matinas biopharma holdings, inc. form 8-k securities … · mat901–uniquegrdo mega-3com psitn•s...

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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): April 30, 2014 MATINAS BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 333-193455 46-3011414 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer ID Number) 1545 Route 206 South, Suite 302 Bedminster, New Jersey 07921 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (908) 443-1860 Not Applicable (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: ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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  • UNITED STATESSECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

    FORM 8-K

    CURRENT REPORTPursuant to Section 13 or 15(d) of the

    Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): April 30, 2014

    MATINAS BIOPHARMA HOLDINGS, INC.(Exact name of registrant as specified in its charter)

    Delaware 333-193455 46-3011414(State or other jurisdiction

    of incorporation) (Commission File Number)

    (IRS Employer ID Number)

    1545 Route 206 South, Suite 302

    Bedminster, New Jersey 07921(Address of principal executive offices) (Zip Code)

    Registrant’s telephone number, including area code: (908) 443-1860

    Not Applicable

    (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 underany of the following provisions:

    ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

    ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

    ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

    ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

  • Item 7.01 Regulation FD Disclosure.

    Matinas BioPharma Holdings, Inc. (the “Company”) intends to use a slide presentation with certain investors during a conference

    held on April 30, 2014. The slide presentation is attached hereto as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibits

    99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), orotherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or theSecurities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

    This Current Report on Form 8-K, including exhibit 99.1, contains “forward-looking statements” made pursuant to the safe harbor

    provisions of the Private Securities Litigation Reform Act of 1995, including those relating to the Company’s product development, clinicaland regulatory timelines, market opportunity, cash flow and other statements that are predictive in nature, that depend upon or refer to futureevents or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as “expects,” “anticipates,” “intends,” “plans,” “could”, “believes,” “estimates” and similar expressions.These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially differentfrom any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risksand uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization ofMAT9001; our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capitalwhich will be necessary to complete the clinical trials for MAT9001; the uncertainties inherent in clinical testing; the timing, cost anduncertainty of obtaining regulatory approvals; our ability to protect the Company’s intellectual property; the loss of any executive officers orkey personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’sproducts; and the other factors listed under “Risk Factors” in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Prospectiveinvestors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation.Matinas does not undertake any obligation to release publicly any revisions to such forward-looking statement to reflect events orcircumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma’s lead product candidate MAT9001is in a development stage and is not available for sale or use.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautions not to place undue

    reliance on any forward-looking statements, which speak only as of the date of this Current Report on Form 8-K. We have no obligation, andexpressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information,future events or otherwise.

    Item 9.01. Financial Statements and Exhibits

    Exhibit Description

    99.1 Slide Presentation, dated April 30, 2014.

  • 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. MATINAS BIOPHARMA HOLDINGS, INC. Date: April 30, 2014 /s/ Roelof Rongen Roelof Rongen, President and Chief Executive Officer

  • C orporate P resentation

  • F orw ard L ooking S tatem ent T his presentation contains "forw ard - looking" statem ents w ithin the m eaning of the P rivate S ecurities L itigation R eform A ct of 1995, including those relating to the C om pany’s product developm ent, clinical and regulatory tim elines, m arket opportunity, cash flow and other statem ents that are predictive in nature, that depend upon or refer to future events or conditions. A ll statem ents other than statem ents of historical fact are statem ents that could be forw ard - looking statem ents. F orw ard - looking statem ents include w ords such as “expects,” “anticipates,” “intends,” “plans,“ “could”, “believes,” “estim ates” and sim ilar expressions. T hese statem ents involve know n and unknow n risks, uncertainties and other factors w hich m ay cause actual results to be m aterially different from any future results expressed or im plied by the forw ard - looking statem ents. F orw ard - looking statem ents are subject to a num ber of risks and uncertainties, including, but not lim ited to, our ability to successfully com plete research and further developm ent and com m ercialization of MA T 9001; our ability to obtain additional capital to m eet our liquidity needs on acceptable term s, or at all, including the additional capital w hich w ill be necessary to com plete the clinical trials for MA T 9001; the uncertainties inherent in clinical testing; the tim ing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the C om pany's intellectual property; the loss of any executive officers or key personnel or consultants; com petition; changes in the regulatory landscape or the im position of regulations that affect the C om pany's products; and the other factors listed under “R isk F actors” in our filings w ith the S E C , including F orm s 10 - K , 10 - Q and 8 - K . P rospective investors are cautioned not to place undue reliance on such forw ard - looking statem ents, w hich speak only as of the date of this presentation. Matinas does not undertake any obligation to release publicly any revisions to such forw ard - looking statem ent to reflect events or circum stances after the date hereof or to reflect the occurrence of unanticipated events. Matinas B ioP harm a’s lead product candidate MA T 9001 is in a developm ent stage and is not available for sale or use. 2

