Earnings call transcript Q2 2023

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Operator

Good morning. Welcome to the Inhibikase Therapeutics Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

Alex Lobo

to call Therapeutics and welcome financial quarter and conference results audio morning the second Inhibikase XXXX Good webcast. With me today is Dr. Executive Chief Officer. Werner, Officer Frattaroli, Joe Milton Chief and Financial

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

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

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

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

Milton Werner

and joining quarter for Alex you Therapeutics call. us you, second today for thank Thank XXXX earnings Inhibikase everyone

across programs are clinical pleased the we of half year. the our in first this have made with progress We

the treat up IkT-XXXXXX first XXX XX planned X Phase using XX with of screening sites, trial dosing regimen. to patients enrolling is across Parkinson’s to patient disease XX-week Our and

Additionally, will and of augmented awareness a we trial. throughout caregiver drive campaign media we that patient with believe us social this United being enable continue website the the to States. launched foundations outreach to through groups, quarter, advocacy is trial in networks, public advertising to The the XXXtrial.com enrollment

June, pivotal of bioequivalence between commercial XXX In trial the we imatinib the completed phase mesylate. evaluating IkT-XXXPro XXX-milligram

dose agreements Following and bioequivalent high-dose we FDA, further to imatinib IkT-XXXPro imatinib. of the the between of mesylate XXX-milligram with contemplating potential safety evaluate the are explore benefit to delivery IkT-XXXPro

tolerated in most to for imatinib full use IkT-XXXPro by of may for that the CML, common overcome. shortcoming mesylate patients, We pathway. the completion regulatory a but pivotal of the of data High-dose XXX(b)(X) is treatment FDA plan we description poorly drug to of a plan discuss in approval engaging of under Upon XXX term. the our near on the release study, parameters trial the the phase

of In development expand lower the but the to drug expertise therapeutic dose once tablet in has commercial daily from the as and benefit as delivery, addition formulation not a The accomplishments, IkT-XXXXXX. of XXXXXX IkT-XXXPro, clinical to these with now our with we also IkT-XXX doubled continue nearly only deliver – to delivery efficiency well therapeutic day consistently opportunity continuous of each dosing. a improve IkT-XXXXXX, for every drug ensure and the providing safety to dose

diseases. MSA progressive a movement or nervous – our results, other to rapidly would neurodegenerative I Multiple Before financial systems. atrophy system is preclinical I a Parkinson’s-related rare and is that is to our in over to of that turn the central neurodegenerative the disorder efforts call review rapidly autonomic on like disease Joe progressive touch

late the progression correct a ability the second of in that disease. one of models, and of to IkT-XXXXXX potential the evaluating are in to early course evaluates model therapeutic we neurodegeneration that and Currently, two course the block MSA the MSA in functional measures loss

We MSA loss Functional in the X Evaluation will course studies the that treatment and planned that once anatomy disease prevented treatment by substantial preserved further of with we first the underlying potential to reduction clinical for updates IkT-XXXXXX model of this in the study of and study form planned on look alpha-synuclein of neural quarters. of nearing in X XX study benefit coming functional the The our IkT-XXXXXX These begins end XXXX. in accomplished weeks, trial orally demonstrated is the in when remains expect by providing in Phase Phase of is and daily. the given ongoing, IkT-XXXXXX was has to and complete of mice basis MSA. completion model effect when timing IkT-XXXXXX the pathology. these late forward studies

turn will to now to our Frattaroli over for Joe? Financial Chief Officer, it financial our results the I review Joe quarter.

Joe Frattaroli

Thank you, Milton.

bid indicating we review that highlight results, Before the that under our clinical compliance with regained generate price I work share Nasdaq had Nasdaq XXXX(a)(X). our will received shareholders. The compliance meaningful drive Rule ultimately Staff forward us $X of Regaining allows like financial of minimum that recently Market, and the move to Listing Listing I’d requirement we Stock per from full Qualifications notice data to to value for

ended June me XXXX. for let our X review financial XX, Now the results months

X clinical for CML program. compared ended to ended June XXX the $X increase XX, $X.X loss primarily were reported The XX, quarter $X.X in share XXXX, the expenses share loss or costs XX, XXXX. $X.X second for million PD compared a for ongoing development or ended to trial we IkT-XXXPro Research the million per June XXXX. of of per million quarter $X.XX the For due and net was and to quarter million quarter the a XXXX, $X.XX company’s net June Phase

million for increase administrative quarter Selling, driven selling, $X.X quarter by The the a to XXXX. administrative increase XX, June for were normal expenses. XX, net $X.X and compared June expenses ended general XXXX, general ended in the million was and

