10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended August 31, 2013

OR

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

Commission File Number: 000-28385

Protalex, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	91-2003490
(State or Other Jurisdiction of	(I.R.S. Employer
Incorporation or Organization)	Identification Number)

133 Summit Avenue, Suite 22

Summit, NJ 07901

(Address of Principal Executive Offices and Zip Code)

215-862-9720

(Registrant’s Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

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

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

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

Large accelerated filer  ¨	Accelerated filer  ¨
Non-accelerated filer  ¨	Smaller reporting company x

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

Number of shares outstanding of the issuer’s Common Stock, par value $0.00001 per share, as of October 11, 2013: 28,296,180 shares.

PROTALEX, INC.

Quarterly Report on Form 10-Q

For the Period Ended August 31, 2013

TABLE OF CONTENTS

		Page No.
PART I.	FINANCIAL INFORMATION
ITEM 1.	Financial Statements:
	Condensed Balance Sheets at August 31, 2013 (Unaudited) and May 31, 2013	3
	Condensed Statements of Operations for the three months ended August 31, 2013 and August 31, 2012 and the period from September 17, 1999 (inception) to August 31, 2013 (Unaudited)	4
	Condensed Statement of Changes in Stockholders’ Equity (Deficit) for the period from September 17, 1999 (inception) through August 31, 2013 (Unaudited)	5
	Condensed Statements of Cash Flows for the three months ended August 31, 2013 and August 31, 2012, and the period from September 17, 1999 (inception) to August 31, 2013 (Unaudited)	9
	Notes to Unaudited Condensed Financial Statements	10
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	30
ITEM 4.	Controls and Procedures	30
PART II.	OTHER INFORMATION	31
ITEM 5.	Other Information	31
ITEM 6.	Exhibits	31
	SIGNATURES	32

FORWARD-LOOKING STATEMENTS

Certain statements made in this Quarterly Report on Form 10-Q are “forward-looking statements” regarding the plans and objectives of management for future operations and market trends and expectations. Such statements involve known and unknown risks, uncertainties and other 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 such forward-looking statements. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Our plans and objectives are based, in part, on assumptions involving the continued expansion of our business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond our control. Although we believe that our assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. We undertake no obligation to revise or update publicly any forward-looking statements for any reason. The terms “we”, “our”, “us”, or any derivative thereof, as used herein refer to Protalex, Inc., a Delaware corporation, and its predecessors.

2

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

PROTALEX, INC.

(A Development Stage Company)

CONDENSED BALANCE SHEETS

	August 31,		May 31,
	2013		2013
	(Unaudited)
CURRENT ASSETS:
Cash and cash equivalents	$	2,018,645	$	2,457,046
Prepaid expenses		17,204		42,320
Total current assets		2,035,849		2,499,366
OTHER ASSETS:
Intellectual technology property, net of     accumulated amortization of $13,323 and $13,068 as     of August 31, 2013 and May 31, 2013, respectively		6,212		6,467
Total other assets		6,212		6,467
Total Assets	$	2,042,061	$	2,505,833
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable	$	303,547	$	671,738
Accrued expenses		137,750		62,517
Current portion – long term debt, related party,		2,085,833		4,210,833
Total current liabilities		2,527,130		4,945,088
LONG TERM LIABILITIES:
Senior Secured Note – related party		7,000,000		6,000,000
Senior Secured Note Accrued Interest – related party		103,950		57,616
Total liabilities		9,631,080		11,002,704
STOCKHOLDERS' EQUITY (DEFICIT)
Preferred stock, par value $0.00001, 1,000,000 shares authorized; none issued     and outstanding		0		0
Common stock, par value $0.00001,     100,000,000 shares authorized; 28,296,180 and 18,926,615 shares issued     and outstanding, respectively		283		189
Additional paid in capital		55,657,994		53,237,993
Deficit accumulated during the development stage		(63,247,296)		(61,735,053)
Total stockholders’ equity (deficit)		(7,589,019)		(8,496,871)
Total liabilities and stockholders’ equity (deficit)	$	2,042,061	$	2,505,833

The accompanying notes are an integral part of these unaudited condensed financial statements.

3

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENTS OF OPERATIONS

	Three Months Ended August 31, 2013		Three Months Ended August 31, 2012		From Inception  (September 17, 1999) Through August 31, 2013
	(Unaudited)		(Unaudited)		(Unaudited)
Revenues	$	0	$	0	$	0
Operating Expenses
Research and development (including depreciation and amortization)		933,118		675,028		37,308,613
Administrative (including depreciation and amortization)		372,759		314,127		20,187,194
Professional fees		129,777		126,611		5,201,379
Depreciation and amortization		255		255		183,221
Operating loss		(1,435,909)		(1,116,021)		(62,880,407)
Other income (expense)
Interest income		1		24		2,211,848
Interest expense		(76,335)		(248,975)		(2,578,737)
Net loss	$	(1,512,243)	$	(1,364,972)	$	(63,247,296)
Weighted average number of common shares outstanding		19,338,464		18,926,615
Loss per common share – basic and diluted	$	(0.08)	$	(0.07)

The accompanying notes are an integral part of these unaudited condensed financial statements.

 

4

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

From Inception (September 17, 1999) through August 31, 2013

(Unaudited)

									Deficit
									Accumulated
					Additional		Common		During The
	Common Stock				Paid in		Stock-		Development
	Shares		Amount		Capital		Contra		Stage		Total
September 17, 1999 — initial issuance of 2,000 shares for intellectual technology license at $.15 per share		2,000	$	300	$	0	$	0	$	0	$	300
September 30, 1999 — cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		0		0		0		(250,000)		0		(250,000)
October 27, 1999 — issuance of 17 shares to individual for $25,000		17		25,000		0		0		0		25,000
November 15, 1999 — reverse merger transaction with Enerdyne Corporation, net transaction amounts		1,794,493		118,547		0		(118,547)		0		0
November 18, 1999 — February 7, 2000 — issuance of 91,889 shares to various investors at $1.80 per share		91,889		165,400		0		0		0		165,400
January 1, 2000 — issuance of 20,000 shares in exchange for legal services		20,000		15,000		0		0		0		15,000
May 1 - 27, 2000 — issuance of 128,000 shares to various investors at $5.00 per share		128,000		640,000		0		0		0		640,000
May 27, 2000 — issuance of 329 shares to an individual in exchange for interest Due		329		1,644		0		0		0		1,644
Net loss for the year ended May 31, 2000		0		0		0		0		(250,689)		(250,689)
Balance, May 31, 2000		2,036,728		965,891		0		(368,547)		(250,689)		346,655
December 7, 2000 — issuance of 85,000 shares to various investors at $5.00 per share		85,000		425,000		0		0		0		425,000
May 31, 2001 — Forgiveness of debt owed to stockholder		0		0		40,000		0		0		40,000
Net loss for the year ended May 31, 2001		0		0		0		0		(553,866)		(553,866)
Balance, May 31, 2001		2,121,728		1,390,891		40,000		(368,547)		(804,555)		257,789
August 13, 2001 — Contribution by Stockholders		0		0		143,569		0		0		143,569
November 7, 2001 — issuance of 176,320 Shares at $6.25 per share		176,320		1,102,000		0		0		0		1,102,000
November 26, 2001 — options issued to board member		0		0		133,000		0		0		133,000
Net loss for the year ended May 31, 2002		0		0		0		0		(1,280,465)		(1,280,465)
Balance, May 31, 2002		2,298,048		2,492,891		316,569		(368,547)		(2,085,020)		355,893
July 5, 2002 — issuance of 168,400 shares at $7.50 per share		168,400		1,263,000		0		0		0		1,263,000
July 1, 2002 - May 1, 2003 – purchase of common stock from stockholder at $3.50 per share		(26,191)		(91,667)		0		0		0		(91,667)
January 15, 2003 - May 15, 2003 — common stock issued to Company president		8,334		82,841		0		0		0		82,841
May 14, 2003 — common stock issued to employee		1,000		11,250		0		0		0		11,250
June 1, 2002 - May 31, 2003 – compensation related to stock options issued to board members, employees and consultants		0		0		287,343		0		0		287,343
Net loss for the year ended May 31, 2003		0		0		0		0		(1,665,090)		(1,665,090)
Balance, May 31, 2003		2,449,591		3,758,315		603,912		(368,547)		(3,750,110)		243,570

The accompanying notes are an integral part of these unaudited condensed financial statements.

5

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)- (continued)

From Inception (September 17, 1999) through August 31, 2013

(Unaudited)

									Deficit
									Accumulated
					Additional		Common		During The
	Common Stock				Paid in		Stock-		Development
	Shares		Amount		Capital		Contra		Stage		Total
June 15, 2003, common stock issued to Company president		1,667		16,418		0		0		0		16,418
June 15, 2003, purchase of common stock from stockholder		(2,419)		(8,333)		0		0		0		(8,333)
September 18, 2003 – issuance of 1,489,129 of common stock issued in private placement At $8.50 per share, net of transaction costs		1,489,129		11,356,063		0		0		0		11,356,063
September 19, 2003 – repurchase and retired 598,961 shares for $300,000		(598,961)		(300,000)		0		0		0		(300,000)
December 12, 2003 – issuance of 7,880 shares to terminated employees at $13.00 per share		7,880		102,438		0		0		0		102,438
March 1, 2004 – common stock issued to employee at $12.75 per share		10,000		127,500		0		0		0		127,500
May 31, 2004 – reclassify common stock contra to common stock		0		(368,547)		0		368,547		0		0
June 1, 2003 – May 31, 2004 – compensation related to stock options issued to board members, employees and consultants		0		0		448,096		0		0		448,096
Net loss for the year ended May 31, 2004		0		0		0		0		(2,989,364)		(2,989,364)
Balance, May 31, 2004		3,356,887		14,683,854		1,052,008		0		(6,739,474)		8,996,388
November 30, 2004 – adjust March 1, 2004 common stock issued to employee		0		(20,000)		0		0		0		(20,000)
January 13, 2005 – common stock issued to employee at $12.75 per share		3,000		38,250		0		0		0		38,250
February 28, 2005 – Reclass Par Value for Reincorporation into DE as of 12/1/04		0		(14,702,070)		14,702,070		0		0		0
May 25, 2005 - issuance of 518,757 shares of common stock issued in private placement At $9.75 per share, net of transaction costs		518,757		5		4,851,188		0		0		4,851,193
June 1, 2004 – May 31, 2005 – compensation related to stock options issued to board members, employees and consultants		0		0		308,711		0		0		308,711
Net loss for the year ended May 31, 2005		0		0		0		0		(5,567,729)		(5,567,729)
Balance, May 31, 2005		3,878,644		39		20,913,977		0		(12,307,203)		8,606,813
August 23, 2005 – common stock issued to employee		8,000		0		100,000		0		0		100,000
October 19, 2005 – common stock issued to employee		2,000		0		25,000		0		0		25,000
December 30, 2005 – issuance of 519,026 shares of common stock issued in private placement at $11.25 per share, net of transaction costs		519,026		5		5,510,962		0		0		5,510,967
June 1, 2005 – May 31, 2006 – warrants exercised		70,320		1		786,537		0		0		786,538
June 1, 2005– May 31, 2006 – compensation related to stock options issued to board members, employees and consultants		0		0		404,679		0		0		404,679
Net loss for the year ended May 31, 2006		0		0		0		0		(6,104,402)		(6,104,402)
Balance, May 31, 2006		4,477,990		45		27,741,155		0		(18,411,605)		9,329,595

The accompanying notes are an integral part of these unaudited condensed financial statements.

6

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)- (continued)

From Inception (September 17, 1999) through August 31, 2013

(Unaudited)

									Deficit
									Accumulated
					Additional		Common		During The
	Common Stock				Paid in		Stock-		Development
	Shares		Amount		Capital		Contra		Stage		Total
July 7, 2006 – issuance of 1,214,203 shares of common stock issued in private placement at $12.50 per share, net of transaction costs		1,214,203		12		14,217,709		0		0		14,217,721
June 1, 2006 – May 31, 2007 – warrants exercised		26,700		0		300,374		0		0		300,374
June 1, 2006 – May 31, 2007 – stock options exercised		1,200		0		15,200		0		0		15,200
June 1, 2006 – May 31, 2007 – share based compensation to board members, employees and consultants		0		0		1,826,850		0		0		1,826,850
Net loss for the year ended May 31, 2007		0		0		0		0		(8,451,942)		(8,451,942)
Balance, May 31, 2007 – (Unaudited)		5,720,093		57		44,101,288		0		(26,863,547)		17,237,798
June 1, 2007 – May 31, 2008 – share based compensation to board members, employees and consultants		0		0		1,011,025		0		0		1,011,025
Net loss for the year ended May 31, 2008		0		0		0		0		(10,490,758)		(10,490,758)
Balance, May 31, 2008 – (Unaudited)		5,720,093		57		45,112,313		0		(37,354,305)		7,758,065
June 1, 2008 – May 31, 2009 – shared-based compensation to board members, employees and consultants		0		0		753,268		0		0		753,268
Net loss for the year ended May 31, 2009		0		0		0		0		(7,230,206)		(7,230,206)
Balance, May 31, 2009		5,720,093		57		45,865,581		0		(44,584,511)		1,281,127
June 1, 2009 – May 31, 2010 – shared-based expense to employees and debt holders		0		0		335,741		0		0		335,741
November 11, 2009 – record beneficial conversion value attached to senior secured convertible debt		0		0		521,793		0		0		521,793
November 11, 2009 – issuance of 8,695,692 shares of common stock at $.23		8,695,652		87		1,999,913		0		0		2,000,000
Net loss for the year ended May 31, 2010		0		0		0		0		(3,067,842)		(3,067,842)
Balance, May 31, 2010		14,415,745		144		48,723,028		0		(47,652,353)		1,070,819
June 1, 2010 – May 31, 2011 – shared-based expense to employees and debt holders		0		0		124,722		0		0		124,722
February 11, 2011 – record beneficial conversion value attached to senior secured convertible debt		0		0		1,616,667		0		0		1,616,667
February 11, 2011 – issuance of 4,510,870 shares of common stock		4,510,870		45		1,037,455		0		0		1,037,500
Net loss for the year ended May31, 2011		0		0		0		0		(3,357,882)		(3,357,882)
Balance, May 31, 2011		18,926,615		189		51,501,872		0		(51,010,235)		491,826
June 1, 2011 – May 31, 2012 – shared-based expense to employees and debt holders		0		0		829,144		0		0		829,144
Net loss for the year ended May31, 2012		0		0		0		0		(4,444,584)		(4,444,584)
Balance, May 31, 2012		18,926,615		189		52,331,016		0		(55,454,819)		(3,123,614)
June 1, 2012 – May 31, 2013 – shared-based expense to employees and debt holders		0		0		906,977		0		0		906,977
Net loss for the year ended May31, 2013		0		0		0		0		(6,280,234)		(6,280,234)
Balance, May 31, 2013		18,926,615		189		53,237,993		0		(61,735,053)		(8,496,871)

The accompanying notes are an integral part of these unaudited condensed financial statements.

7

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)- (continued)

From Inception (September 17, 1999) through August 31, 2013

(Unaudited)

									Deficit
									Accumulated
					Additional		Common		During The
	Common Stock				Paid in		Stock-		Development
	Shares		Amount		Capital		Contra		Stage		Total
June 1, 2013 – August 31, 2013 – share based compensation to employees		0		0		265,095		0		0		265,095
August 27, 2013 – issuance of 9,369,565 shares of common stock		9,369,565		94		2,154,906		0		0		2,155,000
Net loss for the period ended August 31, 2013		0		0		0		0		(1,512,243)		(1,512,243)
Balance, August 31, 2013 – (Unaudited)		28,296,180	$	283	$	55,657,994	$	0	$	(63,247,296)	$	(7,589,019)

The accompanying notes are an integral part of these unaudited condensed financial statements.

8

PROTALEX, INC.

(A Development Stage Company)

CONDENSED STATEMENTS OF CASH FLOWS

	Three Months		Three Months		From Inception (September 17, 1999)
	Ended		Ended		Through
	August 31,		August 31,		August 31,
	2013		2012		2013
	(Unaudited)		(Unaudited)		(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(1,512,243)	$	(1,364,972)	$	(63,247,296)
Adjustments to reconcile net loss to net cash and     cash equivalents used in     operating activities
(Gain) on disposal of equipment, net		0		0		(81,544)
Depreciation and amortization		255		234,313		1,971,395
Equity based expense		265,095		195,997		8,859,066
(Increase)/decrease in:
Prepaid expenses and deposits		25,116		24,036		(25,194)
Increase/(decrease) in:
Accounts payable and accrued expenses		(216,624)		(222,004)		1,191,584
Net cash and cash equivalents used in operating activities		(1,438,401)		(1,132,630)		(51,331,989)
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisition of intellectual technology license – fee portion		0		0		(20,000)
Refund of security deposits		0		0		7,990
Acquisition of equipment		0		0		(905,936)
Excess of amounts paid for public shell over assets acquired     to be accounted for as a recapitalization		0		0		(250,000)
Proceeds from disposal of equipment		0		0		229,135
Net cash and cash equivalents used in investing activities		0		0		(938,811)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from stock issuance, including options and warrants exercised		0		0		42,658,458
Principal payment on equipment notes payable and capital leases		0		0		(295,411)
Contribution by stockholders		0		0		183,569
Principal payment on note payable to individuals		0		0		(225,717)
Issuance of note payable to individuals		1,000,000		1,000,000		12,368,546
Acquisition of common stock		0		0		(400,000)
Net cash and cash equivalents provided by financing activities		1,000,000		1,000,000		54,289,445
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS		(438,401)		(132,630)		2,018,645
Cash and cash equivalents, beginning of period		2,457,046		190,395		0
Cash and cash equivalents, ending of period	$	2,018,645	$	57,765	$	2,018,645
SUPPLEMENTAL SCHEDULE OF CASH FLOW INFORMATION:
Interest paid	$	0	$	0	$	66,770
Taxes paid	$	0	$	0	$	100
NON-CASH FINANCING ACTIVITIES:
Conversion of debt for equity	$	2,155,000	$	0	$	3,192,500

The accompanying notes are an integral part of these unaudited condensed financial statements.

9

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 1. ORGANIZATION AND BUSINESS ACTIVITIES

Protalex, Inc., a Delaware corporation, (“we,” “us,” “our,” the “Company” or “its”) is a development stage company focused on the development of a class of biopharmaceutical drugs for treating autoimmune inflammatory diseases including rheumatoid arthritis(RA). Its lead product, PRTX-100, is a formulation of highly-purified form of staphylococcal protein A, which is an immune modulating protein produced by bacteria.

The Company maintains an administrative office in Summit, New Jersey and currently outsources all of its product development and regulatory activities, including clinical trial activities, manufacturing and laboratory operations to third-party contract research organizations and facilities.

In April 2009, the Company ceased all operations and terminated all employees in light of insufficient funds to continue its clinical trials and related product development. The Company’s business was dormant until new management took control of its operations in November 2009 following the change in control transaction more fully described below. The Company is currently actively pursuing the commercial development of PRTX-100 for the treatment of RA.

On December 8, 2010, the Company effected a reverse stock split of the outstanding shares of its common stock, with par value of $0.00001 per share (“Common Stock”), on the basis of one share of Common Stock for each five shares of Common Stock outstanding. Unless otherwise noted, all references in these financial statements and notes to financial statements to number of shares, price per share and weighted average number of shares outstanding of Common Stock prior to this reverse stock split have been adjusted to reflect the reverse stock split on a retroactive basis.

PRTX-100 has demonstrated effectiveness in animal models of autoimmune diseases as well as demonstrated activity on cultured human immune cells at very low concentrations, although the effectiveness of PRTX-100 shown in pre-clinical studies using animal models may not be predictive of the results that the Company would see in future human clinical trials. The Company does not anticipate generating operating revenue for the foreseeable future and does not currently have any products that are marketed.

NOTE 2. CHANGE OF OWNERSHIP TRANSACTION

On November 11, 2009 (the “Effective Date”), the Company consummated a financing transaction (the “Financing”) in which it raised $3,000,000 of working capital pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with Niobe Ventures, LLC, a Delaware limited liability company (“Niobe”). Pursuant to the Purchase Agreement, the Company issued to Niobe (i) 8,695,652 restricted shares of Common Stock at a purchase price of $0.23 per share (or $2 million in the aggregate) and (ii) a senior secured convertible promissory note in the principal amount of $1 million convertible into shares of Common Stock at an initial conversion price equal to $0.23 per share (the “$1 Million Secured Note”). On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of Common Stock. 

On February 11, 2011, for the purpose of providing the Company with additional working capital, pursuant to an existing Credit Facility Agreement dated as of December 2, 2009 (the “Facility”) with Niobe, the Company issued to Niobe a senior secured convertible promissory note in the principal amount of $2 million (the “$2 Million Secured Convertible Note”). The $2 Million Secured Convertible Note provided for conversion of interest and principal into shares of the Company’s Common Stock at a conversion price of $0.23 per share, bore interest at a rate of 3% per annum and had a maturity date of December 31, 2013. The original maturity was December 31, 2012 but in December 2012 Niobe agreed, for no consideration, to extend the maturity date to December 31, 2013.

The $2 Million Secured Convertible Note was convertible at any time, by the holder, subject only to the requirement that the Company have sufficient authorized shares of Common Stock after taking into account all outstanding shares of Common Stock and the maximum number of shares issuable under all issued and outstanding convertible securities.  On August 27, 2013, Niobe elected to convert the $2 Million Secured Convertible Note and $155,000 of accrued interest thereunder into 9,369,565 shares of Common Stock.

On February 1, 2012, the Company raised $1,000,000 of working capital pursuant to a loan from Niobe. The Company issued to Niobe a secured promissory note in the principal amount of $1,000,000 (the “February 2012 Secured Note”). The February 2012 Secured Note bears interest at a rate of 3% per annum and matures on February 1, 2014.

10

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 2. CHANGE OF OWNERSHIP TRANSACTION (Continued):

On June 5, 2012, the Company raised an additional $1,000,000 of working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on May 31, 2014 (the “June 2012 Secured Note”).  

On October 1, 2012, the Company raised $800,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $800,000, which bear interest at a rate of 3% per annum and matures on October 1, 2014 (the “October 2012 Secured Note”). 

On December 3, 2012, the Company raised $700,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $700,000, which bears interest at a rate of 3% per annum and matures on October 1, 2014 (the “December 2012 Secured Note”). 

Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.” 

On January 18, 2013, the Company raised $2,500,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,500,000, which bears interest at a rate of 3% per annum and matures on January 15, 2015 (the “January 2013 Secured Note”). 

