman of the Board, if any, or any two members of the board of directors, or by the Secretary or any other officer upon the written request of one or more stockholders holding of record at least a majority of the outstanding shares of stock of the corporation entitled to vote at such meeting may call special meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our bylaws limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.

Amendment to Certificate of Incorporation and Bylaws

Any amendment of our certificate of incorporation must first be approved by a majority of our board of directors and must thereafter be approved by the affirmative vote of the holders of a majority of the outstanding shares of our common stock. Our bylaws may be amended by the affirmative vote of a majority of the directors present at any regular or special meeting of the board of directors at which a quorum is present; and may also be amended by the affirmative vote of the holders of a majority of the shares of our capital stock issued and outstanding and entitled to vote at any regular meeting of stockholders, or at any special meeting of stockholders provided notice of such alteration, amendment, repeal or adoption of new by-laws shall have been stated in the notice of such special meeting.

Section 203 of the Delaware General Corporation Law

We are subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. Under Section 203, a business combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:

before the stockholder became interested, our board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting

stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances, but not the outstanding voting stock owned by the interested stockholder; or

at or after the time the stockholder became interested, the business combination was approved by our board of directors and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested stockholder.

Section 203 defines a business combination to include:

any merger or consolidation involving the corporation and the interested stockholder;

any sale, transfer, lease, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;

subject to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

subject to exceptions, any transaction involving the corporation that has the effect of increasing the proportionate share of the stock of any class or series of the corporation beneficially owned by the interested stockholder; and

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the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits provided by or through the corporation.

In general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by the entity or person.

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PLAN OF DISTRIBUTION

We have entered into the Distribution Agreement with the Distribution Agents under which we may issue and sell from time to time up to $100,000,000 of our common stock through SVB Leerink LLC and Raymond James & Associates, Inc. as our distribution agents. Sales of our common stock, if any, will be made at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act, including sales made directly on Nasdaq or any other trading market for our common stock. If authorized by us in writing, the Distribution Agents may purchase shares of our common stock as principal.

The Distribution Agents will offer our common stock subject to the terms and conditions of the Distribution Agreement on a daily basis or as otherwise agreed upon by us and the Distribution Agents. We will designate the maximum amount of common stock to be sold through the Distribution Agents on a daily basis or otherwise determine such maximum amount together with the Distribution Agents. Subject to the terms and conditions of the Distribution Agreement, the Distribution Agents will use their commercially reasonable efforts to sell on our behalf all of the shares of common stock requested to be sold by us. We may instruct the Distribution Agents not to sell common stock if the sales cannot be effected at or above the price designated by us in any such instruction. The Distribution Agents or we may suspend the offering of our common stock being made through the Distribution Agents under the Distribution Agreement upon proper notice to the other party. The Distribution Agents and we each have the right, by giving written notice as specified in the Distribution Agreement, to terminate the Distribution Agreement in each party’s sole discretion at any time.

The aggregate compensation payable to the Distribution Agents as distribution agents is equal to 3% of the gross sales price of the shares sold through them pursuant to the Distribution Agreement. In addition, we have agreed to reimburse the Distribution Agents for fees and disbursements, including related to its legal counsel in an amount not to exceed $50,000 as provided in the Distribution Agreement.

The remaining sales proceeds, after deducting any expenses payable by us and any transaction fees imposed by any governmental, regulatory, or self-regulatory organization in connection with the sales, will equal our net proceeds for the sale of such common stock.

The Distribution Agents will provide written confirmation to us no later than the opening of the trading day immediately after each day of trading on Nasdaq in which common stock is sold through them as distribution agents under the Distribution Agreement. Each confirmation will include the number of shares of common stock sold through them as distribution agents on that day, the volume weighted average price of the shares sold, and the net proceeds to us.

We will report at least quarterly the number of shares of common stock sold through the Distribution Agents under the Distribution Agreement, the gross and net proceeds to us and the compensation paid by us to the Distribution Agents in connection with the sales of common stock.

