Celcuity Inc.

Q4 2022 Earnings Conference Call


spk_0: welcome to sell curious four year twenty twenty two financial results conference call at this time all participants are in a listen only mode a brief question and answer session will follow the formal presentation if anyone should require operator assistance during the conference please press start zero on your telephone keypad as a reminder this conference is being recorded it is now my pleasure to introduce your host robert you with i see our westwick think he robert you may begin
spk_1: thank you operator and good afternoon to everyone on the call thank you for joining us to review so curious fourth quarter and four year twenty twenty two financial results and business update earlier today so purity released financial results for the fourth quarter and four year ending december thirty one twenty twenty two the press relief can be found on the investor section of the website joining me on the call today or brian sullivan so curious chief executive officer and cofounder vicky on chief financial officer as well as igor gorbachev skate chief medical officer who will be available during the day before we began i would like to run mindless listeners that are comments today will include some forward looking statements these statements and wallet number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the fcc actual events or results may differ materially from those projected in the forward looking statements the it's forward looking statements on their implications evolve known and unknown risks uncertainties and other factors that may cause actual results or performance to differ materially from those projected on this goal we will also referred to non gap financial measures these not measures are used by management to make strategic decisions forecasters to result and evaluate the company's current performance management believes the presentation of these non gaap financial measures is useful for investors understanding and assessment of the companies ongoing core operations and prospects for the future you can find the table reconciling the on get financial measures to get measures in today's press release and with that i would now like to turn the call over to bryant sullivan ceo of the acuity please go ahead peggy robert and good afternoon everyone we had an eventful and productive two thousand twenty two our primary goal for the year was the beginning roman of our phase three victoria one clinical trial for a lead candidate gonna to listen the trial is and rolling patients will advance date or positive her to negative breast cancer who's disease progressed after treatment with a cd cape
spk_2: or six inhibitor who began twenty two working with us happy a and the european medicines agency the final i feedback on our clinical trial protocol what we receive feedback we finalize the protocol and uncompleted selection of over two hundred clinical trial sites across five continents to prison participate in the study besides include some of the world's leading breast cancer institutions
spk_1: after formerly activating the study and the third quarter we're very pleased to daughter first patient this past december
spk_2: the dosing of the first station in the victoria one clinical trial trigger the closing of a hundred million dollar private placement and drawdown have a twenty million dollar term on france in december proceeds from the private placement combined with the depth of philadelphia in the company's current cass cass prevalent in marketable securities are expected to be sufficient the fossil fuels his current operating plan to twenty twenty five so far we are very encouraged by the activity at our victoria one trial size we remain on track with our prior guidance and continue to expect data for the pictures vietnamese database and subgroups to be available on a second half of twenty four and data for the picture is the a mutated basin subgroup to be available in the first half of twenty five the scientific rationale for launching victoria one study was predicated on to key factors first there's a significant unmet need for better second line therapeutic options for her age are positive for to negative breast cancer patients who received prior tdk for six inhibitors current therapeutic options offer only modest progress is viable benefit and second we reported very promising results from our phase one be study that evaluated gotta feel as if plus policy when combined with utilities off or for that
spk_3: for patients lacking
spk_2: patricio imitations public data for proof second my therapist and decay they only offer medium pfs of two to four months for patients who have picked through imitations the public data for medium pfs of approved therapies is approximately seven months the of efficacy data we initially reported and twenty twenty one from her face when the study compares very favorably to these posts result we've since updated our data to reflect thirteen months of additional follow up and we presented this data in a spotlight poster presentation at the twenty twenty two salmon san antonio breast cancer symposium in december update included africa as a result broken off of his and subgroups according to pick threes yeah mutation status and you to the for expansion arms for the patients in our v of the phase one the study those who received the favorite dosing schedule of cataclysm the are are projected response rate was sixty percent and picture say while their patients and the percentage of patients who are progressing free a twelve months was forty nine percent these results compare very favorably the published data for for less than the control drugs for pictures here while i patients and our victoria one study and a recent randomized study for that don't report it an objective response rate of six percent and a twelve month pfs rate of twelve percent for walesa for the on the patients who had picked receive mutations the objective response rate was seventy three percent and it's twelve months pfs rate for sixty percent again these results compare very favorably the published results for the upper lips of them for and regimen the control for pictures and mutated patients in the victoria one study and to clinical trials the objective response rate for apple isn't possible best him averaged twenty percent and a twelve month pfs rate averaged twenty five percent the comparable objective of response rates and twelve my pfs rate and a picture is a wildfire and mutated patient subgroups is driven by we believe to keep actors
