MTNB - Earnings call transcript Q4 2019 | Matinas BioPharma Holdings, Inc.

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Operator

Greetings, and welcome to the Matinas BioPharma Fourth Quarter and Full Year 2019 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

As a reminder, this conference is being recorded.

I would now like to turn the conference over to Peter Vozzo, Investor Relations representative from Matinas BioPharma.

begin. may You

Peter Vozzo

press Good business the Rob. the XXXX and you on financial BioPharma issued thank conference and Matinas fourth Thank year the The full BioPharma morning, section. release fourth Investors joining XXXX a we morning, Matinas Earlier along year under with quarter for our call. quarter with you, results this everyone release updates. and website results available full is

Officer, will Officer Speaking Ferguson, Jerry Chief be Dr. on Executive Terry Development Terry Medical Chief Chief Financial call and Dr. Officer, today's Chief Jabbour, Kucinski, Officer. Matkovits, Keith

At forward-looking call remind our may statements and uncertainties. and this the expectations listeners this intentions, like management's of during beliefs, involve hopes, risks made time, I state or would are that These to projections remarks future.

this materially. Forward-looking forward-looking Laws. Securities made current expectations results are the the and on BioPharma's pursuant These of provisions Safe Matinas call actual statements differ on Harbor Federal statements based are to could

should reliance As result, on place statements. you a forward-looking any not undue

of cause the These the those the that and the website with Commission. to Securities documents reports statements available forward-looking are website. Matinas SEC's results could of encourage discussed periodic carefully. are the actual factors by review such We from BioPharma these contemplated Exchange materially Investors files on differ section to documents in Some the company's in and everyone

Investor will Relations this of call posted in be section. to website, the archive An company's the also

session. prepared company's will Following the for up remarks, we call open the question-and-answer

turn I call the will over Jerry. to now

Jerry Jabbour

and XXXX year today as update a taking welcome results. And for us time Good full and fourth the to business and Peter. join provide morning quarter everyone. you, discuss our Thank we thanks

extremely what XXXX accomplished. year-to-date, we team proud we reflect has and the As of on our are

within Our achievements Matinas. well an to exciting recent over time time the prescription be developments as at as market and omega-X the making enthusiasm this

trials represents and study the operational these of MATXXXX and to infrastructure a MATXXXX, head-to-head building in our the efficacy Vascepa support clinical highlight last to programs, Amarin MATXXXX out opportunity lead Corporation’s the leading prescription advancements, profile progress and significant it moving against into the therapy once of our substantial again two key MATXXXX space. the in omega-X versus made superior enhance We’ve XX-months,

also important EnACT in with blood the barrier to cryptococcal study the B our enthusiastic technology crossing are We while breakthrough about utilizing MATXXXX and patients effectively The patients potential deliver delivery physicians. for safely be LNC of an meningitis. and could platform orally amphotericin brain

points relatively timelines investors for company, inflection compressed. in studies these data value our Importantly are and from the to impactful

fourth in We from line year, EnACT in expect we announce as soon of data ENHANCE-IT the year. this be second quarter the the as top cohort to position progression and quarter should trial of in this

EnACT and on discuss MATXXXX study the MATXXXX, design the morning, level overview Dr. a turn I Terry in provide to high will omega call ENHANCE-IT few provide comments well meningitis. both of Terry over MATXXXX as This then landscape. Then the recent discuss X developments Dr. the of cryptococcal as and impacting trial who Matkovits the will an Ferguson will further

our analyst for brief the up questions. Finally Kucinski we before fourth overview will provide results, full open of a financial XXXX line and Keith year quarter

MATXXXX, studies We for manufactured composition, into the prescription capsules, to has and period this supply our took fatty redundancy progress MatXXXX, For steps omega next technical only X successfully complete important of promising of a [Indiscernible] critical to highly multiple, clinical supportive generation acid consistent been past candidate. chain, our for solidify batches we pathway. regulatory initiate year and and used build which and drug

to End-of-Phase these as comparative next X year. study. discuss a from X early of convene the in XX-day we studies in-life expect to data for and quarter Once agreement which on the MATXXXX study an commence clinical comparative clinical the completed well expect we study our third bridging to the study protocol final recently the with toxicology a XXXX reports meeting and bioavailability as these portion request gain Phase become We in FDA for of available, severe dosing of hypertriglyceridemia,

