MTNB - Earnings call 3 2023 | Matinas BioPharma Holdings, Inc.

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Operator

Welcome to the Matinas BioPharma Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to Jody Cain. Please go ahead.

Jody Cain

This is Jody Cain with LHA Investor Relations. in participating for you today's call. Thank

Financial from Officer; Dr. me Ferguson, Officer, Medical Kucinski, will Matinas Chief to the Officer; the BioPharma Executive Chief Chief Q&A Chief Keith and questions Jabbour, be Jerry Officer; Tom Terri Business Terry Hoover, company's are Dr. Joining Officer. answer Matkovits, during available Development Chief session.

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

Forward-looking statements to BioPharma's could pursuant based forward-looking made of results the the Matinas provisions are statements safe federal current on These actual materially. harbor expectations and securities laws. differ are

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

materially discussed by sec.gov. Furthermore, forward-looking available section by Matinas the XXXX. the only documents Some and of the statements events the in the except X, factors in Securities that These Investors could call November BioPharma update that content those differ revise and statements obligation such live from files broadcast, or required are date cause or information are conference the reports. to on periodic Matinas actual Commission. with website Exchange contemplated company's of to reflect the as as any of undertakes of law. no this BioPharma to is accurate circumstances, results contains

to Jerry? Jabbour. Jerry like over I'd call now the And turn to

Jerome Jabbour

tremendous been our months. has during Good attention Jody. of company asset, Much focused a There's you, afternoon, and Thank amount rightfully on this us. industry you everyone, been of thank few on MATXXXX. joining activity and past the our lead attention for

compassionate use in can a results the program excited for access options. or very about drug positive demonstration are the that MATXXXX and limited life-saving treatment clinical our expanded no We MATXXXX with be and consistent

create historically product infections. and to issues the and opportunity that the inconvenient and potential to afforded drug a has administration that treatment safe powerful convenient paradigm spectrum the has most amphotericin fungal take with platform invasive LNC severe change the settled and broad B, antifungal Our toxicity has for

of saving suffering history from both of has the of young disease after Candida male our XX-year-old lung clinical treatment. MATXXXX disease for diabetes, it clinical use or invaluable expanded disease, life for successfully a trial. resolution very girl kidney increases been in a access a similar Phase III compassionate X in Whether patient Each of lifeline MATXXXX has to in the program proposed krusei are Nucor aspergillosis become just are Phase who The patients. treated an those to complete weeks infection and achieving with covenants for our and treat heart III. our with AML intended patients

step-down potential registration willingness forward superiority composite constructive market and dialogue look it's We're that a something X we today, away these our expressed with superiority FDA to FDA Earlier with label. the finalizing win and will significant a that a design; formally a a go much could endpoint Matkovits opportunity. a position areas: more all candidate for under composite moment, possible. potential a third, endpoint areas end to for the important Dr. that primary First, pathway; on acknowledge composite successful emphasize stronger from endpoint patient supported but the in into point. very population key target with label is commercial a FDA the detail LPAD recent move meeting grateful FDA stronger was non-inferiority that second, is MATXXXX to our announced brings a soon and as to a as for to our more MATXXXX in superiority significant intended much a FDA accept And it ongoing

Building docetaxel. of cells, efficacy in results week, delivery by LNC forward platform, reported beyond formulation we vitro in up on administered these big successfully that successful demonstrations vivo molecule target an of tumor in large data demonstrating therapeutic small for this clinical the LNCs oral our step vivo new proof get of Earlier our LNC a that taking can were tumors diseases success us effectively principle and orally our and therapeutics. deliver taken in providing infectious

model. our LNC some in advanced activity also early of have clinical benefit We of psoriasis are small the internal knockdown, documented a and induced oligonucleotide program murine to evidence and form in tangible biological oral disease excited imiquimod cytokine

details We platform the models, more of we have oligonucleotides formulated small bit Ferguson LNC additional our will call. quarter. vivo expect Dr. and in inflammatory a later LNC work the fourth studies ongoing disease in on data provide in in later

the with is pleased recent very our team Overall, progress.

