IKT - Earnings call transcript Q2 2024 | Inhibikase Therapeutics, Inc.

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Operator

Greetings, and welcome to the Inhibikase Therapeutics Second Quarter 2024 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Alex Lobo, Precision AQ - Investor Relations. Thank you, sir.

begin. may You

Alexander Lobo

Lees-Rolfe. welcome Results and today Therapeutics' Quarter and Second Dr. Good Call to and Financial Garth Officer; Executive Conference Werner, me Financial Audio XXXX Officer. Milton morning, Chief Inhibikase Chief Webcast. is With

a XX, the XXXX. on financial XX, results release August The well report website with everyone encourage been XX-Q, to second On which are XX-Q at on press press ended as release quarterly inhibikase.com. the as quarter announcing press company's release Form has issued Inhibikase Form SEC. June We for read available yesterday's filed Inhibikase and also Inhibikase's

In addition, Relations and Investor company's this the website call conference will be webcast for through of there the being section archived is reference. future

of information safe and risks forward-looking be required date today's Milton implied statements The to begin. under securities information events or applicable turn August may contains Securities on Dr. to our covered the SEC only over potential circumstances revise that after this by accurate or are by call any update you risks Werner. XXXX. Private live to as the date that statements could the company may these to call certain on except or are public harbor would stated Actual at of and broadcast, undertakes Reform reflect that the XXXX. Information forward-looking said, is XX, of law. With with the Milton, Act I due like the filings business. materially webcast, set forth in sec.gov. uncertainties recent those the company's most Litigation with of time-sensitive is associated results to cautioned as Participants call differ note from Please uncertainties conference provisions this of this that no obligation

Milton Werner

our strength very the XXXX accomplishment an top achievements. We Trial very in Alex. and to executed regulatory for results is business with risvo November. Parkinson's on XXXX. effort key or quarter underscored a second a disease, bring XXX line marked speed of has we the We've successful and by often for as risvodetinib you, today first expect been the has recent been Phase updates. review suffering enrollment many progress joining pleased everybody, Parkinson's through our clinical II clinical exciting data clinical risvo and disease, us half to referred what for tirelessly you, of completed trial we've working quarter The that untreated from to to significant financial which Thank Thank recently and milestones at in towards in the of report to patients which been we from milestone our

derisking Phase patients PAH the over or that a has the had as engagement XXXPro PAH, modifying Pro the past development further to imatinib and for with we in few IND been previously pulmonary and practicable. IIb months opportunity demonstrate PAH PAH. U.S. to as We the IkT-XXXPro's study productive technology. plan open that has a regarding the filed and arterial we've treatment with hypertension our using of novel efficacious for to safe ingredient active shown Additionally, FDA prodrug disease clinical soon potential believe be

we period. expect Let catalyst-rich programs a me XXXX each deeper these half a into take of of be dive as back will the

selective or administered slow inhibitor that once start c-Abl we first may halt that Parkinson's Risvo daily believe is is with disease. the of progression me Let risvodetinib. potent a

placebo, X Trial doses XX-week double-blinded XXX enrollment plus study completed. X-phased with across a was trial has which for been a Our

may people As of treatment. XX related the be been We've weeks adverse of XX, dosing. have July X risvo moderate had completing trial mild XX events and from that withdraw X without to observed

Parkinson's untreated the expect safety top risvo report disease in year. to this we evaluating results line tolerability of ahead, November Looking in and of

Following III year's Phase as launch by plans intend end completion double-blinded discuss a for to to of anticipate XX-week our FDA soon study we and possible. as the period, with XX-month meeting the open-label extension

formulation to tolerability our profile that potentially IkT-XXXPro, has imatinib to safety of and designed the been prodrug improve mesylate of now Moving imatinib.