We've assembled advisory in organizations. is a individuals by global for regulatory health Placebo. MATXXXX [ph] this meeting, the well-respected of led versus top one of contract and of us trial research from from Covance, enhanced group Immediately Greenleaf the front

quarter commencing was corporate first are important a have this this in We team. in to very as an study study timely pleased initiated priority of fashion the XXXX, our for

and taken than patients later ensure this help XXX year. timely to steps this top We for delivery of data have have more additional pre-screened study already line

The and evolving discuss of areas, dyslipidemia seen and which dramatic are cardiovascular in importance detail. Dr. treatment will rapidly the developments already have prevention this disease its Ferguson we year of some in more

a the unique a which triglycerides, in or expression Our also protein treatment DPA gene potency impacting which date. making This a instructions acid potentially we with attributable provides MATXXXX or the is therapy eicosapentaenoic the X has of to regulate of amount in EPA and while MATXXXX other cardiovascular combines omega ways believe the conditions high enhanced Docosapentaenoicacid levels impact, that is the PCSKX, in prescription of controlling to the metabolic contained no proprietary reducing for composition, which helps achieves blodemiadeod, cholesterol for of in bloodstream.

is of step from profile to the designed clinical placebo. our further next its in and program study MATXXXX The superior development impressive ENHANCE-IT the distinguish highlight major efficacy

delivery periods well-known as B who as MATXXXX treatment delivered LNC a MATXXXX, longer necessary. meningitis, however phase to upon mucosal its suffering of Its infections, amphotericin of and two preclinical as the cryptococcal now patients package gold when the to technology. could greatly which The nano-crystal standard such is will upon our immunocompromised very the patients lead intravenously be its meningitis up a MATXXXX drug, of now of from MATXXXX infection by is is patients. B. are fungicidal forcing the I Health oral Based challenging treating infections, spectrum due fungal formulation to our desirable studies which is nature. fungal or invasive is for treatment only treatment impacted are brains based turn Amphotericin lipid candidate cryptococcal fungicidal platform our broad profile, until supporting less National two much well Institutes strong of to medicines toxicity physicians immunocompromised turn financially evaluating invading for the investigation of in the data use

the oral blood infections. the demonstration makes amphotericin the MATXXXX allows technology invasive good choice to barrier study for EnACT used positioned This platform is well with technology. our delivery for B of which become treatment of a be across a for potentially very effectively of delivery trial tolerated our fungal to LNC that many can the combined application gateway of deliver broad well drug potential, administration drug brain platform

are Boulware Invasive With notoriously number are we EnACT required infection of direct meningitis. however, the the of enrol, University to to fungal support to the and Minnesota difficult can trials identify of Health patients patients. access immunocompromised to National Uganda, have with Dr. take and often years fortunate multiple in suffering HIV Institutes and to the with cryptococcal working of David be from

safety. expected fungal design for timing the Matkovits bit expect efficiently a enroll infection than result, to more patient the Dr. the a patients cohort EnACT severe little call. typical will progression still trial this prioritizing we other for later treatment is to review and in trials, our in of while able be As trial

of comment advance make a company over on in our I'd company to quarter, like meaningful major, financial strengthen value milestones condition our turning to Dr. assets. financially before Earlier the in well we the creating the took for to brief of lead Ferguson. call the steps potential

current from transformational into institutional and runway XXXX. interest financing, extends expressed completed successfully We capitalized the investors, and our on well-regarded, of new half which cash second a

exclusively execution, to some our now product the to Terry as we company, to I poised details provide over in we ENHANCE-IT space. As candidates. now additional advance on continue like on on the Dr. call Ferguson to focus a commentary developments are would and cardiovascular turn to

Terry Ferguson

study Vascepa is good lipid across initiated the have the stated, Thanks MATXXXX. excited multiple compare efficacy to to of markers. Simply recently and Jerry We're everyone. for and MATXXXX morning ENHANCE-IT extremely designed ENHANCE-IT

with the the levels looking closely omega MATXXXX importance achieved EPA in will for as also for we higher Vascepa. risk of trial; cardiovascular Given mechanistic in blood REDUCE-IT, reduction and levels differences at be Vascepa a driver X seen blood the the

open-label, XX-day enroll subjects per will crossover study an study XXX milligrams to men The levels and approximately deciliter triglyceride XX% or having the equal Vascepa. the versus deciliter. is MATXXXX milligrams to study women ENHANCE-IT of randomized of with assess per greater XXX and with pharmacodynamics between least adult XXX XXX effects at than milligrams triglycerides elevated