and by financial results. our We comments on of the of FDA MATXXXX potential review perhaps our cancer. following into and the clinical dialogue areas expansion interestingly, as continued inflammation additional energized the I'll by the picture LNC and with in the such QX validation outlook have most later call, platform and excited are financial

I turn now, over Dr. to For call Terri? would our Matkovits on the expand update. to like to MATXXXX

Theresa Matkovits

Thanks, everyone. Jerry, afternoon, good and

productive of division reflection and registration. a with in we included last advance John As as the by Farley Director unusual FDA's the Deputy participation of attendance Director. Director a in is the we and of Infectious a Their anti-infectives the meeting that held highly highly and interest month the towards of Diseases, Jerry collaborative FDA division level, MATXXXX at believe mentioned, Office at

to no eradicate and circumstances. clinical to our infections meetings treatment options Program outcome most population was in fungal of different patients to other with As MATXXXX treatment by azole-resistant fungal MATXXXX in target receiving that MATXXXX in MATXXXX in patients Compassionate/Expanded of seen target options. ability highlighting of safely intolerant the Clinical for and in potentially multiple variety deadly be most treatment the in are patients Access or Use effectively which patients a with multiple severe in the in infections meaningful challenging limited receiving invasive in tissues agreed supported be clinically with previous FDA used success agency, likely azole patient or continues the the this

with and of FDA, The with During aspergillosis invasive pathway meeting limited agreement III of FDA the on our population antibacterial the and may confirmed for antifungal LPAD the design the was rarity in elements for population. for general alternatives LPAD. main MATXXXX be pathway that treatment the options. phase limited the treatment that more drug candidate for a the under patients lack drugs Phase Labeling flexibly study available intended there particular the based infection prevalence drug risk for for to that the the can assessment severity, of of benefit approval a considers is the is patient treat the on or

for FDA consideration in priority review under would well as eligible for in Track registration the qualify breakthrough still and years QIDP incentives continue XX LPAD for and for Fast as designation. the that orphan Under U.S. and be possibly the of exclusivities pathway, approval MATXXXX the potentially protection years allow MATXXXX EU. could X exclusivity could to designation also drug

A significant success, mortality, the complete expressed endpoint. study endpoint discussion during openness design. centered are favorable changes a spontaneously composite composite could that trial. positioned as with We in Particularly with regulatory superiority endpoint generated includes important ability was given our around non-inferiority this completed regarding been experience to therapeutic XX or FDA and response point with of considering the a has to compassionate an discontinuations to the study are alternative the program outcome and the assumptions FDA as One partial for we Phase commercial treatment optimally having complete EnACT clinical superiority to believe composite related. no consisting global the the for proposal III statistical be new primary in meeting clinical adverse or dosing events for endpoint, MATXXXX due data treatment use date in our that well that from at day the

not the endpoint XX is would be and projected believe in weeks. believes being to time a change to XX the The patients months. line, believe final FDA company will than superiority we we be alignment in less the composite could will finalized study submitted be the that protocol enrollment which The next for composite size, with or XXX -- which few new endpoint

amphotericin oral with its compared work our to on IV-administered as III off-cycle finalize Matinas substantially toxicity The basis Phase Given the FDA profile including IV to of amphotericin literature. administered with rate in published communicated the protocol B MATXXXX the seen an B with to seen safety soon possible. better commitment date, has of the as

agency goal to patients. the our the meeting to Overall, FDA's the best was with making by widely success for driven forth with MATXXXX outcome design study regulatory and position positive available of ultimately put desire of possible commercial a

label which on upon of asset. increased life this to strength We our optimal at the stronger a during partner in this are product much be cycle a or interest subsequent that can position of with FDA stands unexpectedly, product. An partner initial launch, also design a not us confident launch built has the label puts in

limited that treatment no the believe the to plan patients, highest or options, clinical addressing BARDA with have quite need further development case we funding we of assist that for Given on of is MATXXXX strong. our of most whom

this our process We government III following alignment FDA paper the be time an for award. nondilutive submitting and can and in are funding lines Phase and with associated anticipate challenge funding to a BARDA white preparing the The a on with program. BARDA making decision any