On May 13, 2013, the Company raised $2,000,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,000,000, which bears interest at a rate of 3% per annum and matures on May 13, 2015 (the “May 2013 Secured Note”).

On August 27, 2013, the Company raised $1,000,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on August 27, 2015 (the “August 2013 Secured Note”).

Collectively, the January 2013 Secured Note, the May 2013 Secured Note and the August 2013 Secured Note are hereinafter referred to as the “2013 Secured Notes.”

Collectively, the 2012 Secured Notes and the 2013 Secured Notes represent a total of $9,000,000 in principal amount of loans from Niobe and are hereinafter referred to as the “Secured Notes.”

Payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if the Company undertakes certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

The Company’s obligations under the Secured Notes and the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of its personal property and assets, including its intellectual property.  

All of the securities issued in the aforementioned financings were issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the “Act”) pursuant to Section 4(6) and Rule 506 of Regulation D thereof.  The offer, sale and issuance of such securities were made without general solicitation or advertising. The securities were offered and issued only to “accredited investors” as such term is defined in Rule 501 under the Act.

11

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 3. GOING CONCERN

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern. The ability of the Company to continue as a going concern is dependent upon developing products that are regulatory approved and market accepted. There is no assurance that these plans will be realized in whole or in part. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.

Since inception, the Company has incurred an accumulated deficit of $63,247,296 through August 31, 2013. For the years ended May 31, 2013 and 2012, the Company had net losses of $6,280,234 and $4,444,584, respectively and for the three months ended August 31, 2013, the Company had a net loss of $1,512,243. The Company has used $4,733,349 and $2,351,630 of cash in operating activities for the years ended May 31, 2013 and 2012, respectively, and $1,438,401 during the three months ended August 31, 2013. As of August 31, 2013, the Company had cash and cash equivalents of $2,018,645 and negative net working capital of $491,281. The Company has incurred negative cash flow from operating activities since its inception.  The Company has spent, and subject to obtaining additional financing, expects to continue to spend, substantial amounts in connection with executing its business strategy, including continued development efforts relating to PRTX-100.

The Company has no significant payments due on long-term obligations since, as discussed below in Note 9-Subsequent Events, on October 11, 2013, the Company issued the Consolidated Note to Niobe. However, the Company has entered into a significant number of contracts to perform clinical trials in the remainder of 2013 and that it will need to raise additional capital in the future to fund the ongoing FDA approval process. If the Company is unable to obtain approval of its future IND applications or otherwise advance in the FDA approval process, its ability to sustain its operations would be significantly jeopardized.

The most likely sources of additional financing include the private sale of the Company’s equity or debt securities or loans from majority stockholders. Additional capital that is required by the Company may not be available on reasonable terms, or at all.

NOTE 4. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The interim financial data contained in this Report is unaudited; however in the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim period. The financial statements included herein have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to such rules and regulations, although the Company believes that the disclosures included herein are adequate to make the information presented not misleading. The results of operations in interim periods are not necessarily indicative of the results that may be expected for the full year.

Information regarding the organization and business of the Company, accounting policies followed by the Company and other important information is contained in the notes to the Company's financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended May 31, 2013. This quarterly report should be read in conjunction with our annual report.

Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires the Company to make estimates and assumptions affecting the reported amounts of assets, liabilities, revenues and expense, and the disclosure of contingent assets and liabilities. Estimated amounts could differ materially from actual results.

12

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 4. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued):

Loss per Common Share

The Financial Accounting Standards Board (FASB) has issued guidance for “Earnings Per Share” which provides for the calculation of “Basic” and “Diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net loss to common stockholders by the weighted average number of common shares outstanding for the period. All potentially dilutive securities consisting of employee stock options and warrants have been excluded from the computations since they would be antidilutive. However, these dilutive securities could potentially dilute earnings per share in the future. As of August 31, 2013 the Company had potentially dilutive securities consisting of 3,057,543 stock options. As of August 31, 2012, the Company had potentially dilutive securities consisting of 2,642,191 stock options.

Cash and Cash Equivalents

For the purposes of reporting cash flows, the Company considers all cash accounts which are not subject to withdrawal restrictions or penalties, and highly liquid investments with original maturities of 60 days or less to be cash and cash equivalents. The cash and cash equivalent deposits are not insured by The Federal Deposit Insurance Corporation.

Share Based Compensation

Effective June 1, 2006, the Company adopted the FASB accounting guidance for fair value recognition provisions of the “Accounting for Share-Based Payment” using the modified prospective method. This standard requires the Company to measure the cost of employee services received in exchange for equity share options granted based on the grant-date fair value of the options. The cost is recognized as compensation expense over the vesting period of the options. Under the modified prospective method $265,095 and $195,997 compensation cost is included in operating expenses for the three months ended August 31, 2013 and August 31, 2012, respectively. These amounts included both the compensation cost of stock options granted prior to but not yet vested as of June 1, 2006 and compensation cost for all options granted subsequent to May 31, 2006. In accordance with the modified prospective application transition method, prior period results are not restated. Incremental compensation cost for a modification of the terms or conditions of an award is measured by comparing the fair value of the modified award with the fair value of the award immediately before the modification. No tax benefit was recorded as of May 31, 2013 in connection with these compensation costs due to the uncertainty regarding ultimate realization of certain net operating loss carryforwards. The Company has also implemented the SEC interpretations in Staff Accounting Bulletin (“SAB”) for “Share-Based Payments,” in connection with the adoption of FASB accounting guidance.

The Board of Directors adopted and the stockholders approved the 2003 Stock Option Plan in October 2003 which was subsequently amended in October 2005. The plan was adopted to recognize the contributions made by the Company’s employees, officers, consultants, and directors, to provide those individuals with additional incentive to devote themselves to the Company’s future success, and to improve the Company’s ability to attract, retain and motivate individuals upon whom the Company’s growth and financial success depends. Under the plan, stock options may be granted as approved by the Board of Directors or the Compensation Committee. There are 900,000 shares reserved for grants of options under the plan, of which 88,800 have been issued and 800 were exercised. The Company has issued 271,784 stock options as standalone grants, of which 400 were exercised. Stock options vest pursuant to individual stock option agreements. No options granted under the plan are exercisable after the expiration of ten years (or less in the discretion of the Board of Directors or the Compensation Committee) from the date of the grant. The plan will continue in effect until terminated or amended by the Board of Directors.

The accounting guidance requires the use of a valuation model to calculate the fair value of each stock-based award. The Company uses the Black-Scholes model to estimate the fair value of stock options granted based on the following assumptions:

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

13

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 4. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued):

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

As of August 31, 2013, there were 3,057,543 stock options outstanding. At August 31, 2013, the aggregate unrecognized compensation cost of unvested options, as determined using a Black-Scholes option valuation model was approximately $86,726 (net of estimated forfeitures) will be recognized ratably through July 31, 2014. The remaining amount of options will be valued once they vest upon the future events. During the three months ended August 31, 2013, the Company did not grant any stock options and 28,000 options expired.

The fair value of the options is estimated on the date of the grant using the Black-Scholes option pricing model with the following assumptions:

	Three Months Ended August 31, 2013			Three Months Ended August 31, 2012			From Inception Through August 31, 2013
Dividends per year		0			0			0
Volatility percentage		418% - 426	%		97.5	%		90%-426	%
Risk free interest rate		2.13	%		3.47	%		1.74%-5.11	%
Expected life (years)		7.0-10.0			7.0-10.0			3-10
Weighted Average Fair Value	$	1.22		$	1.07		$	2.30

NOTE 5. RECENT ACCOUNTING PRONOUNCEMENTS

Management does not believe that any recently issued, but not yet effective, accounting standards could have a material effect on the accompanying consolidated financial statements. As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.

NOTE 6. RELATED PARTIES

Niobe, the majority stockholder of the Company and the holder of the Secured Notes (defined in Note 2, above), is controlled by Arnold P. Kling, the Company’s president and director. 

During the year ended May 31, 2013, the Company issued an aggregate of 350,000 options to Kirk M. Warshaw, the Company’s chief financial officer and director. The 350,000 options issued during fiscal year ended May 31, 2013 have a ten year life with an exercise price of $1.05. The options vested 50% upon issuance and the remainder will vest on May 22, 2014. The 350,000 options were valued at $329,000.

The Company’s principal offices are located at 133 Summit Avenue, Suite 22, Summit, New Jersey which are owned by Kirk M. Warshaw, LLC (the “LLC”), an affiliated company of Mr. Warshaw. The Company occupies its principal offices on a month to month basis. On March 1, 2010, it began paying a monthly fee of $500 to the LLC for the use and occupancy, and administrative services, related to its principal offices.

NOTE 7. SENIOR SECURED CONVERTIBLE NOTES - RELATED PARTY

On the Effective Date (defined in Note 2, above), the Company issued the $1 Million Secured Note to Niobe, its majority stockholder which is controlled by Arnold P. Kling, the Company’s president and director.  The $1 Million Secured Note bore interest at a rate of 3% per annum and had a scheduled maturity date of November 13, 2012.  The Company’s obligations under the $1 Million Secured Note were secured by a Security Agreement dated the Effective Date (the “Security Agreement”) which granted Niobe a security interest in substantially all of the Company’s personal property and assets, including its intellectual property. On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of Common Stock.

14

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 7. SENIOR SECURED CONVERTIBLE NOTES - RELATED PARTY (Continued):

On December 2, 2009, the Company entered into the Facility (defined in Note 2, above) with Niobe pursuant to which Niobe agreed to provide up to $2,000,000 of additional capital in the form of secured loans at any time prior to June 30, 2012 subject to the achievement of certain predetermined benchmarks. In connection with the Facility, on December 2, 2009, the Security Agreement securing our obligations under the $1 Million Secured Note was amended and restated to also secure any incremental obligations under the Facility (the “Amended Security Agreement”). Pursuant to the Amended Security Agreement, Niobe has a security interest in substantially all of our personal property and assets, including its intellectual property to collateralize all amounts due to it under the $1 Million Secured Note and the Facility.

Pursuant to the Facility, on February 11, 2011, the Company received $2,000,000 of additional working capital from Niobe and issued the $2 Million Secured Note to Niobe. The $2 Million Secured Note bore interest at a rate of 3% per annum and, as amended was scheduled to mature on December 31, 2013. On August 27, 2013, Niobe elected to convert the $2 Million Secured Convertible Note and $155,000 of accrued interest thereunder into 9,369,565 shares of Common Stock.

NOTE 8. SENIOR SECURED NOTES - RELATED PARTY

On February 1, 2012, the Company raised $1,000,000 of working capital pursuant to a loan from Niobe. The Company issued to Niobe a secured promissory note in the principal amount of $1,000,000 (the “February 2012 Secured Note”). The February 2012 Secured Note bears interest at a rate of 3% per annum and matures on February 1, 2014.

On June 5, 2012, the Company raised an additional $1,000,000 of working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on May 31, 2014 (the “June 2012 Secured Note”). 

On October 1, 2012, the Company raised $800,000 of additional working capital pursuant to loans from Niobe and issued to Niobe secured promissory notes in the principal amount of $800,000, which bear interest at a rate of 3% per annum and matures on October 1, 2014 (the “October 2012 Secured Note”). 

On December 3, 2012, the Company raised $700,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $700,000, which bears interest at a rate of 3% per annum and matures on October 1, 2014 (the “December 2012 Secured Note”). 

Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.” 

On January 18, 2013, the Company raised $2,500,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,500,000, which bears interest at a rate of 3% per annum and matures on January 15, 2015 (the “January 2013 Secured Note”). 

On May 13, 2013, the Company raised $2,000,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,000,000, which bears interest at a rate of 3% per annum and matures on May 13, 2015 (the “May 2013 Secured Note”).

On August 27, 2013, the Company raised $1,000,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on August 27, 2015 (the “August 2013 Secured Note”).

Collectively, the January 2013 Secured Note, the May 2013 Secured Note and the August 2013 Secured Note are hereinafter referred to as the “2013 Secured Notes.”

Collectively, the 2012 Secured Notes and the 2013 Secured Notes represent a total of $9,000,000 in principal amount of loans from Niobe and are hereinafter referred to as the “Secured Notes.”

15

PROTALEX, INC.

(A Company in the Development Stage)

NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS

From Inception (September 17, 1999) through August 31, 2013

NOTE 8. SENIOR SECURED NOTES - RELATED PARTY (Continued):

Payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if the Company undertakes certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

The Company’s obligations under the Secured Notes and the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of its personal property and assets, including its intellectual property.  

All of the securities issued in the aforementioned financings were issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the “Act”) pursuant to Section 4(6) and Rule 506 of Regulation D thereof.  The offer, sale and issuance of such securities were made without general solicitation or advertising. The securities were offered and issued only to “accredited investors” as such term is defined in Rule 501 under the Act.

NOTE 9. SUBSEQUENT EVENTS

On October 11, 2013, the Company issued a Consolidated, Amended and Restated Promissory Note to Niobe in the principal amount of $9,219,366.67 (the “Consolidated Note”). The face amount of the Consolidated Note reflects the $9.0 million aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance. The terms of the Consolidated Note are identical to the Secured Notes except that: (a) the maturity date is September 1, 2015, which is after the latest maturity date of any of the Secured Notes; and (b) it provides for partial mandatory repayment in the event that the Company receives aggregate gross proceeds in excess of $7.5 million from a single or multiple “Liquidity Events” in an amount equal to twenty-five (25%) percent of such gross proceeds. A “Liquidity Event” means (a) the sale of any of our equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party. In the Secured Notes, the entire principal amount of each note was due, at Niobe’s election, upon the consummation of an equity financing of $7.5 million or greater. Consistent with the terms of the Secured Notes and related security agreements entered into, the Company’s obligations under the Consolidated Note are secured by a first priority perfected security interest in all of the assets of the Company pursuant to a Consolidated, Amended and Restated Security Agreement dated October 11, 2013 between the Company and Niobe.

The Company has evaluated subsequent events and has determined that there were no other subsequent events to recognize or disclose in these financial statements.

16

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are a development stage company focused on the development of a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases including rheumatoid arthritis (RA). Our lead product, PRTX-100, is a formulation of highly-purified staphylococcal protein A, which is an immune modulating protein produced by bacteria. PRTX-100 has demonstrated effectiveness in animal models of autoimmune diseases as well as demonstrated activity on cultured human immune cells at very low concentrations, although the effectiveness of PRTX-100 shown in pre-clinical studies using animal models may not be predictive of the results that we would see in future human clinical trials. We do not anticipate generating operating revenue for the foreseeable future and do not currently have any products that are marketable.

In August 2010, we commenced a multi-center Phase 1b clinical trial of PRTX-100 in South Africa in adult patients with active RA on methotrexate (the “PRTX-100-103 Study”). The PRTX-100-103 Study was a proof of concept study to evaluate safety and potential efficacy of PRTX-100 in patients with active RA and was approved to enroll up to 40 patients in four dose escalating cohorts. In January 2012, we completed patient dosing in the fourth cohort of the PRTX-100-103 Study. A total of 37 patients were enrolled in four cohorts ranging from 0.15 micrograms/kg to 1.50 micrograms/kg of PRTX-100 or placebo, administered weekly for four weeks. Safety and disease were evaluated over 16 weeks following the first dose. The PRTX-100-103 Study results demonstrated that PRTX-100 was generally safe and well-tolerated in patients with active RA at all dose levels. More patients in the 0.90 micrograms/kg and 1.50 micrograms/kg cohorts showed improvement in their CDAI (Clinical Disease Activity Index for RA) than did patients in the lower dose or placebo cohorts. The safety, tolerability and pharmacokinetics (PK) of PTRX-100 in humans have now been characterized in four clinical studies. 

In November 2012, we commenced enrollment and dosing of patients in the U.S. for our new multicenter Phase 1b randomized, multiple-dose, dose-escalation study (the “PRTX-100-104 Study”) of PRTX-100 in combination with methotrexate and leflunomide in adults with active RA. The sequential dose escalation phase of this study was expected to enroll up to 40 patients into five cohorts ranging from 1.50 micrograms/kg up to 18.0 micrograms/kg of PRTX-100 or placebo. Similar to the PRTX-100-103 Study, the primary objective of the PRTX-100-104 Study was to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in patients with active RA on methotrexate therapy. The secondary objectives included determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the PK parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.

In August 2013, following a planned interim safety review by our Independent Data Safety Monitoring Committee (SMC) and upon completion of the fourth cohort, we elected to expand the 3.0 microgram, 6.0 microgram, and 12.0 microgram/kg dose cohorts of the PRTX-100-104 Study and an additional nine (9) patients were enrolled. Accordingly, the first four dose-escalating cohorts of the PRTX-100-104 Study, which includes these three expanded cohorts, enrolled a total of 41 patients with doses ranging from 1.5 micrograms/kg up to 12.0 micrograms/kg.

We maintain an administrative office in Summit, New Jersey and currently outsource all of our product development and regulatory activities, including clinical trial activities, manufacturing and laboratory operations to third-party contract research organizations, consultants and facilities.

In April 2009, under prior management, we ceased all operations and terminated all employees in light of insufficient funds to continue our clinical trials and related product development. Our business was dormant until new management took control of our operations in November 2009 following the “change in control” transaction described below. We are currently actively pursuing the commercial development of PRTX-100 for the treatment of RA.

On December 8, 2010, we effected a reverse stock split of the outstanding shares of our common stock, with par value of $0.00001 per share (“Common Stock”), on the basis of one new share of Common Stock for each five shares of Common Stock outstanding. All references in this Report to number of shares, price per share and weighted average number of shares outstanding of Common Stock prior to this reverse stock split have been adjusted to reflect the reverse stock split on a retroactive basis, unless otherwise noted.

Change in Control Transaction and Incremental Financing

On November 11, 2009 (the “Effective Date”), we consummated a financing transaction (the “Financing”) in which we raised $3,000,000 of working capital pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with Niobe Ventures, LLC, a Delaware limited liability company (“Niobe”). Pursuant to the Purchase Agreement, we issued to Niobe (i) 8,695,652 restricted shares of our Common Stock at a purchase price of $0.23 per share (or $2 million in the aggregate) and (ii) a senior secured convertible promissory note in the principal amount of $1 million convertible into shares of our Common Stock at an initial conversion price equal to $0.23 per share (the “$1 Million Secured Note”). On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of Common Stock. 

17

As contemplated by the Purchase Agreement, all of our executive officers and all of the members of our Board of Directors (the “Board”) prior to the closing of the Financing, with the exception of Frank M. Dougherty, resigned effective concurrently with the closing of the Financing.  Mr. Dougherty resigned effective upon the expiration of the 10-day notice period required by Rule 14f-1 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  In addition, effective upon the closing of the Financing, our Board appointed Arnold P. Kling as a director and then elected him as our president and elected Kirk M. Warshaw as our chief financial officer and secretary.

In addition, on the Effective Date, we terminated (i) the Investor Rights Agreement dated September 18, 2003 among us, vSpring SBIC L.P. (“vSpring”) and certain of the investors set forth on Schedule A thereto and the Registration Rights Agreement dated May 25, 2005 among us, vSpring and certain of the investors set forth on Schedule I thereto in accordance with their respective terms and (ii) stock options exercisable for an aggregate of 246,714 shares of Common Stock (approximately 41% of our then outstanding stock options).

On February 11, 2011, for the purpose of providing us with additional working capital, pursuant to an existing Credit Facility Agreement dated as of December 2, 2009 (the “Facility”) with Niobe, we issued to Niobe a senior secured convertible promissory note in the principal amount of $2 million (the “$2 Million Secured Convertible Note”). The $2 Million Secured Convertible Note provided for conversion of interest and principal into shares of our Common Stock at a conversion price of $0.23 per share, bore interest at a rate of 3% per annum and had a maturity date of December 31, 2013. The original maturity was December 31, 2012 but in December 2012 Niobe agreed, for no consideration, to extend the maturity date to December 31, 2013.

The $2 Million Secured Convertible Note was convertible at any time, by the holder, subject only to the requirement that we have sufficient authorized shares of Common Stock after taking into account all outstanding shares of Common Stock and the maximum number of shares issuable under all issued and outstanding convertible securities.  In addition, the $2 Million Secured Convertible Note would automatically be converted if we undertake certain Fundamental Transactions, as defined in the $2 Million Secured Convertible Note, (such as a merger, sale of all of our assets, exchange or tender offer, or reclassification of our stock or compulsory exchange).  The $2 Million Secured Convertible Note also provided for the adjustment of the conversion price in the event of stock dividends and stock splits, and provides for acceleration of maturity, at the holder’s option, upon an event of default, as defined in the $2 Million Secured Convertible Note. On August 27, 2013, Niobe elected to convert the principal and accrued interest under the $2 Million Secured Convertible Note of $155,000 into 9,369,565 shares of Common Stock.

On February 1, 2012, we raised $1,000,000 of working capital pursuant to a loan from Niobe. We issued to Niobe a secured promissory note in the principal amount of $1,000,000 (the “February 2012 Secured Note”). The February 2012 Secured Note bears interest at a rate of 3% per annum and matures on February 1, 2014.

On June 5, 2012, we raised an additional $1,000,000 of working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on May 31, 2014 (the “June 2012 Secured Note”). 

On October 1, 2012, we raised $800,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $800,000, which bear interest at a rate of 3% per annum and matures on October 1, 2014 (the “October 2012 Secured Note”). 

On December 3, 2012, we raised $700,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $700,000, which bears interest at a rate of 3% per annum and matures on October 1, 2014 (the “December 2012 Secured Note”). 

Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.” 

On January 18, 2013, we raised $2,500,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,500,000, which bears interest at a rate of 3% per annum and matures on January 15, 2015 (the “January 2013 Secured Note”). 

On May 13, 2013, we raised $2,000,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,000,000, which bears interest at a rate of 3% per annum and matures on May 13, 2015 (the “May 2013 Secured Note”).

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On August 27, 2013, we raised $1,000,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on August 27, 2015 (the “August 2013 Secured Note”).

Collectively, the January 2013 Secured Note, the May 2013 Secured Note and the August 2013 Secured Note are hereinafter referred to as the “2013 Secured Notes.”

Collectively, the 2012 Secured Notes and the 2013 Secured Notes represent a total of $9,000,000 in principal amount of loans from Niobe and are hereinafter referred to as the “Secured Notes.”

Payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if we undertake certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

Our obligations under the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of our personal property and assets, including our intellectual property.  