LDL-, cholesterol, at baseline primary MATXXXX conducted The accordance at triglycerides. consist of baseline change triglycerides, and and period B treatment be least levels approved twice United HDL-, will eight with daily treatment study study CX, with period. will sites periods endpoint and is Omega-X the be end at each will obtained include blood PCSKX. currently will XX-day VLDL-, labelling. food of treatments, XX washout Total-, plasma in and at be The non-HDL in the to lipid each percent parameters Measured each a States. Vascepa with of days administered the apolipoproteins of in approximately and Vascepa between two and will AX, the end-of-treatment from in

of blood a therapy the exposure any acids, prescription as to achieve science for ability more omega-X significantly of is available it's acids significantly higher total bio success, class believe, MATXXXX’s has or prescription omega-X other evolve. fatty levels believe formulations driver than We than this omega-X fatty ethyl-ester omega-X and that major MATXXXX higher as Vascepa I highlighting that can designed clinical more critical to drug, products in be other to total approved, continues fatty subsequent be well as either acids worth and around omega-X and omega-X development.

it's patient low I January the also On in outcomes exactly benefit”. Epanova. omega-X developments there “A their namely STRENGTH eight with some AstraZeneca’s perspective AstraZeneca stopped prescription STRENGTH likelihood on because believe recent of trial, space, weeks worth a XXth, ago, was XX,XXX omega-X the demonstrating trial providing

fact more this actually know unlikely that later given study, At the why complexity trial until in the and year. see of a much we anything to the the closing large such global stopped, point, don't we're than down

It's of there for one importance scientific TG give, life give it in foundation drove clinical the questioning drive big study the the potential was that study of drivers rich population treatment outcomes. contributors is left that We're is In cardiovascular triglycerides, are to first primary No still the two as things you intact. noting as important STRENGTH the the risk. that only the worth who treated and the why in trials, with and proteins to. place and stopped. What you

just contains clear and an believe don't All what that differences mattered seem contains in the while Vascepa. DHA is what Omega-Xs may as EPA. only is actually and there both almost lipidologist between matter the Epanova DHA biomarker Mostly same, are that X:X be EPA really there ratio, from in not Vascepa in already be and for Epanova blood and levels are less is and of REDUCE-IT, Epanova we simply and harmful, but know EPA outcomes. EPA to

my there study patients differences are prevention big advisory More and between with in later. prior were the in prevention And REDUCE-IT rates importantly much and discussed mind, at seemed attack secondary lower the in diverge committee, were secondary stroke. of in or primary XX% Vascepa the heart least much populations. as prevention at had a patients curves patients, REDUCE-IT that event differences to who FDA

did primary fully with prevention REDUCE-IT, patients Contrast have where half the to not are of have STRENGTH, STRENGTH diabetes. unlike prevention, primary patients in that and

long up in follow STRENGTH the be as not as is Finally, expected to REDUCE-IT. in

event of than half tend rates prevention, primary to up. that less are with shorter diverge curves in later secondary event lower much patients benefit STRENGTH now and prevention, So and numerically with combined in follow the much much

study; enough show half Given not that lower that futility. not up seem been in might have may would STRENGTH the time quite early the risk patients there it stopped meaningful benefit that be simply make so for much surprising to of

More importantly, what though the Matinas. for study stopping mean STRENGTH the

uncertainties triglycerides, may for proteins around changed. the prevention Matinas, less creates contributors acceptance as remain of cardiovascular and a ultimate competitive life not the role while disease rich in much primary of has some omega-Xs major this And I much path forward. to simpler, As of TG mentioned

remaining our and quarter pathway potential except position. Nothing to to have our second gone is you'll be, The only from fourth severe MATXXXX looking treat real has if study the potential is strengthened head-to-head question competitor away. an Vascepa, study major hypertriglyceridemia expression year for, to opportunity compares about be the Vascepa what how versus the exactly exactly changed indication in will of STRENGTH the excuse a where data and the believe we where trial has has that need this I stopping a clinicians STRENGTH to to

In summary, by a year. top with of see from to community. relatively the for I look We made line MATXXXX. I'm quarter data in continued clinical proud fourth period Omega-Xs in progress we've short academic of ENHANCE-IT and enthusiasm forward I'm encouraged time the the And the this providing of from

with that, turn And Matkovits. call to over I'll the Terry

Terry Matkovits

I key on our candidate delivery discuss Terry and highlights everyone. upon MATXXXX, provide Thanks and cryptococcal based good a morning LNC patients with infected meningitis. our HIV lead technology, our-study-to-treat EnACT few will platform

proceed tested safety that at highest the phase the recently day, with We announced escalation monitoring to dosing the in efficacy per data of unanimously the independent X dose EnACT dose board phase. voted in grams

