Galmed Pharmaceuticals (GLMD) 18 Mar 212020 Q4 Earnings call transcript

Good day. Welcome to the Galmed Conference Call to discuss Financial Results for the Fourth Quarter and Year Ended 2020. Today's conference is being recorded.

Before we begin, please note that we'll be making certain forward-looking statements on today's call, including those regarding financial results, statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs as well as other statements that relate to future events. These statements are based on the beliefs and expectations of management as of today and actual results, trends, timelines, and projections relating to our financial position and projected development programs and pipeline could differ materially. significant pandemic the Galmed's and operations. is of and business there COVID-XX the its particular, uncertainty duration about severity and In impact on urge in without the limitation, risks risks under filed carefully our We with Risk SEC with Report the to Factors on heading, disclosed XX-F described filings including today. uncertainties Annual in the SEC, the the investors all our earlier and read Form respective which obligation no forward-looking update only. speak as to their information, assumes Galmed statements of any dates or I Chief call President would turn to over the now like Executive to Allen Baharaff, and Officer. Allen, please go ahead.

with as morning thank as Officer, an of the development conference programs Scientific here Good to Ross. you, report you on fourth end our to with us today for Dr. financial today's Liat Thank provide clinical quarter on to I'm be results well pleased and update XXXX. on Stenzler, Financial you you Hayardeny; Chief joining and our our for year call. Yohai Chief and Officer, our

As this Aramchol, may Earlier for have our Update compound always, conclusion on any X questions Phase and a remarks. the prepared developed happy you be focusing of our chronic NASH Amilo-XMER inflammatory we Symposium we and for and at hosted lead KOL pipeline Pipeline take asset fibrosis; our a quarter, to will compound disorders.

of enroll selected these associated of XXX-milligram Let non-invasive open-label and measure ARMOR well me of addition kinetics The explore XX, treatment the share part twice and Fibroscan ProCX, evaluate with -- treatment It several and programs. patients open-label of to response, NASH and approximately In histological daily for administration XX, duration including as fibrosis two and weeks. data on safety X last with XXX in of BID of XX Aramchol December ELF, we designed outcome part tests, Phase as presented the highlights study. for you the an is the of we registrational year, announced will sites. the our our pharmacokinetics,

us early open-label In for to develop addition, efficacy. includes microbiome the post-baseline pre and help biomarker will part which profiling,

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of As to study form liver at part product subjects is population part not administrated. defined, of you NASH, Furthermore, or by on in similar with and NASH, double-blind, with blood subject similar the Aramchol the for year, data, already is and initial was fibrosis ARMOR we Xb our in very XXXX, once-daily subjects a ARMOR in based NASH revert Phase suggest profile, placebo-controlled protocol with filing half-life overweight, recall, ARMOR other than Cmax optimize subpart very and of meeting the our of And FDA ARMOR a enroll solubility, profile. higher have the will for being the Aramchol protection patient X QX, the potentially last FDA drug effects At program part by exposure end drug stages showed to better may registrational who Aramchol acid, had and also introduce to currently including along higher regardless in PK as part we pre-diabetics. data These an X up into until Aramchol age results registrational homogeneity in PK results may Type By i.e. one may XX% C free study Aramchol able X which also well in PK patent the Aramchol ARREST the the with not the may have in Aramchol can a We developing the is broader we to levels. who that to same we COGS economic blood Type be of to the PK the FDA approved XXX-milligram submit registrational the acid by that study. dose Aramchol, XX% evaluated to or to gaining development is will or open-label first-in-human end modeling clinical once-daily open-label have X a in as with to a and product and be the supportive ARMOR target initiate a for which the part product important and free approval. commercialization that new placebo-controlled, meglumine being able on meglumine QX XXXX. reported treatment that ARMOR results discuss improved reduce may meglumine will get with salt planned diabetes meglumine a meglumine, study. of as circulate Phase to which which meglumine, plan Aramchol double-blind has This plan XXXX. Aramchol expected the

we inhibitor models. half planned proof-of-concept a Phase Amilo-XMER Polymerization Now demonstrated conditions and preclinical shifting a hallmark reduction serum. oral gear to among multiple cytokine Serum in model in resulted animal unique to cytokines trial patients. pro-inflammatory patients. potent efficacy, IL-X inflammation reduced highly the and of the inflammation mice, QX currently under a action, cytokine Top dosing line chronic animal data acute Amilo-XMER include also has the reducing gamma secretion. In trials. will all Amilo-XMER inflammation of XXXX. Amilo-XMER regulates In dosing. biomarker is is as our with mode which serum Elevated for clinical Amilo-XMER. the and XXXX is which X TNF study of aggregation expected Serum include are such A the of production, and in Amilo-XMER in multiple levels LPS-induced dosing, of clinical pro-inflammatory this upstream these second for first-in-human in are Amyloid of in is of COVID-XX announced IBD. single and symptomatic for Phase Amilo-XMER interference studies, chronic include – compound, week, used inflammation A significant and currently inflammatory now Xb Earlier pipeline multiple and development IL-X being IFN levels chronic pro-inflammatory in A. systemic for first Amyloid for the beta of also alpha,

