DMAC - Earnings call transcript Q4 2020 | DiaMedica Therapeutics Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics Fourth Quarter 2020 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 Relation 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 risks 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 including factors that cause actual results. Form forward-looking under the in the recent report regarding issued press DiaMedica's Note annual and yesterday heading from Statement statements company's in release most Cautionary XX-K. Risk Factors at DiaMedica's SEC www.sec.gov. and its website, www.sec.gov filings again, on available are any accurate note on made of transcript replay at of the that only may no rereading. today’s XXXX or March time XX, Please and speak longer as comments also call today, to be any forward-looking DiaMedica disclaims duty any its statements. update to

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

Rick Pauls

year that documents Officer, annual closed. issued and summary section website Thank with hope At you, XXXX filed welcome all update joined Medical Form at We Scott XXXX operator. a a the Investors our Financial business business Alcorn. Kellen financial well our the yesterday you're earnings diamedica.com. Chief call. be this of update press Officer, after morning, in like can markets and XX-K. our and and Relation release our Chief We I'm Good for results everyone. we'd of to to Harry our the on reports by found morning Dr. time, we also Both you

Ischemic our Let a me with begin Stroke program. Acute morning comments on few this

Ischemic pre-IND for of to X/X indicated by we patients. responses As for encouraged plan our key a request recall, were Stroke in you for meeting of DMXXX elements Their our Development the very acceptance questions. with responses Acute trial and Phase accepted Stroke our pleased written their are our program FDA

check. will which adaptive an an us interim of trial evaluate check proposed The allow DMXXX. conduct will performance we Specifically, design, to the interim

evaluate In we forward patient statistical adjustments the is with for our believe if will necessary. guidance received and program. DMXXX Specifically, a plan that FDA effect consistent short, provides analysis size committee for Stroke in path whether having the clear our is from the positive data assumptions monitoring an independent allow that a

this finalizing currently process, to to application to be for drug are to still application initiating In the with study supporting Stroke Acute enrollment Conference organize anticipate this Ischemic virtually proposed study of results the our taking Stroke International We be study are held this subject in at X XXth the the ReMEDy XXXX. We new the later steps The later Phase XXXX run of the summer. oral Phase the this being March and XXth parallel will presentation X/X we upcoming investigational on month. expect submitting our study. an vendors in

potentially stroke an of of who door label mechanism approval along webinar opening had Pennsylvania, were we expansion reducing They product. landscape - The as the current for like the to an of reoccurrence, for We announced, treatment expansion stroke. data approved patients for and for hosting as will generation stroke time. also for stroke. Opinion its blood XXth Acute approval on treating Leader a in at with presentations Stroke, will the reoccurrence University indication our of recurrent Brilinta, of view reducing on Stroke DMXXX thinner out for to latest an relates on received final reoccurrence. point another having University Bristol from rationale and with unmet Dr. doctors, DMXXX clinical March mild note, noon, to stroke we're feature related be pleased its Paolo need AstraZeneca Scott Madeddu the stroke Kasner One November Eastern Webinar that Ischemic Ischemic very I'd and the Program, on Key their of Stroke patients and in the Stroke treatment medical Acute with a AstraZeneca’s of XXXX, treatment discuss label in As in

statistically that These the fatal. observed more health one recoveries the recall and Stroke we patient If both to wide results study DMXXX quality the further be potential the in Phase tends group reserved We compared for stroke stroke in improve seven and in life the we DMXXX significant the disabling, we strokes. reoccurrence. seven signal and an And believe was of costly. improve our from with data, note - X ReMEDy victims. you recurrence physical reduce to reoccurrence were to DMXXX placebo. also believe reduction has in potential reduction of there for reoccurrence the was fatal and to severe placebo XX% were those a where This that

