IKT - Earnings call 3 2023 | Inhibikase Therapeutics, Inc.

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Operator

Hello, and welcome to the Inhibikase Therapeutics Third Quarter 2023 Financial Results. [Operator Instructions] Please note today's event is being recorded. I'll now turn the conference over to Alexander Lobo of Stern Investor Relations. Please go ahead, sir.

Alex Lobo

Thank you, operator. to and Third Audio welcome Results XXXX and Call Conference Webcast. morning, Inhibikase Quarter Therapeutics Financial Good With me today is Dr. Milton Joseph Werner, Frattaroli, and Chief Financial Chief Officer. Executive Officer; a results On release ended Inhibikase XX, Tuesday, XXXX. issued November September XX, announcing the for financial third quarter XXXX press report with everyone quarterly the read SEC. as to which XX-Q, encourage press release Form We well has as yesterday's Inhibikase's on been filed

on press The quarterly Inhibikase's available website and also at release company's are inhibikase.com. report

Investor call for under contains is on of being note In Relations addition, the of XX, will there section XXXX. is the safe this company's Litigation harbor that through Act archived that this future November and Securities time-sensitive website covered conference today's provisions the call live discussed the is webcast Please broadcast, of certain call be Reform information information reference. only accurate date the are that XXXX. of as of Private Participants conference cautioned this

With over statements the may you said, to webcast, turn date law. Milton of or I by except required by stated to to no and uncertainties The revise Actual results this Dr. would like the the public risks with Information potential could forth call as implied associated on any uncertainties that or circumstances Werner. risks undertakes company's update sec.gov. forward-looking differ begin. statements those SEC filings business. securities with are applicable live events now company materially or reflect to after and at obligation the due our to these recent most in from may set Milton forward-looking be

Milton Werner

you, thank and for everyone, Alex, today. joining you, us Thank

remaining lead pipeline disease. clinical actively quarter advanced the and made pleased and our II Parkinson's very enrolling are the clinic, screening continuing candidate, third progress preclinical activating we've The the we risvodetinib in have trial Phase the XXX in and In are our patients evaluate with trial we as sites. to clinical We throughout programs. the is

In briefing in complete, study IkT-XXXPRo submitting the regulatory to meeting for approval XXX(b)(X) now addition, bioequivalent in on the under is we of documents FDA and a our of align the for requirements are process support XXX the pathway. with

efforts receive and c-Abl nervous Our delivery internal brain FDA and the the we system. These and areas, in disease second-generation second-generation U.S. external from c-Abl announce emerge of multiple system designation a improve evaluation excited also that are to medicinal inhibitors chemistry or central for risvodetinib orphan programs be alone for potentially molecules progressing, combination in to are from to In treatment collaborations. deployed the orphan inhibition we atrophy. are the drug pleased as may

the We believe discussing in potential treatments are of conduct our Phase Collectively, transformative towards trial federal trial effort and patients. with industry planned to continue foundations to demonstrate an that initiate and programs for of study this initiation these accomplishments II private of the in the deliver of stakeholders we to working future. the

XXX into us take dive Let a each trial. programs, deep our starting our with of now

reminder, XX-week is the X group. across plus a a study As doses trial placebo XX double-blinded the

are clinical participants trial are participants X say active screening screening to XX our the sites and and undergoing with closely working been XX evaluations enrollment enrolled, informed prospective pleased currently have we into and participants XX We potential consents. accelerate have that to undergoing

participants XX-week full at XX correct prospective X as potential have that. the completed regimen undergoing and participants announced actually yesterday. the press X date. to release me Let consent That's we

exposure exposure study oral disease. used initiate subject additional of to As tablet XXXX. use we designed XXX The overcome participants challenges related extension lower doubles also improve tablet same we validated to mimics and risvodetinib, tolerability XX dose -- This to of study formulation treatment. which for drug the a enroll in animal financing. The for existing evaluate we roll XX-month our additional months tablet in which at safety overall patient models implemented, August will drug announced extension of working could state to to risvodetinib, formulation Parkinson's trial, steady into and that we may allow the evaluate trial formulation XXX doses to are the extension trial, of the The completed will allow a improvement an for the which nearly risvodetinib. continue is of study efficacy novel and lead and into novel who participants for to study have an once

