DMAC - Earnings call transcript Q1 2021 | DiaMedica Therapeutics Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter 2021 Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section.

Before the company proceeds with its remarks, please note that the company will be making forward-looking statements on today's call. These statements are subject to risk and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results appears in the section entitled, Cautionary notes regarding forward looking statements, in the company's press release issued yesterday and under the heading, Risk Factors, in DiaMedica's most recent Annual Report on Form 10-K. available and are its filings SEC at on www.sec.gov website. DiaMedica's no made note May call may rereading. at that or also any on time X, be of the any and today, Please transcript of comments today's replay accurate as speak XXXX, longer only any disclaims update statements. its DiaMedica forward-looking to duty

and we Mr. open call, phone now your you for today's lines to the like questions. [Operator Following introduce Officer. will prepared for Pauls, Chief DiaMedica's may begin. President Rick remarks, Pauls, would the Executive Instructions] I host

Rick Pauls

documents you, joining we providing Erica. release press update closed, our general a XX-Q. and just Harry filed our earnings Good I'm you our Thank markets also was at morning, a everyone, diamedica.com. can that in update quarterly report section and our a Financial last a today we'll questions. Alcorn. business us Relations month-and-a-half first summarizing update. Scott brief found morning Chief thank of At and on our taking Both Officer, and before provide call. the call Dr. for the website Chief our issued Form to Yesterday, QX after Medical your Officer, today. this XXXX be time, joined Since Welcome Investor we results quarter ago, by our Kellen; financial

Let's begin with our Acute Ischemic Stroke program.

FDA's and item confidence review The submission our period the this and for plan of is current the that the the for X/X we The the DMXXX in our but time now end concludes have of XX-day IND have study acute additional behind of on statistical proper pleased are Phase a the March support patients. design. forward pacing be goal, week. to analysis to We stroke IND a We ensure our lines. we proposed next initiating end study April used time bit the in adaptive submitted right with moving ischemic we XX, to study study

we than upon yesterday, December, not receipts study questions from FDA communication from other IND. of Based any don't feedback we As additional the last the significant the received acknowledging they're the protocol. have on the that we any anticipate received of FDA

As X/X powering be study a the statistical XXX primary significance participants. randomized a approximately of placebo Phase upon double-blinded controlled, supposed, Based trial at for modified Scale the endpoint will XX. day this XX% on Rankin of

and include stroke and will points the deaths, MR with KLKX. to end NIHSS along Secondary measures Barthel shift, biomarkers reoccurrence, safety and index, related tolerability

FDA the a Recall X to our X/X as in addition a study, recurrence we significant severe strokes. statistically to Phase clinically stroke preparing discussion significant recurrent regarding reduction a we engage observed ReMEDy In for also endpoint. study, in Phase the expect in that

reduction the group in with we fatal. of were overall control Specifically, actually to group signal fatal. we of the system. the Anything Recurrent be additionally and to greatly stabilized to be also costly, disabling strokes benefit their mechanism and associated saw which in XX% the patient study. recurrence victims more tend potential of DMXXX and that provides X believe which compared reduce for physical for a reduce stroke recurrence the recoveries healthcare believe would plaque. We improve patients the this in an level strong One DMXXX X a and with stroke can done

well Dr. DMXXX, study finalize We Alcorn as part as leaders, key bringing initiating to together scientific our an of and experts. number the for clinical led designation also board to submit process for opinion as a advisory regulatory intend protocol, fast-track comprehensive application a of discussion. this

timely, engage time-sensitive is up efficient sites. to for summer, They accurate, study. for procedures have resources prioritizing FDA key authorization. assure and study Concurrently, a qualify, contract getting We research the team on this clinical services to trial a our organization subject and initiating to are to identify, provide operational engaged the us the and focused with XX anticipation needs and to

program compiled. data XX on includes remain Nephropathy or track XX currently has has IgA in trial, cohorts. the reached to the top-line results cohort participants. We data XX% enrollment chronic these item and to disease look kidney full diabetic with readout being This forward REDUX our IgA pace, and participants from been to kidney XX% enrollment still this disease the Turning the enrollment the data and kidney The waiting XX our the Nephropathy is is REDUX reached or Enrollment for study during this of in provide you for disease with key that the being XX African participants. near-term. continued participants. American Overall, diabetic cohorts, approximately completion the sharing at The the American African preliminary we've quarter has COVID. impacted has the in cohorts cohorts reached slower in in a

We also very that have X and shortly. activated sites additional identified will qualified be

cases new study availability of new completion in XXXX. COVID in vaccines we anticipate and these the these still both sites, of second of declines recent of With half and cohorts significant the

us results Kellen Scott for to first quarter. financial ask take through I'll the the Now