this However, population we this need accelerate remain patient hopeful unmet process. compelling might that the in

the are have this program requests of University NIH received expanded since Michigan, ago, Children's our and back at instituting use Circling year compassionate other Hospital of and They've to Johns access have positions to have significant program, we or of a amphotericin Hopkins, inbound Nationwide or while experienced B renal from over classes unable not others. antifungals. patients toxicity on amongst us tolerate to azoles and/or contacted IV who behalf responded receiving

effects. program function challenging October, his B to achieved deoxycholate with treatment been XX Candida led male history, due with A was enrolled resolution a only discontinued tolerated with was toxicity have In total weeks patients Treatment which to well of amphotericin we of with clinical MATXXXX, was Treatment krusei baseline. patient transitioned of adverse to X date. MATXXXX. also MATXXXX infection announced XX-year-old IV following the to a that no this to complete in kidney medical of and improvement with renal

IV should from to month, in are electrolyte patient Center. enrolled Fusarium treatment abnormalities. suffering this transition Once significant patient the is patient to CNS-based electrolytes from discharged this was Earlier receive at to and be Vanderbilt due amphotericin at this home. from infection This able Medical be hospital program stabilized, another required University a

help without access requests We other treatment use evaluate options. MATXXXX compassionate the continue of to where for may patients

to drug has have we enact we invasive fungal infections. Overall, potential the a a the in shift paradigm believe of treatment

as with We drug. our possibly aligned, Once thereafter. are FDA we is submitting our quickly potential ting III study a into progressing primary final for for forward composite and look an on focused this III the endpoint the advantageous agreement development on Phase trial significant Phase as to

call Officer. I'd like the Terry? our Ferguson, to turn Chief now Medical to over Dr.

James Ferguson

Terri, and everyone. therapeutic Thanks, good X provide initial I'll results areas, work and afternoon, inflammation. Today, important oncology update from our in on an

an of Specifically, small . our LNC in share in review small recent in vivo oral platform results the capabilities delivery with LNC oncology, vivo for molecule and I'll data our highlighting additional oligonucleotides. formulation

docetaxel. First, chemotherapeutic recently announced These results positive LNC successful we've of melanoma a in that in to and results delivery vitro growth confirm was efficacy oral docetaxel the syngeneic tumor inhibiting of Docetaxel comparable culture, LNC in showed cell that the well-known tumors a in progressed formulation malignant vivo that IV response oral management agent from our model. in studies murine to cell diseases. with in docetaxel in widely of docetaxel therapeutic an of is a used conventional earlier vivo to

controls with tumor this in oral developed in reductions reductions XX% significant were significant injected mean at XX% of weeks Similar tumor to response the who rate at least and with tumor weeks LNC-docetaxel volume cells, murine In compares in XX% oral daily with given favorably mice -- reductions compared tumors lower oral untreated with weight LNC and LNCs. melanoma This with noted IV with high-dose showed docetaxel. X study, with dose X LNCs. oral reductions tumor

a parameters These treatment noted confirm X with on controls. our of applications for treatment encouraging daily with stable duration outer potential oral toxicities similar opportunity future hematologic weight oncology tumor LNC of results the Importantly, presents belief untreated surface the to were that Body and no were LNC-docetaxel. platform. was our days phosphatidylserine cells targeting with over expression systemic

macrophages, recent data like oral work on avid oligonucleotide blood, neutrophils whole to and showed Building subtypes. of dendritic previously shared cell T I'd our uptake human highlight that by in LNCs cells, from Next, program. small some

with down culture. TNF administered small IL-XXA recently, docetaxel, We oligonucleotides initial our and have and a emulations vivo to the oligonucleotides series production high murine we of stimulation. LNC investigating alpha. in were knock of inflammatory these using cytokines, model consistently been and lower down studies to biologic able of variety potency of More formulations verified the oligonucleotides to formulations X studies knock evaluated these in Similar a work that the LPS designed X of TNF alpha have a in or in of both cell orally in LNC IL-XXA activity of potency lipopolysacride, vitro