trial, due recently with In to previously work untreated fourth in the in XXXX. addition, functional hold disease trial the from we by are in XXX unblinded data public ongoing our ongoing from who clinical work FDA addition temporary the the Parkinson's to presented imposed the XX patients of quarter the -- XXX removed ill

milligrams, at Movement Of These XXXX. XX participants X XX August results at were Congress given the presented X were placebo. milligrams X XXX the drug; and X XXX at enrolled, Copenhagen were in and at Disorder in active on patients milligrams X

function functional plus and study in average minus time these dose study the treated these score XX XX.X that Part placebo functions score. by XXX-milligram patients, This hierarchical nonmotor of At lower contrast, average spread The a score versus a points. changes as of activities an the such minus secondary evaluated the using X of living X.X X readout point, evaluated of Part was had For nonmotor Part we a X top hierarchy. point the the By scores score actively points. In features using by the functional sum who endpoints. placebo in of X Part participants the between daily the combined and X X.X motor evaluated represents assessments of an participants. using MDS-UPDRS analysis and combined end was of received increased the particular, MDS-UPDRS motor the

an Thus, comparison, a a lower clinical X months. point a to be XX negative score plus score X indication the increase For patients of course sum plus in of typically benefit. or relative have of Parkinson's to placebo might over assessment the

sample However, at dosing the at time. from us each drawing group conclusion precludes this size the present small

X.X XXX-milligram score of minus what minus scale, nonmotor respectively, An experienced the of point participants effect Life of relative minus plus Patients the points X.X Schwab or relative scale, is average and called an of XXX-milligram average average Activities features spread was disease X of England X.X of an for points, is The score. utilized and administered while minus the X.X dose the plus was as the XX S&E no on the average measure, measure for this additional reduced combined between Daily That term placebo lower XXX actively X.X change an baseline, and milligrams for XX-milligram a by placebos. points group we on baseline. those showed to had points. increase dose to treated it, while

the results view XXX set has the with roll to few While participants data trial. optimism ongoing conclude these as continue we patients to benefit, to clinical cautious we a in

be XXX-milligram demonstrated while IkT-XXXPro that developed to to of dose XXX-milligram IkT-XXXPro standard Turning We the imatinib improve IkT-XXXPrO met study imatinib for mesylate. the of imatinib. recently now a mesylate expectations bioequivalent safety to care XXX studies completed program, has XXX-milligram mesylate, formulation The to compared mesylate or and imatinib should IkT-XXXPRo of XXX-milligram mesylate. been equivalent equivalent that the our XXX-milligram imatinib dose to was the prodrug XXX-milligram our of imatinib evaluating

profile subjects intolerability the across safety favorable a with trial. in minimal demonstrated adverse XX events IkT-XXXPro

are to under particulars documents agreement We for to briefing come on approval to IkT-XXXPro currently statute. XXX(b)(X) submitting the FDA of the the

preclinical on I Before our to our the discuss activities. over financials, call I briefly want turn to touch to Joe

developments. improved scientists, we c-Abl arising believe In As the emergence or that activation and excited of we c-Abl from approach ] risvodetinib programs with are acting suppression of we whether could into August, announced the of that inhibition. like medicinal brain. learnings chemistry active always could second-generation through be several neurodegeneration enhance from leveraging new [ work We believe collaborations to of neurodegeneration by external suppressed the new inside molecules, inhibitors molecules prospect such and our internal from combination outside c-Abl in alone an

allow that market. our of exists financial designation people. will quarter. at call work review our This encouraging financial in to the is turn unmet our the drug officer Food of development I'll Drug of Orphan for drugs Joe? see chief us are of advance fewer to MSA In Joseph diagnosis high devastating used biologics system greater risvodetinib from provided that prevention, we treatment were in for receive U.S. advance In drug to designation are to continuing and to these than to or Frattaroli FDA October, early-stage multiple the results Administration. the the to XXX,XXX or need to the addition MSA is efforts, treatment of and that in designation our over speed orphan and now pleased the preclinical affect we atrophy. diseases acknowledge nature

Joseph Frattaroli

Thank you Milton.

