Galmed Pharmaceuticals (GLMD) 13 May 212021 Q1 Earnings call transcript

Good day. Welcome to the Galmed Conference Call to discuss Financial Results for the First Quarter 2021. 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. Risk to filings the without XX-F with risks the investors disclosed and limitation, filed all our under our in in the heading, with urge the read on risks carefully uncertainties the Annual SEC. We Report described Form Factors SEC, including or dates assumes only. Galmed statements obligation as speak update to which no of forward-looking any information, their respective Baharaff, turn President like I to the call to would Chief and Allen Executive Officer. now over ahead. go Allen, please

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

As remarks. always, have happy conclusion may be a of take you questions to any we would our prepared at

be can completed to our in Based KOL with to our As time are is the for subjects, on approval that the ARMOR a an short. this Also to study Australia, that and of We on significant Mexico. milestone and part have accelerate Aramchol liver development Fibrosis in by additional, XXXX of about Foremost and the the available Globe, our give with have the XX That in efficacy may which on the expect coming Aramchol report that's one approximately emerging in Aramchol reported approvals, confirm Aramchol study China post-baseline with ARMOR QX, also biopsy only for and be Starting received exposure Chile previously France, the approval Therapeutic expected market. IND Korea plans to liver I position would double-blind Turkey Phase of Israel, look Canada, and rapid in pace month, biopsy. weeks population, and as reported approved being forward said the of approved randomization the be patients open in Candidates year earlier enrollment NASH the fibrosis in this of fibrosis, has X, QX this Spain, higher with of placebo results and expected part of in the study as results as as one-third the rapidly my ago, initiating the of had was study from Global confirmed regulatory we registrational & ARMOR used we China. the the the weeks planned. large U.S., very few invested and UK, in label liver We end Belgium, China. in National

plan, the double-blind same Phase part the FDA, an product part to reported, XXXX. study. the the Aramchol expected introduce specific And FDA we It's QD on Aramchol of acid submitted profile. during double-blind exposure. receive practical. QX our free Phase short-form registration as registration Gambit of placebo Aramchol expecting SCDX the development with expected ARMOR from with Aramchol to Aramchol controlled X us allow which end as is month, initiate replace with to by enable to the of study meglumine to is ARMOR into is with the meglumine, Aramchol this previously with a to would based of the them improve soon As to control placebo is results Earlier product guidance we of target meglumine QX X be

to shifting our gear Amilo-XMER. Now partner compounds,

Serum Serum inflammatory et orally Amyloid A we inflammation. for the secretion. other the development for developing A. currently Serum a code mild specific down-regulates Amilo-XMER action. today, Amyloid human Polymerization of chronic is study, Amilo-XMER In currently ulcerative we highly mechanism Phase all Amyloid of under dosing. and I'm and periods. XXXXand clinical in potent dosing of a Aggregated Xb half of from oral cytokine form characteristics a significant this first Serum in be in such dosed. models. announced Phase pro-inflammatory Amilo-XMER the which concept to for single a trial being in of and dosing and will is XXXmg.is targeted which currently active In action I efficacy, and Phase PK, of the [indiscernible] colitis. demonstrated for Serum reducing proportional as multiple of doses Amyloid has administrated four unique QX inflammation biomarker administrated data cytokines and multiple second planned XXmg animal multiple proof have for treatment mode is clinical additional of of single moderate reduction weeks A as happy is with to XX pathological main quarter, Topline Amilo-XMER study use. reminder, aggregation, upstream A, biomarkers, would safety brief human that a XXXmg Amilo-XMER with ascended Amyloid expected in in Amilo-XMER currently Amilo-XMER.following and pre-clinical a used of X trial first and pro-inflammatory IBD, weeks patient disease these chronic in include single studies, Phase As completed for Amilo-XMER inhibitor Xb of clinical resulted in as symptoms are being in biomarkers to for CRP, to report in an treatment in Amilo-XMER first to XXXX cetera. is we such production, Earlier four excellent trials the the clinical

action other relevant of to diseases. However chronic is its inflammatory mechanism

formulations looking accordingly. additional and indication also targeted plan We develop to at are