Scott Kellen

as the first Thank financials you, mentioned, filed Rick. we Good quarter and announced on report morning, Rick XX-Q everyone. our afternoon. And yesterday Form quarterly

SEC documents, the If DiaMedica the to on both a or you available they're haven't these had websites. chance review either

of the share share. quarter $X.XX This in per net million net to of period or loss the million the prior for XXXX loss year. first a was same $X.XX or $X.X Our for compares $X.X per

the XX, ended increase ended $X.X a XXXX, for development to X to year-over-year XXXX. Our in X services number study. Phase of with consulting associated for and research million were increase million for due increase XX, staff Phase in required the March stroke million preparation increases levels, of an X and that cost months the $X REDUX was months an costs ReMEDy X/X $X.X X The the non-clinical including from expenses our March CKD for and testing, incurred factors, study support

during decrease year-over-year X by XXXX. in a partially the costs Now completed offset incurred study, these ReMEDy Phase which for increases were stroke

were The expenses officer G&A March for months million ended resulted million prior and costs. administrative liability $X.X primarily X insurance the from general XXXX, in expenses compensation $X.X Our increased director premiums, slightly increase and increased up XX, share-based year personnel non-cash from for the and period.

due balance $XX.X equivalents was the $X marketable as Phase finished associated costs we quarter end securities, Current million with in million. liabilities preparing related XXXX cost This liabilities to were $XX.X cash capital and clinical to to XXXX. $XX million. working in capital million The and are of the and securities first million and working stroke CKD our cash equivalents and study cash, Phase resources of for current sheet, X/X of $XX.X of combined cash capital in in primarily study with On million working $X.X REDUX X marketable compares ReMEDyX the study. in cash, decreases and the

in X current REDUX the study capital should us complete and study planned Phase ischemic Our position fund allow X/X Phase clinical cohorts, mid-XXXX. operations our X initiate stroke, to the acute all through

call Rick. let back over to Now, the me turn

Rick Pauls

Thank the you, analyst. please call questions. you like We'd for could if Operator, introduce open to Scott. the first

Operator

Your Instructions] line question of Capital. Nowak with Craig-Hallum Alex [Operator the first from comes

Alexander Nowak

everyone. Hey,

base the breakthrough on to touch of want designation. fast-track Just the

FDA on what current or whether designation? Have us get or be just or you to any with So front timelines then HHS not that submitted? that - had hear not been pathway remind the you clear, the just has communication back and there that on to

Rick Pauls

Sure. green is to study, for the our with Good to Alex. to getting morning, light fast-track the submit after proceed FDA so designation. this Yeah, plan

Alexander Nowak

the that's And Okay. XX-day review, correct?

Rick Pauls

that's right. Yeah,

Alexander Nowak

really anything give about Okay, to IND. going at vanilla too - you're the know it you the that, be it that's pause in to Anything some review worried that's great. Is FDA the IND that would doesn't expect there or might like it feel pretty here? submission

Rick Pauls

there from always feedback come as fact confident. be guidance following that back or that we and a yes, chance. it'd answer, we're very this Yeah, - comments. December helpful new concerns. know like be we're in for the It I and we with is their will did The you feel the positive. optimistic think the FDA short us get was questions we're And, will very But written FDA

Alexander Nowak

there could maybe the about on some other there's studies, development. CKD obviously then kidney show to under your drugs data readout think you done, got, Phase up guidepost kidney Chinese that compare we DKD? Okay, And have how and to Xb understood. The that you've we then, the is

out So like to you success? what call from would as see to EGFR a UACR standpoint and

Rick Pauls

so again, a is this study. Yeah, X-month

have we're X doses measuring We and different this baseline. versus

be And seeing in see proteinuria so could a to EGFR, - pleased. ideally, increase very we decrease and UACR if we'd a the in stable while

Alexander Nowak

is, timeline your just data XX this completing expect it? puts include days the understood. because second press the XXXX into to completed in needed for mentioned December, you or the last enrollment March. else is And a review The publishing question. the this X end half in then, that was DKD year, the would second question then, the Does cohorts that other a the to And finishing for half of second similar What later readout enrollment in release us enrollment? just the ultimately on of Okay, XXXX? to

Rick Pauls

complete, X for the it relates to reported results of though following out relates the to assays, And of patients to CKD for batches so end as the data. come some X to year. we process be their REDUX we they cohort the cohorts, anticipate Alex, correct, to even of We're DKD, data are reported be X are you and respectively, the as will out the accuracy the other it the currently a ensure the laboratory to to X the June have have through. early DKD, wait by

Alexander Nowak

Thank you. That's great. update. the Appreciate

Operator

the Guggenheim of next line Your from Etzer with comes question Darout Securities.

