CELC - Earnings call transcript Q4 2023

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Operator

Good afternoon, ladies and gentlemen, and welcome to Celcuity Fourth Quarter And Year-end Financial Results Conference Call. [Operator Instructions] I would now like to turn the conference over to Maria Yonkoski with ICR Westwicke. Please go ahead.

Maria Yonkoski

Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review Celcuity's Fourth Quarter and Full Year 2023 Financial Results and Business update. financial December the XX, released full quarter Celcuity ending year XXXX. today, results fourth for and Earlier

The press release section of can be found website. on the the Investors

Joining will Officer; as Sullivan, as Igor are and call Medical Vicky during well me Officer, Q&A. Chief Executive who Co-Founder; Financial Chief available Officer Brian Chief Hahne, Gorbatchevsky, on the be Celcuity's today

factors uncertainties, remind statements. Before we Actual statements. may or results materially of which some to comments forward-looking Such events These from cause involve today differ press in involve our differ outlined and performance release risks begin, SEC. forward-looking materially I statements filings our other are and the implications listeners their would in risks, today's that or forward-looking in unknown may known actual reports will that those those results like projected. with number statements from to a and include and projected and the and uncertainties

will non-GAAP ongoing the these company's operations make measures Management this future for and financial evaluate strategic and also to and useful On the the of understanding presentation results assessment believes refer for investors' decisions, management is These we financial non-GAAP current company's are by future. to non-GAAP call, forecast used measures the of measures. prospects performance. core

press find can release. today's to the in You table measures reconciling measures the financial GAAP non-GAAP

Sullivan, CEO Please I like call Celcuity. now to to that, of would Brian with ahead. the And turn go over

Brian Sullivan

leadership team. of XXXX, adding our sheet while balance made Thank strengthening and and you, significant progress everyone. Maria, gedatolisib advancing development afternoon, we good In to our

of the year subgroup the to line mutated Our for and on the subgroup first second report half Phase PIKXCA III data track remains half this the from in in trial top patient PIKXCA XXXX. data of top patient wild-type VIKTORIA-X line

darolutamide, combination cancer trial past first excited in gedatolisib half data of also this preliminary the in Phase development metastatic to forward Enrollment Ib/II our begin we with evaluating this look XXXX. has and year. were sharing castration-resistant patients with gedatolisib from to of in for prostate begun trial We

clinical gedatolisib whose VIKTORIA-X advanced treatment palbociclib evaluate to has III positive, breast CDKX/X with cancer in progressed combination Phase fulvestrant Our and a trial after with designed without patients HERX-negative with disease hormone with is receptor in inhibitor.

improve that this second-line population, for Current regimens combines globally mTOR only on this challenging basis. the these care of represents to patients for seeking safety alpha offer We patient These standard includes and that in current of And alpha-specific fulvestrant inhibitor, profile. therapies. a an PIXK specific approved fulvestrant today cancer breast limited estimate or survival over target with receives potential We're targeted of endocrine therapy. modest case annual outcomes PIXK therapies the as which initial such from care only standard progression-free XXX,XXX benefit periods. very population an patients therapies

or mutation, The PFS, SERD enrolling. is significant subsequent unmet significant survival, these range an months, to for AKT X.X with breast X.X Phase recently a ESRX need patients for from in progression-free same population the oral has an for inhibitor these number and development investigation new for therapies, cancer of an with led patients patients AKT of to approved. III or in new was PIKXCA X a trial patient Median our mutation therapies respectively,

at PAM mTOR sound these Cancer availability still patients San on drugs, based for of cell to therapeutic To the these breast poster more further session compared of versus gedatolisib results gedatolisib and AKT, the these In lines, of a potent XX series node different least single inhibitors. at the We cancer cancer Antonio performed will PAM Breast lines. cell unmet cytotoxic panel good alternatives we studies the using to on breast While XXX-fold presented PIXK, or new news, for Symposium. was a of of effects always XXXX other is remain. results need a patients nonclinical be inhibitors, drug the elucidate the for the average studies more reported during