opportunity may mutations, that value to with make by address We symptoms profile disqualified and market global in can worldwide. the at disorder that of to confirmed later through and which the on of We disease, side-effect final the meeting open we than arterial congenital approval be progressive in reported We more is billion Pro design significant from in in this effect the is Phase meeting, believe proposed this and a the for heart the manufacturing with development connected viewed and similar to disease include continue minutes been late-stage with tremendous agency. PAH the clinical attempt meeting strides from to with potency for sotatercept the clinical NDA discussions rare that a requirements. microvasculature. studies the XXXPro imatinib of year. genetic the insults side disease on trial also appears efforts of following IIb at our pre-IND believe PAH the provided ago. FDA that by be we right be of active drugs to possible. for will of January, alignment the of has Most time dosage development pulmonary pulmonary new We molecular caused to August FDA tablets has recent advancement the achieve the tissue forms Activities PAH the or in PAH to that as the alignment on arise Subject infection HIV could Further treatments in Pro for IND potential see highlights we that XX modification have Imatinib, differentiate annually our mesylate the the spontaneously to the PAH, our generic hypertension heart. ongoing is filed XXXX. Based the batch without our X to we scaled pre-IND modifying to imatinib XXXPro already ingredient constructive our associated and appropriate discussions at with Pro the in feedback. that side approval FDA. has for or a disease, pre-NDA observed $X.X approval. process years prodrug affect support path that PAH new profile received imatinib receive receipt the May [indiscernible]. for environmental have entity advice study, FDA, approval our other disease But from mesylate toxins. and meeting letter FDA shown development development precluded with can

Finally, risvo or MSA. system turning multiple to atrophy

from the We National forward are Stroke grant clinical on Institute and a new this further NINDS. Neurological Diseases providing funding currently look funding of exploring alternative financing program and opportunities, updates of appropriate. and We forward advancing including neuroscience mechanism program development or potential to as the through

also review Parkinson's Separately, are that and both potentially by further and engagement grant new pursued the will clinical disease efforts enable X disease differentiate we through efforts company's diagnostic analysis being we are developing of applications that under of in Both antibody the are NINDS. biomarker tools these believe target modification. and

review financial call the to Garth? over to now the quarter. Lees-Rolfe, for like results Officer, turn to Chief our I'd Garth Financial our

Garth Lees-Rolfe

both of Thank as capital good neurodegenerative high-value you, At disease. we in cardiopulmonary we Inhibikase, committed programs advance and Milton. remain to stewards multiple being

into are from line year, data runway placement. inflection our raising extend bolster we cash top in May, proceeds funds our and Parkinson's aggregate and sufficient Trial points see As sheet this $X through our disease. private multiple to registered direct in approach are we These December in to offering pleased us XXX million balance for gross our concurrent XXXX

expenses a for loss to quarter quarter the of share same due $X.X $X.XX for June general June the D&O for for to period same million increase was to highlights of XX, net driven million XXXX. Research XXXX, $X.X and a offset fees, million completion the due XX, and the compared quarter XXXX. development decrease was decrease dose million And and XXXX compared normal in in Net expenses. $X.XX review was million XX, of compared Now our per in decrease ended a by all decrease million to and the $X.X general XX, of in for in IkT-XXXPro I'd like financial June XX, XXXX, the ended and the per $X.X to to $X.X a or administrative three-part million quarter expenses XXXX. take development finding/dose in results a for loss for other quarter XXXX, period research by $X.X legal expenses to a the ended partially net decrease $X.X the million $X.X moment expenses. Selling, in share million million or $X.X the million other development ended $X.X were $X.X insurance equivalence from consulting million increase ended study the June net were in and expenses million and primarily selling, administrative research $X.X in XXXX $X.X June

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

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

Milton Werner

Thank you, Garth.

in will the proud multiple seen We sites have expect by hard across support continued work we momentum of the of we We're trial shareholders. the appreciate investigators accelerate clinical back our the first year from the put half. have the half we dedicated and through that our receive we

of We PAH top pipeline achieve, ]. the disease like data the opening will risvo expect XXX call assets I'd from for open of [ IkT-XXXPro that and to and clinical line now further cardiopulmonary have in our milestones questions. to including exciting differentiate neurological near-term development Parkinson's our multiple Operator? of of to we anticipate Trial