Etzer Darout

for question. Great. taking Thanks the

patient DKD Just anything for me, have as gotten trial? on cohorts the you they I guess, first disposition for exit question the anecdotal

Rick Pauls

at fully look data. that have want and We don't set a like understand make individually. sure we complete to to data We analyze the to the

at a answer we're question so that we until point, report. to final unable And this see

Etzer Darout

itself, X patients for sort - your And it. a SGLTX SGLTX I inhibitors, sort of as similar, guess, just design, for thoughts or the trials are sort asking and terms that around you in more the to inhibitors maybe this only maybe that. be the and sort of getting Phase thinking patients about but of on implications the of of would the guess, of DKD but sense of maybe readout I expect, I not data now sort the number of really then, in guess, Got

Rick Pauls

think DMXXX think of terms where proteinuria, months disease. based more vascular conditional is - X first about Yeah, IgA in nephropathy. likely full We the term, potential of we'll of is we longer then after very excreting follow we pathway, What is rare And disease, SGLTXs opportunity versus And clear I the improving is is approval, have here, EGFR. upon a diabetic for really the a X pathway I a to the glucose the are cohorts. data based mechanism the in the X the approval is anticipate it's that action kidney the see the on years urine. via for plan turf

So mechanism we closely be we'll as we complimentary, different that's have think data. to that ultimately look that at analyze more our it's something could a but

Etzer Darout

Great. Thank you.

in Looking all to forward updates XXXX. the

Rick Pauls

Thank you, Etzer.

Operator

comes of Brisebois next line Your from Francois Oppenheimer. question the with

Francois Brisebois

thanks questions. Hey, taking for the

of and talk just then, outcome, of a here, a mechanism about plaque terms a just action stroke explain little strategy, bit of be for just a FDA there outcome, to this bit complete a little study, any new timing whole in Would can you outcomes the on that stroke a Just recurrence would here? And of make could lot sense stabilizing secondary recurrence? a that more be answer, the approaching how a just the and there? what the the couple co-primary can of thoughts you

Rick Pauls

Sure.

is sub-study Phase a the study. recurrence. required, we here study separate possibility proceed to the be okay potential the looking for X/X. and also a not looking a but what also could So number proposed, is of pathways after plan This for current endpoints, We're at as at with different get co-primary currently for the our we're both stroke the within

on strokes, we recurrence ischemic Phase the on When again, we look although And small had X when at X X X drug. earlier at study, strokes, on drug. on placebo, placebo, about we how for we talked we look recurrent severe had so X data,

do to that action, of the so through plaque. applicable And mechanism this occlusions. vessel recent the events, feel lot for a vessel, we small our medium and be on believe on something KOL we DMXXX this, of for and stabilize KLKX And if potential at went you that is we actually look the detail both large vessel and could

recurrence minimum the data at a And of also we've though, should the reported and data seen that's the very reduce been in so that our that's part the with very in to that At ability this to protein Asia the form is and with rationale important stroke us we're today. important be something urinary looking further. very

Francois Brisebois

IgA here, then can just protein And you to DKD data, if on would in can what of see but we it's on then out, a on sneak biomarkers talked in important IgG Great. the through like it some obviously And I importance once read reads Okay. side? through for Nephropathy eGFR any read about here seeing what any couple the data here, that maybe more area, be and months X think there you'd about the data? IgA the side,

Rick Pauls

Yeah.

looking the at study of purpose as the is So approach. this basket a

the like kidney causes cohorts see, different cohorts? excited And in a significant I for mentioned, would think, is but and feel part the autoimmune that, I'm increase preclinical did type got will overall that also there again, that and some aspects IgA, the really to we've in be are Tregs see modifying. about a we as X of amongst differences thought also of we've attack. X animal potential of different kidney the halting So that work we to the model, we And DMXXX of improve conducted across rationale, function disease disease, you X our

are a other development that impact the help our potential from I the we today. could if that in think autoimmune compounds differentiator improve not but greater So kidney potentially drug a case, attack, function, to that's think, just the to and have greater for

Francois Brisebois

Okay, then on stroke guess. just XXXX, here one And study I the great. last in

interim that X seeing Thank we about into is necessarily here interim still goes understand, XXXX? read that talked can help on results the in here, can you is - there result us You've the what through you. blinded, without efficacy that

Rick Pauls

Sure.

and have approximately DSMB, outcomes. really XX% and have is the we'll So the interim will blinded, the there's have after we'll analysis, X patients DiaMedica potential sold an completed plan of up, remain

So X study is planned. as to continue to

opportunity if in the less effects, would it, to excellent effect increase excellent anticipated, the outcomes. data a the study. than the would little if with drug, in between as XX%, study X% study XX% anticipated, is are no there's the terminate And and for So improvement or if the coming than outcomes, coming X is less X size. the we powered we've absolute If the call we so have outcomes or data then

indication, think So drug in it should efficacy is give a as terms of, coming the good I us anticipated? in

Francois Brisebois

very you Thank much.