Settlement for sales of common stock will occur, unless the parties agree otherwise or otherwise required by law, on the second business day that is also a trading day following the date on which any sales were made in return for payment of the net proceeds to us. There is no arrangement for funds to be received in an escrow, trust or similar arrangement.

In connection with the sales of our common stock on our behalf, the Distribution Agents may be deemed to be “underwriters” within the meaning of the Securities Act, and the compensation paid to the Distribution Agents may be deemed to be underwriting commissions or discounts. We have agreed in the Distribution Agreement to provide indemnification and contribution to the Distribution Agents against certain liabilities, including liabilities under the Securities Act. As distribution agents, the Distribution Agents will not engage in any transactions that stabilizes our common stock.

Our common stock is listed on The Nasdaq Capital Market and trades under the symbol “BCLI.” The transfer agent of our common stock is American Stock Transfer & Trust Company LLC.

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The Distribution Agents and/or their affiliates have provided, and may in the future provide, various investment banking and other financial services for us for which services they have received and, may in the future receive, customary fees.

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LEGAL MATTERS

Certain legal matters in connection with this offering and the validity of the securities offered by this prospectus will be passed upon for us by Goodwin Procter LLP, Boston, MA. SVB Leerink LLC and Raymond James & Associates, Inc. are being represented in connection with this offering by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, N.Y.

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EXPERTS

The consolidated financial statements of Brainstorm Cell Therapeutics Inc. as of December 31, 2020 and 2019 and for each of the years in the two-year period ended December 31, 2020 incorporated in this Prospectus by reference from the Brainstorm Cell Therapeutics Inc. Annual Report on Form 10-K for the year ended December 31, 2020 have been audited by Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network, an independent registered public accounting firm, as stated in their report thereon, incorporated herein by reference, and have been incorporated in this Prospectus and Registration Statement in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.

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WHERE YOU CAN FIND MORE INFORMATION

We file annual, quarterly and current reports, proxy statements and other information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s website at www.sec.gov. Copies of certain information filed by us with the SEC are also available on our website at www.brainstorm-cell.com. Our website is not a part of this prospectus and is not incorporated by reference in this prospectus.

This prospectus is part of a registration statement we filed with the SEC. This prospectus omits some information contained in the registration statement in accordance with SEC rules and regulations. You should review the information and exhibits in the registration statement for further information on us and the securities we are offering. Statements in this prospectus concerning any document we filed as an exhibit to the registration statement or that we otherwise filed with the SEC are not intended to be comprehensive and are qualified by reference to these filings. You should review the complete document to evaluate these statements. You can obtain a copy of the registration statement from the SEC at the address listed above or from the SEC’s website.

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INCORPORATION BY REFERENCE

The SEC allows us to incorporate by reference the information and reports we file with it, which means that we can disclose important information to you by referring you to these documents. The information incorporated by reference is an important part of this prospectus, and information that we file later with the SEC will automatically update and supersede the information already incorporated by reference. We are incorporating by reference the documents listed below, which we have already filed with the SEC, and any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, except as to any portion of any future report or document that is not deemed filed under such provision, including all filings made between the date of this prospectus and the effectiveness of the registration statement and following the effectiveness of the registration statement until the termination or completion of this offering:

Annual Report on Form 10-K for the fiscal year ended December 31, 2020, which was filed with the SEC on February 4, 2021;

Quarterly Reports on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, which were filed with the SEC on April 26, 2021 and August 5, 2021, respectively;

Current Reports on Form 8-K filed on May 28, 2021; and

The description of our common stock contained in our Registration Statement on Form 8-A filed on September 24, 2014, including any amendments or reports filed for the purpose of updating such description.

We incorporate by reference any future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act between the date of this prospectus and the termination of the offering.

Notwithstanding the foregoing, unless specifically stated to the contrary, information that we furnish (and that is not deemed “filed” with the SEC) under Items 2.02 and 7.01 of any Current Report on Form 8-K, including the related exhibits under Item 9.01, is not incorporated by reference into this prospectus or the registration statement of which this prospectus is a part.