decreased PIXK/mTOR replication, in other and production inhibitor highly gedatolisib most of the gedatolisib address glucose of need, studies cell protein mutational synthesis, PIXK/mTOR effectively than inhibition PAM that In a patient-derived since consumption, tumor. ESRX than differentiated oxygen especially more inhibitors. suited lactate cancer action xenograft consumption, to PIKXCA an equipotent without gedatolisib single mutations. effectively We mechanism PAM survival, believe growth effectively cell this Mechanistically, is PAM activity confirmed has node pathway or DNA the tumor with reduced models vivo by unmet and of as status patient's independent uniquely gedatolisib demonstrated inhibitors more breast PAM

from data in published dosing which receiving Ib was very results months, standard PFS of III favorably patients combination and our Phase was regimens. the care compares was The gedatolisib of for in objective XX%, for response with study very both rate to the Median XX.X schedule Phase fulvestrant current promising. and polociclib

enrolled Another for XXXX a to us of to preliminary fourth inhibitor, our potent trial half gedatolisib in expect the combination patient in evaluate tumor we data In initiated gedatolisib darolutamide, study and patients in XXXX. report of in cancer. type. to first new a is receptor Ib/II with development quarter, androgen metastatic in which was clinical with first important the castration-resistant February, goal we signaling in begin in a prostate the Phase We

a patients that Numerous with for are them. Treatment new and an effect antitumor pathways, cancer. to a may demonstrated there's patients receptor PAM the an drugs and inhibitor induce these synergistic interaction urgent treat limited in inhibitor receptor studies prostate need have with between androgen androgen preclinical suggesting for combining options PAM

and marketing PAM compelling inhibitor data to breast groundwork commercial having the providing And hypothesis to with cancer necessary patients finally, gedatolisib wild-type clinic. may in study, Phase to earlier begin closer PIKXCA our to as inhibitor bring also our a need the be laying get with generation we for the combining receptor an III we clinical of of androgen an evidence concept proof There's gedatolisib that efficacious.

years February. full-scale To Eldon head in over early-stage ] efforts, Eldon from has pharmaceutical commercial exceptional including ranging our our up building therapeutic in to joined Commercial experience companies ground track first as commercialization Mayer an up XX to of biotech proven companies our the drug. team organizations oncology. Eldon record biopharma the is of of with from biotechs management commercial leader Officer areas, [ Chief company's across many a a support launch

now with review turn Hahne, over to Chief our financial to Commercial the results. that, our And Vicky Officer; I'll call

Vicky Hahne

and and our good filed afternoon, which Brian, detailed quarter discussion. you for review of the a overview results brief our a XX-K, invite be you, today financial Thank for to and fourth I'll everyone. later will year 'XX, I provide more full

million $XX.X loss quarter share or fourth was fourth net per quarter per 'XX. of $X.XX loss Our for million share compared or the $X.XX $XX.X net to

or loss and significant per Net net December including year our net noncash in $X.XX share adjusted $XX.X and for loss include million full losses or ending full compensation quarter also to for full the XXXX. year in XXXX interest, items, per for was compared stock-based these year period press include the and million of the XX, we noncash non-GAAP net loss same share $X.XX $XX.X quarterly Because XXXX. release

of $X.XX was non-GAAP million non-GAAP adjusted non-GAAP $X.XX fourth quarter million compared share year the net compared adjusted loss of loss full adjusted Non-GAAP share per 'XX per for share $XX or net 'XX. $XX.X or year quarter per $X.XX XXXX the for the full loss to share XXXX. net fourth $XX.X of or per million for to for net of Our million the loss or adjusted $X.XX was $XX.X

expenses $XX.X supporting year. increase the the trial expenses fourth million and was million compared in Research for Of expenses of fourth development $XX.X the Phase and R&D compared were for Phase of million the the the VIKTORIA-X million year-over-year, activities quarter related R&D 'XX. approximately 'XX quarter to for clinical year prior the were full Ib/II $XX.X $XX.X initiation of for III million $XX.X 'XX the million to to trial. $XX.X