colitis. currently to are treatment as developing mild ulcerative oral We for an Amilo-XMER moderate

other However, we it inflammatory relevant diseases, mechanism multiple formulations additional is develop of is accordingly. to looking at also indications action and are chronic

and Before use the a proceeds offering proceeds the offerings underwritten gross dollars role Mount Downregulates at-the-market gross as longstanding further Diseases, the School the continued publication Medicine in Phase million of potential in effect Icahn the in purposes. to well development of directly at paper Jose Medicine "Aramchol SCDX Professor anti-fibrotic role New products Attenuate these net Laboratory, our of pipeline facility. in through as and approximately stellate of paper which the mechanism of We Spain, corporate of $XX.X outlining including by recent Scott hepatic of – fibrosis in our in we first describing SCDX Aramchol in the Precision concluding, with our advancement reversal, Data entitled Mato Friedman, activities fibrosis. for is ongoing ARMOR during to down the York; its patients fibrogenesis intend Aramchol's Cellular hepatic summarized development an February, in least in research activity public but and Cells for Sinai, CIC not Stellate the of new cells. Professor bioGUNE of SCDX exerts The and in and the Liver Hepatic Metabolism programs, NASH by general Last reports. Fibrogenesis" business and collaboration the by JHEP study time of regulation in Chief Division support X anti-fibrotic raised

Now let call Yohai Yohai? our CFO, Stenzler. the to me transfer

quarter with This morning, results ended year and our for call December providing XXXX. Allen. and fourth today. you, morning be Good thanks Thank joining the our you will financial XX, for I

today the please For which XX-F financial SEC, among refer more other of results. to a our such things on Form filed with information, summary report earlier provide

XX months and period compared respectively and million net for for Our corresponding million the $X.X December $XX.X the totaled of three million net XX, with $XX.X $XX.X XXXX, XXXX. loss in and a ended million loss

December The million. $X.XX $XX.X development As trial million in compared our our and resulted an in development the and $XX.X period and studies. as increase Aramchol study for Research an for connection months expenses manufacturing share and primarily clinical three million to with $X.XX XX, $X period XXXX corresponding December in million for per XX XX the in XXXX. expenses, in the months of $X.XX per ended increase the and per drug three clinical XXXX, corresponding in ARMOR with connection from share share a This compared support per share and increase was the with expenses $X.X ended XXXX. totaled loss and result, $X.XX XX, and

Turning now G&A. to

XX, million for the expenses versus and the respectively, ended and and XXXX. administrative The with pretty $X.X expenses and totaled general $X.X corresponding XXXX. period December XX are in three $X.X months for million XXXX, Our million million consistent $X.X

million financial three million million ended December and respectively $X.X net of income million versus the XXXX. XXXX, we $X.X During $X.X had a and XXst XX during and months $X.X

million $XX.X balance underwritten marketable facility. net an raised million. short-term from With the cash, our Question-and-Answer totaled said, This as operator, restricted Session December of Q&A cash equivalents, does the that of call. during and cash please proceeds cash, ATM which $XX deposits February includes securities of not for in Our amount XXst equity XXXX, debt offering public our portion instructions and provide include

Thank you. Thank Instructions] you. [Operator

Please from Our question. coming first of question with the Ed proceed is with your Arce H.C. line Wainwright.

for the morning, and and good you progress. congrats Thank everyone. Great. recent Thanks this on update

question now you you. Allen, as readout? for ARMOR meglumine, enrollment me to you look Thank the us study with timeline is, if data the full of switch expected remind And then, beginning the First of could dosing? ultimately, to in actual the and switch

Okay.

So, thank you, Ed.

to to part reason goes believe ARMOR QX, as I now XXXX. So, mean, going are things the all is far see study reinitiate -- said, well can everything we as If expecting of I that planned. the there's and double-blind by no we as as

expecting patients XX in are months. enroll X,XXX that We to

kinetic whether much XX weeks will So of depend very -- is weeks that it XXXX. to the of there will QX, This able generate study, would open-label data -- from open-label on efficacy kinetics treatment be will be to XX or take the Then a us treatment. study.

that still XX of be difference sufficient. weeks the efficacy. will XX There XX be in between We weeks, and weeks will hoping terms are no

So that's one year later.