Any statement contained in a document that is incorporated by reference will be modified or superseded for all purposes to the extent that a statement contained in this prospectus, or in any other document that is subsequently filed with the SEC and incorporated by reference into this prospectus, modifies or is contrary to that previous statement. Any statement so modified or superseded will not be deemed a part of this prospectus, except as so modified or superseded. Since information that we later file with the SEC will update and supersede previously incorporated information, you should look at all of the SEC filings that we incorporate by reference to determine if any of the statements in this prospectus or in any documents previously incorporated by reference have been modified or superseded.

Upon request, we will provide, without charge, to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, a copy of the documents incorporated by reference into this prospectus but not delivered therewith. You may request a copy of these filings, and any exhibits we have specifically incorporated by reference as an exhibit in this prospectus, at no cost by writing or telephoning us at the following address: Brainstorm Cell Therapeutics Inc. 1325 Avenue of Americas, 28th Floor, New York, NY 10019, Attention: Chief Executive Officer; telephone: (201) 488-0460.

You may also access these documents, free of charge on the SEC’s website at www.sec.gov or on our website at www.brainstorm-cell.com. Information contained on our website is not incorporated by reference into this prospectus and you should not consider any information on, or that can be accessed from, our website as part of this prospectus.

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This prospectus is part of a registration statement we filed with the SEC. We have incorporated exhibits into this registration statement. You should read the exhibits carefully for provisions that may be important to you. You should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone to provide you with different information. We are not making an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this prospectus or in the documents incorporated by reference is accurate as of any date other than the date on the front of this prospectus or those documents.

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BRAINSTORM CELL THERAPEUTICS INC.

Up to $100,000,000

Common Stock

SVB Leerink     Raymond James

               , 2021

PROSPECTUS

PART II.
INFORMATION NOT REQUIRED IN PROSPECTUS

Item 14.Other Expenses of Issuance and Distribution

 

The following table setsItem 14. Other Expenses of Issuance and Distribution.

Set forth below is an estimate (except in the various costscase of the SEC registration fee) of the amount of fees and expenses to be incurred in connection with the issuance and distribution of the offered securities, other than underwriting discounts payable by us in connection with the sale of the securities being registered. All such costs and expenses shall be borne by us. Except for the SEC registration fee, all the amounts shown are estimates.commissions.

 

 Amount
to be paid
 
SEC registration fee $1,228  $21,820 
Accounting fees and expenses  * 
Legal fees and expenses  30,000   * 
Accounting fees and expenses  3,000 
Transfer Agent and Registrar fees  2,500 
Printing fees and miscellaneous expenses  2,500 
Transfer agent’s, trustee’s and depositary’s fees and expenses  * 
Printing fees and expenses  * 
Miscellaneous  

*

 
Total $39,228  $* 

 

*These fees and expenses are calculated based on the securities offered and the number of issuances and distributions of the offered securities and, accordingly, cannot be estimated at this time.
Item 15.Indemnification of Directors and Officers

Item 15. Indemnification of Directors and Officers.

 

Section 145(a)145 of the Delaware General Corporation Law, provides, in general, thator the DGCL, authorizes a corporation mayto indemnify any person who wasits directors and officers against liabilities arising out of actions, suits and proceedings to which they are made or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the rightreason of the corporation), because hefact that they have served or she is or was a director, officer, employee or agent of the corporation, or is or wasare currently serving at the request of the corporation as a director or officer employee or agent of another corporation, partnership, joint venture, trust or other enterprise, againstto a corporation. The indemnity may cover expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the persondirector or officer in connection with any such action, suit or proceeding, if he or she acted in good faith and in a manner he or she reasonably believedproceeding. Section 145 permits corporations to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

Section 145(b) of the Delaware General Corporation Law provides, in general, that a corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor because the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, againstpay expenses (including attorneys’ fees) actually and reasonably incurred by directors and officers in advance of the person in connection with the defense or settlementfinal disposition of such action, suit or suit if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made with respect to any claim, issue or matter as to which he or she shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, he or she is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or other adjudicating court shall deem proper.

proceeding. In addition, Section 145(g) of the Delaware General Corporation Law145 provides in general, that a corporation mayhas the power to purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterpriseits directors and officers against any liability asserted against such personthem and incurred by such personthem in any suchtheir capacity as a director or officer, or arising out of his or hertheir status as such, whether or not the corporation would have the power to indemnify the persondirector or officer against such liability under Section 145 of the Delaware General Corporation Law.145.