inclusion meet prepared dose for that are patients the to trial. we the today, otherwise meningitis with present this of cryptococcal and infection criteria As

system, severe unmet infection alternatives. fungal poor for life induction study MATXXXX the currently a and need threatening X nervous explore very patients. is these of with use sick is meningitis This maintenance medical treatment of therapy is of designed an both to central area in the Cryptococcal phase high and

of options. period renal ineffectiveness its Within fluconazole extended the is rate followed to this toxicity of standard treatment an which population, intravenous XX% underscores of mortality current maintenance care there amphotericin treatment. the patient involves limited a Current upto course of due a with by

administered part randomized XXX from of doses across therapy by MATXXXX infected with HIV treatment this patients that safe efficacy Data tested. MATXXXX IV with all approximately three followed of EnACT a study B is treatment to compared efficacy The two perspective safety in of demonstrated of and part was evaluating tolerated phase patients trial the meningitis, standard cryptococcal tolerability well amphotericin and as with MATXXXX. the one daily induction maintenance

The treatment separate broken each MATXXXX MATXXXX four cohort amphotericin increasing followed be will be with induction into IV versus The period cohorts weeks of four XXX additional will by B. of treatment the for an the of maintenance phase. all XX-days patients sequential with during patients patients duration

The XX, be the days the the count endpoint administration cerebrospinal will five the of measure IV first at the of days of be primary administered MATXXXX. induction reduction in cohort The nine measured first will include of period last of induction by patients fluid. a in XX day for amphotericin period followed oral and will efficacy of fungal day

or B a they proceed efficacy of will as be to cohort review to MATXXXX. IV There by recommendation be for the DSMB oral cohort period, the of The the safety patients first data independent XX-days approximately of all administration followed will will patients next and and make two amphotericin whether within to of days for not induction XX and X administered

B IV of will days. administration include amphotericin induction Cohort the followed who commence X of administration MATXXXX XX with five for will patients oral by the period for days nine

Finally, period, receive XX-day in period. for cohort XX maintenance four, throughout the subsequent will induction an the entire patients and additional oral MATXXXX then

this and be the viewed and during from guided, study brain we infection. to crossing delivering of that XXXX As site cohort-to-cohort MATXXXX the a blood sign positively that as in is barrier progression previously we drugs believe may

come cohort patients We data Full of evaluation as from this anticipate expected second the soon data that from DSMB first as the EnACT quarter of however the until not of is the from fungal suffering year. of as MATXXXX to half by infections. potential of life it excited the the other solution We cryptococcal patients could provide second well profile as and XXXX. genuinely remain threatening could meningitis

designations which orphan important exclusivity designated infectious as much we out MATXXXX a if an also is as believe an product, drug. is well XX-years disease provide pointing of that qualified It commercial for approved has MATXXXX worth again as been advantage. could These as both

call will CFO turn over the year. who to like quarter discuss our for financial now Kucinski, our Keith to results and would the the I

Keith Kucinski

for Thanks, Terry. and today our XXXX. a Please for fourth refer of issued summary to press results of earlier release financial full quarter our year the

for same $X.XX diluted net $X.X quarter shareholders of or company previous and common net diluted shareholders per the of of attributable common and share, loss the basic compared basic quarter a fourth million loss For year. a share the or to the to to XXXX, $X.X of million attributable reported $X.XX per

loss and $X.XX company For per loss a common attributable the XXXX. per of $XX.X year net a the common to diluted net or basic of attributable or and full $X.XX share of shareholders compared basic to XXXX, shareholders $XX reported to million diluted in share million

Research and XX-month were in related to and expenses manufacturing Full of year XXXX. development fourth the million compared expenses same employee primarily and costs of development to and process $X.X quarter million expenses, three The in $XX.X due the preclinical to the compared XXXX were in MATXXXX were of $X.X the XXXX. both million quarter increases in XXXX compensation, R&D million higher and development month clinical MATXXXX. for periods to $X.X development

to in expenses expenses administrative fourth were and quarter fourth of of the the XXXX, million. year's G&A $X.X million General previous compared quarter $X.X

G&A year full compensation XX-month XXXX. due both The employee were three million $X slight primarily million and for XXXX, costs. in the to periods compared the month were For to decreases expenses $X.X decreased