Let REDUX, of XX treatment participants for and trial a chronic three is target disease as studying a us X a XX a update study or of next causes in cohorts centers CKD. enrollment DMXXX you Phase XX different REDUX will with hypertensive on study of overall patients. kidney our CKD DMXXX approximately disease, The kidney Participants weeks albuminuria the are African efficacy Cohorts REDUX the Americans. include dose in in improvements for eGFR. XX at and Nephropathy, endpoint two and study IgA or for receive DKD, levels. diabetic primary three

criteria in cohort IgA evaluating matches enrollment to potential in in impact very includes to largely the in we're making pleased the DMXXX [ph] reached despite Overall, concerns the full REDUX DKD, recall that the XX enrollment was at the recruit Obviously, has DKD to cohort. for the cohort Secondary to of CKD. the cohort in to participants. XX Nephropathy XX% of enrolled due the each participant remains cohort. our XX enrollment enrollment see the American XX% our reached last positive in participants, DKD enrollment far causes participants, related population has the size underlying XX Also, in or is study. Enrollment the African including COVID. This of easier endpoints, this rapid for the the or it in participants This mid-December. DKD that and

top respect the XXXX. Nephropathy are IgA to With results that of significant COVID that preliminary to Americans, on ask African the has of report a much announce in We declines and from signs for at the anticipate in half Kellen through expected pace, continued can provide and pleased XXXX. XXXX. vaccines, we this I where than second Scott of of of the these we increased are track in we now cohorts line are of to we new still With enrollment slower now to cohort to second both seeing availability a very completion quarter cases, financial results us recently take like would activity. much

Scott Kellen

Thank you, Rick. Good morning, everyone.

full XX-K our and As results year financial Rick yesterday release we mentioned, filed XXXX our didn't afternoon.

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

Our million or net share. the net XXXX This per $X.XX the compares was of $XX.X full loss year. of prior for a for share loss or$X.XX year $XX.X to million per

ended research million development compares year Our for this the and an point to million XX, expenses increase were for and year $X.X $X.X $X.X of XXXX, XXXX, XX, the December December ended million.

a cohort, Phase by incurred CKD course third which Now our was during late the of fourth X initiated XXXX. the in patients, which addition driven in the combination REDUX of costs primarily the particular study, increase of to targeting XXXX, fully DKD enrolled the for due and quarter of

the in share-based decreases XXXX and study, the for to partially non-cash during XXXX. Stroke increased non-recurring first offset costs. costs and costs incurred study CKD related Phase costs clinical the wound compensation by ReMEDy half incurred completed study, Xb also And was of which a of down We these were which started

a decrease Additionally, drug was and manufacturing year-over-year there costs. net in development

professional This costs, XXXX, ended share-based general respectively. to the XX, compensation $X.X for million administrative years expenses Our December XXXX increased and were was instituted the increase and increased $X.X outside directors pandemic. non-cash as and and travel primarily due countermeasures to driven million $X.X services million increased reduced COVID-XX in the by partially restrictions officers’ liability increase was insurance. offset costs, by XXXX meeting and and And

compares of This of is XXXX. are the foreign ReMEDy Australian ended XXXX, to XXXX. net million half from the total Our XXXX, was this million work all the performed our recognized reduced during during which course the study transaction the research by by incentives This XX, primarily year of to for qualifying increased first by decrease offset during for wind gains the subsidiary related other partially down Government, income, currency $X.X and paid decrease December $X driven receivable XXXX. was for Australian R&D was this of

we $XX.X if million, million capital raising And as February an the our $X.X working to combined you are XXXX current we net and of of million, raising compares end public million August, underwritten Turning offerings proceeds proceeds marketable fourth to and of in the we $X securities of current million of balance the $XX.X. in an of in quarter sheet, or public to increases cash common securities, proceeds company’s the XXXX. XXXX equivalents of and our And offering, This of proceeds liabilities securities shares. capital marketable offering in and cash, finished of working in The working were million liabilities or $XX.X and February, in gross August recall, equivalents and $X.X marketable $X.X with completed net cash cash and million. due million. gross $X.X cash, was capital million $XX completed $X.X in

into should along of further all the Phase for our study position REDUX and Ischemic in the cohorts quarter with allow capital XXXX. for X our Stroke, three CKD significant DiaMedica, to our initiating complete number third a operations study, planned us readouts including current Phase data Our fund of X/X milestones of Acute

me turn let Rick. back to the Now call over

Rick Pauls

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

Operator

Sure.