for $X.X $X.X for period remaining for and related G&A is same fourth year expenses. prior in the expense administrative for 'XX. increase $X.X million were million to of compared expenses $X million General consulting 'XX and the The $X.X the million of were increased to in to quarter full 'XX million compared the year. R&D expenses employee

of in the million expenses G&A increased related 'XX fourth fees working was capital operating expenses, professional for activities $XX.X and to and and activities million for million net used approximately a 'XX. increase adjusted fourth loss Net of that This support $X.X was financing employee-related was $X.X other non-GAAP operations. compared quarter $XXX,XXX approximately clinical compliance-related the with million, related of plus to million cash of result million quarter $X.X Of $X.X to associated of $XX.X expenses changes. the in

the $XX.X of of $X.X We net 'XX. full approximately offset year to and the compared approximately full the a of and for in activities of XXXX. in offset $XXX.X $XX.X cash to operating 'XX in cash was million that fourth proceeds used short-term working activities million, $XX of equivalents $XXX.X approximately activities $XX for year increase million operating was the the non-GAAP was compared cash changes is in by capital cash with of ended million which 'XX. X result of XX, million This million by result 'XX cash, loss adjusted million, million. Net year year-over-year used The on investments in yielded $XX.X occurred December financing of quarter gross

million offering included gross a through warrant activity in which placement The $XX proceeds. first financing prefunded a generated private arrangement,

second activity proceeds $XX offering. financing million The generated of by at-the-market accessing gross our

half hand to investments operational the We our first call funds now under and facility fund the of expect capital back provide equivalents cash, debt cash I to XXXX. will activities Brian. available current into to and adequate

Brian Sullivan

please Operator, Vicky. for questions. you, Thank the open could you call

Operator

TD from Instructions] is Tara question first [Operator Cowen. from Bancroft Your

Tara Bancroft

I mutations. into C of could now and a launch more A if elacestrant. comparator fulvestrant considers Arm us alone, or and ESRX the PIKXA about the B, was year if the best you overlap tell And for FDA still of Arms the wondering

wild even level just basically trying what? B I'm go endpoint confidence for subset that C gauge to or or labeling versus Arm the ESRX for in of that chances an you might type So

Brian Sullivan

the for question, Tara. Thanks

any in of ESRX patients this study. not the have we're We associated seen with combination that outcomes variation evaluating therapy with for in mutation,

so close in We meetings NDA. study with an our anticipate associated we the what design with and clinical with collaborated hope contact with them B we the through closely development study. collaborating also And a to type of series on reviewed front. them developing when on work the don't We've is but of basis only a that we not review challenge FDA ongoing a we were are future where the

As that. was changing months. control, recently used as consideration Drug approved no past there's this a control discussion the [indiscernible] fulvestrant few as just that of or far

differences any outcomes certainly anticipate, meaningful potential find so mutational as patients to according or we And said differences. clinically but report in to meet don't to we'll us their earlier, have I data available status, to

Tara Bancroft

Great. the Have endpoint? you're B HR versus that? commented for to which the You you powering said on

Brian Sullivan

support We But sufficiently on haven't again, that. powering we're study regulatory commented approval. to the

Operator

is Maury question next Raycroft from Jefferies. Your from

Maurice Raycroft

timing is enrollment seems the else intact It and rate. Is like on about data saying there you're track. anything

enroll by the patients I achieved you And think mentioned of end of if could milestone? quarter. point, for at aim something Wondering cohort? that wild-type you XX% you've X that wild-type you is first the that announce to the the

Brian Sullivan

associated terms one is milestone our quarter. milestone of during that that achieve facility, Yes, we debt the and of this did with

we half year. provided about data the the is consistent we so on And remain second in guidance that track with this of having

Maurice Raycroft

of will for have an estimate much how you data provide Okay. by Great. the Phase III you time you the follow-up readout, for the And think can readout?

