Galmed Pharmaceuticals (GLMD) 2 May 222021 Q4 Earnings call transcript

Good day and welcome to the Galmed Conference Call to discuss Financial Results for the Fourth Quarter and Year-end 2021. Today’s conference is being recorded.

Before we begin, please note that we will 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. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under the heading Risk Factors described in our latest Annual Report on Form 20-F filed with the SEC. to of forward-looking their obligation which or no as speak respective assumes update statements any information, Galmed dates only. like and now Allen would to call the I over Baharaff, President Chief Officer. Executive turn to ahead. go please Allen,

us Thank you, Peter. our be conference Doron morning, Chief and Chief to Scientific I clinical pleased today development Liat Cohen Chief on for Hayardeny, Officer our an Financial Stenzler update for am our you thank call. provide here today’s you report Good joining to with the quarter and Officer, Dr. results with as Accounting full results. you programs, on year and Yohai fourth financial as well financial on our XXXX Officer,

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proteins, human volunteers. of consisting SAA As Amilo-XMER preventing pipeline that reported of January peptide the inflammatory immune is Government efficient from number markets, label synthetic advance that provide XXXX, CFO. monomers thereby earlier binding SAA compound clinical assessing appointed year is positive Amilo-XMER serum in of a Doron brings data results clinical X next and steps forward. exerts of five Amilo-XMER and the the next X effects of sciences on will study induced of with program interfering cell Doron XX welcome first we pro we in as significant an update drive to our to including trial amino than positive the part ARMOR the from Phase a a the healthy the activities, we life newly potential data continue amyloid global acids experience Along on Amilo-XMER. We polymerization Cohen, details open plant announced amyloid financial currently activation. anti-inflammatory our buy and few our On interim this of Phase companies. we to in are years experience proof of pleased of generate the clear to more intend side concept in with the months. more studies route rapidly designed to with by

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

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

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

December $XX.X XX million As in December and months XXXX $X.XX for totaled a per share, months $X.XX result, our and million $X share for the XXXX. in corresponding loss XXXX. $X.XX XX and XX XXXX per compared share and the million. ended and ended with was corresponding $X.X million the This $X.XX period the three $XX.X periods for compared as and development to Research and expenses for per respectively, three

G&A. to now Turning

December XXXX ended three Our for and respectively, $X.X XXXX. administrative expenses the $X.X general million for $X.X and versus and XX-months million and million $X.X totaled million

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

of XX balance XX December for operator, December equivalents first Our said, marketable million XXXX. instructions as Q&A cash proceed XXXX, $XX cash $XX.X totaled that which compares million. from your line the the has Seedhouse, ahead. go can [Operator with question Raymond Instructions] our been is Steven with Our Mr. call. Please This cash securities restricted includes of and unmuted, please line on James. cash, with With question. you of portion your Seedhouse, provide

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line ahead. is next Kristen Please with go Cantor Kluska Our from question Fitzgerald. of

taking Hi, Thanks so morning, afternoon. and question. much good good for my

guidance I to XXXX on registration first ask the the wanted half second was one of in terms of The study. of

some the course, out things were that, some of like as things that factors understanding could of of But are evaluate. control. you patient population your which control, the cited you then of to you factors cited So company the

So primary surrogate biopsies the you know, is for example, understanding the endpoint.

and timeline you understand from by this just wanted you time the hope year. about what to a to So more understand next broadly, start little bit plan the field to study this

recently And the we is involved the participated. the the liver right the developing So where space believe we've direction. there companies FDA presented forum NASH a and was many field pharma the in also in of in

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how that PK the you meglumine of Okay, thinking thank of the between wanted shared you're shared that some for then could recent one work it week, ask the of the how profile light daily And last correlate Aramchol you data two some drugs. in to you that. early

So recall, uncle meglumine as is our Aramchol. you is out circulated

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Okay, first the to might I number ask you looking Thank you. thanks. had concept plans terms you on you share me still introduced highlighted Amilo-XMER first I some just for And wanted know but IBD, to in you're a was question then just programs. assess over last study, proof months of discussed if of potential of to you next Amilo-XMER, couple of the that

colonic is IBD. So is indeed, the we this formulation developed formulation, an for for and first Amilo-XMER, inter developed oral

for kind this we Now, landscape. Amilo-XMER competitive an competitive the And create we to look in the trying edge space of carefully and landscape. are

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Thank you, Allen.

