IKT - Earnings call transcript Q1 2024 | Inhibikase Therapeutics, Inc.

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Operator

Greetings, and welcome to Inhibikase Therapeutics First 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, Mr. Alexander Lobo, Stern Investor Relations. Thank you, Mr. begin. may you Lobo,

Alexander Lobo

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

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

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

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

call Dr. would you to turn Werner. over that said, Milton, now like With to I may begin. Milton the

Milton Werner

important first inflection today our programs be business points, we clinical to achievements shaping regulatory you, by and the proud year quarter us XXXX financial results for of the advance recent accomplished and updates. execution already quarter. to a thank you, and first and and our XXXX review Alex, are as in is joining of Thank everyone, we towards core clinical team our up

progress the II XXX Risvodetinib in final line Parkinson's we Phase making disease, anticipate trial June enrollment the in of the enrolling data and are in risvo with second patient We year. rapid in or reported of half top for the our

opportunity asset stomach with On our and divisions interactions in imatinib hypertension front, cancers. we had and program, potential arterial existing opportunity as positive X IkT-XXXPro this blood the for regulatory for we pulmonary prodrug in continue to FDA the the pursue position

our administered So dive a Risvodetinib. daily, each let's is c-Abl may believe the Parkinson's deeper into slow of progression potent or halt of once we disease. take that of inhibitor is Risvo programs, a that beginning selective with

double-blinded we ongoing with XXX XX-week X-phase is an believe Our plus a trial be across trial doses, achieved should therapeutic effect X study placebo.

approximately participants of medical as being enrolled XX with The screening, for initiate May XX, trial is XX% screening. participants potential in participants, medical evaluated to XX suitability XX prospective

X and full the completed have without be mild may trial completing -- weeks. might Additionally, observed be XX-week XX risvo that date, dosing to To been adverse XX X moderate have there the period. XX from withdrew treatment. events people participants that related

the line will be this As June, expect results we second last top anticipate I of that mentioned the we the year. to half from earlier, patient report and enrolled in in study

in which speed the nationwide. period, of the been the request meeting XX-week community to of impressed by broader enrolling an patients our Overall, Parkinson's well Phase double-blinded interest the the expect at FDA. completion we as has trial we remain II as the with Following End expressed

has involved our open sites. that been and regarding instrumental how accurate accessible our the enabling trial www.theXXXtrial.com, trial updated information and to make patient get and to XX portal all effectively at hard enroll across portal, participants sure in worked to clinical We've dedicated believe us provides that

capital the work initiate biomarker find is As to front. to continue what the on XXX necessary are extension we emerging the to encouraged trial, by we

Recently, antibody pathology an marker will key novel phosphorylated measure against the the believe of Parkinson's disease, by this XX. with can possible pathology us alpha-synuclein in that engagement development its elimination, of to allowing antibody disclosed target risvo. purpose a dual we We tyrosine track a namely the serve along recognize antibody of alpha-synuclein of and

would an the National incorporated in This is our used or central Institute [ test ], recent the which pathology biopsy (sic) Health, Neurological of prompted of of NINDS, The and Institute and the development track to of being that are grant of disease National of both risvo the and in skin to the in systems. Institutes Stroke already on amplification Stroke Disease underlying test the effect National antibody this nervous and be trial of the both NIH. institute peripheral Disorders antibody XXX seed submissions Neurological or

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

the FDA. the pleased the we discussion significant our begin held we first pre-NDA meeting a XXX(b)(X) advancement our we building January prodrug the ongoing with the of On potential approval had under with with to the through statute. the as of We discussions to NDA for agency XX, strides in the continue requirements package. FDA We process make were discuss with the

as road imatinib dose and mesylate. of XXX to to Our to discussion milligrams a equivalent transporters with NDA the test X,XXX-milligram and -- to the a to preclinical FDA affect conduct approved certain XXXPro evaluating include possible of of agreement how preclinical submission gut provided consider evaluate imatinib dose to our map XXXPro a the

all approved. are mesylate for approval which to Notably, XX we able imatinib is indications of pursue