Rick Pauls

Thank you, Francois.

Operator

Flaten Your Lake next question comes from the line the of with Thomas Street Capital.

Thomas Flaten

want you to Hey, questions morning. just couple comment recurrence study. the a Good I about follow-up on made Rick, of a ago

an for are confirm, that after going study have primary in sense or that just of want endpoints mean you X success, to co-primary flows idea you endpoints. the mentioned You did discreet? co-primary to get I

Rick Pauls

So, be to we would want would dual endpoints. not have They independent.

would So be then if it on hit we either, a had significance success.

with and should we our with also So we to the experts could proceed it's very important understand, But At will is that to separate an this talking we not? minimum, and be that consultants want is of endpoint as the early. be study. some something secondary that something part this still or of are a this advisors,

Thomas Flaten

Have number in you just give those, mentioned And identifying terms sense the overall of of then are of of IND you the you you quantitatively or the identified activating I qualitatively, - assumption XX. or clearance, you however can sites? or think like? study just a where in at of you are all the with us where

Rick Pauls

Yeah.

our of already to identified XX are sites. CRO. fair already, Harry's So with also number the network sites planning with a both up We've and we

we're so sites been and getting squint here we summer. ready process And study to this this the start a while on running has working been and started back, now, those the up right something and that's so can that

Thomas Flaten

know you coming to you there cohorts that X anything from? terms slog study, total? are And year. be, on you're is where anything then those finally patients specific Can a or sites color give there I going going the been it's these to IgA and of us were kidney on start seeing that African patients, other disease new Is of you were the the determine how these Americans, some seeing the online? in bring where since where you're did in in

Rick Pauls

are these or the IgA, African DKD in In or primarily Sure. if specializing CKD have space, in sites a strong hypertensive group. either they American

we for recruit an so patients want we that beyond and study at qualifying respectively that engage that. the And would to database the can their site look they actually before screen do our have and they even analysis

their for can only clinics to about the to also to patient COVID, XXX%? sure specific clinic, very other demographics, but physically perspective are of the the feeling and the they that making not where from ensure they're we've screened? they to in recruit, bringing screen the of and patients accuracy been we've come be open addressed database So willing Are What's that of fact those the actually patients the located, population? needs their social the

Thomas Flaten

to up believe you Okay. the And just of year. the that out the end you then, sorry, follow read that. And earlier other X I want cohorts I said would on by

in August. patients to database implication, that to lock Is plus those X compilation, for give read months about have by and And July, yourself some so by time you the last would right, have et out in cetera? or

Rick Pauls

Correct.

Thomas Flaten

Okay. Thanks. got I taking it. appreciate the question.

Harry Alcorn

Thomas. thanks, Yeah,

Operator

Piros comes question the of with line Capital ROTH from Elemer Partners. next Your

Elemer Piros

hand, the shelf-life do DMXXX. what have please? morning, gentlemen. How drug the I you available and have just doses related is Good many on DMXXX for at study of of X the to question hand

Rick Pauls

study this today. amount is of required have is on we that drug hand the for So currently what double

X Obviously, a dating now, date right have rolling and we expiration additional on ample So our is drug amount goes on out basis, years. expiration hand. the of

Elemer Piros

Thank you.

Rick Pauls

having terms our another we manufacturing complete end from of to run in concerns no these studies. run while So

Elemer Piros

Okay. you very Thank much.

Operator

Your Maxim next McCarthy of from comes question Jason Group. the with line

Jason McCarthy

everyone. Thanks my Hey, for question. taking

plan approval respect And you clinical the is, do we U.S. question second for trial the When Phase X/X work expect my initial utilize an with potentially regulators? study? everything assuming So outside to can I'm readout? to data ex-U.S. expect goes with to the and stroke sites

Rick Pauls

Yeah, thank Jason. you,

currently planning rates. in in patient to our and estimating XX months interim recruitment terms site, the year upon looking sites. rate complete X of results as Based CRO with every X also study be at U.S. and get next to We're per running, we're in of recruitment So working then at XX the we'd XXXX, going we're in up looking the and be we are EU. XXXX. all in sites The into the expanding this this sites and

Jason McCarthy

additional the it. color. for I Thanks Great. appreciate

Rick Pauls

Thank you, Jason.

Operator

are over the at speakers to there back turn for questions further time. no this remarks. any And call At this closing I'll time, the

Rick Pauls

All these to joining you. Thank for everyone support. And this We morning. interest we'd your right, in continued challenging stay and like today. again, us call our concludes this Please safe times. thank your appreciate

Operator

participating. for you Thank

You may disconnect this at time.

DiaMedica Therapeutics (DMAC) 9 May 212021 Q1 Earnings call transcript