Thank you, Kristen.

from line Maxim the Naz of with next is Please Group. Our question Rahman go ahead.

for Thanks everyone. question. our Hi, taking I have few. a

methodology prefer KOLs different? the of versus or fibrosis would a like use find start FDA and the with have on the you more to you recent so FDA three like on stricter, methodologies your going rates what Could methodology? a I'm sharing of strict on of First any so data you as the on, conversation these were methodologies? started you value -- more see improvement sort Or, that clinical methodologies. like how how about of different potentially And did KOLs like, you just the different the are AI talk had

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are they of AI. forefront So clearly the

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one On question. potentially development considering Just the sources future considered financing? product and partnering you you -- Amilo-XMER, last for non-dilutive are have of

Justin, Naz this years, to assets sorry, competence is think Phase core our for quickly these is questions. We proof what is demonstrated preclinical we've of and studies. Galmed thank And Absolutely, clinical, those I absolutely. the -- over concept advance you for again, preferably X -- into

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taking for my questions. Thanks

you. Thank

Our next Please question is Ed from sir. ahead, line go [indiscernible]. of

you can Hi, hear me?

Yes. Hi, Ed.

Great. Thanks my questions. for Allen. taking Hi,

half I and bit of considering a of with were reviewing you part in were some were next a better of And the you perhaps the as you the necessary? March you I that X the this you First, late. us joined working just on more pushing was bit moving timeline Could the But least felt that year. did the give why sense a to give at endpoint of for FDA? criteria do Just with second primary this having the detail understand portion to back? for Phase our defining

So, thank you, Ed.

but have study NASH between don't about start for at people patients. something would It in patient. to the And study, to a to you expect. I no and means I other XX,XXX run to order fader. patients that should the to need the with It order biopsy should over one patients, studies, biomarkers of biopsy validated and our only together eligible think know think and cost this to everyone the reduce XX running I'm numbers working How who for the studies you screen the in into wait a fader better, instance, XX% to XXXX one Because which with patient, to is NASH So screen is don't is of for these including for you also these get When sensible look XX%. you sensitivity seeing we the smaller see frustration all we're numbers. patient. the find on biomarkers study, into that the AI. both better and do method with biopsies, for looking patients a the sample a DI need and to the size, allow will not And unnecessary

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one these better combination. combinations. the more a How studies, the we that myself, by test in of all study, think whether than So no answers guidance two the think go still include arm time And addition should demand I've get argue these on I blind study, So earlier, of to the large pivotal we design the smaller whether go in advanced double we study, combination population, for initiate to the hope the what should that you part whether reinitiate, I will said rather we two questions. we ability kind do pivotal study? population, the for about there's should

Okay, great.

fibrinous the a fibrosis devise the correlate your score, So your initial the does it necessarily the fact, method, this well truly really have CRN data, I data trying want NASH histology. with understand at And question to you to time histology. X.X of compelling not over correlate and definition wouldn't of you that better period. if next of were units in to obviously, regarding reduction And on out data least composite is, that

it. still has to histology have had having in So to end, several move and 'XX, the trying correlate away you space of years’ have yet attach and the to for from sort

these have question Or the to are being to FDA better the to tie biopsy? to with to essentially in hand, worked things to on patients not of groups the and this large data a are listen method several to in years. U.S. of you moving over like the say is is, a basically that some Europe intending are to FDA with and that having more inclined base So continue discussions data

So thank you.

I this important is So think a very question.

We P to accurate. you from cannot by a are a can method, trying sequential value which is the definition move sensitive hence more number. into but method also more and demonstrate And categorical we demonstrate or categorical

it I support. think AI first the with that of in stage, a combination could be

use You CRN that has reader. Because that this know to as another to now good are And creates keeps FDA false NASH allowed enough. reading There's employees. not we us already AI AI not additional a and alone. is the but

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correlations that plan Now, between methods. we fix

So, for is the method XX. XX example, and

the the fact is XX direction across way -- these see the notwithstanding this same. methodologies. very, And numbers, XX sets clear XX all very are that the better and there is methodologies. So, already we from is different using by three is than is the we across -- that this data

paired whether is it's gives or So, the you this AI. a the lot directly same. And paired, and in CRM, of confidence AI, see,

Great, thanks, Allen. Thanks taking my for questions.

the Allen Baharaff Thank the have now of to to closing turn for would And session. and end you, I back ladies the reached we gentlemen, answer and question call remarks. like

all. So forward joining seeing for for is which -- just thank first everyone you today's up questions. on our sorry, next follow much, as always, you XXXX Thank look to And you quarter call, we're the we very call. first corner any XXXX quarter call. Bye-bye. around available And,

concludes This teleconference. today's Thank you.

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