8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

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

Date of report (Date of earliest event reported): September 4, 2014

PROTALEX, INC.

(Exact Name of Registrant as Specified in Charter)

DELAWARE	000-28385	91-2003490
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)
131 Columbia Turnpike, Suite 1 Florham Park, NJ 07932		07932
(Address of Principal Executive Offices)		(Zip Code)

(215) 862-9720

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act of 1933, as amended (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Securities Exchange Act of 1934, as amended (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Securities Exchange Act of 1934, as amended (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Securities Exchange Act of 1934, as amended (17 CFR 240.13e-4(c))

Item 8.01.       Other Events.

On September 4, 2014, Protalex, Inc. (“Protalex”) announced that it will be a participant in the Rodman & Renshaw Annual Global Investment Conference, to be held September 8-10, 2014 at the New York Palace Hotel in New York City, at which James W. Dowe, Protalex’s Vice Chairman of the Scientific Advisory Board, will present a corporate overview on Wednesday, September 10th at 10:00 a.m. Eastern time. A copy of the press release and presentation is attached as Exhibits 99.1 and 99.2, respectively, hereto.

Item 9.01.       Financial Statements and Exhibits.

(d)  Exhibits

Exhibit No.	Description
99.1	Press release dated September 4, 2014.
99.2	Presentation at the Rodman & Renshaw Annual Global Investment Conference.

*       *       *       *       *       *

SIGNATURES

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

	PROTALEX, INC.
Dated: September 5, 2014	By:	/s/ Arnold P. Kling
		Arnold P. Kling
		President

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contact:

LHA

Anne Marie Fields

afields@lhai.com

212.838.3777

PROTALEX TO PRESENT AT RODMAN & RENSHAW ANNUAL GLOBAL INVESTMMENT CONFERENCE

Florham Park, N.J. (September 4, 2014) – Protalex, Inc. (OTCBB: PRTX), a clinical-stage biopharmaceutical company, today announces its participation in the Rodman & Renshaw Annual Global Investment Conference to be held September 8-10, 2014 at the New York Palace Hotel in New York City.

James W. Dowe, Vice Chairman of the Company’s Scientific Advisory Board, will present a corporate overview on Wednesday, September 10th at 10:00 a.m. Eastern time. The presentation will be webcast live and archived on the Company’s website at www.protalex.com.

The Company will also file the corporate presentation with the U.S. Securities and Exchange Commission on a Current Report on Form 8-K.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating autoimmune and inflammatory diseases including rheumatoid arthritis (RA). Protalex’s lead product, PRTX-100, is a formulation of a proprietary, highly purified form of Staphylococcal Protein A, which is an immunomodulatory protein produced by bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. The safety, tolerability, and pharmacokinetics of PRTX-100 have been characterized in five clinical studies. In a Phase 1b clinical trial in adult patients with active RA in South Africa PRTX-100 was generally safe and well tolerated at all dose levels, and at the higher doses, more patients showed improvement in their CDAI (Clinical Disease Activity Index) for RA than did patients at the lower dose or placebo cohorts.

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EX-99.2

Exhibit 99.2

September, 2014

Protalex , Inc. Forward - Looking Statement Statements made in this presentation stating the Company ’ s beliefs, intentions, and expectations are forward - looking statements. The company ’ s actual results could differ materially from those projected. Additional information is contained in the company ’ s SEC filings such as our Form 10 - K and Form 10 - Qs filed at www.sec.gov . 2 Protalex , Inc .

Protalex , Inc . (Ticker: PRTX)  Biotechnology company developing a new class of drugs with the potential to revolutionize the treatment of autoimmune diseases  Lead product: PRTX - 100 ▪ Highly purified formulation of Staphylococcal protein A, a natural protein isolated from cultured bacteria ▪ Safe and well - tolerated in five human clinical studies ▪ Efficient and inexpensive proprietary production process 3 Protalex , Inc.