We ended to company's from million XXXX. equivalents includes offering cash securities XXXX of of with completed million compared cash, at and public year-end last $XX.X $XX.X marketable March. $XX.X This the net million approximately proceeds increase

and this addition, common of other deducting offering XX.X stock the of sold generating net estimated $XX.X shares January approximately proceeds expenses. approximately underwriting million million its company after discounts, In commissions

fund turn Jerry remarks. cash second on the company the projections, Based half now closing is some back XXXX. into for call sufficient on over current of to to the hand believes operations I'll that

Jerry Jabbour

we initiated sit and the on that get know for assets. Thanks, we the And to for we here huge is analysts trials very know as XXXX we up coming Xth today, But Keith. I'll you from see briefly is, very summarize key two these us our questions. front want expect what And clinical Matinas from we quickly have of data I to in heard to year. trials team, what we've quickly. already March a is lead

the our ENHANCE-IT, XXXX, the looking hard infrastructure the eventual in benefit are that these going to news many assets, us for and to work year, during second lot ready to quarter I of soon the of execute with against that out now be the XXXX this clinical about placebo supply of EnACT the All build advance of commercialization quarter continue a these development, fourth trials patients. get think our not as and in on in trial progression hopeful data then we has during with believe data ourselves entire as with XXXX of due XXXX, our the them through but has second investors put team as positioned products to only to forward we head-to-head many filled product for candidates, to a excitement flow, is of certainly

and And answer so the our for will turn with that, call session. to question the back I operator

Operator

you. Instructions] Thank [Operator

coming Our question question. first Hazlett today your from proceed Please is with with BTIG. Bert

Robert Hazlett

these that maybe change in it come Thank thank And for with LNC of the that -- you. appears we a you results two based platform. I the have the STRENGTH. construct comments you hand results XXXX, questions, question. again a XXXX material, on for out one marketplace On And the that in the on one with be will as and STRENGTH, thank well taking as that on comprehensive STRENGTH. have the with on, have there the

might Thank or the likely -- you that, that and be on XXXX consideration When think is other do the do, that do for LNC molecule? construct that other of And Genentech position under just platform, take? they what’s same ultimate you discussed that of agreements for do, the then you. -- the the collaboration. patients the influence secondly How terms could the that in deliverables

Jerry Jabbour

Bert. Great, question. thanks the Appreciate

REDUCE-IT the MATXXXX we obviously data what's there have the the competition. class exact as have look a think January into could but to So we'll an with in the same why time with in both to you positive generated the for wait STRENGTH. in Ferguson the a the I see down, belief that the account for and we overall against was, yes, reasons emphasize advance you alluded Vascepa take STRENGTH start announcement, and combination Dr. And positive at think, and And to reasons reduction in it's marketplace. impression that the a MATXXXX, we time, we'll I think prior important there know STRENGTH I first to of to effect to happened potential went as head-to-head

that same hand; is the boats. to lifts one on it's the effect, omega-Xs boats. a there where rising It's have nice those tide class tide overall the an all lifts time, all rising At

I the of to all think tell are of you at that importance out ultimately the the and Omega-Xs MATXXXX the of the omega-X. us REDUCE-IT not highlighting back data will day, same. Vascepa, that the And STRENGTH end versus profile what is blood levels look of comes of continued

a not that it have our so look in a you for that's is a have That's And reduction on at of distinguish lipids and able profile have terms bioavailable, like the going if going you the study, MATXXXX I we're company to thing levels ENHANCE-IT from for important. we're drug we that EPA. its think the to approval drug we're not on blood good when look versus think you drug, So to of required but the of high impact achieve highly at space. one that's competition to also in that's look the be of Vascepa overall does some at the going then ability unique Vascepa, have, to in market where hand, leader study why to this that's we a And know Matinas.

than and studies changed, our for as study And a indication you the with That's our Getting possible, at head-to-head similar our think severe patient quickly of approval a to drug that hypertriglyceridemia, an in to a would focus. us then would as ability and we're available payers indications versus addressable from with patient larger open clear. population, continue what to and may X to can give we number population be approval look and with severe our need certainly approval goal. hypertriglyceridemia as so, to data hypertriglyceridemia. MATXXXX, patients give an to in discussions get we has patients two Phase single have which That's we that utilize to is those severe pathway see believe very other we that The from investigate very not but I pathway access physicians and to the STRENGTH. have Vascepa

We to will clear own a and we the benefit about path, take broader that profile are to but in could an to advantage the Dr. have the continue science with understand discussion evolving of our our that? how FDA can development anything to of patient get meantime, we very we the hypertriglyceridemia in want a will But patients Ferguson, approval for drug severe add population. you