So we XXXX. QX, are about, talking

sub-age to be for conditional So around we should able the Aramchol submit that approval. time,

needed additional we X,XXX continue that we the which course, recruitment are will at the for will of patients study. the continue the outcome part Of -- time, of

a And then Great. follow-ups as Fantastic. couple of well.

should Amilo-XMER how to ARMOR But inflammatory of of the pipeline potential you on think And focused the Amilo-XMER. for given through you Turning you your to that for might we lastly, the compound? there also chronic pace just if IBD interesting both the is be then could increase the week. other as development? Thanks. this those of of then R&D mentioned level about think the expense started and candidate that mechanism your X given this I'm conditions. some you're you the And or types wondering support describe Clearly, Phase XXXX

Okay.

of mechanism is is it's and which first, is -- a mind nowadays. with So, immediately of number COVID-XX, comes relevant action inflammatory RA for relevant indicates, diseases. one chronic Amilo-XMER it to The of which to more the

we this said we compound to are gradually. As before, looking develop

biomarker the So, thing is see to Phase in first we a a Xb would study. like

described are going local patients from for that would this our and we month This initiate investor if the XX we're the to half symposium we able ulcerative IBD on RA, also are KOL in looking is I or oral also to studies, be financing an for biomarker will second for as we formulation very for such on we'd study for be would of or indications. at secure regulatory, COVID-XX small this is we Symposium also assume look and initially formulation, As if in initiate simultaneously different formulation different injectable proof-of-concept we've disclosed, looking local our formulations governmental colitis for that story. it time -- subject opportunistic financing. the formulation our simultaneously, different develop we more year. only We a to BARDA would be same IBD, liquid is study which a to but would go direction for for NIH, It's joints. to to study these a developing an and that expecting ago, as this of -- earlier be -- the would are also

go that independently. not will We into

So, that's other about indications. the current

which is are This definitely We are this of indications, pursue relevant action. multiple for for of are the -- going out open to and other the scope sclerosis completely mechanism Galmed. not collaboration. is we But of

be to based for will there any study So, with happy on that. us the indications. that on these would we'll to Xb CNS of be collaborate very pharma collaborate partner any like indications,

to advantages working of the this As one Israel. financing, of is I from think

so to low all very R&D the work seen do all work, you've the R&D radar As far, the a under we've for Amilo-XMER, budget. managed with

in Phase US$X really we -- million. are so about to Phase So we And early study, studies on are to work are still US$X same the far still number about the R&D million in with early US$X X spent million US$X same Amilo-XMER. A talking X single-digit, between work the million ballpark magnitude.

of activity, cash So registrational destruct Phase with the it is of ARMOR the part really which X balance, Phase our the part of doesn't X main our study. the initiation ARMOR

in. I spend? I Allen. Great, And what the program Actually, if better for a overall have there that may is determine trying squeeze one of last to really mind a one actually in you terms R&D ARMOR is, question in was budget

so -- variables, It there number varies it's with very of are difficult. a

at that at depends XX% most patients But will are least are recruited it today again U.S. -- be south patients. be patients, we We US$XXX are seen of a definitely U.S., the million. the the XX% expensive much patients would talking very competitive as will on the a landscape of outside of time. what reminder, We've that of

would come half cost outside we and we have patients. of these or XX% know average are -- U.S., that one-third So the the of on about even of U.S.

we registration Phase many of the advance for to initiating into other how XX% Novo I Gilead assets Phase morning, year depends Phase very up depends It Xb -- about the and this -- X for combination. by start competitive X. on The it X is large the Phase would study much landscape. next the part when another Phase the recruitment saw ramp X, news

-- ensure but on to centers about numbers. once budget million, We these conditions the $XX so Phase $XX are be in XXX open-label may be full to the that my these have $XX should we is patients with that that subject market to just and XX So, have But that require million validated open XXX not the planned since all additional of the a recruitment million. now firm These far had that and are we million, part. $XX are like was numbers still we would mind, as number this In may I reminder still would have between we X to somewhere the the these of time for part months -- for are as believe not that count double-blind increase. funding.

That’s Great. Thank very helpful, so Allen. much. you

Thank Ed. you,

Our next question Seedhouse is question. proceed Raymond with from the with line of James. Steve Please your

good Hey, morning, everyone.

of fact FX I question FX patients, to, had Phase to understand part or in open is to if scheduled a you just the FX but program. as expect to run Type C pivotal patients let's or the First on at about sponsors broader was X histology X Phase curious, thinking have sort into data NASH. you now in And also something programs outcomes discuss patients incorporating a that's that say looking I at with collect encouraging design? of I'm data Galmed's FDA meeting

Steve, part you that yes, thank received – the Steve. guidance of but seen also So from this for I've not the – the is question, you thank we FDA.