Protalex , Inc. Protalex , Inc. 4 Lead Product PRTX - 100 Market Opportunity Company Structure ▪ Rheumatoid Arthritis (>$18B) ▪ ITP (~$1B) ▪ Other Autoimmune Diseases ($Bs) ▪ Experienced Management ▪ Strong Scientific Advisors ▪ Low - burn Model ▪ Funded - to - date by majority shareholder ▪ Proprietary Staphylococcal protein A formulation ▪ Well - studied Immunomodulatory Protein ▪ Multiple clinical indications

Protalex , Inc. Protalex Investment Thesis  PRTX - 100 is a novel immunomodulatory biological with potential to be a blockbuster drug in various autoimmune diseases ▪ ITP — an orphan disease ▪ Rheumatoid arthritis — the largest autoimmune market  To date, 5 clinical studies conducted demonstrate that PRTX - 100 is safe and well - tolerated in humans  Positive therapeutic effects seen in RA patients and in ITP preclinical models  Potential efficacy in a number of orphan disease indications  Validated manufacturing process; significantly lower cost of goods relative to other biologics  Strong and growing IP position 5 Protalex , Inc.

Protalex , Inc. Animal Studies of PRTX - 100  PRTX - 100 reduces footpad swelling in the murine CIA model of arthritis  PRTX - 100 inhibits platelet phagocytosis by human macrophages in vitro — model for ITP, and orphan disease  PRTX - 100 is not immunosuppressive like anti - TNFs ▪ Pretreat w drug ▪ Challenge w Candida albicans ▪ Anti - TNF potentiates infection 6 0 20 40 60 80 100 -1 1 2 3 4 5 6 7 8 9 PERCENT SURVIVAL STUDY DAY Vehicle Etanercept PRTX 50 PRTX 250 anti-TNF

Protalex , Inc. Efficacy trends from two phase I clinical studies in RA patients — US and So Africa  PRTX - 100 - treated patients showed greater response than placebo - treated patients in all common measures of disease activity, including: ▪ ACR20/50/70 (American College of Rheumatology “patient only” index) ▪ CDAI (Clinical Disease Activity Index, only clinical parameters) ▪ DAS28 - CRP (Disease Activity Score, clinical and blood parameters)  In most recent trial, 43 % of PRTX - 100 treated patients achieved DAS28 - CRP < 3.2 (mean pretreatment DAS28 - CRP was 4.93 )  Other promising trends with categorical analyses  Furthermore , the magnitude of the benefit compares favorably to published efficacy data for in - market RA biologicals with “black box” safety warnings 7 Protalex , Inc.

PRTX - 100 Increases ACR50 Response in RA Patients on Background MTX Therapy ACR50 Response Rate 0 5 10 15 20 25 30 35 0 29 57 85 PRTX - 100 + MTX  Trial PRTX - 100 - 104: 41 patients w active RA randomized 3:1  Baseline MTX vs MTX + PRTX - 100, five weekly i.v . doses, 1.5, 3, 6, or 12 mcg/kg  Last PRTX - 100 dose at day 29  No drug - related SAEs 8 Percentage of Patients >50 ACR Days on Treatment MTX MTX + PRTX - 100

Protalex , Inc. PRTX - 100 treatment reduces CDAI<14 for three or more consecutive visits 36% 31% 13% 0% 5% 10% 15% 20% 25% 30% 35% 40% MTX + PRTX-100 6 and 12 mcg/kg MTX + PRTX-100 All Doses MTX only Percent (%) 9

PRTX - 100 effectively reduces measures of disease activity in RA patients 0 5 10 15 20 25 30 PRTX-100 Placebo Patients with DAS28 score < 3.2 3/29 6/29  Trial PRTX - 100 - 103: 37 patients w active RA randomized 3:1  Baseline MTX vs PRTX - 100 + MTX, four weekly i.v . doses  Last PRTX - 100 dose at day 22  No drug - related SAEs 10 % of patients Day 42 Day 70 Day 42 Day 70 zero

Protalex , Inc. DAS28 categorical analysis from US Ph 1 similar to APPEAL trial data ( Enbrel ) 50% 50% 39% 0% 10% 20% 30% 40% 50% 60% Day 85 PRTX-100 Day 113 PRTX-100 Day 102 Enbrel APPEAL % with DAS28 < 3.2 MTX MTX + PRTX-100 (or Enbrel) 11

PRTX - 100 Competitive Advantage  Considerably lower cost production  No immunosuppression / no “Black Box”  Attractive safety profile allows for potential use in combination therapy  Potentially applicable across a broad set of autoimmune diseases PRTX - 100 vs. current Biologicals 12 Protalex , Inc.