from Your comes Nowak first Craig-Hallum. question from Alex

open. line Your is

Alex Nowak

to stroke study reoccurrence, that the frankly, indication. just pivotal in Maybe everyone. XXX Phase for that patients expansion that single Great. support there to recurrence? label an speak that get would you Good the from What being morning, stroke FDA? hearing do to label X/X how And, you’ve include alone the is on could would you powering anticipate enough work,

Rick Pauls

Alex. Thanks, Yeah.

request potential. we after plan to plan profile stroke do something the get our plan out a Phase believe our want to clinical a paths powering. that to So the based our of go the IND upon there we the that, this therapy is and reach for first. to with is know, recurrence truly the X/X, clarity We and for is FDA you discuss the surely FDA meeting filing real And

Alex Nowak

it. sense. That Got makes Okay.

got from later. submit will fast around labels? and maybe track decision like, the okay. you breakthrough would the the in did FDA plan feedback December, two from And from come to you that two - say sounds designation? they feedback for back those okay, or So those when what - maybe And It

Rick Pauls

look Yeah, so upon the our fast FDA, our pathways with our that designation. And plan approval. discussions other is shortly for we'll we filing track IND will for be after at then filing based expedited

Alex Nowak

all costs timing update patients? And would of long the the it. there about any in stroke US? any that And XXX pivotal discussion to on outside on for what the then been take? participants include has got stroke And how Just run study? partnering Okay, sort to

Rick Pauls

Yeah.

in million And for anticipating the to So be, planning a for the that XXXX. on study interim discussions And always the XX% in ongoing will overall. yeah, the partnering, XXXX, cost close - start year we're will discussions, - And finish right then right you we're halfway XXX upon in having to overall next now. patients. study what's of we're based $XX an planning patients study and know, about then terms That ideally of we're have The to now approximately XXX this happen to after powering, that through. summer. analysis powering

think disease much is and cohorts both a partner this getting chronic I better kidney that for Our point be position, after real though, in in globally. we'll focus, I a IND getting completed. time, looking Asia And filed, think in the

Alex Nowak

you cohorts release take am the sense. the reading forward my makes in press that's then in mentioned seeing to that you That intend even data, just Understood. before IgA do Nephropathy. drug the And I And IgA and seen correctly to the how before picked perhaps guess I results to correlate now, the you upcoming even three this of population? data. you’ve speak DKD syndication closely And should that why the

Rick Pauls

Yeah.

number a So compounds see IgA for clear Nephropathy, regulatory rare pivotal a other for There that different cohorts, look path these we for very at path studies we the the of form. clinical, into recent are moving Nephropathy. as are IgA

think us moving we is path So forward. the this clearest for

study overall partner just you know, today, And the into is, term, disease size and us we’re larger. then to [ph] for cost we off moving in CKD, that so – potential DMXXX the and pivotal kidney disease how of potential see for longer the running part the kidney start kidney for is And of the disease. diabetic comes a the to or much diabetic rare

path is, CKD we here a this So in you could population. having taking or DKD a and we patient for rationale longer to can how this term, clear it, see pathway see the the IgA, for overall again, then interest know, partner see the we for and

Alex Nowak

And to Okay, results just got DKD of then a it. IgA? correlation

Rick Pauls

ultimately, improve differences to of you the that modulating and, clarity purpose optimistic DMXXX see, between, to into effect. that think one the I DKD different Yeah, we the believe immune on mean, for IgA ultimately, all really, you know, amongst will feel know, And IgA that we I get kidney potential you study three I we to causes. the follow a we're and of there's function is the know, clarity is cohorts But again, plan think, data. after

Alex Nowak

Thank makes update. That sense. Appreciate you. the

Operator

from comes Guggenheim. question Etzer next from Darout Your

Your line is open.

Etzer Darout

taking Thanks for the questions.

