Earnings call transcript Q1 2023

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Operator

Good morning and welcome to the Inhibikase Therapeutics First Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Alexander Lobo with Stern Investor Relations. ahead. go Please

Alex Lobo

release press morning, Werner, Good Financial me is March issued today On the results Thank quarter first Executive everyone. Officer; Milton ended report are yesterday’s a the which XX-Q has Inhibikase available XXXX, Chief filed May XXXX. with to We Chief as website announcing as Form encourage and Dr. read at everyone report Inhibikase's financial Monday, on well The for you. XX, XX, and company's on Inhibikase's press SEC. release, also press With annual quarterly release Joseph Officer. – quarterly inhibikase.com. Frattaroli, been

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

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

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

Milton Werner

Inhibikase for thanks joining call. and Therapeutics to for Alex, you, quarter XXXX Thank earnings first today us everyone

to industry including in disease. Parkinson's quarter, potentially IkT-XXXXXX AD/PD our at our IkT-XXXXXX the Parkinson's halt is validate or conference, multiple where oncology to Throughout and programs. of continued progression the against of focus conferences, data we disease, lead program program date the execute XXXX in the to first we portfolio highlighted neurodegenerative into to heading Our our slow annual generated

We of to actively ‘XXX’ sites the had into our disease end end for X and for the XX by Phase trial announced study. at up morning, the patient screening This Parkinson's enrolled to first began screening first anticipate of patients patients the quarter the XXX been we be May.

dose the study CML addition, four In completed analysis bioequivalence the for rapidly study we phase following completion and escalation of Stable-Phase the the and our we are for in across recently advancing XXX of of cohorts. all portion IkT-XXXPro data life pharmacokinetic

able of We will to the the in XXXPro standard-of-care mesylate. relative XXX determine bioequivalent dose milligram be to imatinib

commence the analysis confirmatory the in We study June. phase have of

to start IkT-XXXXXX. program with me an for lead Let our update

motor Kinases selective XXXXXX barrier a progression brain, is Tyrosine disease designed and Abelson XXXXXX functional know, and of you the functional GI c-Abl As the tract. drive Parkinson’s and to human that potential non-motor accumulate toxicity and We and to inhibitor related a have of or has ability disease have in in the the and disorders. the blood-brain recovery of non-receptor cross halt to low brain leading the function profile recovery the

and double-blind, The of tolerability will expand placebo across IkT- three XX XXXXXX the trial actively XX-week with the we May. safety and are endpoints. We primary evaluating sites, screening per multiple The XXXXXX trial which end a doses is by study is of patients as patients anticipate of sites XX assessing at randomized, cohort. the X:X:X:X

have the and assessments selected have contracting to needed Currently, As in Parkinson of completed we gut. in the XX secondary endpoints, will sites, or all XX the hierarchy exploratory participate a XX trial which steps disease of brain measure trial. related

treatment Lancet manifestation. protein Parkinson’s in publication Recently lack showing accurately disease seed fluid SAAs the who form basis even been spinal assays disease, Parkinson's Parkinson's benefit as in analysis could for or amplification diagnose patients how of and of the biopsy Neurology progression The Parkinson's for use evaluating to in a published treatment has patients concludes disease. research further marker for analysis different the Similarly, skin of new validated fluid spinal SAAs discriminating biomarker initiative biomarker resource that forms benefit. with

analyze spinal these implemented for patients. to treatment skin analyses into and in described order have We XXX fluid the enrolled biomarker to in trial the the newly response

gather In dose evaluated completed of We requested an to for analysis as of and by XXX XXX the (ph) addition to the of data expectations recently the consistent of earlier daily we were XXX XXXXXX. volunteers milligram once enhancements, study. XXX dose the milligram The XXXX state healthy six profile pharmacokinetics FDA. these our on the steady safety milligram days dose in with additional pharmacokinetic seven and

by Steady-state reached was IkT-XXXXXX a the XX-hour and fourth had half-life. day

continue the of to Subsequent to dose XXXXXX milligram in development There reported without drug only of and events data for FDA. mild April and to were adverse this, have In dose potentially clinical each we believe of adjustment from the these the the XXX We linearly dose. milligram that significance. event data ethics committee submitted the with addition, support submitted six related to the exposure review. inclusion not increased resolving any XXX

a in doses, staggered XXX milligram we'll XXX have have to against were trial. start of the the which the initial relative milligram Inclusion staggered, dose, we'll doses