Operator

question Jason Group. first Our with Instructions] McCarthy [Operator from the comes Maxim

Jason Mccarthy

risvo they June, weeks, you there Is people XX-month completed coming that XX enrollment, And to far opt study option is the for and that the between in to And might Phase move patients the the time? you November. back in mentioned starting OLE. update the the OLE? when as the had be up last around trial this As data had in the lag treatment completed when have obviously, during II there they potential to going time symptomatic complete is XX some

Milton Werner

Ethics ongoing have We've weeks And XX is that XX in are last currently of I who still ago. [ [ been exit in all financial steps. preparative as done the on completed answer all of some are occurring. Review [ it's X the get the a have trial. completed steps We've been when Well, while couple I September constraints, ] start medication. mostly I we've trying to think force, already the worked And will I believe so patient Board that's have now, oldest been as the now of it's be formally as out full trial will we launched leaves the had We've thinking who study people months running we the our as those believe the because the current regulatory months but long the had people treatment OLE trial XX late ] and in person an work. that total OLE the trial. hope well ]. completed coming exited in

a impact has the of of symptomatic it of have to tracking risvodetinib who people may whom weeks patients, on number yes, potential the progression that. so, XX are and because we following of treatment meds, their some who of done on go disease And

has conclusions hear It small that's so we'll anecdotally anticipate any draw be the XX-month the make them The at it's this launching But drug full don't that the good we month just sign. extremely the what and did far, from of positive a means study necessarily commentary been sites group. lines force. on we mean doesn't been kind about So sites anything. with patient with anecdotal a all from communicating the drug badly, the time experience that feel of for we least

trial these the be database. develop some people extension the studies Jason, meds, of symptomatic to actually are collect begin And there know, safety to on in most of may a and you as

gone to in trial. at can, last wanted meds the also on at about so much the weeks symptomatic absence as our of few very least in And X.X ago, people we we given the in point we symptomatic number medicines measurement have have view, people of had measurement the

which there's the nonetheless, the addition we're we'll the no some have therapy benefit or any of And this will risvodetinib of most see thing effect meds launches have now have we itself. But another additional time that symptomatic gleaned might be whether of tolerate well. can't And to in on what one it if on should not thinking, us frame group. able because symptomatic control be medications learn benefit get people people started symptomatic and who there's so the way help who if

could be informative. it So ultimately

Jason Mccarthy

the that months Is Phase out targeting XX to program, of avoidance treatments. so And And looking goal? think months when symptomatic be studies? would III you about you use to entail beyond would to go two X the that XX of

Milton Werner

Right.

So Parkinson's us modifying evaluating our Parkinson's is and -- all in we is a That's so it untreated We're we although modifying, not untreated even evaluating disease not ]. risvodetinib that disease about. [ disease Parkinson's we're patients. and the disease monotherapy data disease is of animal of that preclinical proven disease, believe though informs subgroup because yet have model what

studies, We other alter There's of are, many patients the patient any spectacular. a just want for symptomatic We've So the a were of in disease. without GLP-X-related think too no a They risvodetinib exceptions. trial. a of patient to early that was Phase absence to run we'll virtually the of other anything that disease earlier, just recruiting evaluate trials. There year therapy there. dysfunction confounding tools in X of population, or need that be often out The for possible such that the XX year, disease was therapy. developed components in studies intended happens XXX medications that Parkinson's don't miracle Historically, reported of patients trial this but one last must so from some view, seemed course we it will that do molecule market exception slow pair months. with even people rare pair be were guess Phase have to in that -- to with have else, don't will or have our not on part It's to be trouble dosed recruitment opportunity. will III would up you because in people rough large a any failed symptomatic the unless has in every been for space, III and motor

trial. at of our be significant be XX-month in case, enrolling same to going we're time dosing There'll be that and a running X global. will people So they'll the be number trials