PRTX - 100 Development Plans 13 2012 2013 2014 2015 2016 2017 PRTX - 100 Rheumatoid Arthritis PRTX - 100 Immune Thrombocytopenia Phase 1 So. Africa PRTX - 100 - 103 Phase 1 in USA PRTX - 100 - 104 Phase 2 Phase 3 Explore Partnership Preclinical Phase 1/2 Phase 3 Protalex , Inc.

Protalex , Inc. Patents and Intellectual Property  Patents (five issued in US and one in Japan) ▪ Initial US patent 7,211,258, “Protein A compositions and methods of use” filed 2002 and issued 2007 for RA, juvenile RA, and systemic lupus erythematosus ▪ Continuation patents expanding use were issued for: o ITP or autoimmune TP in 2008 o Acute inflammatory response or inflammation in 2012 o Psoriasis and scleroderma in 2012 o MS in 2013 ▪ Japanese patent issued with 2023 expiration date o April 2014 notice of allowance for psoriasis, scleroderma, Crohn’s Disease ▪ Additional patent applications pending in Europe, Canada, Japan, and US  Other Intellectual Property ▪ Considerable know - how in the manufacture and QA of highly purified SPA expected to remain trade secret 14 Protalex , Inc.

Protalex , Inc. Protalex Key Team Members  Arnold P Kling – President, Director; Principal of Niobe Ventures, LLC, experienced investor in and manager of early stage technology companies  James W Dowe III – Vice - Chair of SAB; active investor in biotechnology, computer software and investment management companies  William E. Gannon, MD – Chief Medical Officer; more than 20 years experience in clinical development and regulatory affairs at Quintiles, PPD, and other companies  Bruce McClain, MD – Medical Director; more than 20 years experience in clinical development and product safety; senior roles at Aeras Global and MedImmune  Richard Francovitch , Ph.D . -- VP of ITP Programs; 27 years pharma experience, former Head of Hematology Franchise and Global Commercial Leader for Promacta / Revolade at GSK  Benjamin R Bowen, Ph.D . – Senior Advisor; background in pharma and biotech R&D at Genentech, Ciba - Geigy, and Novartis; ten years in investment banking  Michelle Catalina, Ph.D . – Director of Preclinical Studies; academic research background in immunology, former instructor at U Mass Medical Center 15

Protalex , Inc. Protalex Milestones x 2Q13 Safety data from first three cohorts of PRTX - 100 - 104 x 3Q13 Initiation of cohort 5 extension study, to investigate monthly maintenance doses x 2Q14 Top - line results of PRTX - 100 - 104 trial □ 3Q14 Filing IND for PRTX - 100 in ITP □ 4Q14 Top - line results from cohort 5 extension study □ 4Q14 First dose in Phase 1/2 study of PRTX - 100 in ITP □ 1Q15 Submit end of study report from PRTX - 100 - 104 trial 16

Protalex , Inc. Protalex Investment Thesis Summary  PRTX - 100 – potentially a blockbuster drug ▪ Multiple clinical indications in both large and niche markets (RA, ITP) ▪ Potentially applicable across a broad set of autoimmune diseases ▪ Considerable cost advantage over competitors ▪ Preliminary results demonstrate safety and proof - of - principle  Market Opportunity ▪ RA = $18 Billion annual market size ▪ ITP = $1 B market ▪ Future expansion into other disease areas  Company Structure ▪ Experienced Management and Advisory Teams with “skin in the game” ▪ Committed support from expert Scientific Advisory Board ▪ Established IP protection and trade secrets 17

September, 2014