Terry Ferguson

the dyslipidemia not needs Just changed. prevention. than and There's importance risk cardiovascular the and clinical lots gone I really world treating that have around of risk, rather of have residual briefly, secondary think about discussion in the just persistent away, not now, cardiovascular

what that questions primary going prevention role But around, in the think are the we to is more STRENGTH learn again, need secondary as this study. I to prevention. and there that about mentioned I arise primary cohorts prevention in play

what mentioned, We're a extends about more to dyslipidemia think just gone path changed. learning our that think I not And as has hypertriglyceridemia beyond that. severe towards I lot away. has not Jerry going be

Jerry Jabbour

the our our impact having and one availability same for drug comment. think potency doses that the I And of different on the the Bert, severe multiple hypertriglyceridemia we just to will I drug look of mean, patients. final continue at

have, bioavailability go through So some there to opportunity have only at We dose. to study. than think whether six or overall going outcome approved, we X has a Vascepa it's competitive different and to day the a approved are doses are having a they year be potency the advantages without gram

Genentech, kind that interest companies, of at lot terms a not announce the talk our that We've labs, that to molecules We're of in interest details in lot targeting. entertained They've quickly about the a they're Jumping is, really of lot the liberty expressed kind obviously of gotten what us of their the important to of and the was for a We've But and number, collaboration of here two or team momentum. early at end the an there, interest. target of January. one of between lot in XXXX. amount the the given dialogue is. what there's a to there's

their the So at formulation we that in does are one stage of molecules period that a time. of for take of already least

in, able see a but this much we the way I other therapeutic then collaborators of these category usually do companies potentially them. mean, half you're few months like the the that's molecule molecules of our that in what period data year and different be then for preparing it's so back the for expect into would with structured to where from to what molecules, we formulate different of may and depending we target Typically testing very be are bird collaborations what on take formulations that proof-of-concept a to

that ViiV. continues true of advance. The to same about that. excited is really So We're

either become to that these already that into in of getting safety And We we formulations profiles have can ViiV the kind different two the believe with of issues. Targets challenges a or have antiviral a for for space. lot continue drugs solution worked on platform

Robert Hazlett

XXXX. programs. eventful the Thank to an like you. Look Looks progress on forward Thanks. all and data

Jerry Jabbour

Thanks.

Operator

next question Edward The from Piper of with Tenthoff is Please the line your question. with Sandler. proceed

Edward Tenthoff

Thank morning, Good very everyone. Great. you much.

change and much. you around X. Phase the to in assumptions Thanks some the around the X So are you really in analysis just But designed to little a disciplining replicate what study wanted of be what sense to the levels, triglyceride we what a phase able patients? so I show know would saw with you that, the know I statistical it's in to respect bit ask from significance that, more

Jerry Jabbour

that -- you that very fat of prior period that triglyceride not difference can think think a study. patients the is the this It's prior the larger look on low I population. as And for time. to treated a the I where of that It's how study ENHANCE-IT big is look longer diet. a you to generally at number and same compares other

provide directional triglycerides. to sort can and underperformed XX% guidance Vascepa about consequence only one think reduction was the the I probably as to of concerns look study that with diet a of and study prior that prior So the ballpark in estimates, you about of a the

you diet, even in a it XX% study As REDUCE-IT a reduce has in by there triglycerides other at was where and able what at was recognize triglycerides, look with then over to you that very XX%. fat achieved low the a prior trials in head-to-head little reduction about and MATXXXX look

in triglyceride. at in XX% And think figure. I a to that ballpark the is powered study detect absolute changes get XX% difference you a

think that, a that's So reasonable I assumption.

you'll it's I what we've in guided sort a highly that's and prior studies. by reduction, likely see seen in of think difference significant that triglyceride statistically

Terry Ferguson

to the fat add there treat I first lower the acids with on clear, to and notwithstanding, in you're reality is, are diet, that's study. a then of that's And the fatty meal content. the patients, absorbed Ted be of free diet, that the diets. lot way is the fat thing reality be a made really only And a higher here, or better they a That Yes, and ethyl-esters has that should trying would absorbed. about ethyl-ester a let's was

going acid acid but the same free meal absorption a like we time free will expect that with also content. absorption generated expect fat they a that expect do look fatty that to is which is also a will that with did numbers its higher based exists REDUCE-IT, we know was they're there look upon a no better, fatty at so improve and data improve, reason that you with of Epanova, in that And more will Vascepa’s and to

in disadvantage well. bring to to to our bit, it's absorption. So the drug in And terms up the may the of going little diet study change the it's anything, not study going a if enhance absorption first Vascepa MATXXXX of from but second as