inflammatory More LPS, of LPS about inflammatory targeted of in LPS an therapies studies reductions varying response. LNC potent are the lower activity knockdown. inflammatory cytokines. have measured resulting effect in model studies is usually showing Biologic recent the lesser substantial an is complete evaluate in used to is knockdown IL-XXA XX% severe healthy knockdown. documented injected with acute biologic model shown targeted using animals acute with LPS stimulation of Initial cascade. This more The stimulation in the of of a model levels potency commonly of animals the targeting cytokines with doses which IL-XXA degrees by

with of small studies an activity administered Similar of the of formulations formation preliminary supporting oligonucleotides. blocking alpha oral are of These evidence orally ongoing. LNC provide biological an studies oligonucleotide TNF LNP formulation

a necessary can additional to to both clinical We're clarify knockdown strength and the will oligos work disease with will to the and alpha in models. sufficient cytokines of achievable for inhibition cytokine small these be rule. TNF whether course therapeutic of level time benefit and be However, administered orally determine targeting play cytokine meaningful provide IL-XXA

a this closely in an resembling LNC with oral end, vivo applied In was a an induced murine daily we skin conducted resulting studies of healthy whole recently imiquimod formulation in in model. psoriatic preliminary irritant human pathological this the model, have to imiquimod, psoriasis lesions. picture To mice,

Importantly, both severity blocking with has in been human IL-XXA of skin psoriasis. the improvement lesions model associated in and in with monoclonal this antibodies

evaluated appearance, studies and model to small Thus of orally reductions severity in in formulation the the to anti-IL-XX associated More benefit qualitative alone. confirming an with as LNC improvements provided pilot response activity biological the oligonucleotide additional Similar recent An in the high-dose of to disease model, model in is evidence skin model. imiquimod of our such lower the imiquimod exposure. identified clinical amount a initial imiquimod of the duration comparison oligonucleotide with study IL-XXA of LPS imiquimod have and a proportional and the expression skin of a redness scaling administered treatment mRNA in dose lesion in lesions. oral

oral studies disease are of vivo and alpha in knockdown Additional LNC the evaluating year. the therapeutic readouts potential in other this quarter of models data of both in fourth ongoing TNF with IL-XXA expected

With financial Chief call Keith performance. Officer, those our comments, the Keith? Kucinski, turn our Financial to like to over to review I'd

Keith Kucinski

with $X.X The reported the manufacturing for third Total XXXX you, BioNTech. We Terry. for we million trial of of revenue consulting of Thank collaboration lower was clinical with attributable today of generated XXXX, results. million quarter primarily third Starting research decrease from revenue quarter quarter and X costs expenses. whereas were $X.X reported the XXXX, for with in fees our our the the XXXX. quarter which and third which to of third third compares of million $X.X lower clinical lower expenses was quarter headcount-related materials, costs

million, loss net was of with Our share. $X.XX third net also per of quarter million or XXXX $X.X of share. for a $X.XX for This quarter third XXXX compares the loss per the $X.X

of months XXXX the with the months $X.X Total costs were results. X XXXX The months months loss first of company's XXXX. with million, for to million and $XX compared compared first This X months now $X.X expenses $XX.X million XXXX. X-month for for was Turning the $XX.X share. first of first X the $X.XX our of the Revenue million was with first for net 'XX X loss million of net X million per months $XX.X per the of $X.XX of first for share. or for compares a XXXX also X

third marketable equivalents planned cash believe were XXXX. cash million. of XXXX, on Based quarter $XX.X current is and we into September fund of sufficient the securities XX, Cash, operations projections, to as our

extend well partners through potential private actively are grant We securing funding government agencies equity and as by runway BARDA, as offerings. potential from programs to seeking from development as or public third-party cash nondilutive such our