  • T eam out of R eliant P harm aceuticals ( L ovaza ® ) w ith strong developm ent & com m ercialization track record U nique and differentiating expertise in lipidom ics and lipid chem istry H istorical lack of innovation/investm ent in lipid - based therapies Initial focus on low er risk hypertriglyceridem ia opportunity in a large and grow ing m etabolic/C V disease arena 3

  • H IG H triglycerides P ancreatitis C ardiovascular D isease T ype 2 D iabetes F atty L iver D isease H IG H risk: 4

  • H IG H num ber of patients w ith high triglycerides 5 ~ 4M ~ 65M (T G ≥ 150m g/dl) (T G ≥ 500m g/dl)

  • 2012 2013 L ack of G ood P rescription O ptions 6 ~ 2.5M R x/ yr lost U S N O N - L D L - L O WE R IN G P R E S C R IP T IO N S – 2012 & 2013 T otal P rescriptions T R x S ource: IMS 35.0 32.5

  • T he good new s: R esearch show s strong evidence that O m ega - 3s low er triglyceride levels 7

  • N ot all O m ega - 3s are the sam e: N ot all R x O m ega - 3s are the sam e: 8 C O MMO N O ME G A - 3S E P A D H A is associated w ith an increase in L D L cholesterol U N IQ U E O ME G A - 3S D H A A L A E T A H P A L O V A Z A (E P A and D H A ) E P A N O V A (E P A and D H A ) V A S C E P A (P ure E P A ) H igh D H A L ow D H A D P A S D A

  • MA T 9001 A next generation prescription - only om ega - 3 fatty acid m edication 9

  • MA T 9001 – U nique engineered O m ega - 3 com position • S evere H ypertriglyceridem ia (≥ 500m g/dL ) • H ighest potency • U nique Mechanism of A ction • T race am ounts of D H A 10 E P A S P E C IF IC A L L Y D E S IG N E D T O T R E A T D Y S L IP ID E MIA D P A

  • Q uality by D esign O ur targeted developm ent activities and related clinical investigations m ay yield a stronger therapeutic profile com pared to the currently - existing therapies. 11 F A S T IN G T G R E D U C T IO N IN “F A T T Y Z U C K E R ” R A T MO D E L T riglyceride P ercent R eduction F rom B aseline – In V ivo -60% -50% -40% -30% -20% -10% 0% 50 200 400 1000 E P A 200 m g/kg E P A 400 m g/kg E P A 1000 m g/kg D P A 50 m g/kg P ercent reduction from baseline in “F atty Z ucker ” rats after one w eek of dosing ( n = 8 per treatm ent group). S ource: Matinas B ioP harm a research; unpublished

  • 0 0.5 1 1.5 2 0 1 2 3 4 5 O live O il (O O ) O O + E P A 1 g/day O O + D P A 1 g/day 0 0.2 0.4 0.6 0.8 1 0 1 2 3 4 5 D P A V E R S U S E P A IN P O S T P R A N D IA L T G C O N T R O L IN H U MA N S H um an P ostprandial T G L evels ( m m ol /L ) over 5 hours, after 7 days treatm ent (3 - w ay cross - over, N = 10) E xploratory studies show potent effects on hum an triglyceride levels 12 * S ignificant difference from O live O il tim epoint (p< 0.05) + S ignificant A U C difference (p< 0.1) O O vs. O ther O m ega - 3 + + S ignificant A U C difference (p< 0.05) O O vs. O ther O m ega - 3 S ource: L inderborg et al.; P L E F A (2013) 88, 313 - 319 T G in C hylom icrons + + T G in T otal P lasm a +