All of the securities issued in the aforementioned financings were issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the “Act”) pursuant to Section 4(6) and Rule 506 of Regulation D thereof.  The offer, sale and issuance of such securities were made without general solicitation or advertising. The securities were offered and issued only to “accredited investors” as such term is defined in Rule 501 under the Act.

About PRTX-100

PRTX-100 is a formulation of a proprietary, highly purified form of the Staphylococcal bacterial protein known as Protein A which is an immune modulating protein produced by bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to activate processes that mediate inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific immunologic signaling pathways. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune-mediated inflammatory diseases. The PRTX-100-103 Study demonstrated that PRTX-100 was generally safe and well tolerated at all dose levels up to 1.5 micrograms/kg, and at the higher doses, more patients showed improvement in their CDAI scores for RA than did patients at the lower dose or placebo cohorts.

Animal Studies

Protalex’s lead candidate, PRTX-100, has proven effective in two standard mouse models of autoimmunity:

Collagen-Induced Arthritis - PRTX-100 has demonstrated reproducible efficacy in this well-established animal model of RA. Mice received two injections of collagen in order to stimulate an inflammatory response. One group was treated with various doses of PRTX-100, a second group received Enbrel®, a leading commercially available treatment for RA, and the control group was injected with vehicle saline solution. The mice were observed for clinical symptoms, joint size and loss of function. The results showed that very low doses of PRTX-100 and standard doses of Enbrel® suppressed clinical symptoms including joint swelling over the first two to three weeks of treatment, and slowed disease progression as compared with the control group. Thereafter, the PRTX-100-treated mice continued to remain disease-free whereas the mice treated with Enbrel® showed a resumption of joint inflammation and tissue damage. This response to Enbrel® was expected because the mice developed immune response to it because it is a foreign protein. Overall, these results indicate that PRTX-100 is a potential treatment for RA in humans. The data from these studies has served as a rationale for conducting clinical trials in human patients.

BXSB Mice  - These animals are genetically predisposed to autoimmune diseases. This model is used to evaluate drugs for autoimmune diseases such as Lupus and other autoimmune diseases. This genetic model more closely approximates the human condition in that it is complex, multi-factorial and usually treated by multiple drug regimens. In these studies, mice were treated with PRTX-100 and sacrificed at regular intervals. Their organs were weighed and sectioned for histological analysis and their spleens were used for immunological assays. Spleen enlargement, or splenomegaly, was significantly reduced in treated animals compared with the controls at almost every time point, demonstrating the ability of PRTX-100 to delay the onset and severity of this disease.

Completed pre-clinical safety studies in animals have shown no drug-related toxicity at doses up to 5-fold the highest currently planned clinical trial dose. These studies were conducted on New Zealand white rabbits and on cynomolgus monkeys. No differences were observed in body weight gain or food consumption, nor in hematology, clinical chemistry, urinalysis, or organ weight data in animals treated with PRTX-100 compared with controls treated with vehicle. These study results were an important component of our IND application with the FDA.

Additional studies in monkeys have further characterized the pharmacokinetics, toxicity, and pharmacodynamics of PRTX-100 with up to 12 weekly doses.  

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Clinical Trials

Favorable pre-clinical safety and efficacy studies for our lead compound, PRTX-100, laid the foundation for the Investigational New Drug Application or IND for treating RA. We submitted the IND to the U.S. Food and Drug Administration (the “FDA”) in March 2005 and later in March 2005 the FDA verbally disclosed to us that it had placed our IND on clinical hold, pending additional product characterization. In August 2005, we formally replied to the FDA and in September 2005, the FDA notified us that it had lifted the clinical hold on our IND and that our proposed study could proceed. We commenced our first Phase I single-dose clinical trial in December 2005 and completed the Phase I clinical trial in March 2006. This trial was performed in healthy volunteers and was designed primarily to assess the safety and tolerability of a single intravenous dose of PRTX-100. This study demonstrated that PRTX-100 appeared safe and well-tolerated at the doses administered. There were no deaths or serious adverse events. The PK profile was determined and found consistent with that projected from pre-clinical models.   

In May 2007, we filed an amendment to the IND with the FDA. This amendment included the final Phase I safety study report, CMC update, and a protocol for a second single-dose Phase I clinical trial. In July and August 2007 a second Phase I study was performed under the IND, to further characterize the safety, pharmacokinetic, and pharmaco-dynamic profile of a single-dose of PRTX-100 in healthy volunteers at doses in the projected therapeutic range. Final results indicated that the drug was safe and well-tolerated. In August 2009, a Phase 1b randomized, double-blind, placebo controlled, multiple dose, dose escalation and tolerability study of PRTX-100 in combination with methotrexate in patients with active RA was approved by the South African Medicines Control Agency. The PRTX-100-103 Study commenced in August 2010 at three sites in South Africa and was completed in January 2012 as detailed below. In November 2012, we commenced enrollment and dosing of patients in the U.S. for the PRTX-100-104 Study, a second multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active RA and is still in progress as detailed below. The PRTX-100-104 Study sequentially escalated the weekly dose of PRTX-100 from 1.5 micrograms/kg, the highest dose in the prior RA patient study, to doses of 3.0, 6.0, and 12.0 micrograms/kg. of PRTX-100.

Idiopathic Thrombocytopenic Purpura - ITP is an uncommon autoimmune bleeding disorder characterized by too few platelets in the blood. The affected individuals make antibodies against their own platelets leading to the platelets' destruction, which in turn leads to the abnormal bleeding. A small clinical trial in adult patients with chronic ITP was designed to provide safety data on repeated weekly dosing with PRTX-100 (the “PRTX-100b-103 Study”). This clinical study was conducted under the Australian and New Zealand Clinical Trial Notification procedure, not under a U.S. IND. After the approval of the clinical protocol by ethics committees at six sites in Australia and one in New Zealand, the PRTX-100b-103 Study began enrolling patients in the second quarter of 2008. A leading Australian clinical research organization was contracted to manage and monitor this clinical trial. The PRTX-100b-103 Study was designed to evaluate the safety and pharmacokinetics of up to four doses of PRTX-100, starting at the lowest dose, and escalating upwards after safety review of the prior dose.  

The PRTX-100b-103 Study proved extremely difficult to enroll due to other on-going ITP Phase III studies and subsequent availability of two new and effective medicines for ITP. Nine patients were dosed at the first two dose levels by the end of the first quarter 2009. At this point further recruitment of patients was suspended. No side effects or toxicities were noted with repeated weekly doses of PRTX-100 that were not seen with single doses in healthy volunteer trials. This repeated-dose safety data from the PRTX-100b-103 Study formed the basis for the clinical trial application to evaluate PRTX-100 in patients with RA.

Rheumatoid arthritis - RA is a highly inflammatory polyarthritis often leading to joint destruction, deformity and loss of function. In addition to characteristic symmetric swelling of peripheral joints, systemic symptoms related to chronic inflammation can commonly occur. Chronic pain, disability and excess mortality are unfortunate sequelae. RA is the most common autoimmune disease, affecting 1 to 2 percent of the world’s population, with prevalence rising with age to about 5% in women over 55.

PRTX-100 shows measurable activity in a standard mouse model of autoimmune arthritis. A substantial body of published literature and proprietary data delineate the immune-modulatory activities of PRTX-100, which are distinct from those of current major biologic treatments for rheumatoid arthritis. Accordingly, we believe that RA represents a potentially important clinical indication for treatment with PRTX-100. While recent advances in biologic treatments for RA (with monoclonal antibodies) have improved the prognosis for many patients, many others continue to live with debilitating RA disease activity due either to the cost, side-effects, or limited effectiveness of these newer therapies.  

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The PRTX-100-103 Study

In August 2010, we commenced a multi-center Phase 1b clinical trial of PRTX-100 in South Africa on adult patients with active RA on methotrexate. The PRTX-100-103 Study was a proof of concept study to evaluate safety and potential efficacy of PRTX-100 in patients with active RA and was approved to enroll up to 40 patients in four dose escalating cohorts. In January 2012, we completed patient dosing in the fourth cohort of the PRTX-100-103 Study. A total of 37 patients were enrolled in four cohorts ranging from 0.15 micrograms/kg to 1.50 micrograms/kg of PRTX-100 or placebo, administered weekly for four weeks. Safety and disease were evaluated over 16 weeks following the first dose. The PRTX-100-103 Study results demonstrated that PRTX-100 was generally safe and well-tolerated in patients with active RA at all dose levels and at the higher doses, decreased RA activity as scored by the CDAI.

The primary disease activity response endpoint was the number of patients with a DAS28-CRP < 3.2 at week six. The results showed that the PRTX-100 patients as a group had more responders than placebo at all times, that responders increased over time during the 16 week study evaluation period, and that the maximum tolerated dose was not reached at the highest dose level.

Additionally, the results indicated that PRTX-100 did not decrease CRP (C-Reactive Protein) levels, even in those patients whose swollen and tender joint count and global VAS (Visual Analogue Scale) scores had decreased to low levels after treatment. Because of the influence of the CRP component on the DAS28-CRP score, a post-hoc analysis was performed examining changes in the CDAI scores in all patients to remove the influence of changes in CRP. In the placebo, 0.15 micrograms/kg, and 0.45 micrograms/kg dose groups, one out of eight patients in each group attained low disease activity (CDAI ≤ 10) on two or more consecutive visits. In the 0.90 micrograms/kg and 1.50 micrograms/kg dose groups, two of eight and two of five patients, respectively, attained this same endpoint, and maintained a CDAI < 10 until the week 16 final visit. Of the 4 apparent responders in the 1.50 micrograms/kg group, 2 attained a CDAI ≤ 6 (remission), one attained a CDAI ≤ 10 (low activity), and one achieved a CDAI of 10.1 at one or more visits. The mean time to peak response in this group occurred six weeks after their last dose.

As the disease activity results from the PRTX-100-103 Study demonstrated an acceptable safety profile, we commenced the PRTX-100-104 Study in November 2012 to provide a better understanding of safety and treatment effect on RA disease activity measurements as well as help define the optimal dose.

The PRTX-100-104 Study

In November 2012, we commenced enrollment and dosing of patients in the U.S. for the PRTX-100-104 Study of PRTX-100 in combination with methotrexate or leflunimode in adults with active RA. Similar to the PRTX-100-103 Study, the primary objective of this study was to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in patients with active RA on methotrexate therapy. The secondary objectives included determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the PK parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.

The sequential dose escalation phase of the PRTX-100-104 Study was expected to enroll up to 40 patients in the U.S. into five cohorts ranging from 1.50 micrograms/kg up to 18.0 micrograms/kg of PRTX-100 or placebo. The dose escalation phase could be followed by up to 12 additional patients for cohort expansion at the optimal dose. Following the enrollment and dosing of the fourth cohort, a planned interim safety review by the SMC took place in July 2013. As a result of the review, we elected to expand the 3.0 microgram, 6.0 microgram, and 12.0 microgram/kg dose cohorts of the PRTX-100-104 Study following completion of the fourth cohort, and subsequently, an additional nine (9) patients were enrolled in these expansion cohorts. Accordingly, the first four dose-escalating cohorts of the PRTX-100-104 Study, which includes these three expanded cohorts, enrolled a total of 41 patients with doses ranging from 1.5 micrograms/kg up to 12.0 micrograms/kg.

In addition, the SMC indicated that our plan to amend the PRTX 100-104 Study with respect to the fifth and final dosing cohort did not represent any safety concerns. The fifth cohort sub-study will include additional monthly maintenance doses of PRTX-100. The dose for infusions will be in the 3.0 micrograms/kg to 6.0 micrograms/kg range. Patients may receive up to nine doses of PRTX-100 over the six month study visit period, but the cumulative dosage will not exceed that of the fourth cohort (12.0 micrograms/kg). This fifth cohort sub-study is expected to enroll up to 16 additional patients.

Enrollment in the PRTX-100-104 Study is currently taking place at five study sites in the U.S. which may be expanded by an additional two to five U.S. sites.

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Manufacturing

We currently contract the manufacturing of our lead drug substance PRTX-100 to Eurogentec S.A. in Belgium where it is produced under Current Good Manufacturing Practice, or cGMP, conditions. In June 2012, we contracted with Eurogentec for the manufacture of additional bulk drug substance that we believe will be sufficient supply for completion of the PRTX-100-104 Study as well as other future studies. We have also contracted with an FDA-approved facility in Europe for the formulation of new drug product at higher concentrations in anticipation of administering higher dosages in this study as well as in future studies. The stability testing and packaging of the final drug product for clinical supplies are conducted at several other FDA-approved facilities in the U.S. These companies, in the aggregate, have provided the drug product for both toxicological testing and clinical supplies. We believe that this entire process is scaleable to commercial production but will require additional manufacturing resources. The original three clinical trials of PRTX-100 were conducted with a liquid formulation. The PRTX-100-103 Study and the PRTX-100-104 Study utilized a newer lyophilized formulation designed to achieve better stability and longer product shelf-life. Compared to therapeutic doses of other biologic products used to treat RA, we believe the overall costs for these proposed therapeutic doses of PRTX-100 are significantly less due to the low dose and the simplicity of drug substance manufacture.

Markets

RA is our current focus as a primary indication. RA is a serious autoimmune disorder that causes the body’s immune system to mistakenly produce antibodies that attack the lining of the joints, resulting in inflammation and pain. RA can lead to joint deformity or destruction, organ damage, disability and premature death. According to both the Arthritis Foundation and the American College of Rheumatology websites during 2012, approximately 1.3 million people in the U.S. have Rheumatoid Arthritis which is approximately 1% of the nation’s adult population. There are nearly three times as many women as men with the disease. The disease occurs in all ethnic groups and in every part of the world.

RA was chosen as a target disease because it represents a well-defined, rapidly growing market for which there is no current uniformly effective treatment. It is estimated that despite treatment with current approved RA therapeutics, at least a third of patients continue to have significant disability and limitations due to their disease. Current treatments are costly, some are associated with increased risk of cancer and opportunistic infections, and in most cases must be continued for decades. The market for the existing biologic RA drugs is primarily limited to those countries that have a high per capita income because the cost of treatment is about $30,000 per patient per year. Thus, a large portion of the world’s patient population cannot afford the existing biologic RA drugs. In contrast, we believe that PRTX-100 could potentially provide these patients with a therapy that is efficacious, cost-effective, and has a highly favorable benefit-risk ratio. 

Once further developed and approved, we believe that our products could be used to treat patients with moderate to severe cases of RA, and particularly those individuals for whom other treatments have failed. Given the differences in the regulatory approval process in different parts of the world, it is reasonable to believe that PRTX-100 might first be used in the developing world and then in Europe and North America.

Preliminary information gained in the laboratory on the mechanism of action of PRTX-100 suggests potential efficacy in a range of autoimmune diseases, including, but not limited to psoriasis, myasthenia, ITP and pemphigus.

Our long-term strategy, should PRTX-100 demonstrate safety and clinical proof of concept in RA, contemplates the pursuit of FDA approval to treat other autoimmune diseases where the drug’s ability to decrease the inflammatory response will abrogate the underlying disease processes. 

Competition

We believe, based on the pre-clinical trials and the results to date of our four Phase I clinical trials, that PRTX-100 has a potential competitive advantage as it may be safer and more efficacious than existing therapies, and may cost less to manufacture than competing biologic-based therapies. Current RA treatments are characterized by complex manufacturing methods and, in 2012, resulted in an average annual retail cost of approximately $15,000 to $25,550 per patient. The cost can increase according to the size/weight of a patient and the number of doses required. Additionally, patients are faced with the cost of the infusion itself and blood tests which are often not included in those cost estimates. A number of pharmaceutical agents are currently being used, with varying degrees of success, to control the signs and symptoms of RA and slow its progression. Available treatment options include:

· Analgesic/anti-inflammatory preparations, ranging from simple aspirin to the COX-2 inhibitors;

· Immunosuppressive/antineoplastic drugs, including azathioprine and methotrexate;

· TNF (Tumor Necrosis Factor) inhibitors, also known as anti-TNF therapy, currently represented by etanercept (Enbrel®), infliximab (Remicade®), and adalimumab (Humira®) and the newer entries, certolizumab (Cimzia®) and golimumab (Simponi®);

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· Soluble Interleukin-l (IL-I) Receptor Therapy, Anakinra (Kineret®) and (Il-6) tocilizumab (Actemra®);

· Costimulatory molecule inhibitor (abatacept, Orencia®);

·  Anti CD20 B-cell-directed therapy, rituximab (Rituxan®); and

· Janus Kinase (JAK) inhibitor, tofacitinib citrate (Xeljanz).

Many large and small pharmaceutical companies are active in this market, with Amgen Corporation (with Pfizer), Johnson & Johnson, Inc. (with Merck) and Abbott Laboratories dominating the market for biologic therapies with their respective products, Enbrel®, Remicade® and Humira®. According to each company’s 2012 annual reports, Enbrel generated revenues of approximately $7.9 billion combined for Amgen and Pfizer, Remicade generated revenues of more than $8.2 billion combined for Johnson & Johnson and Merck, and Abbott reported revenues of $9.3 billion for Humira. The final two TNFa inhibitors, usually second line use, have also increased their revenues. Cimzia generated revenues of $619 million for UCB and Astellas, and Simponi generated revenues of $938 million for Johnson & Johnson and Merck. Orencia generated revenues of $1.2 billion for Bristol Myers Squibb. Kineret generated revenues of $74 million for Amgen, and Actemra generated revenues of $699 million for Roche. Rituxan generated revenues of $6.8 billion for Roche and Xeljanz which was approved in 2012 for Pfizer has not reported revenues to date. These revenues reflect the use of these drugs for RA, other indications and off label uses.

Post-marketing experience has indicated an enhanced risk for serious and opportunistic infections in patients treated with TNF inhibitors. Disseminated tuberculosis due to reactivation of latent disease was also seen commonly within clinical trials of TNF inhibitors. There is also a possibly increased risk of lymphoma in patients treated with TNF inhibitors. TNF inhibitors are not recommended in patients with demyelinating disease or with congestive heart failure. Transient neutropenia or other blood dyscrasias have been reported with Enbrel® and the other TNF inhibitors. There was also an increased risk of serious infections with rituximab therapy in clinical trials, and abatacept has also been associated with an increased risk of serious infections. In addition, according to a study by a Swedish research group published in November 2012 by the American College of Rheumatology entitled, “Mortality Rates In Patients With Rheumatoid Arthritis Treated With Tumor Necrosis Factor Inhibitors”, following treatment of RA with either of the TNF inhibitors etanercept, infliximab, or adalimumad, mortality rates were on average approximately 1 death per 30 patients treated in the first three years of treatment. Findings such as these indicate that new and safer treatments for autoimmune diseases such as RA are needed.

As mentioned above, several companies have marketed or are developing thrombopoetin agonists for treatment of ITP. They include Amgen’s Nplate and GSK’s Promacta, both FDA approved.

Government Regulation and Product Approval

The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (preclinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of drugs and drug product candidates. If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted.  We and our manufacturers may also be subject to regulations under other U.S. federal, state, local and foreign laws.

In the U.S., the FDA regulates drugs under the Food Drug and Cosmetic Act, or FDCA, and implementing regulations. The process required by the FDA before our drug candidates may be marketed in the U.S. generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):

⋅	completion of extensive preclinical laboratory tests, preclinical animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice or GLP regulations and other regulations;
⋅	submission to the FDA of an IND application which must become effective before clinical trials may begin;
⋅	performance of multiple adequate and well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication;
⋅	submission of a Biological License Application or BLA to the FDA;
⋅	satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with cGMP, regulations and other applicable regulations; and
⋅	the FDA review and approval of the BLA prior to any commercial marketing, sale or shipment of the drug.

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The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all. Risks to us related to these regulations are described in the Risk Factors in Item 1A of this Report.

A separate submission to the FDA, under an existing IND must also be made for each successive clinical trial conducted during product development. The FDA must also approve changes to an existing IND. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice or GCP requirements and regulations for informed consent.

Clinical Trials

For purposes of BLA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different trials may be required by the FDA as well):

⋅	Phase I clinical trials are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients. In some cases, particularly in cancer trials, a sponsor may decide to conduct what is referred to as a “Phase 1b” evaluation, which is a second safety-focused Phase I clinical trial typically designed to evaluate the impact of the drug candidate in combination with currently FDA-approved drugs.
⋅	Phase II clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the drug candidate for specific targeted indications and to determine an optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials. In some cases, a sponsor may decide to conduct what is referred to as a “Phase IIb” evaluation, which is a second, confirmatory Phase II clinical trial that could, if positive and accepted by the FDA, serve as a pivotal clinical trial in the approval of a drug candidate.
⋅	Phase III clinical trials are commonly referred to as pivotal trials. When Phase II clinical trials demonstrate that a dose range of the drug candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

In some cases, the FDA may condition continued approval of a BLA on the sponsor’s agreement to conduct additional clinical trials with due diligence. In other cases, the sponsor and the FDA may agree that additional safety and/or efficacy data should be provided; however, continued approval of the BLA may not always depend on timely submission of such information. Such post-approval studies are typically referred to as Phase IV studies.

Biological License Application

The results of drug candidate development, preclinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, and the payment of a user fee, are submitted to the FDA as part of a BLA. The FDA reviews all BLAs submitted before it accepts them for filing and may request additional information rather than accepting a BLA for filing. Once a BLA is accepted for filing, the FDA begins an in-depth review of the application.

During its review of a BLA, the FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA may refuse to approve a BLA and issue a not approvable letter if the applicable regulatory criteria are not satisfied, or it may require additional clinical or other data, including one or more additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaboration partners interpret data. If the FDA’s evaluations of the BLA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue either an approval letter or an approvable letter, which contains the conditions that must be met in order to secure final approval of the BLA. If and when those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the drug for certain indications. The FDA may withdraw drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label. Further, if there are any modifications to the drug, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require us to develop additional data or conduct additional preclinical studies and clinical trials.

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Fast Track Designation

The FDA’s fast track program is intended to facilitate the development and to expedite the review of drugs that are intended for the treatment of a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs. Under the fast track program, applicants may seek traditional approval for a product based on data demonstrating an effect on a clinically meaningful endpoint, or approval based on a well-established surrogate endpoint. The sponsor of a new drug candidate may request the FDA to designate the drug candidate for a specific indication as a fast track drug at the time of original submission of its IND, or at any time thereafter prior to receiving marketing approval of a marketing application. The FDA will determine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request.

If the FDA grants fast track designation, it may initiate review of sections of a BLA before the application is complete. This so-called “rolling review” is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant has paid applicable user fees. The FDA’s Prescription Drug User Fee Act or PDUFA review clock for both a standard and priority BLA for a fast track product does not begin until the complete application is submitted. Additionally, fast track designation may be withdrawn by the FDA if it believes that the designation is no longer supported by emerging data, or if the designated drug development program is no longer being pursued. 