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

learning. Thank you, Allen. Good morning and textbook

with Joining ended quarter XXXX. I our today XXst, be you financial for this results providing morning, March will the

take among results. please financial information other primarily X-K with things SEC, of more Form summary the a [indiscernible]on such For provides yourself which

$X.X first totaled per $X.XX the million Research and share, for an expenses the loss of XXXX. in manufacturing $X.X increase net the to connection expenses QX, net to our or million, $X.XX increase meglumine. for XXXX, million loss or compared in share, with for March of development quarter million from XX, quarter first The quarter the totaled per For compared $X.X ended drug in Aramchol primarily development $X.X of XXXX. the resulted a XXXX,

Turning now to G&A, for million expenses the general our for to $X.X and XXXX. million totaled QX quarter $X.X administrative in compared the

public During ATM approximately net from we the net million $XX.X our income had underwritten quarter, equity and facility. and proceeds of offering financial

marketable As $XX.X with million. operator, Q&A XXXX, cash deposits Would call. cash, of that $XX ask on which a December securities If the net March our XXst, XXst of the portion as equivalents, and debt million of totaled rate provide compared instructions for results includes cash, discount short-term our and balance our cash please loss, XXXX. restricted

The please now of is go Seedhouse you. ahead. Steve Raymond questions. Thank for [Operator open Instructions] floor from James, coming first our is question

you just about the you. you seeing in Can Amilo-XMER? initial the study Thank tested mean, dose obviously Great. in you're talk highest you're the that doubling single ascending the dose escalation. what I for

of Just curious that that's you're if indicated if that's inflammatory some based on collecting. you PK the alone, based data biomarker or on

utilisation. have only regulation and hyper Amyloid No aggregation line polymerization of of the Steve. and and that full It that on ability of Serum production healthy A. and have happens of obligation to and Thank is times action of Serum Amilo-XMER into do you, Amyloid not Serum inflammation, A, You safety PK volunteers

into use in volunteers. a So which there's of Serum not no is downregulation elevated A, looking Amyloid in

is a you're it. meglumine, and expecting Perfect. third meeting meeting C Aramchol then or or the you awaiting had FDA feedback in written And if C Got you. regarding type you've just clarify having just are are still that, subsequent just a on with Thank you you can type planning quarter? feedback a to

for I obviously written mean, cannot now. due We the submitted to request are waiting travel to we me. We for Washington a bond. co-pays,

the, a response results the methylamine we in a the all we So XXXX have plan, studies so together of our also And on sense we had to from old fully with applied bio-equivalence for compared and [indiscernible] that package. June FDA as got written the to their they meeting co-lead expect

under time done which FDA But the response. is table the mandatory meeting for timetable confirmed has a DC's

Sorry.

is Our Ed Arce ahead. next question go of from please H.C. Wainwright, coming

congrats a quarter. questions this you've Thomas asked made for progress other is This me on couple of

Just been wondering many percentage XX? XX patients how of patients for have data weeks histology what's will treated the patients how that XXXX, be from off weeks or the or XX

you. thank Okay,

XX my week. double-blind XX the on XX are patients not majority, if from for the one FX, and placebo the of about to have be weeks biopsy these front are for going as to patients part, recruited would so are we HX; patients FX, on FX XX on go have head, we're which all And you know, So, going double-blind top this transitioned be and XX about patients placebo. talking

the for get the formulation? with for study. China the new thanks Okay, additional then new Aramchol amount And the we'll meglumine for started

IE existing the exposure, the the So, the so we coated from data IMD protocol which the is open the protocol the with see what approved that X label will that of higher ARMOR also RM XX% was the twice This enhanced is DID daily, the exposure. study, was study.

the now open We X, study the protocol is process. have in label this and

protocol approve then X the to of including meglumine course, China. now first we and to be the amend FDA. protocol; which these has We will to discussion And amendment, is in are by going amendment or approved globally, be

only to for our hopefully meglumine starting but all China, are world. but over we not when allowed So with Aramchol over, swiftly the all acid moving

Okay.

you over Perhaps So rational Xb is it of one sounds going Xb? the our final [indiscernible] question thing ahead [indiscernible]phase Amyloid Phase study, think good. but from can with

Yeah, definitely.