X a net loss $X.XX the review XX, XXXX the or me September report quarter Now ended a September loss approximately million to $X.X compared third let ended for share million per results share $X.XX of net or XX, months our for of we per quarter $X.XX financial XXXX, for XXXX.

was for increase expenses ended normal in September quarter company's XX, expenses driven This million were Parkinson's ended September XXX $X.XX compared disease. a selling, quarter general due and expenses. Phase XXXX. and was general XX, to ended ongoing development administrative September to increase Research million primarily were quarter compared in the to quarter ended the XXXX million million This XXXX. XXXX, $X.XX the for $X.X and increase trial net $X.XX the by for XX, September for XX, Selling, administrative XII

had equivalents in of we September XX, securities. marketable As cash cash, approximately million XXXX, $XX.XX and

will our operations hand back financial the like closing equivalents I'd and remarks. We review of cash to statements. of our marketable fourth quarter be expect securities concludes fund That XXXX. cash, call that the sufficient over existing to to for financial Milton into

Milton Werner

with Parkinson's Joe. disorders. provide you, the We that and potential believe efficacious have to programs patients for safe Parkinson's treatment our Thank options and related

that a recognized for in focus the neurodegeneration community, be will in continues Parkinson's. believe continue potentially the treatment of scientific potential on disease-modifying As inhibition c-Abl the of to we to too as come to risvodetinib value

for our our to the call diseases. we partners demonstrate the updates now with like investor We Inhibikase. for look we partners call importance paradigm I and would pipeline our open neurodegenetive work Operator? the and thank to like I forward shareholders their across to order Before questions. our diligently of in transform scientific to communities, in questions, treatment to open we providing studies to shareholders and dedication with as to and support the to the continued and progress would research all

Operator

from will At with session. comes [Operator we And the this first question White Ed H.C. time, begin Instructions] Wainwright. the question-and-answer

Edward White

XXX to patients go First, for to little from Phase wanted Milton, information II consent bit trial. typical dosing? the What I on time informed the a get more just to is

Milton Werner

one screening come the than informed in typically location safety measures That more disease-related cases, because safety measures, same facility cardiovascular requiring laboratory separate in then ECG assessments. consents involved. for separate varies and authorization of widely Committee to function and for following a site They'll a baseline Parkinson's visits go and by screening followed appointment. enrollment measures They visits are there's some the in or the at

The ensure could normal be that more they're they'll protocol. back a we've criteria authorization to they parameters suitable questions. committee enrollment exams typically the takes person by X their for then X the the to go they authorization in thereafter. have days whether have meet decision and on within enrollment forth that ophthalmology unless or the If committee, defined accepted for to there baseline If vision is for they last days for come questions,

So X number, collectively, and best I'm take and guesstimate. it X that the it's can it how order. that's something but between probably that in weeks, but my depends organized, on exaggerating site

Edward White

you Thanks plan just on Milton. opening? And sites how do many Okay. more

Milton Werner

we'll Q, to from practice dissolved medical down site clinical are staff as their the time, We for activities, have talking to wind in sites. plans research There our have we've and don't those long disclosed X get continue practice that research sites breaking the now and practices X that clinical we the last will XX are a in their been to that off we had XX. about month, have

XX. on plan we now, right So

We that satisfy trial program XXX are timely with manner. patient coupled sites our are coming up the enrollment sites, that large have several I think needs potential that in trial from outreach will a

Edward White

little a more on multiple potential system atrophy the just And Okay. information bit trial.

should how You trial. about be that Is I'm -- just you as XXXX curious funding, thinking be to a event? to to start going we provided said that the get