Brian Sullivan

to disclose a fulsome by and in and is mature We of the point. that top not data. factors reporting follow-up data we'll set will data this sufficient -- the get line that readout triggered obviously achieving anticipate necessary events be That's a period number at

Maurice Raycroft

at in non-PIXK would have other pathway, including mutations. lastly, Phase can other Phase and But it PIXK makes efficacy in another you me without mutations. patients the analyze on looked you with sense. And you you Yes, evaluate AKT, you on with you reported FDA When [indiscernible]. if remind mutations patients III, how Okay. Ib data, the And had for or mTOR question with similar the discussions mutations.

Brian Sullivan

of with numbers mutations, patients small. We've the are done these an analysis but other

at the feel didn't that would analysis interpretation results with that's on did, we we sample detailed based reporting . And with saw that that our PIKXCA. least as you statistical results review or we so analysis assumptions and would have bit, the prescribed. might well that seen have small how wild-type were to essentially least versus with them agency haven't design to to comparable feedback support the really and mutated is discuss, to other sizes, And but or trial, the essentially inconsistent the a satisfactory, be scientifically rigorous Phase and ensure concerning when PIKXCA NDA with we interact those of and that And III you mutations we as subject enough evaluated and clinical far anything front trial, changed. nothing quite their be clinical at interact an on plan a statistical our you protocol has with very to get FDA, a

we're primary inhibitor. patients using PIKXCA mutation. PIKXCA and to that the approval lack a is supported that's mutations what to randomizing study or with have focusing that's patients biomarker who that And assign the PIKXCA mutated the using alpha PIKXCA primarily study associated patients And we're on of

submission. test on support an test subject again, will by to relying So we're PIKXCA FDA that, confidence have NDA that review the approved and and

Operator

from Gil Needham. from is question next Your Blum

Gil Blum

there. name I think severely pretty was my butchered

Sorry.

quick question on a cancer. prostate the So okay,

little mean company for or would be this. I What far So just responses understand, study? signs early to the in from looking mean here kind PSA I of activity? efficacy [indiscernible] having that of

Brian Sullivan

Sure.

We While is PFS, months and after well the to primary a X the PFS which for study important that's that at as then treatment in -- PSA the think most XX progressive-free the endpoints, include since end evaluation related there and of is is use study. survival are rate endpoint number secondary of X rather would we a or milestone endpoint as change. evaluating registrational a PFS months regulatory point radiographic at

patients with that And will whether . that data who've will we'll -- will number that reporting months or so number. milestone, matures X-month have I number And X achieved rhythm conduct consistently that of we XX-month milestone, the a be -- think for that or reporting as that be

Gil Blum

the another Maybe on here. helpful. enrollment very That's detail

like So on enrolling sounds is cohort? the the mutant it wild-type well. cohort Any thoughts

Brian Sullivan

have that in tandem. criteria meet of had enrolling CDKX/X. patients Essentially, If PIKXCA randomized. then includes we're screening who assessment status, enroll they criteria, their they They prior and screening get

wild-type of enrollment the mutant and concurrently. are occurring essentially, So

our on is then enrollment designed. the track, if track, population mutant so is on way And wild our trial of type just because is the

Operator

Your from Brad next Stifel. question is Canino from

Bradley Canino

is track I to mitigation stomatitis mouthwash VIKTORIA-X? way you've in ask, adherence the want . to any prophylactic able for there with been

Brian Sullivan

infusion. that of primary and is the we X compliance come we patients one on, Well, off -- for do monitoring week managing in when advantages their have in week the X

are questionnaire. standard the physicians with the or compliance prophylactic evaluating, that treating nurses so including And and associated

we'll based And of so we we have patients if out, reinforce on the a high degree find that, but also that that of compliant, aren't confidence value prophylaxis.

and treatment. cycles occur fairly And just of as for a of reminder, that cycles be prophylaxis mucositis, is almost X patients the first data is all of X likely to development in in clear for it's only prescribed may cases, to treatment. prone The used that first who the

much, X that And prophylaxis period. manifestation so are to that that you provide first the if that mucositis for cycles of is able lower that after much

patients for then requirement remain cycles. a beyond X not it's first to those that on So prophylaxis