In some cases, a fast track designated drug candidate may also qualify for one or more of the following programs:

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Priority Review. As explained above, a drug candidate may be eligible for a six-month priority review. The FDA assigns priority review status to an application if the drug candidate provides a significant improvement compared to marketed drugs in the treatment, diagnosis or prevention of a disease. A fast track drug would ordinarily meet the FDA’s criteria for priority review, but may also be assigned a standard review. We do not know whether any of our drug candidates will be assigned priority review status or, if priority review status is assigned, whether that review or approval will be faster than conventional FDA procedures, or that the FDA will ultimately approve the drug.

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Accelerated Approval.  Under the FDA’s accelerated approval regulations, the FDA is authorized to approve drug candidates that have been studied for their safety and efficacy in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments based upon either a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than patient survival or irreversible morbidity. In clinical trials, surrogate endpoints are alternative measurements of the symptoms of a disease or condition that are substituted for measurements of observable clinical symptoms. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies with due diligence, or to validate a surrogate endpoint or confirm a clinical benefit during post-marketing studies, may cause the FDA to seek to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA

When appropriate, we intend to seek fast track designation, accelerated approval or priority review for our drug candidates. We cannot predict whether any of our drug candidates will obtain fast track, accelerated approval, or priority review designation, or the ultimate impact, if any, of these expedited review mechanisms on the timing or likelihood of the FDA approval of any of our drug candidates.

Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a drug candidate is intended to treat a chronic disease, as is the case with the drug candidate we are developing, safety and efficacy data must be gathered over an extended period of time. Government regulation may delay or prevent marketing of drug candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for changes in dosage form or new indications for our drug candidates on a timely basis, or at all. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a drug may result in restrictions on the drug or even complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain, regulatory approvals for our drug candidate would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.

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Other Regulatory Requirements

Any drugs manufactured or distributed by us or any potential collaboration partners pursuant to future FDA approvals are subject to continuing regulation by the FDA, including recordkeeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the BLA for that drug.

The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning and/or untitled letters, corrective advertising and potential civil and criminal penalties.

Orphan Drug Designation in the United States, the European Union and other foreign jurisdictions

We are currently evaluating filing for Orphan Drug Designation in the U.S. as well as certain foreign jurisdictions from among several disease indications. Based upon study data to date, we believe that PRTX-100 may be effective in the treatment of ITP, as well as other orphan immune systems diseases.

Under the U.S. Orphan Drug Act, Orphan drug designation is granted by the FDA to drugs intended to treat a rare disease or condition, which for this program is defined as having a prevalence of fewer than 200,000 individuals in the U.S. Orphan drug designation must be requested before submitting a marketing application. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.

Orphan drug designation does not shorten the regulatory review and approval process, nor does it provide any advantage in the regulatory review and approval process. However, if a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to an orphan exclusivity period, in which the FDA may not approve any other applications to market the same drug for the same indication for seven years in the U.S., except in limited circumstances.

In addition, outside of the U.S. medicinal products used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in European Union and medicinal products which, for economic reasons, would be unlikely to be developed without incentives may be granted orphan designation in the European Union. The application for orphan designation is submitted to the European Medicines Agency (EMA) before an application is made for marketing authorization. Once authorized, orphan medicinal products are entitled to ten years of market exclusivity. During this ten year period, with a limited number of exceptions, neither the competent authorities of the European Union member states nor the EMA are permitted to accept applications or grant marketing authorization for other similar medicinal products with the same orphan indication. However, marketing authorization may be granted to a similar medicinal product with the same orphan indication during the ten year period with the consent of the marketing authorization holder for the original orphan medicinal product or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities. Marketing authorization may also be granted to a similar medicinal product with the same orphan indication if this product is safer, more effective or otherwise clinically superior to the original orphan medicinal product.

Foreign Regulation

In addition to regulations in the U.S., we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our future products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The mutual recognition procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval.

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In addition to regulations in Europe and the U.S., we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future products.

Patents, Trademarks, and Proprietary Technology

Patents and other proprietary rights are important to our business. Our practice is to file patent applications to protect technology, inventions and improvements to our technologies that are considered important to the development of our business. We have filed several U.S. patent applications and international counterparts of certain of these applications. We also rely upon our trade secrets, know-how, and continuing technological innovations, as well as patents that we may license from other parties, to develop and maintain our competitive position.

Our success will depend on our ability to maintain our trade secrets and proprietary technology in the U.S. and in other countries. We filed an initial therapeutic use patent application with the U.S. Patent and Trademark Office, or PTO, which issued in May 2007, as U.S. 7,211,258. The 258 patent has claims relating to the treatment of acute inflammation as well as rheumatoid arthritis (RA) and systemic lupus erythematosis (SLE) using protein A. A second patent claiming the use of protein A to treat idiopathic thrombocytopenia or autoimmune thrombocytic purpura issued as U.S. 7,425,331 in September, 2008. A further patent for the use of protein A issued as U.S. 7,807,170 in October, 2010. The 170 patent claims the use of protein A to reduce an acute inflammatory response or inflammation, including when these symptoms are associated with myasthenia gravis, ulcerative colitis, Crohn’s disease, psoriatic arthritis or pemphigus vulgaris. A further patent claiming the use of protein A to treat psoriasis and scleroderma issued as U.S. 8,168,189 in May, 2012. We have also filed for foreign patent protection in Canada, Japan and the European Union. Japanese patent JP 4598404 issued in October, 2010 with claims relating to use of protein A to treat rheumatoid arthritis, systemic lupus erythematosis (SLE), idiopathic thrombocytopenia, and autoimmune thrombocytopenia purpura.

It is our policy to require our employees, consultants, and parties to collaborative agreements to execute confidentiality agreements upon the commencement of employment or consulting relationships or collaborations with us. These agreements generally provide that all confidential information developed or made known during the course of the relationship with us is to be kept confidential and not to be disclosed to third parties except in specific circumstances.

Employees

We have three part-time employees, our president, our chief financial officer and an administrative person. In addition, we also have a Scientific Advisory Board which is staffed by highly qualified consultants with the background and scientific expertise we need to carry out our long-term business objectives. We believe that our relationship with all of our employees and our Scientific Advisory Board is generally good.

Critical Accounting Policies

Our financial statements are prepared in conformity with accounting principles generally accepted in the United States of America. Note 2 to the financial statements describes the significant accounting policies and methods used in the preparation of our financial statements.

We have identified the policies below as some of the more critical to our business and the understanding of our financial position and results of operations. These policies may involve a high degree of judgment and complexity in their application and represent the critical accounting policies used in the preparation of our financial statements. Although we believe our judgments and estimates are appropriate and correct, actual future results may differ from estimates. If different assumptions or conditions were to prevail, the results could be materially different from these reported results. The impact and any associated risks related to these policies on our business operations are discussed throughout this Report where such policies affect our reported and expected financial results.

The preparation of our financial statements, in conformity with accounting principles generally accepted in the United States, requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and equity and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. These estimates have a material impact on our financial statements and are discussed in detail throughout this Report.

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As part of the process of preparing our financial statements, we are required to estimate income taxes in each of the jurisdictions in which we operate. This process involves estimating actual current tax expense together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within the balance sheet. We must then assess the likelihood that our deferred tax assets will be recovered from future taxable income and to the extent we believe that recovery is not likely, we must establish a valuation allowance. In the event that we determine that we would be able to realize deferred tax assets in the future in excess of the net recorded amount, an adjustment to the deferred tax asset valuation allowance would increase income in the period such determination was made.

We account for our stock option grants under the provisions of the accounting guidance for Share-Based Payments. Such guidance requires the recognition of the fair value of share-based compensation in the statements of operations. The fair value of our stock option awards was estimated using a Black-Scholes option valuation model. This model requires the input of highly subjective assumptions and elections in adopting and implementing this guidance, including expected stock price volatility and the estimated life of each award. The fair value of share-based awards is amortized over the vesting period of the award and we have elected to use the straight-line method for awards granted after the adoption of this guidance.

Results of Operations

Research and Development Expenses - Research and Development expenses (“R&D Expenses”) were $933,118 and $675,028 for the three months ended August 31, 2013 and August 31, 2012, respectively. The increase in R&D Expenses for the three month period ended August 31, 2013 compared to the three month period ended August 31, 2012 was primarily the result of an increase in the activities associated with the activities associated with the PRTX 100-104 Study. 

There are significant risks and uncertainties inherent in the preclinical and clinical studies associated with our research and development program. These studies may yield varying results that could delay, limit or prevent a program’s advancement through the various stages of product development and significantly impact the costs to be incurred, and time involved, in bringing a program to completion. As a result, the costs to complete such programs, as well as the period in which net cash outflows from such programs are expected to be incurred, are not reasonably estimable.

Administrative Expenses - Administrative expenses were $372,759 and $314,127 for the three months ended August 31, 2013 and August 31, 2012, respectively. The increase in administrative expenses for the three month period ended August 31, 2013 compared to the same prior year period was due to increased employee stock compensation.

Professional Fees - Professional expenses were $129,777and $126,611 for the three months ended August 31, 2013 and August 31, 2012, respectively. The increase for the three month period ended August 31, 2013 was due to an increase in SEC related filing expenses as compared to the same period last year. 

Net Loss Outlook

We have not generated any product sales revenues, have incurred operating losses since inception and have not achieved profitable operations. Our accumulated deficit from inception through August 31, 2013 was $63,247,296 and we expect to continue to incur substantial losses in future periods. We expect that our operating losses in future periods will be the result of continued research and development expenses relating to PRTX-100, as well as costs incurred in preparation for the potential commercialization of PRTX-100.

In addition to additional financing, we are highly dependent on the success of our research and development efforts and, ultimately, upon regulatory approval and market acceptance of our products under development, particularly our lead product candidate, PRTX-100. We may never receive regulatory approval for any of our product candidates, generate product sales revenues, achieve profitable operations or generate positive cash flows from operations, and even if profitable operations are achieved, they may not be sustained on a continuing basis.

Liquidity and Capital Resources

Since 1999, we have incurred significant losses and we expect to experience operating losses and negative operating cash flow for the foreseeable future. Historically, our primary source of cash to meet short-term and long-term liquidity needs has been the sale of shares of our common stock. We have issued shares in private placements at discounts to then current market price.

On September 18, 2003, we raised $12,657,599 through the sale of 1,489,129 shares of our common stock at $8.50 per share, with warrants to purchase an additional 632,879 shares of our common stock, at an exercise price of $12.00 per share. These warrants expired on September 19, 2008. Net of transaction costs of $1,301,536, our proceeds were $11,356,063.

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On May 25, 2005, we raised $5,057,885 through the sale of 518,757 shares of our common stock at $9.75 per share, with warrants to purchase an additional 184,024 shares of our common stock, at an exercise price of $11.25 per share. All of these warrants expired on May 25, 2010. Net of transaction costs of $206,717, our proceeds were $4,851,168.

On December 30, 2005, we raised $5,839,059 through the sale of 519,026 shares of our common stock at $11.25 per share, with warrants to purchase an additional 129,757 shares of our common stock, at an exercise price of $14.95 per share. We also issued warrants to purchase 45,415 shares of our common stock, at an exercise price of $14.95 per share, to the placement agent. All of these warrants expired on December 30, 2010. Net of transaction costs of approximately $328,118, our proceeds were $5,510,941.

In the fourth fiscal quarter of 2006, existing investors exercised 70,320 warrants which resulted in $786,538 in cash proceeds.

On July 7, 2006, we raised $14,217,660, net of transaction costs of $959,874, through the sale of 1,214,203 shares of our common stock at $12.50 per share, with warrants to purchase an additional 303,551 shares of our common stock, at an exercise price of $19.25 per share. We also issued warrants to purchase 106,243 shares of our common stock, at an exercise price of $19.25 per share, to the placement agent. All of these warrants expired on July 7, 2011.

In the first fiscal quarter of 2007, existing investors and option holders exercised 26,700 warrants and 1,200 options which resulted in $315,574 in cash proceeds.

On November 11, 2009, we raised $3,000,000; $2,000,000 from the sale of Common Stock and $1,000,000 from the issuance of the $1 Million Secured Note to Niobe.

On December 2, 2009, we entered into the Facility with Niobe to provide us with up to $2,000,000 of additional working capital in the form of secured loans at any time prior to June 30, 2012 subject to our achievement of certain predetermined benchmarks. On February 11, 2011 we received $2,000,000 of additional working capital from Niobe under the Facility and issued the $2 Million Secured Convertible Note to Niobe. The $2 Million Secured Note was convertible into shares of Common Stock at a conversion price equal to $0.23 per share, for an aggregate of 8,695,652 shares of Common Stock (net of accrued interest thereon), bore interest at a rate of 3% per annum and had a maturity date of December 31, 2013.  On August 27, 2013, Niobe elected to convert the $2 Million Secured Convertible Note and $155,000 of accrued interest thereunder into 9,369,565 shares of Common Stock.

Beginning in February 2012 we have raised an aggregate of $9,000,000 of working capital pursuant to loans from Niobe. In connection with these loans, we issued to Niobe the Secured Notes.

Our obligations under the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of our personal property and assets, including its intellectual property, to collateralize all amounts due under the Secured Notes.  In addition, payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if we undertake certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

Net Cash Used In Operating Activities and Operating Cash Flow Requirements Outlook

Our operating cash outflows for the three months ended August 31, 2013 and August 31, 2012 have resulted primarily from research and development expenditures associated for PRTX-100 and administrative purposes. We expect to continue to use cash resources to fund operating losses and expect to continue to incur operating losses in this fiscal year and beyond due to continuing research and development activities.

Net Cash Used In Investing Activities and Investing Requirements Outlook

We do not expect to be required to make any significant investments in information technology and laboratory equipment to support our future research and development activities.

We may never receive regulatory approval for any of our product candidates, generate product sales revenues, achieve profitable operations or generate positive cash flows from operations, and even if profitable operations are achieved, these may not be sustained on a continuing basis. We have invested a significant portion of our time and financial resources since our inception in the development of PRTX-100, and our potential to achieve revenues from product sales in the foreseeable future is dependent largely upon obtaining regulatory approval for and successfully commercializing PRTX-100, especially in the United States. We expect to continue to use our cash and investments resources to fund operating and investing activities.

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Off-Balance Sheet Arrangements

As of August 31, 2013, we had no off-balance sheet arrangements such as guarantees, retained or contingent interest in assets transferred, obligation under a derivative instrument and obligation arising out of or a variable interest in an unconsolidated entity.

ITEM 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company we are not required to provide the information required by this Item.

ITEM 4. CONTROLS AND PROCEDURES

(a)  Evaluation of Disclosure Controls and Procedures

Our management, with the participation of both of our president and chief financial officer, carried out an evaluation of the effectiveness of our “disclosure controls and procedures” (as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Rules 13a-15(e) and 15-d-15(e)) as of the end of the period covered by this Report (the “Evaluation Date”). Based upon that evaluation, both of our president and chief financial officer concluded that as of the Evaluation Date, our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (ii) is accumulated and communicated to our management, including our president and our chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

(b) Changes in Internal Control over Financial Reporting 

There were no changes in our internal controls over financial reporting that occurred during the quarter covered by this Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II – OTHER INFORMATION

ITEM 5.      OTHER INFORMATION

On October 11, 2013, we issued a Consolidated, Amended and Restated Promissory Note to Niobe in the principal amount of $9,219,366.67 (the “Consolidated Note”). The face amount of the Consolidated Note reflects the $9,000,000 on aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance. The terms of the Consolidated Note are identical to the Secured Notes except that: (a) the maturity date is September 1, 2015, which is after the latest maturity on any of the Secured Notes; and (b) it provides for partial mandatory repayment in the event we receive aggregate gross proceeds in excess of $7.5 million from a single or multiple “Liquidity Events” in an amount equal to twenty-five (25%) percent of such gross proceeds. A “Liquidity Event” means (a) the sale of any of our equity, or equity -linked securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party. In the Secured Notes, the entire principal amount of each note was due, at Niobe’s election, upon the consummation of an equity financing of $7.5 million or greater. Consistent with the terms of the Secured Notes and related security agreements entered into, our obligations under the Consolidated Note are secured by a first priority perfected security interest in all of our assets pursuant to a Consolidated, Amended and Restated Security Agreement dated October 11, 2013 between us and Niobe (the “Consolidated Security Agreement”).

The Consolidated Note and the Consolidated Security Agreement are filed as Exhibits 4.1 and 10.1, respectively, to this Report.

ITEM 6. EXHIBITS

Exhibit
No.	Description
4.1	Consolidated, Amended and Restated Promissory Note in the principal amount of $9,219,366.67, dated October 11, 2013.	Filed herewith.
10.1	Consolidated, Amended and Restated Security Agreement dated October 11, 2013, between the Company and Niobe Ventures, LLC.	Filed herewith.
31.1	Certification of Chief Executive Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
31.2	Certification of Chief Financial Officer pursuant to Section 302(a) of the Sarbanes-Oxley Act	Filed herewith.
32.1	Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Filed herewith.
32.2	Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act	Filed herewith.
101.INS	XBRL Instance Document.	Filed herewith.
101.SCH	XBRL Taxonomy Extension Schema Document.	Filed herewith.
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document.	Filed herewith.
101.LAB	XBRL Taxonomy Extension Label Linkbase Document.	Filed herewith.
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document.	Filed herewith.
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.	Filed herewith.

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SIGNATURES

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

Date: October 11, 2013	PROTALEX, INC.
	By: /s/ Arnold P. Kling
	Arnold P. Kling, President
	(Principal Executive Officer)

Date: October 11, 2013
	By: /s/ Kirk M. Warshaw
	Kirk M. Warshaw, Chief Financial Officer
	(Principal Financial Officer)

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EX-4.1

CONSOLIDATED, AMENDED AND RESTATED PROMISSORY NOTE

$9,219,366.67	October 11, 2013
	New York, New York

This CONSOLIDATED, AMENDED AND RESTATED PROMISSORY NOTE (this “Note”) consolidates, amends and restates in their entirety the terms and provisions of those certain promissory notes as more fully described on Exhibit A attached hereto (said promissory notes being hereinafter referred to as, collectively, the “Prior Notes”) so that this Note shall hereafter constitute evidence of but one debt in the principal sum of Nine Million Two Hundred Nineteen Thousand Three Hundred Sixty Six and 67/100 Dollars ($9,219,366.67). The conditions contained in this Note shall supersede and control the terms, covenants, agreements, rights, obligations and conditions of the Prior Notes (it being agreed that the modification of the Prior Notes shall not impair the debt evidenced by each of the Prior Notes). This Note does not create new or additional indebtedness but evidences the same indebtedness evidenced by the Prior Notes and secured by the Security (as hereinafter defined).

The Prior Notes, as consolidated, are hereby amended, restated and superseded in their entirety to read as follows:

FOR VALUE RECEIVED, PROTALEX, INC., a Delaware corporation (“Protalex”), having an address at 133 Summit Avenue, Suite 22, Summit, NJ 07901 (the “Company”), unconditionally promise to pay to the order of NIOBE VENTURES, LLC, a Delaware limited liability company (hereinafter referred to as the “Holder”), at the offices of Morse, Zelnick, Rose & Lander LLP, 405 Park Avenue, Suite 1401, New York, New York 10022, or at such other place as Holder may designate in writing, the principal sum of Nine Million Two Hundred Nineteen Thousand Three Hundred Sixty Six and 67/100 Dollars ($9,219,366.67) (the “Principal Sum”), with interest thereon computed from the date hereof until maturity, whether on the Maturity Date (as hereinafter defined), by acceleration, or otherwise, at the rate of three percent (3.00%) per annum (the “Interest Rate”), and thereafter, in accordance with the terms of this Note, at the Default Rate (as hereinafter defined and governed), together with any costs, expenses and attorneys’ fees incurred by Holder pursuant to the provisions hereof. Any amounts that remain unpaid after the Maturity Date shall thereafter bear interest at the rate of twelve percent (12%) per annum (the “Default Rate”). Interest as aforesaid shall be calculated on the basis of actual number of days elapsed over a year of 360 days.

The Principal Sum and all accrued interest on this Note shall be due on September 1, 2015, or such earlier date as provided for in Section 5 hereof (the “Maturity Date”). The Maturity Date is subject to acceleration in accordance with Section 4 hereof.

Section 1. Promissory Note. This Note is a direct debt obligation of the Company and, pursuant to the Consolidated, Amended and Restated Security Agreement dated the date hereof (the “A/R Security Agreement”) all of the Company’s obligations hereunder are secured by a first priority perfected security interest in all of the assets of the Company (the “Security”) for the benefit of the Holder.

Section 2. Definitions. For the purposes hereof, in addition to the terms defined elsewhere in this Note the following terms shall have the following meanings:

“Business Day” means any day except Saturday, Sunday and any day which shall be a federal legal holiday in the United States or a day on which banking institutions in the State of New York are authorized or required by law or other government action to close.

“Event of Default” shall have the meaning set forth in Section 6.

“Fundamental Transaction” shall have the meaning set forth in Section 4.

“Liquidity Event” shall have the meaning set forth in Section 5.

“Original Issue Date” means the date of the first issuance of this Note regardless of the number of transfers of any Note and regardless of the number of instruments which may be issued to evidence such Note.

“Person” means a corporation, an association, a partnership, organization, a business, an individual, a government or political subdivision thereof or a governmental agency.

“Subsidiary” means any Person in which the Company owns more than 50% of the outstanding equity.

Section 3. Registration of Transfers and Exchanges.

a) Different Denominations. This Note is exchangeable for an equal aggregate principal amount of Notes of different authorized denominations as requested by the Holder surrendering the same, No service charge will be made for such registration of transfer or exchange.

b) Reliance on Note Register. Prior to due presentment to the Company for transfer of this Note, the Company and any agent of the Company may treat the Person in whose name this Note is duly registered on the Company’s books and records as the owner hereof for the purpose of receiving payment as herein provided and for all other purposes, whether or not this Note is overdue, and neither the Company nor any such agent shall be affected by notice to the contrary.

Section 4. Acceleration of Maturity Date. If, at any time while this Note is outstanding: (A) the Company effects any merger or consolidation of the Company with or into another Person, (B) the Company effects any sale of all or substantially all of its assets in one or a series of related transactions, (C) any tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to tender or exchange their shares for other securities, cash or property, or (D) the Company effects any reclassification of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (in any such case, a “Fundamental Transaction”), then, immediately prior to the occurrence of such Fundamental Transaction the Principal Sum and all accrued but unpaid interest payable hereunder shall automatically become, at the Holder’s election, immediately due and payable in cash.