Milton Werner

to is preliminary increase in We the in set the -- increasing yes, it's because draw small pulled assessments those still in pushing Xx patients XXXX disease saw going a MSA it's the trial us. in of at money faster strong And to encouraging, which aspirational rate be it's to will a the that, with from these But a we are you it's is mild future. hard range -- mode, benefits. decline the implemented was XXXX. until conclusion. measurement and extension than bigger XX many indications, a with patients moment have MSA that although anti-Parkinsonian data amplify because benefit over the encouraging outcomes just hopefully, near to be at opportunity who really bigger the patients able potential is offers you're be bank. important. the to from as MSA the dose, Because a dynamic too -- are study or range And across saw to we to see that planned indications but you you data The and The Parkinson's planned

indication, to calibrate XX,XXX the little U.S. and it's is between people to number people patients. It's XX,XXX registry and an patients, U.S. hard somewhere a XX,XXX orphan a large of today, of worldwide, it XX,XXX the although in perhaps there's

think trial medications preexisting about since very feasible. MSA anti-Parkinson's so to we don't the respond have don't And Unlike to worry meds. is Parkinson's, patients we

they that biomarker have that means a in benefit. faster faster validated validated are analyses MSA the Parkinson's a and are progression potential the in of We rate not in imaging of readout and yet way

started interest both a we're that aspirational trial extension is They'll level protocol I in of some an We in additional get run manner. with and trial provided X foundation The will in for months we federal NINDS think well as a updated there's level, working take but with lot through the as be those plan in to planned the at discussions. registrational primary X-month that and the time, this XXXX. am will that

Edward White

Can XXXPro. potential a on any just comments question And make partner on Okay. you interest?

Milton Werner

of GIST attractive, CML areas in diagnosed. seeking application there But drug X a we're stromal label hypertension. could indications may in imatinib imatinib, and be the intolerance where from and attractive, where just initially additional are be that community, to very to there gastrointestinal safety that's improved CML Well, or the also pulmonary newly very the an certainly, and arterial XXXPro for is although of

not in about any have potential We imatinib. spoken hypertension current medication the players in pulmonary the with interest this of arterial and

it arterial rejected pursued from for of of Phase not because the years further the doses at factors. by III by is you those but move acronym recall, away may number XXXPro As a safety risk ago, concerns Novartis program imatinib which Novartis the offers for was and FDA a hypertension, was from pulmonary used in PAH,

an And further potential be it's application that explored. interesting so can

And areas next going large to the both we approvals. and that. data more something Now companies we're package, small around XXX(b)(X) be that work a complete we'll say to have after have partners, specialty in that of part about hopefully, going early in year,

Edward White

said include into the the that the or quarter One, Does 'XX. And had that you of Great. the more if have for preparation could initiation you fourth ask X MSA I trial? questions. just financial perhaps cash

Milton Werner

not Well, is MSA funded program. the currently in

go that. to Joe, and So ahead speak

Joseph Frattaroli

but There's budgeted normal capital additional within of raise expenses or working not initiation trial, nondilutive funding study the the really sources? MSA an pending

Edward White

And just then last Okay. the question.

onetime You we in last quarter? -- was anything just but be there's excuse mentioned the about down from And XX% nature that year, down from the wondering fourth how we if spending me, saw R&D quarter-over-quarter. in should I quarter? was up thinking

Joseph Frattaroli

-- costs started, enrollment. To costs cost many of great rate are of will incurred. the there that upon Yes, the variable were some question. get nonrecurring the of be Most depending trial are

to a to we enrollment that through But month-to-month rate $X.X the of about of -- So quarter-to-quarter. year, subject and recruitment. $X.X an average rate again, expect will to actual of next million month, fluctuate the million burn rate have of a

Operator

question-and-answer Thank you. call session And you itself. the concludes for today's the attending well as as Thank presentation. this

You lines. now may disconnect your

Inhibikase Therapeutics (IKT) 15 Nov 232023 Q3 Earnings call transcript