Bradley Canino

in be maybe VIKTORIA-X I the because another ask then going slightly investors. for important question And to enrollment line reiteration is of think top continued try guidance to a Okay. I'll for way different

you based got could you anything you I on type pace that would the sufficient you've to time wild second guidance be rate see, can a the point think the share for enrollment events. this is where enrollment assumptions fully year for using about half the secure that passed there reach

Brian Sullivan

closer for guidance granular. update the we that, we'll think get each the we can of year. I provided And this to quarter. again, second as I Obviously, more get that think half we

we're to be. again, far. monitoring so event more make We're And think event descriptive tracking And monitor assumptions rate, our so we and But you assumptions we closer we far, rate. are what about the the so the certain the can get, I enrollment.

Operator

is from Your next Wainwright. question Ramakanth Swayampakula H.C. from

Swayampakula Ramakanth

Quick been RK is have question. answered. from This of H.C. Wainwright. Most my questions

you appropriate information? the or So release a medical type data data press -- the second at how in would do to when medical -- out the when a disseminate be time? then you're trying and I'm would that meeting half, the publish meeting with up that a to ready that wild figure follow from Would the just

Brian Sullivan

meetings on released depending situational able the timing will publicly. be and somewhat when the to be cleaned data It's of and

-- But an was probably trial ongoing that triggered, significance, telling basis. and meaning the top would what line what Obviously, that's we is we so is the event met data whether And relevant clinically not up going but and positive statistical at whether how finish characterize it we'll us gross when would point. threshold not -- we whether our or the be announce this that gross on on, results data expectation understand are. the those would cleaning results,

that typical that depending study again, we'll is medical when a it's meeting. I That would be of reconsider. -- timing results we But of available, III the But wait present with drugs. data think that more used desire. a I to is the will then think provide of think, you the been at current our of But coincident But availability may these top other fulsome Phase on data the our people follow, practice until description fairly the that's line it's if meeting that major meeting scheduled I with isn't results. medical a typical provide a and

Operator

Alex from [Operator next Craig-Hallum from question Instructions] Your Nowak Capital. is

Alexander Nowak

getting Officer, on brought readout new Commercial here, first we're you that's close to Chief As VIKTORIA-X great. the

commercial are year? this other what additional to Just plan do here talent, you the resources investment in commercial for over need

Brian Sullivan

Sure.

out significant more efforts operations. for And for necessary marching specific date once towards a do lay team I who planning up person would person the underneath head start to to you and which up think you're really build that head market can a up will You that's would the head launch. lot who your a access, who includes a reads data typically the Eldon out team, and a obviously commercial groundwork with person the marketing your

so that factored year. to forecast needs this And incorporated requirements. what our to in they're that extraordinary, not appropriate they're of We've for and assumptions our into we relative in cash when. done budget the And be

Alexander Nowak

sense. And cancer? that then the breast other And you Makes expand remind within length position the indications? Okay. GEDA within or IP then can potential to of us potentially cancer breast

Brian Sullivan

Right.

patents XX we approved for So GEDA. have have different been that

The we We But exclusivity administer the ingredient have December is very the is period to would expiration will provide GEDA to have that be formulated because and at 'XX. drug, because patent pharmaceutical formulation actually able would the pending. critical December And are patent relevant. patent drug, through 'XX. several an active deliver that being think date that an

an we so have potentially plan. period XX than would years is that's think we'll And for extended carry exclusive our that post more launch

Operator

proceed. are Please further questions There no time. this at

Brian Sullivan

Well, call, look on your we and you appreciate to future. the updating we attendance the in forward

Operator

Thank has conference for you. Thank joining. all you gentlemen, the and Ladies ended. now

may You disconnect. all

Celcuity (CELC) 27 Mar 242023 Q4 Earnings call transcript