 

The CertificateWe have adopted provisions in our certificate of Incorporationincorporation and bylaws that limit or eliminate the Bylawspersonal liability of our Company provide that our Company shall indemnify,directors to the maximumfullest extent permitted by the Delaware General Corporation Law, each person who isDGCL, as it now exists or wasmay in the future be amended. Consequently, a director are not personally liable to us or officer of our Company. Pursuant to Delaware law, this includes elimination of liabilitystockholders for monetary damages foror breach of the directors’ fiduciary duty of care to our Company and its stockholders. These provisions do not eliminate the directors’ duty of care and, in appropriate circumstances, equitable remedies such as injunctive or other forms of non-monetary relief will remain available under Delaware law. In addition, eacha director, will continue to be subject toexcept for liability forfor:

any breach of the director’s duty of loyalty to us or our Company, for actsstockholders;

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any act or omissionsomission not in good faith or involvingthat involves intentional misconduct foror a knowing violationsviolation of law for

any unlawful payments related to dividends or unlawful stock purchases, redemptions or other distributions; or

any transaction from which the director derived an improper personal benefit, and for paymentbenefit.

These limitations of dividends or approval of stock repurchases or redemptions that are unlawfulliability do not alter director liability under Delaware law. The provision also does not affect a director’s responsibilities under any other laws, such as the federal securities laws and do not affect the availability of equitable remedies such as an injunction or state or federal environmental laws.rescission.

 

Our Company maintains a policyIn addition, our bylaws provide that:

we will indemnify our directors, officers and, in the discretion of directors’our board of directors, certain employees to the fullest extent permitted by the DGCL, as it now exists or may in the future be amended; and officers’ liability insurance

we will advance reasonable expenses, including attorneys’ fees, to our directors and, in the discretion of our board of directors, to our officers and certain employees, in connection with legal proceedings relating to their service for or on behalf of us, subject to limited exceptions.

We have entered into indemnification agreements with each of our directors and executive officers. These agreements provide that insures itswe will indemnify each of our directors, certain of our executive officers and, at times, their affiliates to the fullest extent permitted by Delaware law. We will advance expenses, including attorneys’ fees (but excluding judgments, fines and settlement amounts), to each indemnified director or executive officer in connection with any proceeding in which indemnification is available and we will indemnify our directors and officers againstfor any action or proceeding arising out of that person’s services as a director or officer brought on behalf of us or in furtherance of our rights. Additionally, certain of our directors or officers may have certain rights to indemnification, advancement of expenses or insurance provided by their affiliates or other third parties, which indemnification relates to and might apply to the costsame proceedings arising out of defense, settlementsuch director’s or paymentofficer’s services as a director referenced herein. Nonetheless, we have agreed in the indemnification agreements that our obligations to those same directors or officers are primary and any obligation of a judgment under some circumstances.such affiliates or other third parties to advance expenses or to provide indemnification for the expenses or liabilities incurred by those directors are secondary.

 

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We also maintain general liability insurance which covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act.

 

Item 16. Exhibits.

The exhibits to this Registration Statement are listed in the exhibit index, which appears elsewhere herein and is incorporated herein by reference.

 

Item 16.Exhibits and Financial Statement Schedules

Exhibit No.