So of the with, Ferguson I the statistics let bullets the first we aside, and studies. really about good to always taking which design, Dr. holes it's of study anybody deal of poke out trying feel terms the in about very gun,

I'll and So leave that. at it

Operator

line from Greg SunTrust. is with question questions. with next proceed The Please of your the Fraser

Greg Fraser

when we and also comparative importance that can on the R&D It’s Greg morning folks. stand how comment expect for to you study, SG&A you on you in Good read the think Gilbert. first Thanks. should Can about on then, And Fraser comment and out? of study XXXX? Gregg bioavailability

Jerry Jabbour

Sure.

study, as concern. -- comparative of the So at omega-Xs of drug is, what looking a in not This there safety And of you're achieved for whether versus relative for bioavailability the that which there about purpose you're it's with example fed the a is of bioequivalence. levels, not with at of at in bioavailability, trying the look all study And versus a at determine what fasted study? the blood you when FDA. concern MATXXXX your safety Comparator study. looking is is that you're anything or reason there study to so what Lovaza. is this both That's to and XXX(b)(X) a our with to Lovaza causes conditions, look designed is in show MATXXXX under It's the comparative importance not pathway. what are bioavailability first And eyes

to and generated rely So, and exposed Epanova versus a with your data which them drug pathway or FDA was upon a be And Lovaza and toxicity Lovaza. Epinova allowing by would that's give would study shorten perspective, anything does this is see patients a to development then number also that done all to to concern. from with about how and like the years years to of over safety else, that the years, your need [Indiscernible] by by you

you the you what concern, safety. feel you bioavailability bioequivalence, omega-X a to relative idea pretty comfortable. it's some And where so FDA safety about is to expect. get this about raise good there overall profile would as again, of have range know And not we but the because a So expect is to

simply then we being of an plus about X. meeting, a And the that kind next that months, in that for have study press then going clinical said, a then get X with data in so may on be of XX-day and know you be the down that FDA, point not data some is the Phase it's as and X comparative report the we've the but of meeting. But a completed to be dosing not FDA that release end we'll as the study have Phase talks expect available used briefing not the of Phase few package published end months. talk for few with part at compiled, over the next data that's We've but that's final that's line, again -- to and agreement will protocol

terms SG&A, of trial. it XXXX the in In ENHANCE-IT of conduct the will XXXX increase over because mostly of

more Phase also increase, terms territory to color for certainly going We be provide we're can yet additional X. accommodations higher we XXXX, make will X Phase preparation supply of in but yet. but some not product And in into it’s than for

would XXXX year XXXX. expect to actually bigger than we a be so And

Greg Fraser

Got it. Thank you.

Operator

Maxim Your next Please Group. with the your with questions. Instructions] from is proceed [Operator Jason McCarthy line question of

Jason McCarthy

the maybe some talk antifungal and about in antifungal with with little Hello, day for that patient relatively you're also, your but Also a question. terms XXXX, in that I of see little know a taking asset, IV MATXXXX, [ph] per potential bit recently a finding for what know particular towards pharma potential how about X talked gram relatively to about recently space? with can toxicity? and in the moving you Genentech, we've partnerships, a seen Pfizer that Basilea thanks Jerry, would dosing, is then and dosing with enhanced you thinking sticking space, Sedara deal that kind something for bit had with partnership the that compares you was back of MundiPharma activity this

Jerry Jabbour

being again your Jason. on for question. a part for finding questions. and And good you Yes. way call, use of term as the to ENHANCE-IT Good thanks the thank

was great. that think I that

Jason McCarthy

didn't even I realize. actually Sorry,

Jerry Jabbour

it just tongue. rolls let’s the off Okay, say

tolerated the study XXXX, maximum of the part is. dose of to So for establish that was X purpose what

you because want impact patients you sacrificing and do the want give into going safety, to the is set without up forward is And dose to have have so and yourself the hope high efficacy what the infection. an success, drug do to to one high you want going the to a you're for opportunity study, that greatest to the you always the on of is want to to yourself and what take you the be dose and portion to is, a increase exposure middle low the

look but what to opposed in given doses the cryptococcal taken the studies. doses into of at and have with we you to meningitis just need that so, study or MATXXXX previous And compare

study of NIH a we For day. into lowest milligrams a was example, study XXX cryptococcal the Part took day. taking with three dose that That XXX with And of the that years the drug, for day meningitis toxicity. in no the X a which X patients milligrams yet was are still gram

you grams on creatinine And half, meaningful then two. even see And didn't any we two any didn't concern, change you also levels, and day, any see with reasons one what saw took a patients. patients or potassium didn't at and you these see a then you tolerability in these for impact

of study. that because fact grams at but right of go taking you grams impact patients than cryptococcal the who's day. of the a have it more patients the us a perspective the everyone safety the independent, with And NIH X the in duration dose been comfort know to best efficacy So an from opportunity looked with also and exposed all milligrams we at we'll how day, that's were study, the those gave a to the DSMB that a data said amount the X the XXX we think perspective, gave arrived yes, meningitis day long who Xx NIH from