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

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

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

Milton Werner

Thank you, Joe.

of for lead promising. treatment the trials support treatment Parkinson’s our disease reporting c-Abl plans to share look multiple atrophy. thank We of our of safety of disease for and the demonstrate neurodegenerative We seek forward remains paradigm shareholders investigators, we our the to neurodegenerative We’d paradigm continue the ambition to and in IkT-XXXXXX diseases. future site inhibitor continued partners outcomes system of and XXX therapeutic and our value profile trial transform like to for to their our for the as c-Abl

to now to Operator? call questions. I’d open like the

Operator

ahead. Ed H.C. question The first with from White [Operator Instructions] comes Please Wainwright. go

Ed White

my questions. Thank morning. taking Good for you

XXX process, screening far? ongoing enrolled in is sites. And coming XX said the How of patients Phase us the expectations? just many sites X trial, you at about on meeting have your number screening is can you tell the So patients so

Milton Werner

the Well, into so advent first start physical are of telehealth in patients other physicians done. the much previously patients of to since COVID disease. of all, patients the treatment this that the and Parkinson medical challenging has States driven actually better during patient require is had would Parkinson’s as than much they exercise benefit who the many untreated when such earlier therapy population, appointments course led Often interventions than patients has and United a disease with diagnosed sooner

how are fall, So, implementation of sites want outreach and on because for to last enrolling not bears fruit. all see – the provided activities yet our of we that into guidance we the rate patients enrollment over six the have the the that weeks patient number of really

guidance report. to I providing be the next have guided quarterly that we think closer that we will

Ed White

considering trial when a XXX Maybe the with on And had review running that cohort? cons of for Milton. could the bioequivalence Thanks considering high-dose pros and that stated about cohort. discussions following Okay. you IkT-XXXPro, are thinking FDA, you you are just you that some the

Milton Werner

had Well, FDA the so with to have we to safety. related discussion a

in to in So, these quite X oncology to the because the days unlike Phase agents are often many is the treat of target cancer norm population FDA toxic IkT-XXXPro. do the studies division

it so to to FDA these work the healthy some subjects. studies do in And takes them have with agree

single with trials XXX in the far, We in and agreed things do so the have both the study escalation pivotal FDA agency We to us did allow agreement to dose that to at has doses. and of cohort treating is for by limited also dose in same patients very the milligram number XXX The the in clinicians poorly many are it’s use but do who next wide CML, patients. generally for tolerated. a

similar with And that’s so agency design escalation to did the and description. we in full safety full a phase, to dose the dose what description single a a agreed has subjects, a PK eight

addition of. And we are so contemplating that’s the what

nuances going in just trial We pivotal of from pharmacokinetic those analysis. through the the profile has completed that safety are has the should results and details been releasing detail. that shortly the all be subject XX We very of

Ed White

have be the for we half my thinking the the R&D last patients the of is question where trial Thanks. year potential XXX IkT-XXXPro expenses. And on enrolling expenses then just and should How you cohort? in high-dose into second of this Okay.

Milton Werner

Well, part of activities our existing all budget. current our of are

the will So, current a have we concern rate increase and exceed resources. burn don’t our that

know, that’s to you have are don’t asking, So, you you Joe, add? I color if if want question additional the

Joe Frattaroli

that’s mean I Yes. exactly it.

budgeted in rate dependent on out When will still are flow part right, it All in are present be will of contemplated assessing. of the items the enrollment, our we which forecast. cash

Ed White

Thanks question. Great. my Okay. for taking

Milton Werner

Ed. Thanks Sure.

Joe Frattaroli

Ed. Thanks

Operator

concludes closing session. over I back any turn to for conference Dr. like to the This would Werner our question-and-answer Milton remarks.

Milton Werner

a earnings call time for for second Well, the challenging This public participating thank obviously in everyone our the you markets. is in quarter.

ability remains financial up will Our be the kinase our track year. in goals diseases your diseases trial and our treated outcomes and we on further And trial shortly to forward Thank to Abl look by of the in overall consistent, and XXX those you attention. the reading for how and control in current strong picture coming that inhibitors. inform XXX remain can with work other neurodegenerative

Operator

now presentation. concluded. for you has conference Thank attending today’s The

may You disconnect. now

Inhibikase Therapeutics (IKT) 15 Aug 232023 Q2 Earnings call transcript