 Description 

Exhibit Index

1.1* Form of Underwriting Agreement
2.11.2 Distribution Agreement, and Plan of Merger, dated as of November 28, 2006,August 9, 2021 by and betweenamong Brainstorm Cell Therapeutics Inc., a Washington corporation, and Brainstorm Cell TherapeuticsSVB Leerink LLC and Raymond James & Associates, Inc., a Delaware corporation, is incorporated herein by reference to Appendix A of the Company’s Definitive Schedule 14A dated November 20, 2006 (File No. 333-61610).
4.13.1 Certificate of Incorporation of Brainstorm Cell Therapeutics Inc. is incorporated herein by reference to Appendix B of the Company’s Definitive Schedule 14A dated November 20, 2006 (File No. 333-61610).(1) 
4.23.2 Certificate of Amendment of Certificate of Incorporation of Brainstorm Cell Therapeutics Inc. dated September 15, 2014 is incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated September 15, 2014 (File No. 000-54365).(2) 
4.33.3 Certificate of Amendment of Certificate of Incorporation of Brainstorm Cell Therapeutics Inc. dated August 31, 2015 is incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated September 15, 2014 (File No. 001-366641).(3)
4.43.4 ByLaws of Brainstorm Cell Therapeutics Inc. is incorporated herein by reference to Appendix C of the Company’s Definitive Schedule 14A dated November 20, 2006 (File No. 333-61610).(1)

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4.53.5 Amendment No. 1 to ByLaws of Brainstorm Cell Therapeutics Inc., dated as of March 21, 2007 is incorporated herein by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K dated March 27, 2007 (File No. 333-61610).(4)
4.64.1 Specimen Certificatecertificate evidencing shares of Common Stock of Brainstorm Cell Therapeutics Inc., is incorporated herein by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K dated September 15, 2014 (File No. 000-54365).common stock (2) 
4.2 Form of Senior Indenture (including Form of Senior Note)
5.1*4.3Form of Subordinated Indenture (including Form of Subordinated Note)
4.4*Form of Warrant Agreement
4.5*Form of Unit Agreement
5.1 Opinion of BRL Law Group LLC.Goodwin Procter LLP

10.15.2 FormOpinion of Warrant is incorporated herein by referenceGoodwin Procter LLP relating to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on June 7, 2018 (File No. 001-36641).distribution agreement prospectus
10.2Warrant Exercise Agreement is incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 7, 2018 (File No. 001-36641).
10.3Leak-Out Agreement is incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on June 7, 2018 (File No. 001-36641).
10.4*Share Cap Agreement.

23.1*23.1 Consent of Brightman Almagor Zohar & Co., a member ofFirm in the Deloitte Touche Tohmatsu Limited.Global Network, independent registered public accounting firm for the Registrant
23.3*23.2 Consent of BRL Law Group LLCGoodwin Procter LLP (included in Exhibit 5.1).
23.3 Consent of Goodwin Procter LLP (included in Exhibit 5.2)
24.1 PowerPowers of Attorney (included in the signature pages hereto)
25.1**The Statement of Eligibility on signature page).Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Senior Indenture
25.2**The Statement of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Subordinated Indenture

*To be filed by amendment or by a Current Report on Form 8-K.

**To be filed pursuant to Section 305(b)(2) of the Trust Indenture Act of 1939, as amended.

(1)Incorporated by reference to the Registrant’s Definitive Schedule 14A (File No. 333-61610) filed on November 20, 2006.

(2)Incorporated by reference to the Registrant’s Definitive Schedule 14A (File No. 000-54365) filed on September 16, 2014.

(3)Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 000-366641) filed on September 4, 2015.

(4)Incorporated by reference to the Registrant’s Current Report on Form 8-K (File No. 000-61610) filed on March 27, 2007.

 

* Filed herewith. 

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Item 17. UndertakingsUndertakings.

 

The undersigned registrantRegistrant hereby undertakes:

 

(1)    To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(1)To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:

 

(i)Toto include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”);Act;

(ii)Toto reflect in the prospectus any facts or events arising after the effective date of the registration statementthis Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement.this Registration Statement. Notwithstanding the foregoing, any increase or decrease in the volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule Rule��424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

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(iii)Toto include any material information with respect to the plan of distribution not previously disclosed in the registration statementthis Registration Statement or any material change to such information in this Registration Statement; provided, however, that paragraphs (i), (ii) and (iii) of this section do not apply if the registration statement.information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Securities and Exchange Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in this Registration Statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of this Registration Statement.

 

(2)That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

Provided, however,that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

(2)    That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide  offering thereof.