X will That at broken once. not also all a the is be grams day up,

Remember, with the of, So day. should the oral it easy milligrams tolerability or into them milligrams XXX course day, is patients to a take, separate that's four an over broken XXX also suspension, up will up of very help about the for doses also be this which broken too.

of infection, in the dosing how ability feel well, went. barrier barrier. And that balance we crossing challenging more that perspective pleased from that's of or clinically. challenge brain the be the multiple up and pre showing we cryptococcal So results studies of part to two just to that have of a the by nature supported set do technology do we one is again, meningitis against But part our with couldn't additional the the and blood

the around And, second So about a imminently. kind the inform we we'll study see position two. to will that right market of in stage of be dosing end progression to will begin quarter, cohort the in

In what for terms partnerships. that of means

to a than XX the immediate, of relying because yes, if from with giving successful that doctors now need but technology up the EnACT, barrier to XX from broaden experience who and safety. past of ideal before. overall only an other Yes, only our not safety is use infectious of be are profile need, kind do tough is more has and I there a it's couple the then EnACT, perspective lot to efficacy comfort has infections. has essential, who the clinical the ability We at think safety ideal growing. that failure of under used believe of area otherwise. is MATXXXX are used But for to those partnership. believe ever years investors blood an amphotericin for over -- been data a upon would with you to cryptococcal years regulatory crossing there faster looking our going deal to three developed that on indications an the but over the drug at be a treatments has a mitigates with disease broadly physicians last than this who broadly, only infectious to it unmet risks. it's no is, data companies we years, fungal this amphotericin is way are brain EnACT not you're been set already with is and is a partnership to failed And not drug meningitis, invasive XXX(b)(X), franchise, this this the into reality have the Because question the of have disease for It's NIH, the drug successful,

part a XXXX So big us. definitely is for EnACT of

Jason McCarthy

quick, just your real just going to partnerships. Okay, back

or in the shortly? had You of about here Corona? Has Glaxo. for antiviral moving that ViiV with they They space. been Healthcare with forward mentioned, talked any that, discussion something is just are there Have

Jerry Jabbour

our lot is deliver antivirals. A Corona of that the prospective a in we've trials, this were seen, how effectively area. clinical to take to pretty seen advantage around are of a of companies lot they're about be some those, territory. this, There's a working hype getting And into to in months that medicines we're And lot obviously, say So virus. of treat interesting six to this remains probably use is, technology has say to can help bandwagon. what a that to deliver effectively year version of an as simply vaccine want call Do they're the all believe that? jump on IV we don't opportunity away The the delivered. ability to and certainly do we an ability to But potentially, answer we to yes. the provide I and have oral

dialogues active this, this. can there going to in with are waving we become the do flag to your a but lot not have on. coalition find on, when out a of and concentrate we're seen other on what how We the of believe movement, raised NIH things our hands of technology out We combine a delivery lot is said, But to what platform a actually you better part we've obviously can do. a we we're we NIH trying with front

so And we'll see.

in ViiV, to with to their contribute is around a there were may mean of how the certainly our creating But obviously it that paying doesn't be of to waves specifically we're kind to we've targets what lot markets something world. the in the not and attention at intended limited discussions able beginning. which As we to

Jason McCarthy

you, Jerry. Thank Right.

Operator

the you. floor end this session. reached our to we've the remarks. At answer turn for Thank Jabbour of time, I'll back and question Jerry And closing

Jerry Jabbour

wanted ENHANCE-IT Thanks, everyone and we're great to We course Thanks. believe, to two and wish Rob. executing as everyone We over great points not on both EnACT the detail a to keeping value an into for our in participating can for our progress, your that inflection but -- the represent day. Obviously look patients, patience. call studies provide forward important, thanks only We on. go certainly opportunity you XXXX investors. apprised our opportunities be great of for for today, to

Operator

today's conference. concludes This

your this disconnect Thank time. your at participation. lines may you for You

Matinas BioPharma (MTNB) 9 Mar 202019 Q4 Earnings call transcript