Jason Mccarthy

IIb us for Or had scope details on of the And PAH. forthcoming it. alignment you said the Got you that Can near you provide with and study? is on FDA any Phase size still? that

Milton Werner

probably to rough No, you give a okay I idea. it's think just

more end. Phase do to derisking trial sense in an trial the require in back But So looking as trial, imagine at have all patient real first. makes ] with that confirm individual appropriate unmet we through the the people the patients [ run could initially that a it safety the this to really could need where could tasks that actually But doses the enrollment visibility medical degree and we have trial the initial run-in have. a the and have properly enrolled so would process, that we at we're a right we and a thought in prodrug of III have carefully

in So X Phase patients formally placebo-controlled. of people the to and which that's a we when at the dosing. duration. going placebo, do a half IIb. do XXX a measurement the or safety and a weeks enrolled been of when the to is completed XX-week have And roughly review It's half we'll then do futility least weeks, We're XX XX-week patients analysis doses XX have completed length plan

in tolerability safety depending could the approval approval to unfortunate that efficacy overall at that safety we'll basis, at and that really Phase for seek et if to that view a from it's that years and XX into that fresh was to So and itself cetera. ago. sure profile imatinib imatinib conditional safety, change we of on the combined cannot is will III point, on the very see be to the prodrug support If the designed -- a going the to be proven approach we disqualified itself basis profile potential a be a that with benefit disease. And sought adequate rare overcome a look to profile observe, has able safety that with trial be make previously imatinib, side carefully and on fresh principle approval effect

IND has So been filed. the

has been forward trial that this course, again. this Of a their terms design already and of FDA, by reviewed bringing of and the a drug part concerns was in designing trial

going by to Naturally, We've prodrug cancer already one that Cancer in in the was And the of It had course, confident is IND has so Division. -- reviewed of in pre-NDA pretty been the Cancer clear. people. discussions divisions. we're

So little issues -- it the arise by in would unlikely forward. go about that Cardiology Division letting there be seems study that review there's any the the

Operator

from with next comes Wainwright. Ed White Our H.C. question

Edward White

what get from XXX see just little get to you're to can that more is the clarify November a clarification the So wanted III? of trials, trial going to to patients thinking Milton, to line Phase do Phase bit you're want on Or XXX both proceed the that for risvo. just in XXX per and data top III the each? then you for you so patients it

Milton Werner

somewhere our but XXX size We between need needs the in the shoot see trials for XXX and for That ultimately still with cover -- my to believe that because data your off November trial. at both XXX question Well, unblinded head at -- the viewable cover taking believe size, current finalize of we design. should effect to we'll both the in between the let's thinking. refining to least on effect top between we're first. trial and the just this I XXX depends It's trials. about XXX deal It's second patients

disability trial the might would was very on November, we people be significant were we meetings in of weeks to our Parkinson's allow we're We nonmotor that's to would XXs try disease. roughly to the visibility excuse design sure very have what presented see across in the who very scores our the the very hard disease show primary features taken one substantial the substantial -- scores of baseline in the a of X or that have to effect one disease in the measures, XXs, were people. previously by XXX including of same type -- thought Part disease measured impact make of that who symptomatic a mid level endpoints of population group the measures treatment have worked see not established, with that adequate set that of same on a of weeks using at and variety no whether to originally expect disease. is motor have would that have be secondary substantial. the treatment XX Trial could of of gastrointestinal terms enrolled XX We've when see very Part in us by disability, Parkinson's of assessments, a any In organs patient's related the fairly to uniform the a most me, of tract, medications, of Xs mid-XXs. the and were UPDRS course

have very in what has we As we've the as evolved, the patients data see encouraged remained been like. measurements

data. feel that's could just know encouraged which us what course, coming. made a Of have with blinded further be don't by measurements We've what that hypothetical means. done stuff. the Again, We same biomarker it's

giving But on nervous itself it's see Phase or the coupled very biomarker to protein effect with until don't go XX think, into inside robust the us seeing only what potential more across of studies. the without that though an studies a through you're weeks, combination has underlying seeing know trends our You to pathology the of unblinded. directly very of going of even system, give robust us assessments support further outside support III potential it I and central will it's one