Section 5. Mandatory Prepayment, Partial Prepayment. If, at any time while this Note is outstanding, the Company receives in the aggregate, from a single or multiple “Liquidity Events” (as defined below), gross proceeds in excess of $7,500,000 (“Gross Proceeds”), then, in such event, a payment in reduction of the amount then outstanding under this Note shall immediately be due and payable in an amount equal to twenty-five (25%) percent of the Gross Proceeds received (each, a “Mandatory Prepayment Event”). A “Liquidity Event” shall mean each of (a) the sale of any of the Company’s equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party.

Section 6. Events of Default.

a) Event of Default. Wherever used herein, means any one of the following events (whatever the reason and whether it shall be voluntary or involuntary or effected by operation of law or pursuant to any judgment, decree or order of any court, or any order, rule or regulation of any administrative or governmental body):

i. any default in the payment of (A) the principal, or (B) interest on this Note or any other note issued by the Company to the Holder as and when the same shall become due and payable (whether on the Maturity Date, upon a Mandatory Prepayment Event or by acceleration or otherwise) which default is not cured within ten (10) Business Days after written notice from the Holder;

ii. (A) there is commenced against the Company or any Subsidiary thereof a case under any applicable bankruptcy or insolvency laws as now or hereafter in effect or any successor thereto, or any other proceeding under any reorganization, arrangement, adjustment of debt, relief of debtors, dissolution, insolvency or liquidation or similar law of any jurisdiction whether now or hereafter in effect relating to the Company or any Subsidiary thereof which remains undismissed for a period of 60 days; or (B) the Company or any Subsidiary thereof is adjudicated by a court of competent jurisdiction insolvent or bankrupt; or any order of relief or other order approving any such case or proceeding is entered; or (C) the Company or any Subsidiary thereof suffers any appointment of any custodian or the like for it or any substantial part of its property which continues undischarged or unstayed for a period of 60 days.

b) Remedies Upon Event of Default. If any Event of Default occurs, the full principal amount of this Note, together with interest and other amounts owing in respect thereof, to the date of acceleration shall become, at the Holder’s election, immediately due and payable in cash. The Holder need not provide and the Company hereby waives any presentment, demand, protest or other notice of any kind, and the Holder may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such declaration may be rescinded and annulled by Holder at any time prior to payment hereunder and the Holder shall have all rights as a Note holder until such time, if any, as the full payment under this Section shall have been received by it. No such rescission or annulment shall affect any subsequent Event of Default or impair any right consequent thereon.

Section 7. Miscellaneous.

a) Priority of Payment. Payments under this Note shall be applied first to accrued and unpaid interest and then to the Principal Sum outstanding. All amounts due under this Note shall be payable without setoff, counterclaim or any other deduction whatsoever.

b Notices. Any and all notices or other communications or deliveries to be provided by the Holder hereunder shall be in writing and delivered personally, by facsimile, sent by a nationally recognized overnight courier service, addressed to the Company, at 133 Summit Avenue, Suite 22, Summit, NJ 07901, attention: Chief Financial Officer, or such other address or facsimile number as the Company may specify for such purposes by notice to the Holder delivered in accordance with this Section. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile, sent by a nationally recognized overnight courier service addressed to the Holder at the facsimile, telephone number or address of such Holder appearing on the books of the Company, or if no such facsimile telephone number or address appears, at the principal place of business of the Holder. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered via facsimile at the facsimile telephone number specified in this Section prior to 5:30 p.m. (New York City time), (ii) the date after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile telephone number specified in this Section later than 5:30 p.m. (New York City time) on any date and earlier than 11:59 p.m. (New York City time) on such date, (iii) the second Business Day following the date of mailing, if sent by nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.

c) Absolute Obligation. Except as expressly provided herein, no provision of this Note shall alter or impair the obligation of the Company, which is absolute and unconditional, to pay the principal of, interest and liquidated damages (if any) on, this Note at the time, place, and rate, and in the coin or currency, herein prescribed. This Note is a direct debt obligation of the Company.

d) Lost or Mutilated Note. If this Note shall be mutilated, lost, stolen or destroyed, the Company shall execute and deliver, in exchange and substitution for and upon cancellation of a mutilated Note, or in lieu of or in substitution for a lost, stolen or destroyed Note, a new Note for the principal amount of this Note so mutilated, lost, stolen or destroyed but only upon receipt of evidence of such loss, theft or destruction of such Note, and of the ownership hereof; and indemnity, if requested, all reasonably satisfactory to the Company.

e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Note, and any claim, controversy or dispute arising under or related to this Note, the relationship of the parties, and/or the interpretation and enforcement of the rights and duties of the parties hereunder shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations or enforcement of this Note (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state or federal courts sitting in the City of New York, Borough of Manhattan (the “New York Courts”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, or such New York Courts are improper or inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Note and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Each party hereto hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Note or the transactions contemplated hereby. If either party shall commence an action or proceeding to enforce any provisions of this Note, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorney’s fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.

f) Waiver. Any waiver by the Company or the Holder of a breach of any provision of this Note shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Note. The failure of the Company or the Holder to insist upon strict adherence to any term of this Note on one or more occasions shall not be considered a waiver or deprive that party of the right thereafter to insist upon strict adherence to that term or any other term of this Note. Any waiver must be in writing.

g) Severability. If any provision of this Note is invalid, illegal or unenforceable, the balance of this Note shall remain in effect, and if any provision is inapplicable to any person or circumstance, it shall nevertheless remain applicable to all other persons and circumstances. If it shall be found that any interest or other amount deemed interest due hereunder violates applicable laws governing usury, the applicable rate of interest due hereunder shall automatically be lowered to equal the maximum permitted rate of interest. The Company covenants (to the extent that it may lawfully do so) that it shall not at any time insist upon, plead, or in any manner whatsoever claim or take the benefit or advantage of, any stay, extension or usury law or other law which would prohibit or forgive the Company from paying all or any portion of the principal of or interest on this Note as contemplated herein, wherever enacted, now or at any time hereafter in force, or which may affect the covenants or the performance of this indenture, and due Company (to the extent it may lawfully do so) hereby expressly waives all benefits or advantage of any such law, and covenants that it will not, by resort to any such law, binder, delay or impeded the execution of any power herein granted to the Holder, but will suffer and permit the execution of every such as though no such law has been enacted.

h) Next Business Day. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day.

i) Headings. The headings contained herein are for convenience only, do not constitute a part of this Note and shall not be deemed to limit or affect any of the provisions hereof.

[SIGNATURE PAGE FOLLOWS]

IN WITNESS WHEREOF, the Company has caused this Note to be duly executed by a duly authorized officer as of the date first above indicated.

PROTALEX, INC.
By:	/s/ Kirk M. Warshaw
	Kirk M. Warshaw, Chief Financial Officer

EXHIBIT A

PRIOR NOTES

Issuance Date	Principal Amount		Accrued Interest		Total
February 1, 2012	$	1,000,000	$	51,416.67	$	1,051,416.67
June 5, 2012	$	1,000,000	$	41,000.00	$	1,041,000.00
October 1, 2012	$	800,000	$	24,933.33	$	824,933.33
December 3, 2012	$	700,000	$	18,141.67	$	718,141.67
January 18, 2013	$	2,500,000	$	55,208.33	$	2,555,208.33
May 13, 2013	$	2,000,000	$	25,000.00	$	2,025,000.00
August 27, 2013	$	1,000,000	$	3,666.67	$	1,003,666.67
				Total:	$	9,219,366.67

EX-10.1

CONSOLIDATED, AMENDED AND RESTATED SECURITY AGREEMENT

THIS CONSOLIDATED, AMENDED AND RESTATED SECURITY AGREEMENT (this “Agreement”), dated as of October 11, 2013, is made by and among Protalex, Inc. a Delaware corporation, (the “Grantor”), and Niobe Ventures, LLC (the “Secured Party”) and amends and restates the Security Agreements by and between Grantor and Secured Party described on Exhibit B hereto.

WHEREAS, the Grantor has issued to the Secured Party a Consolidated, Amended and Restated Promissory Note in the principal amount of Nine Million Two Hundred Nineteen Thousand Three Hundred Sixty Six and 67/100 Dollars ($9,219,366.67) (the “Consolidated Note”); and

WHEREAS, the Grantor and the Secured Party have agreed to execute and deliver this Agreement, among other things, to continue to secure the obligations of the Grantor to the Secured Party.

NOW, THEREFORE, The Grantor and the Secured Party hereby agree as follows:

SECTION 1.           Definitions; Interpretation.

(a)          As used in this Agreement, the following terms shall have the following meanings:

“Collateral” means the property described on Exhibit A attached hereto and all Negotiable Collateral and Intellectual Property to the extent not described on Exhibit A, except (i) to the extent any such property is nonassignable by its terms without the consent of the licensor thereof or another party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation, applicable provisions of the New York Uniform Commercial Code as amended or supplemented from time to time.), or (ii) the granting of a security interest in such property is contrary to applicable law, provided that upon the cessation of any such restriction or prohibition, such property shall automatically become part of the Collateral.

“Copyrights” means any and all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret, now or hereafter existing, created, acquired or held.

“Event of Default” has the meaning set forth in the Note.

“Intellectual Property” means all of Grantor’s right, title, and interest in and to the following, except to the extent any security interest hereunder would cause any application for a Trademark to be deemed invalidated, canceled or abandoned due to the grant and/or enforcement of such security interest, including, without limitation, all U.S. trademark applications that are based on an intent-to-use, unless and until such time that the grant and/or enforcement of the security interest will not affect the status or validity of such trademark:

(a)          Copyrights, Trademarks and Patents;

(b)          and all trade secrets, and any and all intellectual property rights in computer software and computer software products now or hereafter existing, created, acquired or held;

(c)          and all design rights which may be available to Grantor now or hereafter existing, created, acquired or held;

(d)          and all claims for damages by way of past, present and future infringement of any of the rights included above, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the intellectual property rights identified above;

(e)          licenses or other rights to use any of the Copyrights, Patents or Trademarks, and all license fees and royalties arising from such use to the extent permitted by such license or rights;

(f)           amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents; and

(g)          proceeds and products of the foregoing, including without limitation all payments under insurance or any indemnity or warranty payable in respect of any of the foregoing.

“Lien” means any mortgage, deed of trust, pledge, security interest, assignment, deposit arrangement, charge or encumbrance, lien, or other type of preferential arrangement.

“Obligations” means the indebtedness, liabilities and other obligations of the Grantor to the Secured Party under the Consolidated Note including without limitation, the unpaid principal of the Consolidated Note and all interest accrued thereon payable by the Grantor to the Secured Party thereunder or in connection therewith.

“Patents”means all patents, patent applications and like protections, including, without limitation, improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

“Permitted Liens” mean: (i) Liens in favor of the Secured Party in respect of the Obligations hereunder; (ii) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings and which are adequately reserved for in accordance with GAAP; (iii) Liens of materialmen, mechanics, warehousemen, carriers or employees or other like Liens arising in the ordinary course of business and securing obligations either not delinquent or being contested in good faith by appropriate proceedings; (iv) Liens consisting of deposits or pledges to secure the payment of worker’s compensation, unemployment insurance or other social security benefits or obligations, or to secure the performance of bids, trade contracts, leases, public or statutory obligations, surety or appeal bonds or other obligations of a like nature incurred in the ordinary course of business; (v) easements, rights of way, servitudes or zoning or building restrictions and other minor encumbrances on real property and irregularities in the title to such property which do not in the aggregate materially impair the use or value of such property or risk the loss or forfeiture of title thereto; and (vi) Liens upon or in any equipment now or hereafter acquired or held by the Grantor to secure the purchase price of such equipment or indebtedness incurred solely for the purpose of financing or refinancing the acquisition of such equipment, provided that the Lien is confined solely to the equipment so acquired and accessions thereon and proceeds thereof.

“Person” means an individual, corporation, partnership, joint venture, trust, unincorporated organization, governmental agency or authority, or any other entity of whatever nature.

“Trademarks”means any trademark and service mark rights, whether registered or not, applications to register and registrations of the same and like protections, and the parts of the goodwill of the business connected with the use of and symbolized by such marks.

“UCC” means the Uniform Commercial Code as the same may, from time to time, be in effect in the State of New York.

(b)          Where applicable and except as otherwise defined herein, terms used in this Agreement shall have the meanings assigned to them in the UCC. 

(c)          In this Agreement, (i) the meaning of defined terms shall be equally applicable to both the singular and plural forms of the terms defined; (ii) the captions and headings are for convenience of reference only and shall not affect the construction of this Agreement; (iii) the words “hereof,” “herein,” “hereto,” “hereunder” and the like mean and refer to this Agreement as a whole and not merely to the specific Article, Section, subsection, paragraph or clause in which the respective word appears; (iv) the words “including,” “includes” and “include” shall be deemed to be followed by the words “without limitation;” and (v) the term “or” shall not be limiting.

SECTION 2.           Security Interest.

(a)          Subject to the Permitted Liens, as security for the payment and performance of the Obligations, the Grantor hereby pledges, assigns and grants to the Secured Party a security interest in all of the Grantor’s right, title and interest in, to and under all of the Collateral (other than as set forth in Section 2(b) hereof).

(b)          Notwithstanding the foregoing, except for fixtures (to the extent covered by Article 9 of the UCC), such grant of a security interest shall not extend to, and the term “Collateral” shall not include, any asset which would be real property under the law of the jurisdiction in which it is located.

(c)          This Agreement shall create a continuing security interest in the Collateral that shall remain in effect until terminated in accordance with the provisions hereof.

SECTION 3.         Financing Statements, Etc. The Grantor hereby authorizes the Secured Party to file (with a copy thereof to be provided to the Grantor contemporaneously therewith), at any time and from time to time thereafter, all financing statements, financing statement assignments, continuation financing statements, and UCC filings, in form reasonably satisfactory to the Secured Party. The Grantor shall execute and deliver and shall take all other action, as the Secured Party may reasonably request, to perfect and continue perfected, maintain the priority of or provide notice of the security interest of the Secured Party in the Collateral (subject to the terms hereof) and to accomplish the purposes of this Agreement. Without limiting the generality of the foregoing, the Grantor ratifies and authorizes the filing by the Secured Party of any financing statements filed prior to the date hereof that accomplish the purposes of this Agreement. 

SECTION 4.          Representations and Warranties. The Grantor represents and warrants to the Secured Party that:

(a)          Grantor is a business entity duly formed, validly existing and in good standing under the law of the jurisdiction of its organization and has all requisite power and authority to execute, deliver and perform its obligations under this Agreement.

(b)          The execution, delivery and performance by the Grantor of this Agreement has been duly authorized by all necessary corporate action of the Grantor, and this Agreement constitutes the legal, valid and binding obligation of the Grantor, enforceable against the Grantor in accordance with its terms, except as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance and other laws of general application affecting enforcement of creditors’ rights generally, as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies.

(c)          Except for the filing of appropriate financing statements, no authorization, consent, approval, license, exemption of, or filing or registration with, any governmental authority or agency, or approval or consent of any other Person, is required for the due execution, delivery or performance by the Grantor of this Agreement unless the same has already been obtained or is being obtained simultaneously in connection herewith.

(d)          This Agreement creates a security interest that is enforceable against the Collateral in which the Grantor now has rights and will create a security interest that is enforceable against the Collateral in which the Grantor hereafter acquires rights at the time the Grantor acquires any such rights.

(e)          The Grantor has the right and power to grant the security interests in the Collateral to the Secured Party in the Collateral, and the Grantor is the sole and complete owner of the Collateral, free from any Lien other than the Permitted Liens.

SECTION 5.           Covenants of the Grantor. Until this Agreement has terminated in accordance with the terms hereof, the Grantor agrees to do the following:

(a)          The Grantor shall give prompt written notice to the Secured Party (and in any event not later than ten (10) days following any change described below in this subsection) of: (i) any change in the Grantor’s name; (ii) any changes in the Grantor’s identity or structure in any manner which might make any financing statement filed hereunder incorrect or misleading; or (iii) any change in jurisdiction of organization; provided that the Grantor shall not locate any Collateral outside of the United States nor shall the Grantor change its jurisdiction of organization to a jurisdiction outside of the United States.

(b)          The Grantor shall not surrender or lose possession of, sell, lease, rent or otherwise dispose of or transfer any of the Collateral or any right or interest therein, except in the ordinary course of business consistent with past practice and except to the extent of equipment that is obsolete or no longer useful to its business.

(c)          The Grantor shall keep the Collateral free of all Liens except the Permitted Liens.

SECTION 6.           Collection of Accounts. The Grantor shall endeavor in the first instance diligently to collect all amounts due or to become due on or with respect to the accounts and other rights to payment. 

SECTION 7.           Authorization; Secured Party Appointed Attorney-in-Fact. The Secured Party shall have the right, to, in the name of the Grantor, or in the name of the Secured Party or otherwise, upon notice to, but without the requirement of assent by the Grantor, and the Grantor hereby constitutes and appoints the Secured Party (and any employees or agents designated by a Secured Party) as the Grantor’s true and lawful attorney-in-fact, with full power and authority to: (i) assert, adjust, sue for, compromise or release any claims under any policies of insurance; and (ii), execute any and all such other documents and instruments, and do any and all acts and things for and on behalf of the Grantor, that such Secured Party may deem necessary or advisable to maintain, protect, realize upon and preserve the Collateral and the Secured Party’s security interests therein and to accomplish the purposes of this Agreement. The Secured Party agrees that, except upon and during the continuance of an Event of Default, it shall not exercise the power of attorney, or any rights granted to the Secured Party under this Section 7. The foregoing power of attorney is coupled with an interest and is irrevocable so long as the Obligations have not been indefeasibly paid and performed in full and the commitments not terminated. The Grantor hereby ratifies, to the extent permitted by law, all that the Secured Party shall lawfully and in good faith do or cause to be done by virtue of and in compliance with this Section 7.

SECTION 8.           Remedies.

(a)  Upon the occurrence and during the continuance of an Event of Default, the Secured Party shall have, in addition to all other rights and remedies granted to the Secured Party in this Agreement or the Consolidated Note, all rights and remedies of a secured party under the UCC and other applicable laws. Without limiting the generality of the foregoing, upon the occurrence and during the continuance of an Event of Default, the Secured Party may sell, resell, lease, use, assign, license, sublicense, transfer or otherwise dispose of any or all of the Collateral in its then condition or following any commercially reasonable preparation or processing (utilizing in connection therewith any of Grantor’s assets, without charge or liability to any Secured Party therefor) at public or private sale, by one or more contracts, in one or more parcels, at the same or different times, for cash or credit, or for future delivery without assumption of any credit risk, all as the Secured Party deem advisable; provided, however, that the Grantor shall be credited with the net proceeds of sale only when such proceeds are finally collected by the Secured Party. Each Secured Party shall have the right upon any such public sale, and, to the extent permitted by law, upon any such private sale, to purchase the whole or any part of the Collateral so sold, free of any right or equity of redemption, which right or equity of redemption the Grantor hereby releases, to the extent permitted by law. The Grantor hereby agrees that the sending of notice by ordinary mail, postage prepaid, to the address of the Grantor set forth herein or subsequent address that the Grantor provides to the Secured Party in writing, of the place and time of any public sale or of the time after which any private sale or other intended disposition is to be made, shall be deemed reasonable notice thereof if such notice is sent ten (10) business days prior to the date of such sale or other disposition or the date on or after which such sale or other disposition may occur.

(b)  The cash proceeds actually received from the sale or other disposition or collection of the Collateral, and any other amounts received in respect of the Collateral the application of which is not otherwise provided for herein shall be applied first, to the payment of the reasonable costs and expenses of the Secured Party in exercising or enforcing their rights hereunder and in collecting or attempting to collect any of the Collateral, and to the payment of all other amounts payable to the Secured Party pursuant to Section 12 hereof; and second, to the payment of the Obligations. Any surplus thereof that exists after payment and performance in full of the Obligations shall be promptly paid over to the Grantor or otherwise disposed of in accordance with the UCC or other applicable law. The Grantor shall remain liable to the Secured Party for any deficiency that exists after any sale or other disposition or collection of the Collateral.

SECTION 9.           Certain Waivers.

(a)  The Grantor waives, to the fullest extent permitted by law: (i) any right of redemption with respect to the Collateral, whether before or after sale hereunder, and all rights, if any, of marshalling of the Collateral or other collateral or security for the Obligations; (ii) any right to require the Secured Party to: (A) proceed against any Person, (B) exhaust any other collateral or security for any of the Obligations, (C) pursue any remedy in the Secured Party’s power or (D) except as provided herein or in the Consolidated Note, make or give any presentments, demands for performance, notices of nonperformance, protests, notices of protests or notices of dishonor in connection with any of the Collateral; and (iii) all claims, damages and demands against the Secured Party arising out of the repossession, retention, sale or application of the proceeds of any sale of the Collateral.

SECTION 10.         Notices. All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally or sent by nationally-recognized overnight courier or by registered or certified mail, postage prepaid, return receipt requested or by facsimile, with confirmation as provided above addressed as follows:

If to Grantor:

Protalex, Inc.

133 Summit Avenue, Suite 22

Summit, NJ 07901

Attention: Chief Financial Officer

With copies to

Morse, Zelnick, Rose & Lander LLP

405 Park Avenue, Suite 1401

New York, NY 10022

Attention: Kenneth S. Rose, Esq.

Fax: 212-208-6809

If to the Secured Party:

Niobe Ventures, LLC

c/o Arnold P. Kling

410 Park Avenue, Suite 1710

New York, NY 10021

Attention: Arnold Kling, Managing Member

Fax: 212-713-1818

With a copy to

Morse, Zelnick, Rose & Lander LLP

405 Park Avenue, Suite 1401

New York, NY 10022

Attention: Kenneth S. Rose, Esq.

Fax: 212-208-6809

SECTION 11.        No Waiver; Cumulative Remedies. No failure on the part of the Secured Party to exercise, and no delay in exercising, any right, remedy, power or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, remedy, power or privilege preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege. The rights and remedies under this Agreement are cumulative and not exclusive of any rights, remedies, powers and privileges that may otherwise be available to the Secured Party.

SECTION 12.        Costs and Expenses. The Grantor agrees to pay all reasonable costs and expenses of the Secured Party, in connection with the enforcement and preservation of any rights or interests under, this Agreement and the protection, sale or collection of, or other realization upon, any of the Collateral, including all reasonable expenses of taking, collecting, holding, sorting, handling, preparing for sale, selling or the like and other such expenses of sales and collections of the Collateral. 