to turn With the that, I'll call Jerry. back

Jerome Jabbour

exciting on of Further an combination designed the potentially In what superiority and potentially potential endpoint while regulatory fungal the summary, superiority treatment advantageous infections. population, is not asset to company. should data to that the our be designed by clinical for and data on need with deadly pathway. The LPAD trial market enter In composite Keith. unmet interest clinical drug Thanks, MATXXXX, robust of in Phase line this perhaps under in focusing by potential or provide for and filling maximize the significantly a over have of the month for positive is the last up time supported registration is approval, treatment so. patient has a a III. supported orphan late-stage the a very current years endpoint composite positioned This to MATXXXX we invasive that's primary is increased biggest partner commercial MATXXXX XX surprise exclusivity upon strategy

fund use maximize recent or opportunity. partner accelerate which drug, and to partners the to III for in ensure that Our us as that soon is the discussions identify partner commercial possible, this goal FDA and allow will ideal as commence these to to fully right Phase is the place

to with our our our proprietary Given elements inflammation forge believe generate to potential the small to nondilutive primary a meaningful now remain place and we companies in LNC partnerships cash capital objective and apply looking oligonucleotides, manner. continue molecules extend both Also, unique uncertain are a to the and markets, as the to is open available delivery orally small And volatile in and areas we with we partnership. platform to like molecules. their expanding technology cancer, right data in runway

for technology additional look of will advancement upon if sense expected for of access compelling our opportunities company the our and markets, our the selectively to capital based we generation Additionally, the stockholders make and terms data. the

Finally, we Meeting successfully X in would Annual the our November thank and proposals of proxy X for of to their like Stockholders each our at on for support held our passing statement. stockholders recent

split potentially One our was the the Directors to company proposals of for year. Board shareholder reverse for key next approval of of our the obtaining stock a implement authorization over of

we due to noncompliance progress Although the our of price, increase compliance from received share have in valuation low accompanying potentially notice us MISC in regain organically. recent and September, to positioned

As stock. there our consider is a reverse no result, there no to immediate a -- are of split plans

Moving consider of reverse and deemed our the company. will our effecting our interest best in forward, if a be it's Board only split to stockholders

areas Overall, therapies. maximizing where advantages distinct create the we with our on platform LNG efforts we focus additional resources and to on potential MATXXXX currently continue can believe over is and differentiated in technology for our data and generating our available

We XXXX on and your for are intent thankful ongoing support. very closing remain strong

I'll review, operator to now over for the that turn Q&A. call the With

Operator

Instructions] [Operator

Jerome Jabbour

mention question, to JPMorgan San Conference X Francisco. for January first during being to we Healthcare would will meetings XX professionals While waiting I that with the in XXXX we're like investment the holding be held

LHA in Investor please you schedule a If interested contact are Relations. meeting,

Operator

Harrison We'll with to move first BTIG. Julian

Julian Harrison

progress. the on Congrats

plan And corresponding any in First, to can to you us can invasive opportunity curious arm? there? then the comparator here you also, changes trial. or just the maybe aspergillosis. remind the hear FDA's if us will if not, the of a involve azole-resistant And this great just intolerant superiority market about of remind openness to I'm

Jerome Jabbour

for question. thanks your Julian,

and to it design For of Matkovits the dialogue control how Terri? about I'll can the that that. to the and question, impact specifically our recent turn talk first part over arm Dr.

Theresa Matkovits

Julian. Thanks, Sure.

the will So target changed. with for still with our design trial fundamental options. not has patient The be patients treatment invasive apergillosis trial population limited

issues So patients of nasal or a who receive for of reasons cannot drug-drug intolerance, interactions resistance.

treatment with deemed the patients will on patients down, remaining of X/X for all start treatment down. the are IV And step MATXXXX continue a once amphotericin. decision treated appropriate The oral with will X/X by made will to they only step the of will an be patients. until the the manage patients So to randomized have able drug-drug as they to the be for amphotericin longer if be are no interactions the other to upon IV tolerate option relevant which azole physician would

So much in amphotericin that and treated this Access our patients currently very Program. IV Compassionate the reflective of are is Use being with