Nephrology explored To continue Cardiology to we of could disease-modifying meeting we at be April indications Office the we end, XXXPro, PAH. as As for on of FDA. for or value how to X, and held prove evaluate the treatment a hypertension, Endocrinology which for to potential pulmonary XXXPro effective. maximize this have Nephrology arterial a the non-oncology pre-IND and discussing Division with We in Cardiology, were of XXXPro Hematology, the also

primarily rare at of of pulmonary the treatments the between affects XX. a are and and deliver mesylate to global itself that microvasculature ages arterial profile itself addressing and market safety at imatinib than the to -- hypertension safety approximately size for PAH U.S. with The for There that it. have improved in improved this indication. PAH is billion, are approximately $X.XX the PAH tolerability of valued symptoms mesylate imatinib profile disease IkT-XXXPro potential believe aimed alone, is curing an would of outright relative an XX and disease that many imatinib tolerability Pulmonary and cases XX,XXX women the rather we

our Although late-stage open we New to has trial the and PAH, and Entity to confirm evaluate have for our design yet to conduct to any meeting to status XXXPro PAH clinical review pre-IND served Molecular studies this or was and proposed the unmet XXXPro of XXXPro to approved for indication. not anticipated [indiscernible] was as be substantial an unlock to These to first the need indication exclusivity provide door designations conceived. opportunity that when high outcomes for XXXPro XXXPro

Garth over to I our to will now Garth? for the review quarter. results turn financial our Lees-Rolfe, Chief Financial the conversation Officer,

Garth Lees-Rolfe

Thank you, Milton.

XXXX. results for of the $X.X XXXX. for Net net March XX, or XXXX per million, the per compared year ended or share let ended share $X.XX me financial and million, $X.XX was XX, review Now loss XX, quarter March quarter loss $X.X ended to March our for the quarter a

in expenses. development million XXXX quarter decrease million for a expenses same $X.X Research The million by IkT-XXXPro $X.X $X.X to period million were ended compared in due and the million Risvodetinib $X.X of XXXX. offset a for March [indiscernible] $X.X the increase to in XX, decrease expenses,

and expenses. other increase $X to the The in $X.XX $X.X was the Selling, primarily due for administrative million a and fees to general and million quarter ended general net million in increase expenses same March XX, decrease administrative $X.X XXXX million for compared legal consulting $X.X million and in XXXX. a all period were

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

We and to cash XXXX. operations November sufficient expect will that the be through cash fund equivalents existing

hand review our to remarks. like I'd financial Milton of closing concludes call back That statements. for over to the

Milton Werner

the to now I'd questions. to like Garth. Operator? Thank open you, call

Operator

Instructions] The [Operator line White from of H.C. the first Ed Wainwright. comes question with

Edward White

and just XXXPro. one have risvo one on on I

at So what result? your What your be a result, is pathway And data? assuming then on positive looking a to be you on will steps risvo, how positive next will the to approval? you

Milton Werner

So for us, it's a twofold question.

will and drug species and in pathological aggregate We XXX of system to are There we're the watch of results pathology have measurements pools treatment any underlying treatment going measure development, think biomarker of prior and kind. And no and will forefront defined what they able system of allow pools Since that will biomarker an is those have that know the on sitting XXX, only, are as believe the alpha-synuclein alpha-synuclein of impact tyro what both quite to peripheral at disease. we nervous is, that direct phosphorylated impact of a under yet, hopefully, has namely, but to we be at of biomarker ability us results nervous our that measurement And -- treatment ongoing. we that illustrative. the see been of we've central track species a to in changes that illustrate, whether we're don't serine aggregate.

quality expect Parkinson's of and/or as period -- Scale measurements of remarkable ]. weeks. we a to we're Disease Parts of Score any disease to XX in Secondary short I, known the Parkinson's Universal some of or Parkinson's to expects that, severity only Unified [ well, measures, thereof life Parkinson's some but on disease of II reversal or or impact UPDRS (sic) formal Disease one see see for it's would combination on III Rating the treating No such time, Rating

We view, to that have the know be capital capital will keep Phase the going -- placebo. -- kind, releases many worsening think we there. relative if press pretty in so But right past trends what our might that what don't a happen of run just patients. biomarkers, we this see, -- to so begin XX-month direction we we study coupled to a can we in we to have as times in these in yet, outcome. I without doing will what's to III. hope extension we've said think we're see I this motivate in with remarkable and in be don't the and discussions that's measuring the the to And able we And

Edward White

as on getting viewed Okay. Congratulations it entity And PAH. just for novel chemical XXXPro. a on

like get II/III potential thoughts the protocol Phase Just wanted to the design. what would on your look trial for