SECTION 13.        Binding Effect. This Agreement shall be binding upon, inure to the benefit of and be enforceable by the Grantor, the Secured Party and their respective successors and assigns.

SECTION 14.        Governing Law. This Agreement shall be governed by and construed under the laws of the State of New York without regard to principles of conflict of laws.

SECTION 15.        Entire Agreement; Amendment. This Agreement contains the entire agreement of the parties with respect to the subject matter hereof and shall not be amended except by the written agreement of the Grantor and the Secured Party. Notwithstanding the foregoing, this Agreement may not be amended and any term hereunder may not be waived with respect to any Secured Party without the written consent of such Secured Party unless such amendment or waiver applies to all Secured Party in the same fashion.

SECTION 16.         Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be valid, legal and enforceable under all applicable laws and regulations. If, however, any provision of this Agreement shall be invalid, illegal or unenforceable under any such law or regulation in any jurisdiction, it shall, as to such jurisdiction, be deemed modified to conform to the minimum requirements of such law or regulation, or, if for any reason it is not deemed so modified, it shall be invalid, illegal or unenforceable only to the extent of such invalidity, illegality or limitation on enforceability without affecting the remaining provisions of this Agreement, or the validity, legality or enforceability of such provision in any other jurisdiction.

SECTION 17.         Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

SECTION 18.         Termination. Upon the payment and performance in full of all Obligations, this Agreement shall terminate and the Secured Party shall promptly, at the cost of the Grantor, execute and deliver to the Grantor such documents and instruments reasonably requested by the Grantor as shall be necessary to evidence termination of all security interests given by the Grantor to the Secured Party hereunder; provided, however, that the obligations of the Grantor under Section 12 hereof shall survive such termination.

IN WITNESS WHEREOF, the parties hereto have duly executed this Agreement, as of the date first above written.

GRANTOR:
PROTALEX, INC.
By:	/s/Kirk M. Warshaw
	Kirk M. Warshaw, Chief Financial Officer
NIOBE VENTURES, LLC
By:	/s/ Arnold P. Kling
	Arnold P. Kling, Manager

EXHIBIT A

COLLATERAL DESCRIPTION ATTACHMENT TO SECURITY AGREEMENT

DEBTOR                                      PROTALEX, INC., a Delaware corporation

SECURED PARTY:                    Niobe Ventures, LLC

All personal property of Grantor (herein referred to as “Grantor” or “Debtor”) whether presently existing or hereafter created or acquired, and wherever located including, without limitation:

(a)          all accounts (including health-care-insurance receivables), chattel paper (including tangible and electronic chattel paper), deposit accounts, documents (including negotiable documents), equipment (including all accessions and additions thereto), general intangibles (including payment intangibles and software), goods (including fixtures), instruments (including promissory notes), inventory (including all goods held for sale or lease or to be furnished under a contract of service, and including returns and repossessions), investment property (including securities and securities entitlements), letter of credit rights, money, and all of Grantor’s books and records with respect to any of the foregoing, and the computers and equipment containing said books and records; provided that notwithstanding the foregoing, "Collateral" shall not include more than 65% of the stock of any subsidiary that is not incorporated, formed or organized under the laws of the United States, any state thereof or the District of Columbia (a "Foreign Subsidiary"), or more than 65% of the stock of any subsidiary substantially all of the assets of which are stock in Foreign Subsidiaries;

(b)          all common law and statutory copyrights and copyright registrations, applications for registration, now existing or hereafter arising, in the United States of America or in any foreign jurisdiction, obtained or to be obtained on or in connection with any of the foregoing, or any parts thereof or any underlying or component elements of any of the foregoing, together with the right to copyright and all rights to renew or extend such copyrights and the right (but not the obligation) of Secured Party to sue in their own name and/or in the name of the Debtor for past, present and future infringements of copyright;

(c)          all trademarks, service marks, trade names and service names and the goodwill associated therewith, together with the right to trademark and all rights to renew or extend such trademarks and the right (but not the obligation) of Secured Party to sue in their own name and/or in the name of the Debtor for past, present and future infringements of trademark;

(d)          all (i) patents and patent applications filed in the United States Patent and Trademark Office or any similar office of any foreign jurisdiction, and interests under patent license agreements, including, without limitation, the inventions and improvements described and claimed therein, (ii) licenses pertaining to any patent whether Debtor is licensor or licensee, (iii) income, royalties, damages, payments, accounts and accounts receivable now or hereafter due and/or payable under and with respect thereto, including, without limitation, damages and payments for past, present or future infringements thereof, (iv) right (but not the obligation) to sue in the name of Debtor and/or in the name of Secured Party for past, present and future infringements thereof, (v) rights corresponding thereto throughout the world in all jurisdictions in which such patents have been issued or applied for, and (vi) reissues, divisions, continuations, renewals, extensions and continuations-in-part with respect to any of the foregoing; and

(e)          any and all cash proceeds and/or non-cash proceeds of any of the foregoing, including, without limitation, insurance proceeds, and all supporting obligations and the security therefor or for any right to payment. All terms above have the meanings given to them in the New York Uniform Commercial Code, as amended or supplemented from time to time.

EXHIBIT B

PRIOR SECURITY AGREEMENTS

1) The Second Amended and Restated Security Agreement dated as of February 1, 2012, between Protalex, Inc. and Niobe Ventures, LLC;

2) The Third Amended and Restated Security Agreement dated as of June 5, 2012, between Protalex, Inc. and Niobe Ventures, LLC;

3) The Fourth Amended and Restated Security Agreement dated as of October 1, 2012, between Protalex, Inc. and Niobe Ventures, LLC;

4) The Fifth Amended and Restated Security Agreement dated as of December 3, 2012, between Protalex, Inc. and Niobe Ventures, LLC;

5) The Sixth Amended and Restated Security Agreement dated as of January 18, 2013, between Protalex, Inc. and Niobe Ventures, LLC;

6) The Seventh Amended and Restated Security Agreement dated as of May 13, 2013, between Protalex, Inc. and Niobe Ventures, LLC; and

7) The Eighth Amended and Restated Security Agreement dated as of August 27, 2013, between Protalex, Inc. and Niobe Ventures, LLC.

EX-31.1

Exhibit 31.1

CERTIFICATION

I, Arnold P. Kling, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Protalex, Inc.;
2.	Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;
3.	Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have:

a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this Report is being prepared;
b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this Report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)	Disclosed in this Report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

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

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: October 11, 2013
	/s/ Arnold P. Kling
	Arnold P. Kling
	President
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

I, Kirk M. Warshaw, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Protalex Inc.;
2.	Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report;
3.	Based on my knowledge, the financial statements, and other financial information included in this Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Report;
4.	The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have:

a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this Report is being prepared;
b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this Report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this Report based on such evaluation; and
d)	Disclosed in this Report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

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

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: October 11, 2013
	/s/ Kirk M. Warshaw
	Kirk M. Warshaw
	Chief Financial Officer
	(Principal Financial Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 In connection with the quarterly report of Protalex, Inc. (the "Company") on Form 10-Q for the period ending August 31, 2013 as filed with the Securities and Exchange Commission (the "Report"), I, Arnold P. Kling, President of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Dated: October 11, 2013

/s/ Arnold P. Kling

Arnold P. Kling

President

(Principal Executive Officer)

A signed original of this certification has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 In connection with the quarterly report of Protalex, Inc. (the "Company") on Form 10-Q for the period ending August 31, 2013 as filed with the Securities and Exchange Commission (the "Report"), I, Kirk M. Warshaw, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Dated: October 11, 2013

/s/ Kirk M. Warshaw

Kirk M. Warshaw

Chief Financial Officer

(Principal Financial Officer)

A signed original of this certification has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

XML

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Aug. 31, 2013

Accounting Policies [Abstract]

Fair Value of Assumptions of Options Estimated On Grant Date

The fair value of the options is estimated on the date of the grant using the Black-Scholes option pricing model with the following assumptions:

	Three Months Ended August 31, 2013			Three Months Ended August 31, 2012			From Inception Through August 31, 2013
Dividends per year		0			0			0
Volatility percentage		418% - 426	%		97.5	%		90%-426	%
Risk free interest rate		2.13	%		3.47	%		1.74%-5.11	%
Expected life (years)		7.0-10.0			7.0-10.0			3-10
Weighted Average Fair Value	$	1.22		$	1.07		$	2.30

XML

CONDENSED STATEMENTS OF OPERATIONS (USD $)	3 Months Ended		167 Months Ended
	Aug. 31, 2013	Aug. 31, 2012	Aug. 31, 2013
Revenues	$ 0	$ 0	$ 0
Operating Expenses
Research and development (including depreciation and amortization)	933,118	675,028	37,308,613
Administrative (including depreciation and amortization)	372,759	314,127	20,187,194
Professional fees	129,777	126,611	5,201,379
Depreciation and amortization	255	255	183,221
Operating loss	(1,435,909)	(1,116,021)	(62,880,407)
Other income (expense)
Interest income	1	24	2,211,848
Interest expense	(76,335)	(248,975)	(2,578,737)
Net loss	$ (1,512,243)	$ (1,364,972)	$ (63,247,296)
Weighted average number of common shares outstanding	19,338,464	18,926,615
Loss per common share - basic and diluted	$ (0.08)	$ (0.07)

XML

GOING CONCERN

3 Months Ended

Aug. 31, 2013

Going Concern Disclosure [Abstract]

GOING CONCERN

NOTE 3. GOING CONCERN

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of the Company as a going concern. The ability of the Company to continue as a going concern is dependent upon developing products that are regulatory approved and market accepted. There is no assurance that these plans will be realized in whole or in part. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.

Since inception, the Company has incurred an accumulated deficit of $63,247,296 through August 31, 2013. For the years ended May 31, 2013 and 2012, the Company had net losses of $6,280,234 and $4,444,584, respectively and for the three months ended August 31, 2013, the Company had a net loss of $1,512,243.  The Company has used $4,733,349 and $2,351,630 of cash in operating activities for the years ended May 31, 2013 and 2012, respectively, and $1,438,401 during the three months ended August 31, 2013.  As of August 31, 2013, the Company had cash and cash equivalents of $2,018,645 and negative net working capital of $491,281.  The Company has incurred negative cash flow from operating activities since its inception.   The Company has spent, and subject to obtaining additional financing, expects to continue to spend, substantial amounts in connection with executing its business strategy, including continued development efforts relating to PRTX-100.

The Company has no significant payments due on long-term obligations since, as discussed below in Note 9-Subsequent Events, on October 11, 2013, the Company issued the Consolidated Note to Niobe.  However, the Company has entered into a significant number of contracts to perform clinical trials in the remainder of 2013 and that it will need to raise additional capital in the future to fund the ongoing FDA approval process. If the Company is unable to obtain approval of its future IND applications or otherwise advance in the FDA approval process, its ability to sustain its operations would be significantly jeopardized.

The most likely sources of additional financing include the private sale of the Company’s equity or debt securities or loans from majority stockholders. Additional capital that is required by the Company may not be available on reasonable terms, or at all.

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SENIOR SECURED CONVERTIBLE NOTES - RELATED PARTY - Additional Information (Detail) (USD $)			1 Months Ended			1 Months Ended
	Feb. 11, 2011	Dec. 02, 2009	Feb. 11, 2011 Niobe Ventures, LLC Senior Secured Convertible Notes	Nov. 11, 2009 Niobe Ventures, LLC Senior Secured Convertible Notes	Dec. 02, 2009 Niobe Ventures, LLC Senior Secured Convertible Notes	Aug. 27, 2013 Niobe Ventures, LLC Senior Secured Convertible Notes Subsequent Event [Member]
Debt Instrument [Line Items]
Secured note payable, additional borrowing amount	$ 2,000,000				$ 2,000,000
Debt instrument, face amount			2,000,000	1,000,000
Debt instrument, interest rate during Period			3.00%	3.00%
Secured note payable, maturity date			Dec. 31, 2013	Nov. 13, 2012
Debt conversion, converted instrument, shares issued			4,510,870			9,369,565
Convertible debt, current		1,000,000	1,000,000
Accrued interest on senior secured convertible promissory note			37,500			155,000
Debt conversion, converted instrument, amount						$ 2,000,000

XML

ORGANIZATION AND BUSINESS ACTIVITIES - Additional Information (Detail) (USD $)	Aug. 31, 2013	May 31, 2013	Dec. 08, 2010
Organization and Nature of Operations [Line Items]
Reverse stock split, Common stock, par value	$ 0.00001	$ 0.00001	$ 0.00001

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SUBSEQUENT EVENTS - Additional Information (Detail) (Subsequent Event, Senior Secured Notes, USD $)	1 Months Ended
	Oct. 11, 2013
Subsequent Event [Line Items]
Debt instrument, face amount	$ 9,000,000
Secured note payable, interest rate	3.00%
Secured note payable, maturity date	Sep. 01, 2015
Debt instrument carrying amount	9,219,366.67
Proceeds from Repayments of secured debt	7,500,000
Terms of consolidated note identical to secured notes	(a) the maturity date is September 1, 2015, which is after the latest maturity date of any of the Secured Notes; and (b) it provides for partial mandatory repayment in the event that the Company receives aggregate gross proceeds in excess of $7.5 million from a single or multiple Liquidity Events in an amount equal to twenty-five (25%) percent of such gross proceeds.
Description of liquidity event	(a) the sale of any of our equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party.
Minimum [Member]
Subsequent Event [Line Items]
Consummation of equity financing, amount	$ 7,500,000

XML

SENIOR SECURED NOTES - RELATED PARTY - Additional Information (Detail) (Niobe Ventures, LLC, Senior Secured Notes, USD $)	1 Months Ended
	Aug. 27, 2013	May 13, 2013	Jan. 18, 2013	Dec. 03, 2012	Oct. 01, 2012	Jun. 05, 2012	Feb. 01, 2012	Aug. 31, 2013
Niobe Ventures, LLC | Senior Secured Notes
Debt Instrument [Line Items]
Proceeds from issuance of secured note	$ 1,000,000	$ 2,000,000	$ 2,500,000	$ 700,000	$ 800,000	$ 1,000,000	$ 1,000,000
Secured note payable	$ 1,000,000	$ 2,000,000	$ 2,500,000	$ 700,000	$ 800,000	$ 1,000,000	$ 1,000,000	$ 9,000,000
Secured note payable, interest rate	3.00%	3.00%	3.00%	3.00%	3.00%	3.00%	3.00%
Secured note payable, maturity date	Aug. 27, 2015	May 13, 2015	Jan. 15, 2015	Oct. 01, 2014	Oct. 01, 2014	May 31, 2014	Feb. 01, 2014

XML

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (Parenthetical) (USD $)	3 Months Ended	9 Months Ended	12 Months Ended						9 Months Ended	12 Months Ended	9 Months Ended				12 Months Ended
	Aug. 31, 2013	May 31, 2000	May 31, 2011	May 31, 2010	May 31, 2004	May 31, 2003	May 31, 2002	May 31, 2001	May 31, 2000 Issuance During Period 1st	May 31, 2003 Issuance During Period 1st	May 31, 2000 Issuance During Period 2nd	May 31, 2000 Issuance During Period 4th	May 31, 2000 Legal Service Issuance During Period 3rd	May 31, 2000 Interest Due Issuance During Period 5th	May 31, 2004 President Issuance During Period 1st	May 31, 2005 President Issuance During Period 2nd	May 31, 2003 President Issuance During Period 2nd	May 31, 2006 Employee Issuance During Period 1st	May 31, 2006 Employee Issuance During Period 2nd	May 31, 2005 Employee Issuance During Period 2nd	May 31, 2003 Employee Issuance During Period 3rd	May 31, 2004 Employee Issuance During Period 4th	May 31, 2007 Private Placement	May 31, 2004 Private Placement Issuance During Period 2nd	May 31, 2006 Private Placement Issuance During Period 3rd	May 31, 2004 Terminated Employee Issuance During Period 3rd
Common Stock issued, per share		$ 0.15		$ 0.23			$ 6.25	$ 5.00		$ 7.50	$ 1.80	$ 5.00				$ 9.75				$ 12.75		$ 12.75	$ 12.50	$ 8.50	$ 11.25	$ 13.00
Common Stock issued, issuance start date											Nov. 18, 1999	May 01, 2000					Jan. 15, 2003
Common Stock issued, issuance date	Aug. 27, 2013	Sep. 17, 1999	Feb. 11, 2011	Nov. 11, 2009			Nov. 07, 2001	Dec. 07, 2000	Oct. 27, 1999	Jul. 05, 2002			Jan. 01, 2000	May 27, 2000	Jun. 15, 2003	May 25, 2005		Aug. 23, 2005	Oct. 19, 2005	Jan. 13, 2005	May 14, 2003	Mar. 01, 2004	Jul. 07, 2006	Sep. 18, 2003	Dec. 30, 2005	Dec. 12, 2003
Common Stock issued, issuance end date											Feb. 07, 2000	May 27, 2000					May 15, 2003
Common stock shares repurchased, per share						$ 3.50
Common stock shares repurchased, start date						Jul. 01, 2002
Common stock shares repurchased, end date						May 01, 2003
Common stock shares repurchased, date					Jun. 15, 2003
Common stock shares repurchased and retired, date					Sep. 19, 2003

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ORGANIZATION AND BUSINESS ACTIVITIES

3 Months Ended

Aug. 31, 2013

Organization, Consolidation and Presentation of Financial Statements [Abstract]

ORGANIZATION AND BUSINESS ACTIVITIES

NOTE 1. ORGANIZATION AND BUSINESS ACTIVITIES

Protalex, Inc., a Delaware corporation, (“we,” “us,” “our,” the “Company” or “its”) is a development stage company focused on the development of a class of biopharmaceutical drugs for treating autoimmune inflammatory diseases including rheumatoid arthritis(RA).  Its lead product, PRTX-100, is a formulation of highly-purified form of staphylococcal protein A, which is an immune modulating protein produced by bacteria.

The Company maintains an administrative office in Summit, New Jersey and currently outsources all of its product development and regulatory activities, including clinical trial activities, manufacturing and laboratory operations to third-party contract research organizations and facilities.

In April 2009, the Company ceased all operations and terminated all employees in light of insufficient funds to continue its clinical trials and related product development.  The Company’s business was dormant until new management took control of its operations in November 2009 following the change in control transaction more fully described below.  The Company is currently actively pursuing the commercial development of PRTX-100 for the treatment of RA.

On December 8, 2010, the Company effected a reverse stock split of the outstanding shares of its common stock, with par value of $0.00001 per share (“Common Stock”), on the basis of one share of Common Stock for each five shares of Common Stock outstanding.  Unless otherwise noted, all references in these financial statements and notes to financial statements to number of shares, price per share and weighted average number of shares outstanding of Common Stock prior to this reverse stock split have been adjusted to reflect the reverse stock split on a retroactive basis.

PRTX-100 has demonstrated effectiveness in animal models of autoimmune diseases as well as demonstrated activity on cultured human immune cells at very low concentrations, although the effectiveness of PRTX-100 shown in pre-clinical studies using animal models may not be predictive of the results that the Company would see in future human clinical trials.  The Company does not anticipate generating operating revenue for the foreseeable future and does not currently have any products that are marketed.

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BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Aug. 31, 2013

Accounting Policies [Abstract]

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 4. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The interim financial data contained in this Report is unaudited; however in the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim period. The financial statements included herein have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to such rules and regulations, although the Company believes that the disclosures included herein are adequate to make the information presented not misleading.  The results of operations in interim periods are not necessarily indicative of the results that may be expected for the full year.

Information regarding the organization and business of the Company, accounting policies followed by the Company and other important information is contained in the notes to the Company's financial statements included in the Company's Annual Report on Form 10-K for the fiscal year ended May 31, 2013. This quarterly report should be read in conjunction with our annual report.

Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires the Company to make estimates and assumptions affecting the reported amounts of assets, liabilities, revenues and expense, and the disclosure of contingent assets and liabilities. Estimated amounts could differ materially from actual results.

Loss per Common Share

The Financial Accounting Standards Board (FASB) has issued guidance for “Earnings Per Share” which provides for the calculation of “Basic” and “Diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net loss to common stockholders by the weighted average number of common shares outstanding for the period. All potentially dilutive securities consisting of employee stock options and warrants have been excluded from the computations since they would be antidilutive. However, these dilutive securities could potentially dilute earnings per share in the future. As of August 31, 2013 the Company had potentially dilutive securities consisting of 3,057,543 stock options.  As of August 31, 2012, the Company had potentially dilutive securities consisting of 2,642,191 stock options.

Cash and Cash Equivalents

For the purposes of reporting cash flows, the Company considers all cash accounts which are not subject to withdrawal restrictions or penalties, and highly liquid investments with original maturities of 60 days or less to be cash and cash equivalents. The cash and cash equivalent deposits are not insured by The Federal Deposit Insurance Corporation.

Share Based Compensation

Effective June 1, 2006, the Company adopted the FASB accounting guidance for fair value recognition provisions of the “Accounting for Share-Based Payment” using the modified prospective method.  This standard requires the Company to measure the cost of employee services received in exchange for equity share options granted based on the grant-date fair value of the options.  The cost is recognized as compensation expense over the vesting period of the options.  Under the modified prospective method $265,095 and $195,997 compensation cost is included in operating expenses for the three months ended August 31, 2013 and August 31, 2012, respectively.  These amounts included both the compensation cost of stock options granted prior to but not yet vested as of June 1, 2006 and compensation cost for all options granted subsequent to May 31, 2006.  In accordance with the modified prospective application transition method, prior period results are not restated.  Incremental compensation cost for a modification of the terms or conditions of an award is measured by comparing the fair value of the modified award with the fair value of the award immediately before the modification.  No tax benefit was recorded as of May 31, 2013 in connection with these compensation costs due to the uncertainty regarding ultimate realization of certain net operating loss carryforwards.  The Company has also implemented the SEC interpretations in Staff Accounting Bulletin (“SAB”) for “Share-Based Payments,” in connection with the adoption of FASB accounting guidance.

The Board of Directors adopted and the stockholders approved the 2003 Stock Option Plan in October 2003 which was subsequently amended in October 2005. The plan was adopted to recognize the contributions made by the Company’s employees, officers, consultants, and directors, to provide those individuals with additional incentive to devote themselves to the Company’s future success, and to improve the Company’s ability to attract, retain and motivate individuals upon whom the Company’s growth and financial success depends. Under the plan, stock options may be granted as approved by the Board of Directors or the Compensation Committee. There are 900,000 shares reserved for grants of options under the plan, of which 88,800 have been issued and 800 were exercised. The Company has issued 271,784 stock options as standalone grants, of which 400 were exercised. Stock options vest pursuant to individual stock option agreements. No options granted under the plan are exercisable after the expiration of ten years (or less in the discretion of the Board of Directors or the Compensation Committee) from the date of the grant. The plan will continue in effect until terminated or amended by the Board of Directors.