spk_4: first a victory
spk_2: m tor pathway is a driver hr positive breast cancer regardless of whether the patients tumor has an aggravating threes yeah mutation are not and second and happening before class one pick three a mutations rise of forms and a to and or complexes is required to most efficacious we address pierre three km to op
spk_5: halfway activity
spk_2: this is the optimal approach biologically because it avoids the cross activation of uninhibited sub units and resulting drug resistance that can occur with pr three k i perform specific or am to are specific inhibitors completely blockading a pathway also enhances the potential to induce synergistic inhibition with other targeted therapies such as tdk for six inhibitors get a solicitor differentiated mechanism of action as an equal potent pantheon three km to our never that's uniquely suits we believe to address the need for more effective second line breast cancer therapies we believe that data and the unmet need we're seeking to address played a key role in the us his decision to grant break through therapy designation in july last year to get up to less of get us a list of in combination with power sick with in for vestra for the treatment of age or positive or negative advanced breast cancer
spk_1: we're also very encouraged by the updated advocacy results for the forty one patients in our face when be study who had not received prior treatment for advanced disease
spk_2: these patients receive gotta solicit combined with politics than left result as first line treatment and the combined group of treatment nice patients from escalation arm a and expansion arm a medium pfs was forty two point three months and the object of response rate with seventy nine percent these results compare very favorably to the medium pfs of twenty four point five months and fifty five percent objective response rate reported in the polymer three study for power
spk_6: second person
spk_2: letters off of know is that the media pfs an expansion on a patients alone was not really does have a june twenty two data cut off we will present updated efficacy data for expansion are may as well as for the combined data for the two arms with treatment a patients at the asthma breast cancer meeting in there these results provide another demonstration of the intrinsic roll the ps rica and tor pathway plays as a disease driver in advance later are positive or negative breast cancer the data also highlight the potential opportunity to develop gotta tell us about the first line treatment option while a randomized first line study evaluating cataclysm combined with polycyclic plus letters all is not practical for us to pursue at this time
spk_1: this promising get a certainly worth evaluation in the future
spk_2: another important goal for us and twenty twenty two was to begin evaluating a prioritizing new potential indications we're gonna to listen this evaluation includes assessment of previous trials for other ps repay and i'm torn amateurs review of other pathways length of the be a three game for a pathway and conduct conduct that non clinical studies the car dr the activity of get of listen and other piazza k h a t m for inhibitors and different tumor types a significant body literature is characterized the crosstalk and reciprocal feedback loops between hormonal pathway signaling and the ps retail ha and to are signaling cascade in multiple tumor types interaction plays a central role and disease recurrence and progression and prostate and gonna call logical cancers in addition to breast cancer as has been demonstrated in breast cancer qatar getting the hormonal and ps became a teaching and for pathways is a promising treatment strategy but the approach has confounded by the feedback and feed forward forward loops between the other guy to forms a keynesian and them for that cross activate uninhibited some years this literature review as well as considerations of the unmet needs and brain tumor types let us to focus our initial non clinical research studies on prostate and than elect gynecological cancers rep results first result from our studies which focused on prostate cancer in february twenty three at the american society of clinical oncology genital urinary cancer symposium which has previously discussed how most pietro okay and so i have it was selectively spare or weekly inhibit one or more keep yeah three can tor pathway components and how this can enable drug resistance depending on the mutation status of a business tumor and prostate cancer the p tangerine is linked to be a three game and it is frequently muted inhibitors that only target a single pr three km for component or ha t have demonstrated little limited clinical efficacy and pretend of isn't prostate cancer and know efficacy and pete and while pictures as as been found of breast cancer to suggest that more comprehensive inhibition of the psv and tor pathway maybe require we lost posited get a full list of as a pantheon began to aren't amateur would be infected and both pizza and wildlife and pizza and decision prostate cancer mods to assess this hypothesis we evaluated a panel of prostate cancer cell lines with different p ten status for their sensitivity together for listen and six other inhibitors the target at least one component of the piotr ek a ktm for pathway the result from these guys were very encouraging and support of of a hypothesis are assessments confirm the get to solicit was the only inhibitor that was as pokemon efficacious and pete and wild side as peter mutated prostate cancer cells in addition in every assessment was included side of toxicity potency cell death dna replication and signaling get us or less have exhibited superior activity relative to all of the other pr three k k t where i'm torn hipsters it a particular know with the contrast between get a for listen and the a catering inhibitor cap of massacre cap of acid trip has been evaluated and prostate cancer clinical trials but it has only reported modest advocacy today and peace and mutated editor tumors and know think advocacy in pizza and while that yours the results from are non clinical studies with cap of assets are are consistent with his clinical results we found a couple of assets or with tenfold less potent and pizza and while and pizza and mutated cancer cells