(3)    To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)    That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however,  that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

(5)    That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, such undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

(4)That, for the purpose of determining liability under the Securities Act to any purchaser:

(i)Anyeach prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

(ii)each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference in the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

(5)That, for the purpose of determining liability of a Registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned Registrant undertakes that in a primary offering of securities of the undersigned Registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned Registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)any preliminary prospectus or prospectus of the undersigned registrantRegistrant relating to the offering required to be filed pursuant to Rule 424;

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(ii)Anyany free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrantRegistrant or used or referred to by the undersigned registrant;Registrant;

(iii)Thethe portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrantRegistrant or its securities provided by or on behalf of the undersigned registrant;Registrant; and

(iv)Anyany other communication that is an offer in the offering made by the undersigned registrantRegistrant to the purchaser.

 

(6)    
(6)That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(7)    Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the indemnification provisions described herein, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

(7)Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by a Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

14(8)To file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act of 1939 in accordance with the rules and regulations prescribed by the Securities and Exchange Commission under Section 305(b)(2) of the Trust Indenture Act of 1939.

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SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrantRegistrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statementRegistration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on this 299th day of June, 2018.August, 2021.

 

 BRAINSTORM CELL THERAPEUTICS INC.
 THERAPEUTICS INC.
  
 By:/s/ Chaim Lebovits
  Chaim Lebovits
President and Chief Executive Officer
(Principal Executive Officer)

 

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes

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SIGNATURES AND POWER OF ATTORNEY

We, the undersigned officers and appointsdirectors of Brainstorm Cell Therapeutics Inc. hereby severally constitute and appoint Chaim Lebovits, Uri Yablonka and Eyal Rubin, an each of them, his or herour true and lawful attorneys-in-fact and agents,attorney with full power of substitution and resubstitution,to sign for him or her,us and in his or her name, place and stead,our names in any and allthe capacities to signindicated below the Registration Statement on Form S-3 of Brainstorm Cell Therapeutics Inc.filed herewith and any orand all amendments (including post-effective amendments) theretoto said Registration Statement, and any new registration statement with respect to the offering contemplated thereby filed pursuant to Rule 462(b) of462 under the Securities Act of 1933, as amended, in connection with said Registration Statement, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authoritygenerally to do all such things in our name and perform eachon our behalf in our capacities as officers and every actdirectors to enable Brainstorm Cell Therapeutics Inc. to comply with the provisions of the Securities Act of 1933, as amended, and thing requisite or necessary to be done inall requirements of the Securities and about the premisesExchange Commission, hereby ratifying and confirming all that said attorney-in-fact and agent,attorney, or his substitute or substitutes, may lawfullyshall do or cause to be done by virtue hereof.

 

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statementRegistration Statement has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

 Title

Title(s)

 

Date

     
/s/ Chaim Lebovits President and Chief Executive Officer (Principal Executive Officer)August 9, 2021
Chaim Lebovits  
Chaim Lebovits (Principal Executive Officer) June 29, 2018
/s/ Preetam ShahEVP, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)August 9, 2021
Preetam Shah
     
/s/ Eyal RubinIrit Arbel Chief Financial Officer and TreasurerDirectorAugust 9, 2021
Irit Arbel  
Eyal Rubin (Principal Financial and Accounting Officer)June 26, 2018
     
/s/ Irit ArbelJune S. Almenoff Director August 9, 2021
Irit ArbelJune S. Almenoff   June 26, 2018
     
/s/ June S. AlmenoffJacob Frenkel Director August 9, 2021
June S. AlmenoffJacob Frenkel   June 25, 2018
     
/s/ Arturo O. ArayaAnthony Polverino Director August 9, 2021
Arturo O. ArayaAnthony Polverino   June 28, 2018
     
/s/ Chen SchorMalcolm Taub Director August 9, 2021
Chen SchorMalcolm Taub   June 25, 2018
     
/s/ Anthony PolverinoUri Yablonka Director August 9, 2021
Anthony PolverinoUri Yablonka   June 25, 2018
     
/s/ Sankesh Abbhi Director August 9, 2021
Malcolm TaubJune [   ], 2018
Sankesh Abbhi    
/s/ Uri YablonkaDirector
Uri YablonkaJune 26, 2018

 

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