Jerome Jabbour

add think endpoint. think is composite to Julian, benefits just of I this not and that, one a that you arm as is So that's the And the changing. when to control important about

we've the You exercise superiority a you see would you trial. instances you're going therapeutic IV with amphotericin change to for time have MATXXXX, to which for does, potentially. patients going other you in contrast include in -- a certainly, for in can where this just antifungal in it viewed that success failure control superiority in wouldn't arm given end IV control is regimen, to toxicity if you necessitates the a add from a oral an But the And oral as you're example, composite and what exactly amphotericin, superior change on mortality head-to-head, able to study IV is especially And with and amphotericin which example, -- be with endpoint amphotericin. arm ordinarily treatment non-case therapy. versus periods a be endpoint wouldn't going going be what a seen in don't long a other without certainly as change endpoint of being were seen define

treatment that's at all. how composite is the arm a we to. don't is the this -- really dialogue what that And goes and B position bring but that the the that's see allowing you're time. terms to And the here wouldn't of We then the step think forward we'll program. And safety with invasive patients the there initially aspergillosis. those and of in -- XX,XXX here XX,XXX about patients limited itself annually of treatment of lot that invasive interaction at X/X drug-to-drug in options, That's with is really the We're endpoint in superiority other U.S. the amphotericin taking they So that arena. table azole unique And we you with population that change an a significant They therapy. element for be are looking azole with is meaning of can't with of patients. to for are MATXXXX limited goal. into they're they're -- FDA, to why fall medications ideally, to have cancer can't aspergillosis a take control that market, orphan options category periods About long because resistant targeting used happens in patients that in. a would

the that And value population alternatives. they now right so that and orphan it's of the is no have fact other

the at upon conservatively of of looking market layer desire to hospital groups that alone infectious are have with disease not dependent treat where to their then the typically lives. just pretty will payers, we and the lot the of ideal where in doctors the patient that, out for could you payers. population trials, bring a haven't in in circumstances the get which in fungal an III to It can getting match believe outside pharmacoeconomic these population, the that we set patients data on opportunity the impact these and opportunity. be in where discussions you of $XXX We million be of help orphan going they're antifungal So if patient is productive and their -- save up way seen with discussions the you patient of a with patients this estimate U.S. in is in population. But an that becomes some superiority recently infections. of significant treating Phase we endpoint, a limited that's that A really see

pipeline big then it's for So bridge there limited established fungal product. necessary. think pharmacodynamic alone. move opportunity other this infections to quickly an the III a this And invasive program trials is is remember, a clinical Phase indication a And this into opportunity with we with commercial and by

so with start with her excited a strong to that been far So we're what foundation, and able it's FDA. have team Dr. and achieve Matkovits important by so why that's you

further We to that have to change little a a finalize obviously, bit endpoint, to go noninferiority but from big superiority.

Julian Harrison

soon Is helpful. I'm then Very or confirmed? you that how question, something potential or perhaps wondering around if be may, designation. LPAD regulatory on I And submission earlier? the clarity Excellent. final Okay. might one that expect

Jerome Jabbour

way a LPAD works getting special assessment. No, like not protocol Yes. the is

So how of LPAD FDA to review on consistent it well be that. the other at and certainly, the that they've It approval. by population, the there's Currently, only us is restricted criteria That's LPAD, study patient sort works. declaration filing But that products the the approved gives but X the done data the will target feedback candidate advance. groups. that were NDA and But totality agency address look our the patient time of a issue. fit at with a qualify ability in for of outlined of to the at not with is what design termination made there the any formal you within to we for the But don't population. NDA to opportunity are potential expect

Operator

speakers for the I And turn will any the once call closing -- remarks. more back to

Jerome Jabbour

disease great the joining with for FDA our We're thrilled additional In data call, the our XXXX. LNC-docetaxel and we We've our come very forward can't thrilled thanks happy additional long us for to and everyone today. not We're from to clinical Thanks about small We look We're a impact program. oligonucleotide update. with done. way our in optimistic we data. We're joining excited report holiday. a Have and night, all next Take and a care. the to to anyone wish company's few us. investors listening future, months. Thanksgiving progress meantime, wait of over the

Operator

for you participation. conclude your program. today's This does Thank

and at time, disconnect any evening. You a have wonderful may

Matinas BioPharma (MTNB) 8 Nov 232023 Q3 Earnings call transcript