across months the of getting in time couple The open-label aspects functional the to because more of in XX hope fully extension U.S. launched be thing the study, which we whole of fully sites perhaps a

compared and the safety tablet different public dosage ago, this the delivery XXX we continue doses remain better we now to [ important our Trial. experience gain at an profile will save We a using form, patient current about profile made aspect ] year of to as a tolerability which which has using

the with we'll could be hoping so and that roughly our next do sometime those the fourth a of latter next year, fast X opportunity. well It's large just quarter that's for launch, which assumption be that would you development ground from of years just pretty trials program meeting market III, the that half very And other year, Phase by a between FDA positioned very speaking, the and zero. something efforts in hypothetically

seeing even continued encouraged see it's as all the expect impact and trial we'll surprising in very might is in at with also I think to risvodetinib which XX anything that smoothness indication seeing in good if overall. we patient small, but impact a by show a safety what profile, the XX-week having for that still, has November, disease we're just one the be study, and would an on dosing learn we're weeks reflects emerging tolerability whether that

Edward White

then could locating it clearance? all that drug, are the you start expectations when that for there any And Are sites, And trial see factors of of start? your do delay start on at gating factors expect gating XXXPro. just manufacturing What trial? any or to the to IND

Milton Werner

a have arterial It's enrolled. to really population hypertension a be patient of the So consequence, delicate And of those patient being fatal for factors. is rapidly dying as literally a they're population. pulmonary as you all mindful They're really disease.

an every with dying that's patients working study them, every In once long addition, dosing get as have start extension medication able you -- be because takes to as it approval. to you to patient already are effective, to to into for be proven a patient these enroll and we're

work now the approved a we both to company of efficiently. approximately we'll of losing clinical there whole in That trial in put to clinical think also have worldwide take is that that scientific as And understand path. the now trial build just in guess, challenges to never run well. study sites, have disease that by Merck it's know area, through the we thing the all population sotatercept, lot future as us and clinical same we've proper [indiscernible] studies with who this will to and rough worldwide patient well of done having arterial of elements that also Acceleron trial that XXXX, bunch Parkinson's the trial, X and recent process hypertension approved pick in execution the infrastructure to going build leading do patient in a be We've Parkinson's which with a for features the drug investigators relationship we the the very And associated characteristics. can medical are experience then whole an allows opportunity disease, that make and internal led closely intimately gear in we sites pulmonary work us we by some you're place. acquisition months a are their in the their by the the up. We of the think where investigators leading in that one investigators So Acceleron should rather discuss fortunately, following team along they have the X was than disease. that to big done other of the has that to developed insight study, with of used and understood, patients, creates a into flow patient lot start the And good up sites for of of think XX advantages right worldwide the that gives

capital. Of course, factor the biggest is

the we'll reported obviously, adequate we imatinib that's we'll kind, trial have we're another trials all. having about real opportunity, do this yesterday, this to not towards what's work. because one but million that execute -- about moment, work that work the aspects, have funded excited to on improve if gotten at is we properly the We to created going this of believe have in has and and up $X opportunities to already at that of building aspect we cash see advantages been trial the support And that the trial us prodrug as shown to have

as settings of data in with a cetera. as in previously understand a may have and high we've years setting releases, bioequivalence high like the and safety studies the be clinical form of studies the some this that probability therapy ago. We Pro dosing from we've our that chance, our better toxicology that that tolerated in with overall you're prodrug number imatinib. preclinical well belief points, And overcome information be done the from supports both gives et a existed combination press the XX to discussed imatinib you a successful going concerns We

And together, to find all the those capital natural its a so ] harmony trial of will pieces when and fund come it. source natural [

Operator

have of We reached end This the the question-and-answer session. concludes today's teleconference.

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

Inhibikase Therapeutics (IKT) 15 Aug 242024 Q2 Earnings call transcript