  • E arly data suggests synergy w ith statin usage 13 S T A T IN IN D U C E D G E N E - E X P R E S S IO N C O MP E N S A T O R Y E F F E C T S A N D N - 3 D O C O S A P E N T A E N O IC A C ID (D P A ) R elative levels of m R N A for H MG - C oA R eductase and P C S K 9 in R at L iver – In V ivo 0 0.5 1 1.5 2 2.5 3 V ehicle O nly V ehicle + S tatin D P A + statin 0 0.5 1 1.5 2 2.5 3 V ehicle O nly V ehicle + S tatin D P A + statin R elative m R N A expression levels in R at liver after 4 w eeks dosing (400 m g D P A /kg*day) S ource: Matinas B ioP harm a research; unpublished P C S K 9 H MG - C oA R eductase

  • S H O R T T R A C K T O P H A S E III S olid S afety R ecord w ith O m ega - 3 P roducts MA T 9001 D evelopm ent P lan 2014 2015 2016 2017 A P I m anufacturing, A nim al S tudy and IN D C om parative P K P hase III in patients w ith S evere H T G (T G ≥ 500m g/dL ) P K /D rug Interaction S tudies A dditional P hase III? F ile N D A & F D A R eview 14

  • Managem ent by D esign R oelof R ongen – P resident and C E O G eorge B obotas , P hD – C hief S cientific O fficer A bdel F aw zy , P hD – E V P P harm aceutical & S upply C hain D evelopm ent G ary G aglione , C P A – V P F inance, A cting C F O Jerom e Jabbour , JD – C hief B usiness O fficer & G eneral C ounsel A cquired by G laxoS m ithK line for $1.65B in 2007 15 $16M raised to date

  • B oard of D irectors w ith S trong P harm a E xperience H erbert C onrad, C hairm an – F orm er P resident, H offm ann L aR oche P harm aceuticals – C o - F ounder/D irector: R eliant P harm aceuticals – C hairm an: P harm asset , G enV ec , S apphire, B one C are – D irector: C elldex , R eliant, D ura, S icor , S avient S tefano F errari, D irector – Muram i P harm a , B ioseutica/K D - P harm a (leading m anufacturer of om ega - 3 concentrates) – P rospa , S ocieta P rodotti A ntibiotici (developed first om ega - 3 based m edication) Jam es S cibetta , D irector – C urrent C F O P acira , B ioenvision/G enzym e , Merrim ack – D irector: L abopharm , N ephros A dam S tern, D irector – A egis C apital C orp. / C E O , S ternA egis V entures – D irector: O rganovo , InV ivo T herapeutics, P rolor B iotech, L abS tyle R oelof R ongen , D irector – R eliant, A bbott/B A S F P harm a , e - F A T , E P A X / T rygg P harm a , T he Wilkerson G roup, A rthur D . L ittle 16

  • We S ee… ~ 4 m illion adults w ith severe hypertriglyceridem ia ~ $200/m onth L ovaza/V ascepa pricing A N A T T R A C T IV E MA R K E T … A N D A T T R A C T IV E E C O N O MIC S WIT H A C L E A R N E E D … 17 L ack of S atisfactory R x O ptions

  • D esigned for Market A ppetite $1.65B $323M ~ $300M A cquired by G S K from R eliant P harm aceuticals Inc. in 2007 Market cap A cquired by A straZ eneca in 2013 after com pletion of P hase III “ E panova ” 18

  • A lso in our O m ega - 3 pipeline MA T 8800 – P roprietary O m ega - 3 D iscovery P rogram T reating F atty L iver D isease N A F L D N A S H • C om m on: 30% of U .S . population • A leading cause of cirrhosis • N O A P P R O V E D T R E A T ME N T O P T IO N MA T 9001 D yslipidem ia & cardiovascular indications • H eart disease is the #1 killer 19

  • 20 + H IG H N eed H IG H Im pact H IG H V alue =

  • T hank Y ou