We the to are recruiting not study. patients FX

Our part. and the in It's study with FX double-blind risk changed has registrational not population FX factors.

really it's is not new this Galmed. relevant proposed So for – structure

the just Okay. on then Perfect. question repolarization. impairment, NASH cardiac was with had respect Phase X And on I hepatic studies also to other

those were in I that of think program? past. the curious, the transition Aramchol run these of given you'd the a are with there if meglumine few mentioned being I'm now

was Aramchol recruited where be in is completed the between we've as the multiple patients moderate and the this needed due patients. we've in difference and severe for and we've dose two. both no dose, mild more circulate moiety, progressed to the The part. administrative impairment Aramchol COVID-XX. administrative meglumine weeks, basically, are recent already the delay the same Few single hepatic almost But study, been some has completed well. There So very to – accelerated

So, on so done. what like with will data, we the future, And TQT course will would from we've for TQT cardiovascular conducted open-label study collecting Aramchol. Aramchol we exemption from another XXX need, with a meglumine. of approval new Based the this study, on And benefit have But far are that will that we done done that necessary in studies get studies the have patients. the data we come future study. sure based be this these that be is may not an from

Allen. clarity, the Perfect. Thanks for

Thank you, Steve.

the your is [Operator Instructions] proceed next Fitzgerald. question. from with with Our Please question Cantor Luska of line Kristen

Good and afternoon. taking for the everyone. Thanks questions. good morning Hi,

as one the can you ARMOR data, fourth the first So could at about [ph] Is presented of meglumine. possible do quarter? then, now recently I And of it had was this are that to patent the current us on that here. accepted relates liver US remind it matter during think time? upcoming the patents know, you meeting be it's Aramchol at a composition pending you the IPC I the had just this

you, Okay. Kristen questions. Thank for your

we're QX I date So the be think the data I AASLD the – and September. missing deadline is to the may for just come – we cut-off for expecting early this because

be So we'll communicate have will data accepted breaker. to -- are soon late as I not get in as But be going as we and it the we – I'm certainly, late diseases we'll try first able breaker, that get that study. think don't sure but to moderate open-label a as a this

a basis. the regular on are we accumulating So all data

report after we something timelines. order be if data that. patients So would not cannot the patients XX I try XX and so promise will meet and overwhelming, when -- But or to -- for wait we maybe the would in

its date patent patent, expiry Aramchol the XXXX. of terms December meglumine In is is -- the

additional low This that patent in are patent protected of a are that protected Aramchol. administration extension, is new based before was the until before before for we on accepted U.S. of XXXX. kind dose already this time, exclusivity, we So any

of very still are sure world. there to Aramchol. in it the composition -- dose waiting already same the Aramchol approved U.S. We patent US approved soon, that accepted administration protection in will of the protection the And is for but the the low in was was for in be the this patent of come the I'm matter, from the meglumine rest patent on the way

earnings Thanks all Great. for, the in that then, so XX level key And collecting completed could the the I on quite a these the the And some call, to quarter enrollment of your vaccines. during of with of of changed pandemic? know of just just in confidence bit sometime patients you much. rollout data fourth sets, that have light the you've speak things from last

Yes.

is study, standard adjudication, Phase here data the have the We read large a no done -- study. DMC, study. we collection of and biopsies X,XXX-patient three system mean, a Phase way with all I -- The X geared a readers, and registrational look, the for everything is in X

whatsoever we we very these high will data, no in I meet that have problem So, and the indeed collecting timelines. confidence have

we COVID-XX we We randomized seeing surge been lifted, now are the of And the of new very XXX there’re very -- the are remember in numbers out new two in in the operating that please have are recruiters, patients part. number since are very, fact, that seen have been that double-blind have restrictions last restrictions, Even are sites we that numbers the a sites encouraging. screenings some so for encouraging, selected I've in now weeks.

to which less only affected start by XX with. operating are were XX, COVID-XX selected X-X, We in sites,

working sites So, with a very these for collaboration. there's been good we've now no And -- a-year-and-a-half. it's

any I any don't I of interference, and reporting risk in So data. this don't see see

so to you great Okay, Thank Allen. much, hear.

Thank Kristen. you,

for the closing you. Baharaff remarks. Thank At over to Allen will this turn I call time,

like to call would all today. you for joining the I thank

And the call. to next safe, looking the you on more As into exciting clinic. looking you always, an if to you available keep but and times, additional a require, compound on Aramchol, have calls talking for now and forward and new both time any follow-up always Galmed we forward are information specifically would Amilo-XMER, that in getting having e-mails. which on investor is And

Thank This conference. today's will conclude you.

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