The accounting guidance requires the use of a valuation model to calculate the fair value of each stock-based award. The Company uses the Black-Scholes model to estimate the fair value of stock options granted based on the following assumptions:

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

As of August 31, 2013, there were 3,057,543 stock options outstanding.  At August 31, 2013, the aggregate unrecognized compensation cost of unvested options, as determined using a Black-Scholes option valuation model was approximately $86,726 (net of estimated forfeitures) will be recognized ratably through July 31, 2014.  The remaining amount of options will be valued once they vest upon the future events.  During the three months ended August 31, 2013, the Company did not grant any stock options and 28,000 options expired.

The fair value of the options is estimated on the date of the grant using the Black-Scholes option pricing model with the following assumptions:

	Three Months Ended August 31, 2013			Three Months Ended August 31, 2012			From Inception Through August 31, 2013
Dividends per year		0			0			0
Volatility percentage		418% - 426	%		97.5	%		90%-426	%
Risk free interest rate		2.13	%		3.47	%		1.74%-5.11	%
Expected life (years)		7.0-10.0			7.0-10.0			3-10
Weighted Average Fair Value	$	1.22		$	1.07		$	2.30

XML

CHANGE OF OWNERSHIP TRANSACTION

3 Months Ended

Aug. 31, 2013

Working Capital Information [Abstract]

CHANGE OF OWNERSHIP TRANSACTION

NOTE 2. CHANGE OF OWNERSHIP TRANSACTION

On November 11, 2009 (the “Effective Date”), the Company consummated a financing transaction (the “Financing”) in which it raised $3,000,000 of working capital pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with Niobe Ventures, LLC, a Delaware limited liability company (“Niobe”).  Pursuant to the Purchase Agreement, the Company issued to Niobe (i) 8,695,652 restricted shares of Common Stock at a purchase price of $0.23 per share (or $2 million in the aggregate) and (ii) a senior secured convertible promissory note in the principal amount of $1 million convertible into shares of Common Stock at an initial conversion price equal to $0.23 per share (the “$1 Million Secured Note”).  On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of Common Stock. 

On February 11, 2011, for the purpose of providing the Company with additional working capital, pursuant to an existing Credit Facility Agreement dated as of December 2, 2009 (the “Facility”) with Niobe, the Company issued to Niobe a senior secured convertible promissory note in the principal amount of $2 million (the “$2 Million Secured Convertible Note”).  The $2 Million Secured Convertible Note provided for conversion of interest and principal into shares of the Company’s Common Stock at a conversion price of $0.23 per share, bore interest at a rate of 3% per annum and had a maturity date of December 31, 2013.  The original maturity was December 31, 2012 but in December 2012 Niobe agreed, for no consideration, to extend the maturity date to December 31, 2013.

The $2 Million Secured Convertible Note was convertible at any time, by the holder, subject only to the requirement that the Company have sufficient authorized shares of Common Stock after taking into account all outstanding shares of Common Stock and the maximum number of shares issuable under all issued and outstanding convertible securities.  On August 27, 2013, Niobe elected to convert the $2 Million Secured Convertible Note and $155,000 of accrued interest thereunder into 9,369,565 shares of Common Stock.

On February 1, 2012, the Company raised $1,000,000 of working capital pursuant to a loan from Niobe.  The Company issued to Niobe a secured promissory note in the principal amount of $1,000,000 (the “February 2012 Secured Note”).  The February 2012 Secured Note bears interest at a rate of 3% per annum and matures on February 1, 2014.

On June 5, 2012, the Company raised an additional $1,000,000 of working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on May 31, 2014 (the “June 2012 Secured Note”).  

On October 1, 2012, the Company raised $800,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $800,000, which bear interest at a rate of 3% per annum and matures on October 1, 2014 (the “October 2012 Secured Note”). 

On December 3, 2012, the Company raised $700,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $700,000, which bears interest at a rate of 3% per annum and matures on October 1, 2014 (the “December 2012 Secured Note”). 

Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.” 

On January 18, 2013, the Company raised $2,500,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,500,000, which bears interest at a rate of 3% per annum and matures on January 15, 2015 (the “January 2013 Secured Note”). 

On May 13, 2013, the Company raised $2,000,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,000,000, which bears interest at a rate of 3% per annum and matures on May 13, 2015 (the “May 2013 Secured Note”).

On August 27, 2013, the Company raised $1,000,000 of additional working capital pursuant to an incremental loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on August 27, 2015 (the “August 2013 Secured Note”).

Collectively, the January 2013 Secured Note, the May 2013 Secured Note and the August 2013 Secured Note are hereinafter referred to as the “2013 Secured Notes.”

Collectively, the 2012 Secured Notes and the 2013 Secured Notes represent a total of $9,000,000 in principal amount of loans from Niobe and are hereinafter referred to as the “Secured Notes.”

Payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if the Company undertakes certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

The Company’s obligations under the Secured Notes and the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of its personal property and assets, including its intellectual property.   

All of the securities issued in the aforementioned financings were issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the “Act”) pursuant to Section 4(6) and Rule 506 of Regulation D thereof.  The offer, sale and issuance of such securities were made without general solicitation or advertising.  The securities were offered and issued only to “accredited investors” as such term is defined in Rule 501 under the Act.

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CONDENSED BALANCE SHEETS (Parenthetical) (USD $)	Aug. 31, 2013	May 31, 2013
Intellectual technology property, accumulated amortization	$ 13,323	$ 13,068
Preferred stock, par value	$ 0.00001	$ 0.00001
Preferred stock, shares authorized	1,000,000	1,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.00001	$ 0.00001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	28,296,180	18,926,615
Common stock, shares outstanding	28,296,180	18,926,615

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SENIOR SECURED NOTES - RELATED PARTY

3 Months Ended

Aug. 31, 2013

Senior Secured Convertible Notes

SENIOR SECURED NOTES - RELATED PARTY

NOTE 7. SENIOR SECURED CONVERTIBLE NOTES - RELATED PARTY

On the Effective Date (defined in Note 2, above), the Company issued the $1 Million Secured Note to Niobe, its majority stockholder which is controlled by Arnold P. Kling, the Company’s president and director.  The $1 Million Secured Note bore interest at a rate of 3% per annum and had a scheduled maturity date of November 13, 2012.  The Company’s obligations under the $1 Million Secured Note were secured by a Security Agreement dated the Effective Date (the “Security Agreement”) which granted Niobe a security interest in substantially all of the Company’s personal property and assets, including its intellectual property.  On February 11, 2011, Niobe converted the $1 Million Secured Note, including $37,500 of accrued interest thereon, into 4,510,870 shares of Common Stock.

On December 2, 2009, the Company entered into the Facility (defined in Note 2, above) with Niobe pursuant to which Niobe agreed to provide up to $2,000,000 of additional capital in the form of secured loans at any time prior to June 30, 2012 subject to the achievement of certain predetermined benchmarks.  In connection with the Facility, on December 2, 2009, the Security Agreement securing our obligations under the $1 Million Secured Note was amended and restated to also secure any incremental obligations under the Facility (the “Amended Security Agreement”).  Pursuant to the Amended Security Agreement, Niobe has a security interest in substantially all of our personal property and assets, including its intellectual property to collateralize all amounts due to it under the $1 Million Secured Note and the Facility.

Pursuant to the Facility, on February 11, 2011, the Company received $2,000,000 of additional working capital from Niobe and issued the $2 Million Secured Note to Niobe.  The $2 Million Secured Note bore interest at a rate of 3% per annum and, as amended was scheduled to mature on December 31, 2013.  On August 27, 2013, Niobe elected to convert the $2 Million Secured Convertible Note and $155,000 of accrued interest thereunder into 9,369,565 shares of Common Stock.

Senior Secured Notes

SENIOR SECURED NOTES - RELATED PARTY

NOTE 8. SENIOR SECURED NOTES - RELATED PARTY

On February 1, 2012, the Company raised $1,000,000 of working capital pursuant to a loan from Niobe.  The Company issued to Niobe a secured promissory note in the principal amount of $1,000,000 (the “February 2012 Secured Note”).  The February 2012 Secured Note bears interest at a rate of 3% per annum and matures on February 1, 2014.

On June 5, 2012, the Company raised an additional $1,000,000 of working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on May 31, 2014 (the “June 2012 Secured Note”). 

On October 1, 2012, the Company raised $800,000 of additional working capital pursuant to loans from Niobe and issued to Niobe secured promissory notes in the principal amount of $800,000, which bear interest at a rate of 3% per annum and matures on October 1, 2014 (the “October 2012 Secured Note”). 

On December 3, 2012, the Company raised $700,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $700,000, which bears interest at a rate of 3% per annum and matures on October 1, 2014 (the “December 2012 Secured Note”). 

Collectively, the February 2012 Secured Note, the June 2012 Secured Note, the October 2012 Secured Note and the December 2012 Secured Note are hereinafter referred to as the “2012 Secured Notes.” 

On January 18, 2013, the Company raised $2,500,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,500,000, which bears interest at a rate of 3% per annum and matures on January 15, 2015 (the “January 2013 Secured Note”). 

On May 13, 2013, the Company raised $2,000,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $2,000,000, which bears interest at a rate of 3% per annum and matures on May 13, 2015 (the “May 2013 Secured Note”).

On August 27, 2013, the Company raised $1,000,000 of additional working capital pursuant to a loan from Niobe and issued to Niobe a secured promissory note in the principal amount of $1,000,000, which bears interest at a rate of 3% per annum and matures on August 27, 2015 (the “August 2013 Secured Note”).

Collectively, the January 2013 Secured Note, the May 2013 Secured Note and the August 2013 Secured Note are hereinafter referred to as the “2013 Secured Notes.”

Collectively, the 2012 Secured Notes and the 2013 Secured Notes represent a total of $9,000,000 in principal amount of loans from Niobe and are hereinafter referred to as the “Secured Notes.”

Payment of the principal and accrued interest on the Secured Notes will, at Niobe’s election, automatically become immediately due and payable if the Company undertakes certain Fundamental Transactions or upon an Event of Default, both as defined in the Secured Notes.

The Company’s obligations under the Secured Notes and the Secured Notes are secured by a security agreement granting Niobe a security interest in substantially all of its personal property and assets, including its intellectual property.   

All of the securities issued in the aforementioned financings were issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended (the “Act”) pursuant to Section 4(6) and Rule 506 of Regulation D thereof.  The offer, sale and issuance of such securities were made without general solicitation or advertising.  The securities were offered and issued only to “accredited investors” as such term is defined in Rule 501 under the Act.

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CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (USD $)	3 Months Ended	9 Months Ended	12 Months Ended													167 Months Ended
	Aug. 31, 2013	May 31, 2000	May 31, 2013	May 31, 2012	May 31, 2011	May 31, 2010	May 31, 2009	May 31, 2008	May 31, 2007	May 31, 2006	May 31, 2005	May 31, 2004	May 31, 2003	May 31, 2002	May 31, 2001	Aug. 31, 2013
August 13, 2001 - Contribution by stockholders														$ 143,569
Record beneficial conversion value attached to senior secured convertible debt					1,616,667	521,793
Warrants exercised									300,374	786,538
February 28, 2005 - reclass par value for reincorporation into DE as of 12/1/04											0
Purchase of common stock from stockholder												(8,333)	(91,667)
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share		300
June 1, 2006 - May 31, 2007 - stock options exercised									15,200
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		(250,000)
Common stock issued	2,155,000				1,037,500	2,000,000								1,102,000	425,000
September 19, 2003 - repurchase and retired 598,961 shares for $300,000												(300,000)
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts		0
May 31, 2004 - reclassify common stock contra to common stock												0
November 26, 2001 - options issued to board member														133,000
May 31, 2001 - Forgiveness of debt owed to stockholder															40,000
Net loss	(1,512,243)	(250,689)	(6,280,234)	(4,444,584)	(3,357,882)	(3,067,842)	(7,230,206)	(10,490,758)	(8,451,942)	(6,104,402)	(5,567,729)	(2,989,364)	(1,665,090)	(1,280,465)	(553,866)	(63,247,296)
Ending balance	(7,589,019)	346,655	(8,496,871)	(3,123,614)	491,826	1,070,819	1,281,127	7,758,065	17,237,798	9,329,595	8,606,813	8,996,388	243,570	355,893	257,789	(7,589,019)
Employee
Share based compensation	265,095
November 30, 2004 - adjust March 1, 2004 common stock issued to employee											(20,000)
Board Members, Employees and Consultants
Share based compensation							753,268	1,011,025	1,826,850
Compensation related to stock options issued										404,679	308,711	448,096	287,343
Private Placement
Common stock issued									14,217,721
Employees and Debt Holders
Share based compensation			906,977	829,144	124,722	335,741
Issuance During Period 1st
Common stock issued		25,000											1,263,000
Issuance During Period 1st | President
Common stock issued												16,418
Issuance During Period 1st | Employee
Common stock issued										100,000	38,250
Issuance During Period 2nd
Common stock issued		165,400
Issuance During Period 2nd | President
Common stock issued													82,841
Issuance During Period 2nd | Employee
Common stock issued										25,000
Issuance During Period 2nd | Private Placement
Common stock issued											4,851,193	11,356,063
Issuance During Period 3rd | Legal Service
Common stock issued		15,000
Issuance During Period 3rd | Employee
Common stock issued													11,250
Issuance During Period 3rd | Private Placement
Common stock issued										5,510,967
Issuance During Period 3rd | Terminated Employee
Common stock issued												102,438
Issuance During Period 4th
Common stock issued		640,000
Issuance During Period 4th | Employee
Common stock issued												127,500
Issuance During Period 5th | Interest Due
Common stock issued		1,644
Common Stock
August 13, 2001 - Contribution by stockholders														0
August 13, 2001 - Contribution by stockholders (in shares)														0
Record beneficial conversion value attached to senior secured convertible debt					0	0
Warrants exercised (in shares)									26,700	70,320
Warrants exercised									0	1
February 28, 2005 - reclass par value for reincorporation into DE as of 12/1/04											(14,702,070)
Purchase of common stock from stockholder (in shares)												(2,419)	(26,191)
Purchase of common stock from stockholder												(8,333)	(91,667)
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share (in shares)		2,000
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share		300
June 1, 2006 - May 31, 2007 - stock options exercised (in shares)									1,200
June 1, 2006 - May 31, 2007 - stock options exercised									0
September 19, 2003 - repurchase and retired 598,961 shares for $300,000 (in shares)												(598,961)
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization (In Shares)		0
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		0
Common stock issued (in shares)	9,369,565				4,510,870	8,695,652								176,320	85,000
Common stock issued	94				45	87								1,102,000	425,000
September 19, 2003 - repurchase and retired 598,961 shares for $300,000												(300,000)
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts (in shares)		1,794,493
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts		118,547
May 31, 2004 - reclassify common stock contra to common stock (in shares)												0
May 31, 2004 - reclassify common stock contra to common stock												(368,547)
November 26, 2001 - options issued to board member														0
May 31, 2001 - Forgiveness of debt owed to stockholder (in shares)															0
May 31, 2001 - Forgiveness of debt owed to stockholder															0
Net loss	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ending balance (in shares)	28,296,180	2,036,728	18,926,615	18,926,615	18,926,615	14,415,745	5,720,093	5,720,093	5,720,093	4,477,990	3,878,644	3,356,887	2,449,591	2,298,048	2,121,728	28,296,180
Ending balance	283	965,891	189	189	189	144	57	57	57	45	39	14,683,854	3,758,315	2,492,891	1,390,891	283
Common Stock | Employee
Share based compensation (in shares)	0
Share based compensation	0
November 30, 2004 - adjust March 1, 2004 common stock issued to employee (in shares)											0
November 30, 2004 - adjust March 1, 2004 common stock issued to employee											(20,000)
Common Stock | Board Members, Employees and Consultants
Share based compensation (in shares)							0	0	0
Share based compensation							0	0	0
Compensation related to stock options issued										0	0	0	0
Common Stock | Private Placement
Common stock issued (in shares)									1,214,203
Common stock issued									12
Common Stock | Employees and Debt Holders
Share based compensation (in shares)			0	0	0	0
Share based compensation			0	0	0	0
Common Stock | Issuance During Period 1st
Common stock issued (in shares)		17											168,400
Common stock issued		25,000											1,263,000
Common Stock | Issuance During Period 1st | President
Common stock issued (in shares)												1,667
Common stock issued												16,418
Common Stock | Issuance During Period 1st | Employee
Common stock issued (in shares)										8,000	3,000
Common stock issued										0	38,250
Common Stock | Issuance During Period 2nd
Common stock issued (in shares)		91,889
Common stock issued		165,400
Common Stock | Issuance During Period 2nd | President
Common stock issued (in shares)													8,334
Common stock issued													82,841
Common Stock | Issuance During Period 2nd | Employee
Common stock issued (in shares)										2,000
Common stock issued										0
Common Stock | Issuance During Period 2nd | Private Placement
Common stock issued (in shares)											518,757	1,489,129
Common stock issued											5	11,356,063
Common Stock | Issuance During Period 3rd | Legal Service
Common stock issued (in shares)		20,000
Common stock issued		15,000
Common Stock | Issuance During Period 3rd | Employee
Common stock issued (in shares)													1,000
Common stock issued													11,250
Common Stock | Issuance During Period 3rd | Private Placement
Common stock issued (in shares)										519,026
Common stock issued										5
Common Stock | Issuance During Period 3rd | Terminated Employee
Common stock issued (in shares)												7,880
Common stock issued												102,438
Common Stock | Issuance During Period 4th
Common stock issued (in shares)		128,000
Common stock issued		640,000
Common Stock | Issuance During Period 4th | Employee
Common stock issued (in shares)												10,000
Common stock issued												127,500
Common Stock | Issuance During Period 5th | Interest Due
Common stock issued (in shares)		329
Common stock issued		1,644
Additional Paid in Capital
August 13, 2001 - Contribution by stockholders														143,569
Record beneficial conversion value attached to senior secured convertible debt					1,616,667	521,793
Warrants exercised									300,374	786,537
February 28, 2005 - reclass par value for reincorporation into DE as of 12/1/04											14,702,070
Purchase of common stock from stockholder												0	0
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share		0
June 1, 2006 - May 31, 2007 - stock options exercised									15,200
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		0
Common stock issued	2,154,906				1,037,455	1,999,913								0	0
September 19, 2003 - repurchase and retired 598,961 shares for $300,000												0
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts		0
May 31, 2004 - reclassify common stock contra to common stock												0
November 26, 2001 - options issued to board member														133,000
May 31, 2001 - Forgiveness of debt owed to stockholder															40,000
Net loss	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ending balance	55,657,994	0	53,237,993	52,331,016	51,501,872	48,723,028	45,865,581	45,112,313	44,101,288	27,741,155	20,913,977	1,052,008	603,912	316,569	40,000	55,657,994
Additional Paid in Capital | Employee
Share based compensation	265,095
November 30, 2004 - adjust March 1, 2004 common stock issued to employee											0
Additional Paid in Capital | Board Members, Employees and Consultants
Share based compensation							753,268	1,011,025	1,826,850
Compensation related to stock options issued										404,679	308,711	448,096	287,343
Additional Paid in Capital | Private Placement
Common stock issued									14,217,709
Additional Paid in Capital | Employees and Debt Holders
Share based compensation			906,977	829,144	124,722	335,741
Additional Paid in Capital | Issuance During Period 1st
Common stock issued		0											0
Additional Paid in Capital | Issuance During Period 1st | President
Common stock issued												0
Additional Paid in Capital | Issuance During Period 1st | Employee
Common stock issued										100,000	0
Additional Paid in Capital | Issuance During Period 2nd
Common stock issued		0
Additional Paid in Capital | Issuance During Period 2nd | President
Common stock issued													0
Additional Paid in Capital | Issuance During Period 2nd | Employee
Common stock issued										25,000
Additional Paid in Capital | Issuance During Period 2nd | Private Placement
Common stock issued											4,851,188	0
Additional Paid in Capital | Issuance During Period 3rd | Legal Service
Common stock issued		0
Additional Paid in Capital | Issuance During Period 3rd | Employee
Common stock issued													0
Additional Paid in Capital | Issuance During Period 3rd | Private Placement
Common stock issued										5,510,962
Additional Paid in Capital | Issuance During Period 3rd | Terminated Employee
Common stock issued												0
Additional Paid in Capital | Issuance During Period 4th
Common stock issued		0
Additional Paid in Capital | Issuance During Period 4th | Employee
Common stock issued												0
Additional Paid in Capital | Issuance During Period 5th | Interest Due
Common stock issued		0
Common Stock- Contra
August 13, 2001 - Contribution by stockholders														0
Record beneficial conversion value attached to senior secured convertible debt					0	0
Warrants exercised									0	0
February 28, 2005 - reclass par value for reincorporation into DE as of 12/1/04											0
Purchase of common stock from stockholder												0	0
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share		0
June 1, 2006 - May 31, 2007 - stock options exercised									0
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		(250,000)
Common stock issued	0				0	0								0	0
September 19, 2003 - repurchase and retired 598,961 shares for $300,000												0
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts		(118,547)
May 31, 2004 - reclassify common stock contra to common stock												368,547
November 26, 2001 - options issued to board member														0
May 31, 2001 - Forgiveness of debt owed to stockholder															0
Net loss	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ending balance	0	(368,547)	0	0	0	0	0	0	0	0	0	0	(368,547)	(368,547)	(368,547)	0
Common Stock- Contra | Employee
Share based compensation	0
November 30, 2004 - adjust March 1, 2004 common stock issued to employee											0
Common Stock- Contra | Board Members, Employees and Consultants
Share based compensation							0	0	0
Compensation related to stock options issued										0	0	0	0
Common Stock- Contra | Private Placement
Common stock issued									0
Common Stock- Contra | Employees and Debt Holders
Share based compensation			0	0	0	0
Common Stock- Contra | Issuance During Period 1st
Common stock issued		0											0
Common Stock- Contra | Issuance During Period 1st | President
Common stock issued												0
Common Stock- Contra | Issuance During Period 1st | Employee
Common stock issued										0	0
Common Stock- Contra | Issuance During Period 2nd
Common stock issued		0
Common Stock- Contra | Issuance During Period 2nd | President
Common stock issued													0
Common Stock- Contra | Issuance During Period 2nd | Employee
Common stock issued										0
Common Stock- Contra | Issuance During Period 2nd | Private Placement
Common stock issued											0	0
Common Stock- Contra | Issuance During Period 3rd | Legal Service
Common stock issued		0
Common Stock- Contra | Issuance During Period 3rd | Employee
Common stock issued													0
Common Stock- Contra | Issuance During Period 3rd | Private Placement
Common stock issued										0
Common Stock- Contra | Issuance During Period 3rd | Terminated Employee
Common stock issued												0
Common Stock- Contra | Issuance During Period 4th
Common stock issued		0
Common Stock- Contra | Issuance During Period 4th | Employee
Common stock issued												0
Common Stock- Contra | Issuance During Period 5th | Interest Due
Common stock issued		0
Deficit Accumulated During The Development Stage
August 13, 2001 - Contribution by stockholders														0
Record beneficial conversion value attached to senior secured convertible debt					0	0
Warrants exercised									0	0
February 28, 2005 - reclass par value for reincorporation into DE as of 12/1/04											0
Purchase of common stock from stockholder												0	0
September 17, 1999 - initial issuance of 2,000 shares for intellectual technology license at $.15 per share		0
June 1, 2006 - May 31, 2007 - stock options exercised									0
September 30, 1999 - cost of public shell acquisition over net assets acquired to be accounted for as a Recapitalization		0
Common stock issued	0				0	0								0	0
September 19, 2003 - repurchase and retired 598,961 shares for $300,000												0
November 15, 1999 - reverse merger transaction with Enerdyne Corporation, net transaction amounts		0
May 31, 2004 - reclassify common stock contra to common stock												0
November 26, 2001 - options issued to board member														0
May 31, 2001 - Forgiveness of debt owed to stockholder															0
Net loss	(1,512,243)	(250,689)	(6,280,234)	(4,444,584)	(3,357,882)	(3,067,842)	(7,230,206)	(10,490,758)	(8,451,942)	(6,104,402)	(5,567,729)	(2,989,364)	(1,665,090)	(1,280,465)	(553,866)
Ending balance	(63,247,296)	(250,689)	(61,735,053)	(55,454,819)	(51,010,235)	(47,652,353)	(44,584,511)	(37,354,305)	(26,863,547)	(18,411,605)	(12,307,203)	(6,739,474)	(3,750,110)	(2,085,020)	(804,555)	(63,247,296)
Deficit Accumulated During The Development Stage | Employee
Share based compensation	0
November 30, 2004 - adjust March 1, 2004 common stock issued to employee											0
Deficit Accumulated During The Development Stage | Board Members, Employees and Consultants
Share based compensation							0	0	0
Compensation related to stock options issued										0	0	0	0
Deficit Accumulated During The Development Stage | Private Placement
Common stock issued									0
Deficit Accumulated During The Development Stage | Employees and Debt Holders
Share based compensation			0	0	0	0
Deficit Accumulated During The Development Stage | Issuance During Period 1st
Common stock issued		0											0
Deficit Accumulated During The Development Stage | Issuance During Period 1st | President
Common stock issued												0
Deficit Accumulated During The Development Stage | Issuance During Period 1st | Employee
Common stock issued										0	0
Deficit Accumulated During The Development Stage | Issuance During Period 2nd
Common stock issued		0
Deficit Accumulated During The Development Stage | Issuance During Period 2nd | President
Common stock issued													0
Deficit Accumulated During The Development Stage | Issuance During Period 2nd | Employee
Common stock issued										0
Deficit Accumulated During The Development Stage | Issuance During Period 2nd | Private Placement
Common stock issued											0	0
Deficit Accumulated During The Development Stage | Issuance During Period 3rd | Legal Service
Common stock issued		0
Deficit Accumulated During The Development Stage | Issuance During Period 3rd | Employee
Common stock issued													0
Deficit Accumulated During The Development Stage | Issuance During Period 3rd | Private Placement
Common stock issued										0
Deficit Accumulated During The Development Stage | Issuance During Period 3rd | Terminated Employee
Common stock issued												0
Deficit Accumulated During The Development Stage | Issuance During Period 4th
Common stock issued		0
Deficit Accumulated During The Development Stage | Issuance During Period 4th | Employee
Common stock issued												0
Deficit Accumulated During The Development Stage | Issuance During Period 5th | Interest Due
Common stock issued		$ 0