Amilo-XMER developing in We are formulations. two

a One to [indiscernible] it's of to be in use. colitis. well exposure That be subcutaneous an opened going is we ulcerative pH that certain a do see want of the directed to Parallel formulation to means going

into formulation both Xb. a with go we So Phase

sounds Okay, good.

development to local for go require through require like others indication of RA instance alluded applied kind injectable multiple GI tract. administration indications That's because as for allow oral, the where will the us

the with to to to two for IBD to we us working fix we of described allow expand program are course, for that other development in disease, Once formulation So ulcerative indications. start one we the one colitis. parallel

Yeah.

we for Thank So, much. so yeah, indication. so And the that's forward additional look you

question Kristen Kluska You, coming Fitzgerald. ahead. our - Please from Cantor next is go

being team. Aramchol. today. able on just XX first confidence about a patients light data couple for of ongoing in histology a to I Congrats ask of wanted to is This I comprehensive In team's questions. quarter. in Kristen this the set the for have Rick to ask wanted Hi results on pandemic, to the And

end these for the reinitiating You inclusion-exclusion tailor XX? criteria study could results believe by of first quarter your

working you the our of -- us Shai VP sites, Some we've our in S Feinsod of sites, are our here U from the out of COVID-XX. active recall, as from Israel, which returned about as in So affected I visiting less in study the ARMOR by are treatment a of normal. XXX sites, to carefully just XX terms clinical we fortunately, back may Israel US which affairs almost sites selected mean, were

areas Europe, do from the We and have all for to And of is delays going in But less by and selected not but come are problems, we patients QX from coming the which we with the other Aramchol time. of Europe we just CIS COVID-XX timelines forecast, of but some the would that see many at recently nothing affected our well. were majority patients in sites, XXXX. Expand S U.S. we've re-initiation COVID-XX. U this confirmed with the the double-blind the spot by meeting and

it's alluded you. to the the know, Amilo-XMER, IBD as to as really know and the specific a I more A best the large market for? better order trials? looking there's diverse population of complexity far you populations of this of market what signals would thank you there you serve subset one the Maybe patient target what maybe with to segment knowing proof the to but concept kind kind patient given you just target of markets earlier the data of inform, in Understood, are certainly of

for that. Thanks

secrecy in We are TK. as now deliverability targeting Amilo-XMER tasty animal of see the colitis moderate would mild, we and it patients, models, superior and be

if mean, are all patients compound have these easy. And efficacious, that I immune disease ability risk very you market. to healthy not currently benefit better. the system would form compounds very Mount of site all going be all in the term, extremely in other upstream of and views. the a volunteers understand are is inflammatory is the good Amilo-XMER, pain, going a in harming that a time ability long best crime exercise, response. are mechanism produced the the immune the ability grid so And And I to the focused. or not is same. of is a And that is ratio very, to margin to the extremely response in highly action for be the safety the is the your other say So very safe, is which specific so the idol, to They the in market, very to reducers to

things And study. in One we in it forward as believe data of with which that superior Phase and these the such there lessons system that isn't if profile effective we to for tolerability on additional Amilo-XMER, that.. drugs you demonstrate treated patients efficacy the from X COVID-XX. our exposed such we to suppressor. all and he's immune and many have COVID-XX X Phase and were that modulators very X the Thank system biologics are COVID-XX, safety reasonable learned that is lessons and unfortunately a that for room looking and one been drugs the the all of for the And of those immune see

Thank you. to this back over I would Mr. like time, closing floor the for Baharaff turn At comments. to

and traveling with you to soon. able in with soon you thank are are you you all easel in coming quarterly quarter and [indiscernible] our the in I joining finally hope call, to joining call the be and as come for call, that U very all forward next looking we before very Thank person. visit and lifted, restrictions So our XX to you be very for S see will certainly the us we'll Europe. within and for the always, and next travel contact welcome Both

thank participation. This gentlemen, today's your you concludes for and event. Ladies

You may off and this have log a lines at wonderful time your or webcast disconnect day. the