X and March, of System rare systems. for the in a System Phase month opened have initiating us, Atrophy also nervous advance IND progressive planning MSA or XXXX FDA In for to Atrophy. a autonomic central six for trial. preclinical neurodegenerative is MSA movement the affects Multiple that the disorder steps like, development rapidly the Multiple Parkinson, We continued both

studies. to As loss within with other treating daily once MSA of outcomes has these presented of results untreated were model XX during have neurodegenerative functional of gated in diseases and XXXX of Development studies weeks IkT-XXXXXX is relative studied, clinical Preliminary entry transgenic animal the outcome disease a we of dosing animal model our Research precluded by one model March Parkinson model, controls. this Day for disease. in of

progress, continues providing execution look these IkT-XXXXXX trial the a to clinical guidance of As model in of support this to X whether we study and MSA. planned studies model Phase on study forward second further

well Finally, patients profile study I'd its XXXPro is and The study for better as of prodrug patients has XXXPro. on formulation and XXXPro on alternative bioequivalent also standard be mesylate exposure of evaluating XXX the tolerability touch our XXX mesylate. evaluating of XXXPro to like Myelogenous enhance the in study potential their to imatinib imatinib dose Chronic tolerated chronic our to safety the safer control to The whether phase of to is comparing care of safety intended imatinib of milligrams of imatinib Leukemia. therapy pharmacokinetic as with is disease. stable the the

no In single May, doses date, completed doses. milligram To XXX events observed. of the significant we have escalation XXX, XXX, portion dose XXXPro been XXX, adverse the of study clinically evaluating

In profile imatinib fact closely and imatinib delivered a exposure that matches has to bioavailability pharmacokinetic milligram of XXXPro has shown high that delivered the of it mesylate. imatinib XXX oral as

XX XXXPro, bioequivalent to analytical utilized – a the be the pharmacokinetic analyses data identify completing are the analysis four will in additional which then of of confirmatory of dose cohort volunteers. healthy We

the second of the to trial XXX(b) XXXPro in to parameters I drug the regulatory to the pathway. with the under forward for look are XXXX, of engaging (X) We on quarter discuss complete approval track FDA

to call Financial the turn Joe? now to to the like Officer, I'd our discuss Chief over quarter. financials Frattaroli, our Joseph for

Joseph Frattaroli

Thank you, Milton.

our financial March me months XX, review three Let the results for ended XXXX.

per $X.XX million we or For of XXXX. net loss per of in share, share approximately ended XXXX, the first or $X.X quarter a a $X.XX March loss net million the reported quarter compared to of XX, $X.X

quarter. and March $X XX, primarily for were March XX, due XXXX. ended quarter the restarting clinical in ended trial Phase $X.X Research quarter development the X The million decrease expenses compared the to company XXXX, to ‘XXX’ its million for was the

the general XX, and with ended million March administrative fees for March million $X.X ended expenses Selling, was result XX, and increase for The to the legal primarily $X.X of compared costs. the consulting related were XXXX. promotional quarter XXXX quarter

XXXX million cash registered placement. in and offering cash, As of XXXX, net marketable equivalents had January securities. approximately and proceeds the private we includes This million concurrent March XX, the $XX from company's direct $XX.X

cash will fund of fourth sufficient We quarter be operations the to cash, equivalents securities expect and marketable existing XXXX. into that

that I'd concludes hand the our back remarks. closing like for statements. to financial Milton And call over to