spk_1: and generally inferior to the pan ps uk drugs and much less active and gotta to listen
spk_2: we believe these results and the contrast gotta listen provide further demonstration of the importance of comprehensively rather than selectively blockading that the a three day and tor pathway
spk_1: to assess get up illicit in vivo activity and prostate cancer we evaluated get it's a lot of in three different prostate cancer in a grab models we first of i were together for listen as a single item and pete and wildlife and pete and loss in of crap models that were insensitive to the androgen receptor inhibitor and a lot of it and both models get us elizabeth induced more than eighty percent tumor growth in a bit inhibition whereas and a lot of had no actively we also have i waited a prostate cancers in a graph model that was outfitted two and a lot of it
spk_2: and this model gasless induced eighty percent tumor growth in addition of a single agent and one hundred and sixteen percent inhibition when it was combined with and a lot of it we will preserve results or next set of clinical studies at the american association for cancer research annual meeting which is being held in orlando florida from april fourteenth to the nineteenth he studies evaluated a panel of gynecological cell line miles with get a list of in several other theatrical a katie i'm torn hitters
spk_1: an abstract summarizing the state was published last week
spk_2: consistent with our findings and prostate cancer get up the of exhibited superior activity relative to all of the other the three k k t m to our inhibitors valid based on the results from these internal on clinical studies and on gather to listen highly differentiated mechanism of action and peter dp pd profile we think there is a significant opportunity for us to develop get to listen of any sometimes will provide an update on or clinical development priorities later later this year now i would like to shift our discussions the diagnostic side of our business centers on south sydney a circuitous third generation diagnostics platform
spk_7: as you may recall
spk_2: the enrollment in the fact one in fact to trials there are they waiting early stage breast cancer patients selected using our cell signal for to signaling diagnostic are impacted by corbyn nineteen related lays during up through early two two thousand twenty two these trials are now rolling patients with early stage breast cancer who's or to pathways i brag and as detected with our something signal test our goal is to provide ourselves senior test as a companion diagnostic so that pharmaceutical companies can expand the number of patients eligible to receive a targeted therapy we expect when out and a result from the studies and second half of twenty twenty three with that all now turn our call over to vicky han are cfl to read your financial results
spk_8: thank you brian and good afternoon everyone up provide a brief overview of our financial results for the fourth quarter and four year twenty twenty two and i invite you to review or ten k which will be filed later today for a more detailed discussion our fourth quarter net loss was eleven point six million or sixty nine cents per share compared to six point eight million net loss or forty five cents per share the the fourth quarter of twenty twenty one net loss to the full year twenty twenty two was forty point four million or two dollars and sixty four so cents per share compared to twenty nine point six million net loss or two dollars and twenty one cents per share for the same period and twenty twenty one for purposes of calculating net loss per share the reported not lots of two dollars and sixty four cents per share included an additional two sounds loss per share related to approximately point three million deemed evidence resulting from a warrant modification because his quarterly and full year net losses include significant noncash items including stock based compensation the issuance of common stock and interest we also include in a press release non gap adjusted net loss for the quarter and full year ending december thirty first twenty two me too or non gap adjusted net loss of ten point two million or sixty cents per share for the fourth quarter of twenty twenty two compared to non gaap adjusted net loss of five point six million or thirty seven cents per share to the fourth quarter of twenty twenty one nine def adjusted net loss to the full year twenty twenty two which thirty four point nine million or two dollars and twenty six cents per share compared to non gaap adjusted net loss of twenty one point four million or one dollar and sixty cents per share for the full year twenty twenty one research and development expenses were ten point six million for the fourth quarter of twenty twenty two you compared to five point five million for the fourth quarter of twenty twenty one the increase was primarily the result of activity is supporting the initiation of the victoria one pivotal trial or in the expenses for the full year twenty twenty two were thirty five point three million compared to twenty five point eight million to the prior year the increase in our the expenses included a ten million reduction in get it to listen licensing related expenses this reduction was offset by increases in other are d expenses which included employing consulting expenses as well as increase expenses for existing clinical trials and for activity supporting the initiation of the victoria one little trial general and administrative expenses were one million for the fourth quarter of twenty twenty two compared to point eight million to the same period and twenty one gene expenses for the full year of twenty twenty two or four point one million compared to two point six million to the prior year the increases for the fourth quarter and four year twenty twenty two over the same period and twenty twenty one were driven primarily by noncash stock based compensation net cash used in operating activities for the fourth quarter of twenty twenty two was nine point five million compared to six point one million to the fourth quarter of twenty twenty one this was a result of nine gap adjusted net loss of ten point two million offset by working capital changes of approximately point seven nine i'm net catch excusing next has used and operating activities to the four year twenty twenty two was thirty six million compared to twenty point three million for the four year twenty twenty one this as a result of nine gap adjusted net loss of thirty four point nine million and working capital changes of approximately one point three million offset by point two million of depreciation expenses hundred a year with approximately one hundred and sixty eight point six million of trash trash equivalent and short term investments