Milton Werner

The through recognize enough patients, proven old alone an in believe companies this. SBIR and -- a the of certainly So early favorable or trying this. we that we is were yet, standard think to suitable the recognize tolerability work -- way some then to about idea ideas. allow for National haven't was remarkable not seems non-oncology superior able this this in the that Abl this be try potential pretty us to what done such Cancer And address PAH. could dosed for prodrug that have had all a XXXXs so we GI medication. Two properties, the Once do there's that measure is to Institute of that whether of of inhibitors we other imatinib all, perceived work issues first not to to tolerated design agent purposes. causes to what's fully for is of We is the better but our grant. have that some by paid accomplishment in mask we bioequivalence. to to first was again class And in us, We're

in it of to to And Abl think systemic imatinib, enzymes not is necessary have cause which the so -- do inhibit able with disease. been way we to properly effect the but only an they administration

would Phase I profile II trial a the Phase look is III smaller so is profile And in typical design Phase weeks. the roll design if Phase size would incorporate we'll design. primary those pretty into have a trial patients will that vascular be use pulmonary a period to now resistance, and at trial cohort, a looks measuring XXX patients, XX amend that III. that If safety to program, over safety with design would endpoint II we smoothly which from the so early in roll could people emerging protocol favorable, the it entire that trial, believe

programs The the like II standard. programs III this indication pretty Phase Phase just are in

walking primary like secondary success resistance be hemodynamics distance X-minute measure III. things endpoints X-minute walking to XX-meter vascular as have The than in to distance. typically pulmonary viewed improvement. Phase You at better the endpoint has A is in like

so And what be that's we'd for. looking

perhaps effective approach. XXXPro, that know operates a which even nice us, highly different effective superior it's was by The thing using unique a mechanism opportunity approved about very a as for the we to is same just or Merck, almost agent, imatinib already is which for WINREVAIR,

sotatercept, mechanism. -- WINREVAIR think and that work imatinib are either we complementary. so at disease-causing of And and the ends They

combination And to there agents would you out could can view, a date. compatible our And really where are corrective real be so a one for imatinib imagine people. to of this, lead which are sotatercept quite that like therapies, there and no other therapy just in

And we fantastic opportunity is in hard-to-treat population. so patient think a this a

decades And it's data have you so of portfolio to already different already variety dose a patients. going rare where it, of of in asset have to whole over know you an X how safety types a

as accomplish, the the data treatment just population safety paradigm You in And as approval know line have in for patients. work. indication, target that tolerability need because is long these reevaluate outcome is was to new something you now else that for is going primary to not observed as profile to this your observed the matinib safety in and in older the everything for you

excited So quite this. we're about

Edward White

Okay. mentioned great. And That's just wondering partnering I'm any just update if potential drug. on you this partnering of before. there's had

Milton Werner

as more are available, the because would product The a the hand least see We at with discussions players novel obvious, It's entity an available we in delivered as life approval that regulatory Molecular think I that's with of of prodrug. to of with imatinib them. exclusivity us actively FDA all I available New accelerated stage. And in early and Entity indication. aspects kind seeing a one chemical potentially With pretty say to potentially time. accomplishment and for we achieved that these how novel than view at this cycle, seeking We're could and that. present milestones relation of to patent mechanism have needed the are it's action

much is or to not fund take you of potential under predominantly to the can work. you're on put this patients stronger if trial. that's fund This make the collaborate withdraw trial the a to either and belt, medication help them trivial participate at you indication, our case Now trial that, all work. to will we once And have partners with the in drugs drug license off. Nobody going end never or

the So it fails approved. roll until trial, everybody or approval you keep clinical into extension development program have phase into a get them trial you an be to next to or the of to

So that our really is very and partner for you company a fast, the significant, make commitments a requires very size. of

Operator

to Ladies end you. now question-and-answer Thank and gentlemen, the we like comments. over session. Werner of have reached would Milton to the closing floor turn Dr. I for

Milton Werner

Well, attention today. very thank for much your you

has see whose to And commitment have around the trial continue and shareholders lot ways of with a thank of to our been They all our seen our progress all programs for stock value volatility the trying shareholders, really and participants we're our want unparalleled. Our of to the develop price. return. along shareholder novel on for assets we

explain, they're the in, be For really they're to providing towards participating participants work want in therapy Risvodetinib in understanding disease. reasons transformative invaluable trial trial could that our be we a information involved and neurodegenerative cannot

want for And to of attention all so process. you your through I this thank

Operator

Thank you. concludes today's This teleconference.

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

Inhibikase Therapeutics (IKT) 16 May 242024 Q1 Earnings call transcript