Milton Werner

Joe. you, Thank

art on the make study, into progress for biomarker our significantly of of to XXXXXX and implementation multiple and in spinal skin program. analyses forward to enrolling We Parkinson's in the clinical and state continue efforts the (ph) second strengthens XXX the the quarter. the enhanced the study our for disease, including We patients fluid look we for XXX protocol believe trial

and July on trial our and end our second look later the year. advance complete to expect quarter. bioequivalence XXXPro we to confirmatory to addition, the both on study XXX efforts by in in for updates this preclinical providing analysis forward the track the of We clinical In remain

would open call like questions. to Operator? now I the to

Operator

question-and-answer We Please White Wainwright. go will ahead. [Operator H.C. The with Instructions] the Ed question begin now first from comes session.

Edward White

for Thanks questions. morning. Good taking my

how first patient us So to for thoughts the in whole can patients just long XXX on going very I take? the it's know give dosed you on early, enrollment you the I'm congratulations getting the your XXX if wondering, trial. do think is but

Milton Werner

enrolled that the Research we calendar this in is and had that year. to we under trial XXXX website Presentations our Development and presentation In our the Day, guided have plan on tab,

So cetera. the we activities, to and whether et that get know depend that's That our the on It's leading target. will the rate sites running how is enrollment target. premature of screening all

Edward White

do Okay. to you the Thanks, when interest path schedule you product? a discuss Milton. the the on had to And have with and forward partner in any a XXXPro, expect -- question just meeting FDA

Milton Werner

answer mesylate planned that prodrug. there was. showing bioequivalence in to between This a study and first, the was product, differentiation on standard-of-care going is Well, so partner dependent interest what imatinib establish it's be I'll it’s to question a

used cohort subjects at profile of mechanisms in and is are demonstrate we that the imatinib XXX more see looking have for XXX amplify steady-state, of dose milligram which over look steady-state to XXX can of the XXXPro contemplating two clinic, standard study, types end by where imatinib begun that's that. than we we've mesylate separation for we'll care, a for cohort an the We of the at in a to that is, at because milligram, one added the potential healthy favorably in a at dose the high do safety common imatinib difference improvement

which healthy effects data to the subjects weigh could analysis adding cohort high and in that pharmacokinetic completes, because we bioequivalence to them carry this dose imatinib think we'll number month, component. of side occur to before a has on on that the for we FDA will and sign-off that request for the submit the Once FDA execute

potential trial a target with other is a we've patients. The work study be partner really a is for path, previously in a path that phase superiority population, at is you the CML XX year-long And safety on to that a which roughly in which website. stable corporate outlined our presentations find our would do future formal study can disclosed

the we we'll We because partners yet put profile reached dose need together then equivalent package to start to marketing have have it. and not and the out see pharmacokinetic and the full

and So month should begin to this June. that partners beginning will -- out talking and go able that potential process be to will in within begin we

Edward White

you, R&D was sequentially. questions a couple you. Thank And Okay. Milton. for just Joe, of down

on the reasons thoughts the how trial. XXX year? about you're patients the now I should that of expenses study just think You in and mentioned R&D enrolling why, is we wanted get this to up running, your progression the

Joseph Frattaroli

Thanks, really about current year R&D PD a little quarter, was was R&D total the question. that composition prior the down slightly. over in down XX%. I really But to Yeah. XX% the quarter, year's the mean represented Ed. Great the of

the XX% think I R&D expenses. year, through be of that again end Parkinson's all will to XX% the of the above

Edward White

Thanks, Joe. Okay.

Operator

XXXX Inhibikase quarter the presentation. This you call. Thank results conference financial our attending and session for concludes question-and-answer today's Therapeutics first

may You now disconnect.

Inhibikase Therapeutics (IKT) 16 May 232023 Q1 Earnings call transcript