spk_2: compared to cash and cash equivalents of eighty four point three million on december thirty first twenty twenty one the hundred and sixty eight point six million doesn't include the net proceeds of one hundred and fifteen point two million from the funding of the pipe and the drawdown of the doctor saudi
spk_9: i will now him to call back to brian
spk_0: i you vicky or the operator could you please open the call for questions thank you you will now be conducting a question and answer session if you would like to ask a question please press star one on your telephone keypad a confirmation tone will indicate your line is in the question que you may press start to if you would like remove your question from the queue for participation using speaker equipment he may be necessary to pick up your hands said before pressing the start
spk_10: well moment please while we pull for question
spk_2: thank you are first question is from mori raycroft with jeffries please proceed with your question
spk_11: it's on the progress and thanks for to my questions ah for phase three status i know it's still early days ah but wonder if you talk more about number of sites activated and and what countries and are there any comments on site activation or and roman trends the future at this point
spk_10: so we have a plan your best bet a flight level offer a site in each country and we're on track of aggravating our sights on the schedule that will allow us to eventually be able to report a primary analysis second at twenty two or twenty four and up so so far have you really
spk_2: up report other than than or were on plan
spk_12: got it okay and i'm i'm wondering too if you can remind me what the the data safety monitoring review plan looks like for the face three and ah will you provide general update after the as and be reviewed he be generally know that is that public information ego or maybe you could shed some light on the idea i'm see we have and and their their role and the function yeah i think brian
spk_13: as brand mentioned there are regular update on ah depending on data month and committee review is not is standard practice however this study includes all of the appropriate steps to monitor data including independent eight to one centimeter that includes ah
spk_2: some experts in college and statistics and according to the or data would the reviews are starting to the initial patients enrolled in the study an ongoing basis
spk_10: the system has been set in place and damn i didn't he work will proceed or charter got that idea of see operates independently of the company
spk_1: okay
spk_2: okay and one other are specific question how i'd as just
spk_14: i i see in their the pastry as one of the secondary employed your assessing pf as a our our space on her too low status are just wondering if you remind me if you looked at her too low status in their the face one be in did that have any impact in their face one be to results and so for the i it's easier
spk_0: oh one and two were there any trends observed based on on those patients what we we didn't see any
spk_15: differentiation and and results based on her to status there all the places were her to negative but know whether it was euro one closer to pass got it okay thanks for a day my questions wow
spk_2: thank you our next question is alex know with greg holland please proceed with your question okay great good afternoon everyone on this up in the first one just stepping up for the clinical trials where you at the you figure get a healthy balance right now and just had a think about up expand throughout this year that it's kind of sit around that loving million for core level or to pick up a little that compare up while so there's really two components to the expenses the primary expense for the clinical study eyes run through our
spk_1: zero and and associated vendors ah and so those are control
spk_16: individual we we have an organization to clerk operations organization regulatory
spk_2: that is this essay overseeing and managing ah that process that staff is largely been fired and in place to zero expenses are a function of pub
spk_8: topside activation in the moment and you will see as of in and number of patients aggregate number of patients who are receiving treatment
spk_15: will increase over the of the next few quarters
spk_17: figure don't know sir
spk_2: i don't think we've provided i think the guidance that you have or or what you've indicated in your numbers or would have been reported another or caches is consistent with our internal numbers yeah i i would concur with that some of the st elements of analysts who follows very closely are very reasonable for twenty twenty three as they step up to the corridors i got or that that like that and then he admitted bit more and delay with facts wanted to look like about to get push atticus medal of twenty treachery that push the second half just what you're saying they're the kind of the child's i commend it's an update on fact free three four five timelines and yet the i guess to get a patient and rolled in that one and two requires of screening hill twenty percent of patients who are and twenty percent of the hurting negative patients are eligible for study your based on a test results feel that patients that are hyperactive ah
spk_15: and her to say like and so years is somewhat difficult to predict on a month to month basis proportion of patients that
spk_2: qualify for the study as well as just
spk_1: the other screening activity so you're week we had a forecast and it was