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CONDENSED BALANCE SHEETS (USD $)	Aug. 31, 2013	May 31, 2013
CURRENT ASSETS:
Cash and cash equivalents	$ 2,018,645	$ 2,457,046
Prepaid expenses	17,204	42,320
Total current assets	2,035,849	2,499,366
OTHER ASSETS:
Intellectual technology property, net of accumulated amortization of $13,323 and $13,068 as of August 31, 2013 and May 31, 2013, respectively	6,212	6,467
Total other assets	6,212	6,467
Total Assets	2,042,061	2,505,833
CURRENT LIABILITIES:
Accounts payable	303,547	671,738
Accrued expenses	137,750	62,517
Current portion - long term debt, related party,	2,085,833	4,210,833
Total current liabilities	2,527,130	4,945,088
LONG TERM LIABILITIES:
Senior Secured Note - related party	7,000,000	6,000,000
Senior Secured Note Accrued Interest - related party	103,950	57,616
Total liabilities	9,631,080	11,002,704
STOCKHOLDERS' EQUITY (DEFICIT)
Preferred stock, par value $0.00001, 1,000,000 shares authorized; none issued and outstanding	0	0
Common stock, par value $0.00001, 100,000,000 shares authorized; 28,296,180 and 18,926,615 shares issued and outstanding, respectively	283	189
Additional paid in capital	55,657,994	53,237,993
Deficit accumulated during the development stage	(63,247,296)	(61,735,053)
Total stockholders’ equity (deficit)	(7,589,019)	(8,496,871)
Total liabilities and stockholders’ equity (deficit)	$ 2,042,061	$ 2,505,833

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RELATED PARTIES - Additional Information (Detail) (USD $)	1 Months Ended	12 Months Ended
	Mar. 01, 2010 Monthly Payment	May 31, 2013 Mr. Warshaw
Related Party Transaction [Line Items]
Payment for the use and occupancy, and administrative services, related to principal offices	$ 500
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross		350,000
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period		10 years
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price		$ 1.05
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights		The options vested 50% upon issuance and the remainder will vest on May 22, 2014.
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value		$ 329,000

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RELATED PARTIES

3 Months Ended

Aug. 31, 2013

Related Party Transactions [Abstract]

RELATED PARTIES

NOTE 6. RELATED PARTIES

Niobe, the majority stockholder of the Company and the holder of the Secured Notes (defined in Note 2, above), is controlled by Arnold P. Kling, the Company’s president and director. 

During the year ended May 31, 2013, the Company issued an aggregate of 350,000 options to Kirk M. Warshaw, the Company’s chief financial officer and director.  The 350,000 options issued during fiscal year ended May 31, 2013 have a ten year life with an exercise price of $1.05.  The options vested 50% upon issuance and the remainder will vest on May 22, 2014.  The 350,000 options were valued at $329,000.

The Company’s principal offices are located at 133 Summit Avenue, Suite 22, Summit, New Jersey which are owned by Kirk M. Warshaw, LLC (the “LLC”), an affiliated company of Mr. Warshaw.  The Company occupies its principal offices on a month to month basis.  On March 1, 2010, it began paying a monthly fee of $500 to the LLC for the use and occupancy, and administrative services, related to its principal offices.

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BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Aug. 31, 2013

Accounting Policies [Abstract]

Estimates

Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires the Company to make estimates and assumptions affecting the reported amounts of assets, liabilities, revenues and expense, and the disclosure of contingent assets and liabilities. Estimated amounts could differ materially from actual results.

Loss per Common Share

Loss per Common Share

The Financial Accounting Standards Board (FASB) has issued guidance for “Earnings Per Share” which provides for the calculation of “Basic” and “Diluted” earnings per share. Basic earnings per share includes no dilution and is computed by dividing net loss to common stockholders by the weighted average number of common shares outstanding for the period. All potentially dilutive securities consisting of employee stock options and warrants have been excluded from the computations since they would be antidilutive. However, these dilutive securities could potentially dilute earnings per share in the future. As of August 31, 2013 the Company had potentially dilutive securities consisting of 3,057,543 stock options.  As of August 31, 2012, the Company had potentially dilutive securities consisting of 2,642,191 stock options.

Cash and Cash Equivalents

Cash and Cash Equivalents

For the purposes of reporting cash flows, the Company considers all cash accounts which are not subject to withdrawal restrictions or penalties, and highly liquid investments with original maturities of 60 days or less to be cash and cash equivalents. The cash and cash equivalent deposits are not insured by The Federal Deposit Insurance Corporation.

Share Based Compensation

Share Based Compensation

Effective June 1, 2006, the Company adopted the FASB accounting guidance for fair value recognition provisions of the “Accounting for Share-Based Payment” using the modified prospective method.  This standard requires the Company to measure the cost of employee services received in exchange for equity share options granted based on the grant-date fair value of the options.  The cost is recognized as compensation expense over the vesting period of the options.  Under the modified prospective method $265,095 and $195,997 compensation cost is included in operating expenses for the three months ended August 31, 2013 and August 31, 2012, respectively.  These amounts included both the compensation cost of stock options granted prior to but not yet vested as of June 1, 2006 and compensation cost for all options granted subsequent to May 31, 2006.  In accordance with the modified prospective application transition method, prior period results are not restated.  Incremental compensation cost for a modification of the terms or conditions of an award is measured by comparing the fair value of the modified award with the fair value of the award immediately before the modification.  No tax benefit was recorded as of May 31, 2013 in connection with these compensation costs due to the uncertainty regarding ultimate realization of certain net operating loss carryforwards.  The Company has also implemented the SEC interpretations in Staff Accounting Bulletin (“SAB”) for “Share-Based Payments,” in connection with the adoption of FASB accounting guidance.

The Board of Directors adopted and the stockholders approved the 2003 Stock Option Plan in October 2003 which was subsequently amended in October 2005. The plan was adopted to recognize the contributions made by the Company’s employees, officers, consultants, and directors, to provide those individuals with additional incentive to devote themselves to the Company’s future success, and to improve the Company’s ability to attract, retain and motivate individuals upon whom the Company’s growth and financial success depends. Under the plan, stock options may be granted as approved by the Board of Directors or the Compensation Committee. There are 900,000 shares reserved for grants of options under the plan, of which 88,800 have been issued and 800 were exercised. The Company has issued 271,784 stock options as standalone grants, of which 400 were exercised. Stock options vest pursuant to individual stock option agreements. No options granted under the plan are exercisable after the expiration of ten years (or less in the discretion of the Board of Directors or the Compensation Committee) from the date of the grant. The plan will continue in effect until terminated or amended by the Board of Directors.

The accounting guidance requires the use of a valuation model to calculate the fair value of each stock-based award. The Company uses the Black-Scholes model to estimate the fair value of stock options granted based on the following assumptions:

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using a combination of the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

As of August 31, 2013, there were 3,057,543 stock options outstanding.  At August 31, 2013, the aggregate unrecognized compensation cost of unvested options, as determined using a Black-Scholes option valuation model was approximately $86,726 (net of estimated forfeitures) will be recognized ratably through July 31, 2014.  The remaining amount of options will be valued once they vest upon the future events.  During the three months ended August 31, 2013, the Company did not grant any stock options and 28,000 options expired.

The fair value of the options is estimated on the date of the grant using the Black-Scholes option pricing model with the following assumptions:

	Three Months Ended August 31, 2013			Three Months Ended August 31, 2012			From Inception Through August 31, 2013
Dividends per year		0			0			0
Volatility percentage		418% - 426	%		97.5	%		90%-426	%
Risk free interest rate		2.13	%		3.47	%		1.74%-5.11	%
Expected life (years)		7.0-10.0			7.0-10.0			3-10
Weighted Average Fair Value	$	1.22		$	1.07		$	2.30

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RECENT ACCOUNTING PRONOUNCEMENTS

3 Months Ended

Aug. 31, 2013

Accounting Changes and Error Corrections [Abstract]

RECENT ACCOUNTING PRONOUNCEMENTS

NOTE 5. RECENT ACCOUNTING PRONOUNCEMENTS

Management does not believe that any recently issued, but not yet effective, accounting standards could have a material effect on the accompanying consolidated financial statements.  As new accounting pronouncements are issued, the Company will adopt those that are applicable under the circumstances.

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CONDENSED STATEMENTS OF CASH FLOWS (USD $)	3 Months Ended		167 Months Ended
	Aug. 31, 2013	Aug. 31, 2012	Aug. 31, 2013
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (1,512,243)	$ (1,364,972)	$ (63,247,296)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities
(Gain) on disposal of equipment, net	0	0	(81,544)
Depreciation and amortization	255	234,313	1,971,395
Equity based expense	265,095	195,997	8,859,066
(Increase)/decrease in:
Prepaid expenses and deposits	25,116	24,036	(25,194)
Increase/(decrease) in:
Accounts payable and accrued expenses	(216,624)	(222,004)	1,191,584
Net cash and cash equivalents used in operating activities	(1,438,401)	(1,132,630)	(51,331,989)
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisition of intellectual technology license - fee portion	0	0	(20,000)
Refund of security deposits	0	0	7,990
Acquisition of equipment	0	0	(905,936)
Excess of amounts paid for public shell over assets acquired to be accounted for as a recapitalization	0	0	(250,000)
Proceeds from disposal of equipment	0	0	229,135
Net cash and cash equivalents used in investing activities	0	0	(938,811)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from stock issuance, including options and warrants exercised	0	0	42,658,458
Principal payment on equipment notes payable and capital leases	0	0	(295,411)
Contribution by stockholders	0	0	183,569
Principal payment on note payable to individuals	0	0	(225,717)
Issuance of note payable to individuals	1,000,000	1,000,000	12,368,546
Acquisition of common stock	0	0	(400,000)
Net cash and cash equivalents provided by financing activities	1,000,000	1,000,000	54,289,445
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS	(438,401)	(132,630)	2,018,645
Cash and cash equivalents, beginning of period	2,457,046	190,395	0
Cash and cash equivalents, ending of period	2,018,645	57,765	2,018,645
SUPPLEMENTAL SCHEDULE OF CASH FLOW INFORMATION:
Interest paid	0	0	66,770
Taxes paid	0	0	100
NON-CASH FINANCING ACTIVITIES:
Conversion of debt for equity	$ 2,155,000	$ 0	$ 3,192,500

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CHANGE OF OWNERSHIP TRANSACTION - Additional Information (Detail) (USD $)	3 Months Ended	9 Months Ended	12 Months Ended				1 Months Ended								1 Months Ended				1 Months Ended	3 Months Ended
	Aug. 31, 2013	May 31, 2000	May 31, 2011	May 31, 2010	May 31, 2002	May 31, 2001	Aug. 27, 2013 Senior Secured Note Subsequent Event	May 13, 2013 Niobe Ventures LLC Senior Secured Note	Jan. 18, 2013 Niobe Ventures LLC Senior Secured Note	Dec. 03, 2012 Niobe Ventures LLC Senior Secured Note	Oct. 01, 2012 Niobe Ventures LLC Senior Secured Note	Jun. 05, 2012 Niobe Ventures LLC Senior Secured Note	Feb. 01, 2012 Niobe Ventures LLC Senior Secured Note	Aug. 31, 2013 Niobe Ventures LLC Senior Secured Note	Aug. 27, 2013 Niobe Ventures LLC Senior Secured Note Subsequent Event	Nov. 11, 2009 Niobe Ventures LLC Securities Purchase Agreement	Feb. 11, 2011 Niobe Ventures LLC Securities Purchase Agreement Senior Secured Note	Nov. 11, 2009 Niobe Ventures LLC Securities Purchase Agreement Senior Secured Note	Feb. 11, 2011 Credit Facility Agreement Niobe Ventures LLC Senior Secured Note	Aug. 31, 2013 Credit Facility Agreement Niobe Ventures LLC Senior Secured Note
Class of Stock [Line Items]
Additional working capital raised																$ 3,000,000
Restricted shares of common stock issued																8,695,652
Common Stock issued, per share		$ 0.15		$ 0.23	$ 6.25	$ 5.00										$ 0.23
Restricted shares of common stock issued, value	2,155,000		1,037,500	2,000,000	1,102,000	425,000										2,000,000
Senior secured convertible promissory note							2,000,000										1,000,000	1,000,000	2,000,000
Accrued interest on senior secured convertible promissory note							155,000										37,500
Senior secured convertible promissory note, conversion price per share																		$ 0.23	$ 0.23
Shares of common stock issuable upon conversion of senior secured convertible promissory note																	4,510,870
Senior secured convertible promissory note, maturity date							Aug. 27, 2015	May 13, 2015	Jan. 15, 2015	Oct. 01, 2014	Oct. 01, 2014	May 31, 2014	Feb. 01, 2014						Dec. 31, 2012
Senior secured convertible promissory note, extended maturity date																			Dec. 31, 2013	Dec. 31, 2013
Debt instrument, interest rate, effective percentage																			3.00%
Proceeds from secured notes payable							1,000,000	2,000,000	2,500,000	700,000	800,000	1,000,000	1,000,000
Debt instrument, face amount							$ 1,000,000	$ 2,000,000	$ 2,500,000	$ 700,000	$ 800,000	$ 1,000,000	$ 1,000,000	$ 9,000,000
Debt instrument, interest rate during Period							3.00%	3.00%	3.00%	3.00%	3.00%	3.00%	3.00%
Debt Conversion, Converted Instrument, Shares Issued															9,369,565

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SUBSEQUENT EVENTS

3 Months Ended

Aug. 31, 2013

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 9. SUBSEQUENT EVENTS

On October 11, 2013, the Company issued a Consolidated, Amended and Restated Promissory Note to Niobe in the principal amount of $9,219,366.67 (the “Consolidated Note”).  The face amount of the Consolidated Note reflects the $9.0 million aggregate principal amount of the Secured Notes plus interest accrued at 3% per annum on each note from its respective date of issuance.  The terms of the Consolidated Note are identical to the Secured Notes except that: (a) the maturity date is September 1, 2015, which is after the latest maturity date of any of the Secured Notes; and (b) it provides for partial mandatory repayment in the event that the Company receives aggregate gross proceeds in excess of $7.5 million from a single or multiple “Liquidity Events” in an amount equal to twenty-five (25%) percent of such gross proceeds.  A “Liquidity Event” means (a) the sale of any of our equity, or equity-linked, securities, and (b) the receipt of proceeds, directly or indirectly related to a development and/or commercialization relationship entered into with an unaffiliated third party.  In the Secured Notes, the entire principal amount of each note was due, at Niobe’s election, upon the consummation of an equity financing of $7.5 million or greater.  Consistent with the terms of the Secured Notes and related security agreements entered into, the Company’s obligations under the Consolidated Note are secured by a first priority perfected security interest in all of the assets of the Company pursuant to a Consolidated, Amended and Restated Security Agreement dated October 11, 2013 between the Company and Niobe.

The Company has evaluated subsequent events and has determined that there were no other subsequent events to recognize or disclose in these financial statements.

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Fair Value of Assumptions of Options Estimated on Grant Date (Detail) (USD $)	3 Months Ended		167 Months Ended
	Aug. 31, 2013	Aug. 31, 2012	Aug. 31, 2013
Assumptions used to Determine Fair Value Options [Line Items]
Dividends per year	$ 0	$ 0	$ 0
Volatility percentage		97.50%
Risk free interest rate	2.13%	3.47%
Weighted Average Fair Value	$ 1.22	$ 1.07	$ 2.30
Minimum
Assumptions used to Determine Fair Value Options [Line Items]
Volatility percentage	418.00%		90.00%
Risk free interest rate			1.74%
Expected life (years)	7 years	7 years	3 years
Maximum
Assumptions used to Determine Fair Value Options [Line Items]
Volatility percentage	426.00%		426.00%
Risk free interest rate			5.11%
Expected life (years)	10 years	10 years	10 years

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GOING CONCERN - Additional Information (Detail) (USD $)	3 Months Ended		9 Months Ended	12 Months Ended													167 Months Ended
	Aug. 31, 2013	Aug. 31, 2012	May 31, 2000	May 31, 2013	May 31, 2012	May 31, 2011	May 31, 2010	May 31, 2009	May 31, 2008	May 31, 2007	May 31, 2006	May 31, 2005	May 31, 2004	May 31, 2003	May 31, 2002	May 31, 2001	Aug. 31, 2013	Sep. 16, 1999
Cash Flow Supplemental Disclosures [Line Items]
Deficit accumulated during the development stage	$ 63,247,296			$ 61,735,053													$ 63,247,296
Net loss	(1,512,243)	(1,364,972)	(250,689)	(6,280,234)	(4,444,584)	(3,357,882)	(3,067,842)	(7,230,206)	(10,490,758)	(8,451,942)	(6,104,402)	(5,567,729)	(2,989,364)	(1,665,090)	(1,280,465)	(553,866)	(63,247,296)
Cash used in operating activities	(1,438,401)	(1,132,630)		4,733,349	2,351,630												(51,331,989)
Cash and cash equivalents	2,018,645	57,765		2,457,046	190,395												2,018,645	0
Net working capital deficit	$ 491,281																$ 491,281

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Document And Entity Information	3 Months Ended
	Aug. 31, 2013	Oct. 11, 2013
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Aug. 31, 2013
Document Fiscal Year Focus	2014
Document Fiscal Period Focus	Q1
Trading Symbol	PRTX
Entity Common Stock, Shares Outstanding		28,296,180
Entity Registrant Name	PROTALEX INC
Entity Central Index Key	0001099215
Current Fiscal Year End Date	--05-31
Entity Filer Category	Smaller Reporting Company

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BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Detail) (USD $)	3 Months Ended
	Aug. 31, 2013	Aug. 31, 2012
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, number of options issued during period	271,784
Stock option exercisable expiration period	10 years
Share based compensation, number of stock options outstanding	3,057,543
Aggregate unrecognized compensation cost of unvested options	$ 86,726
Share based compensation, number of stock options expired during period	28,000
Stock Incentive Plan 2003
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares reserved for grants of options	900,000
Share based compensation, number of options issued during period	88,800
Share based compensation, number of options exercised during period	800
Standalone Grants
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, number of options exercised during period	400
Operating Expense
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Compensation cost included in operating expenses	$ 265,095	$ 195,997
Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Potentially dilutive securities	3,057,543	2,642,191