Just stroke. the one first on

the on be if of any in call color know further mechanisms had X/X place Phase you study? allowed Just won't sorry, which on stroke to wanted or medications which beyond to

Rick Pauls

is developed on mechanical in they be allowed and protocol finalized thrombectomy. not which inclusion we've being or or being receive Sure. to be the The delineated criteria, will currently tPA exclusion tPA

that, patient individually. patient exclusions at Beyond as look population. this two will But we the for each that's point only

Etzer Darout

you. wondered, African cohort indications [ph] gets, and you UACR needed particular CDK therapies would you quickly disease kidney diabetic Got to clearly as populations same do indication? regulators CKD and new hypertensive in it. so Just IgA seems of And way Nephropathy, pretty sort by know, that then on trends eGFR know, of defined view [ph] Thank kidney, be decline the or that either improvements American with just the be the other

Rick Pauls

with agency improvement, eGFR Yes, Especially the kidney was they're respectively. that the UACR, to looking UACR correct. CKD a directly fact along last on X, weighed week in, there meeting in where regards as with just at for is that

Etzer Darout

you. Thank it. progress. Congrats Got on the

Rick Pauls

you. Thank

Operator

next Partners. from ROTH Your comes question from Elemer Capital Piros

is Your open. line

Elemer Piros

as Rick, would develop orphan would Yes. indications? therapeutic as If you What it indication. pursue I'd for an subsequently, kidney who other pricing a outlined that ask the how Good Nephropathy in there to is different differential is, then gentlemen. would tackle you morning, like indications, you IgA partner potential the

Rick Pauls

Yeah, a so great that's so – question.

we to and us So [ph] consulting that company you co-position can how disease, the for to question bottom line, recently and first answer and engaged is the stroke this have know, help we the see we kidney a actually feedback DMXXX both setting, a kidney the in prescribed they'll prescribers the have that different distinct rare will numbers, was done will whereas be we stroke nephrologist. the feel disease particularly from NDC be those product will products, perspective, be from and a hospital a

partner that So, And, move to that for find and commercialize forward. partner right We and as data here for can But we ideally, ultimately, we right one ourselves now the feel don't both indications our partner. manage. the Right know, ourselves. much this again, positioning could find we you partner can to focuses, as then do indications. intentions both have getting

Elemer Piros

new what question to Conference? And Stroke data anticipate week's be, do next would at release the next you

Rick Pauls

coming, be until event. we'll that data new could have There potential that is but hold-off some to

March it you great if join on call be XXth. another in So

Elemer Piros

much. very you thank Okay,

Rick Pauls

Thanks, Elemer.

Operator

Lake question from Thomas next from comes Capital Street Your Markets. Flaten

line open. is Your

Thomas Flaten

for Thanks taking guys. Hey, questions. the

couple Is our of the Just part ups exclusion criteria? occlusion vessel follow on a large stroke. still

Rick Pauls

Large mechanical vessel will which exclude automatically occlusions thrombectomy. excluded, will be

Thomas Flaten

And then Yeah. on the back going sub-study Stroke to just Recurrence.

an in amendment? you're that potential then potentially protocol, Would would if mechanics enrollment to that obviously, a as a the of a how help sub-study? just you part integrate lead So through require pause? think of Can going the you to work? re how the would Would know, IND, that me you slowdown submit or

Rick Pauls

Yeah.

And at Recurrence filing potential the the key discussions, of Stroke - slow get be clarity study. for we sub-group not then the upon aspects do don't a this we and But we look from those we'll the anticipate endpoint. after we'll any based a application as FDA, So with down secondary will study.

Harry Alcorn

Or pause it.

Rick Pauls

yeah. pause, Or

Thomas Flaten

as was And you we Great. know, you slowdown of Okay. then the I a Stroke for and CKD it, the Got year? with course should bit the there of think guess, over spending enrollment pickup Scott, the know, study, the one about a how then start on pacing, you the,

Scott Kellen

obviously. chunky, a little, that I Well, guess,

REDUX, the offset of enrollment wrap as decline little by in that's the the up study. on spending So will bit, start we course, a up in Stroke the

mid-year So end the year, as then of see and towards ramp activations site slowdown back the probably a a you commence. up the

Thomas Flaten

Excellent. Thanks, guys taking the questions.

Rick Pauls

Thank you.

Operator

question further like time. Mr. no the to I is this over turn There to back call Pauls.

Rick Pauls

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

DiaMedica Therapeutics (DMAC) 11 Mar 212020 Q4 Earnings call transcript