spk_2: a little optimistic routed what we're seeing her curling as is that apply to the factory three four five than as well yeah and and and that the issues that issues but the challenges in with getting patients i'm old enough that is is that we require research biopsy your on like your victoria one study where the sassy were rolling all comers and is no requirement for anything other than normal of standard of care assessments in the case of or the fact that is we require research biopsy which may not be standard of care to glee isn't ah
spk_15: in order to assess their tumor and determine whether they're for to pappas statuses hyperactive or not and with covered that became very very difficult because patients good sensing were not coming in for non essential or non standard of care procedures
spk_18: and so really what happy or we've been working with our site to get them back
spk_2: into that essentially prescreening mode and scheduling ali's research biopsies for this patient group
spk_1: okay or maxes and as you know it you have cats to the read out a victorian one
spk_2: but you also guy care which looks like from that list and the preclinical standpoint that our that ability in said my breast cancer prostate cancer and so adds up to pay level setting area try to the measures to did get an idea for a job or one apple your head down focus on victorian all that with the cash and and vs baby spending a lot before that puts victoria involvement read out with the cashier have on and at rest api you can go after these other cancers are you can get about that sure i'm not a great question when we raise the money last year we took into account where soon that we would do a single our early phase your face want to study in another tumor type and so we factor that into our cast projections and and so are
spk_11: estimate of a cat availability three twenty five it reflects the assumption that we do feel
spk_2: a of up that early phase study and another tumor time any relatives in and with respect to kill obviously keep your head down our our goal now i would hope we hope to report favorable date on second half of twenty four we think if the in a similar type and on that projecting a timeline but i'm just simply say we could report in the in that zip code of time results in another tumor time we think that would be very creative to the value of the business because it would demonstrate what is the result was successful favorable i would have demonstrated gotta to listen has a potential not only to be we think that that's a standard of care second line drugs they're suggests we could move up line for certainly the potential for that in breast cancer as well as in other tumor types and yeah we think that would just highlight the significant value or the does drugs
spk_15: provides due to cancer patients and and the resulting value to to shareholders so yeah we think of as the fairly long lead time to get that type of data going and and we think it's taboo bodies advantage if we can ya
spk_0: the plant a flag and another two or tight end of get up a perspective on how
spk_18: get his activity
spk_2: which we think it's a favorable would would be very very valuable to everybody absolutely makes total sense thanks for the update walk
spk_19: think you are next question is from for a speaker with pd cohen please proceed with your class
spk_0: great thanks this is my counter boris just one for me what data should we be looking for on from the that's one impact to trials that are going to report in the second half that all show up has a positive effect like what specific on and points should we be focused on that standpoint it
spk_1: trials is a pathological complete response rate which is a measure of whether the tumor ah has has been eliminated in the patient specific assessment to determine that and and so we
spk_2: have a a fiscal plan that the sought to find the benchmark or that we need to beat and order to determine that we have a job potentially significant result that would warrant you're a continuing study but also continuing yeah towards additional evaluations great idea to ferment like you you are next question is from gil blue lived need him and company please proceed with your question
spk_1: hi this is rather on for guild thanks for to your questions or can you just talk about any preliminary discussions he might have had with the appears as if receive any feedback or possible pricing dynamics thanks
spk_14: outwit we have had a good discussions with the pair consultants or to get some perspective on the landscape be a week we have in our plan to to initiate those kind of covered conversations
spk_20: the as we get closer to the end of the year or but they're fairly well established benchmarks for for prices that have been established with novel targeted therapies
spk_21: the city pay for sex therapists of have been on the market and haven't established price that's been supported over time
spk_22: the the others novel sir that was just approved of the advocate drugged out lips ever pick ray as been approved and established right price points are and so our eternal assumptions assume a rather internal for some sense
spk_23: when we derive a pig revenue estimate assume that that our pricing will be at least comparable to let's say what their peak rank is obtaining in the marketplace and and me a week we've we think if i guess favorable that we will generate a greater clinical benefit for those patients and would certainly warren
spk_24: at at at at least and equivalent price take it thank you our next question is from
spk_25: why yam cooler
spk_24: ram cam
spk_2: sorry please proceed with your question thank you this is okay from has surrendered good afternoon brian i'm just a quick a less than two says just trying to think beyond victoria one at this point certainly this is a steady you know where you're combining the city get for six any better
spk_26: are there any thoughts
spk_0: in terms of combination with other immune checkpoint inhibitors because that's also be sorted out a as a way to go on in breast cancer
spk_2: so the music when inhibitors to days have been approved and t n b c or triple negative breast cancer up there there haven't been successful of results in hr parted from only getting breast cancer as as is the case in a prostate cancer so it it appears
spk_0: that is today suggests that are morally driven cancers

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