CRDF - Earnings call transcript Q4 2024

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Operator

Welcome to the Cardiff Oncology Fourth Quarter 2024 Financial Results and Business Update Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded.

I would now like to turn the conference call over to Kiki Patel of Gilman Group -- sorry, Gilmartin Group, my reading. ahead. go Please

Kiki Patel

operator. Thank you,

on Chief the Officer, Cartus us today Levine. call Officer, Mark are Executive Financial Oncology Erlander; Joining from and Jamie Chief

During of data statements, for onvansertib make related management guidance, readouts the trials. limitation, to timing without statements forward-looking and results clinical conference call, including, will

based the current uncertainties. expectations forward-looking inherently involve These on statements and are and company's significant risks

these as those the and of actual events from such of and risks materially timing anticipated results a forward-looking statements Our differ could in result uncertainties.

cause any XX, that Cardiff these in SEC result duty ended XX-K Factors titled in a be statements Form undertakes include results events the year Factors could of new to December the the information, different factors for changes XXXX. its Risk statements describes expectations. forward-looking in future on its with from annual as report the to Oncology company update or no filed or obligation section

With Chief that, I turn Mark Erlander. to Officer, Executive the call over Mark?

Mark Erlander

or Kiki, was a first-line you, CRDF-XXX which ongoing everyone, from million released raise. to call. $XX for our of and afternoon, thank Colorectal initial capital for Cardiff we On Well, data an highly you December believe XXXX successfully our RAS-Mutated us Metastatic we encouraging conference CRDF Cancer basis and trial fourth as in mCRC, served quarter Oncology. XX, business complete The a significant and joining for update thank was good

On today's X call, we address topics.

and plans onvansertib. data in mCRC and update First, enrollment on an we released program our for briefly lead then we previously registrational will review activity from the provide our CRDF-XXX

what XXXX XXXX. expect including the Second, we'll discuss for intellectual our advances we made in strategy, and property

discuss share filing. posters Breast our financial at XX-K from in Form our highlights San we'll position December. in we will Antonio presented And we that today preclinical finally, we disclosed Third, Cancer Symposium the X

plus trial Phase of our mCRC in FOLFOX of initial of which combined or set XX, In I standard for a the on disclosed data standard CRDF-XXX, trial. FOLFIRI or dose from levels an patients November as released randomized XXXX, previously December, with ongoing XX care evaluating of bevacizumab the begin versus X the II data is onvansertib bev first first-line current alone. regimens, review care we of with RAS-mutated

were we the observed the with Overall, pleased efficacy in signal trial.

as XX mg of onvansertib of patients compared the a control a First, demonstrated the XX% data cutoff the ORR XX% on date, to in ORR arm. dose

mg deeper other than the arm demonstrated responses tumor the arms. Second, XX

the on an mCRC. of the trial Specifically, of across of XX released, the receiving for active candidate the onvansertib. is therapeutic effect initial dose and a regressions that treatment this signal serves we correlation biologically as dose X are entire deepest tumor between onvansertib drug in the the onvansertib mg of patients Based seen the magnitude data believe

and Finally, is important the date, like factor XXX favorable inhibitors across been due onvansertib treatment dosed highlight differentiating trials to clinic I in have failed to been multiple would patients to over concerns. with tolerated. Over an onvansertib's toxicity safety well the clinical that profile, has PLKX which have previous

results December from from investor the Investor Relations XX cut, posted CRDF-XXX our presentation corporate full website. the the our For or data trial to refer call clinical on please initial

half expect clinical the to of the XXXX. continue CRDF-XXX in from first We to trial release additional data

enrollment of registrational status mCRC our and pertains strategy. as will I Next, share to our program it the current

patients XXXX. in trial few complete entering anticipate December, next in the complete in early we weeks. We In we to mentioned Today, the CRDF-XXX evaluable share screening. trial of expected XX the enrollment. that this regarding trial in can we enrollment I patients First, week, the planned to closed that enrollment new the

for the onvansertib another from an in registrational in strategy approval FDA mCRC. company validates Secondly, approval important 'XX of QX there our is that

clear, the mCRC a first-line mutation. its patients to Pfizer with a Specifically, be from totally evaluating announced B-RAF separate in And BREAKWATER trial encorafenib drug is RAS-mutated focus. this from its our population mCRC results patient

validity trial of using and their subset patients meaningful ORR achieved The interim survival, FDA encorafenib a as strategy. statistically same agreed which of time regulatory single for approval reinforces pursue in pathway and for plans onvansertib accelerating point approval an is accelerated a BREAKWATER at used a significant and by approval. full improvement full progression-free with registrational the Pfizer from to our subsequently from Pfizer's for therefore, endpoint trial clinically the is achieved our

the intellectual with strategy. lead than treatment XXXX. the the our second KRAS-mutated strengthened who portfolio for previously bev. topic, treated method with earlier not a of has of with claims patient of program in of combination issuance the our cover mCRC been have we XXXX, mCRC our The population aligns date to QX an agenda expected with intellectual The property property using bev new of on move expiration In now onvansertib no patients target onvansertib our I patent for and patent.

of believe powerful demonstrating inhibiting new We patent bev groundbreaking synergy discovery, the with underscores in our the nature onvansertib's angiogenesis.

to new We efforts year. made this to we more convert continue novel the regarding discoveries the new on inhibition property, role these you could PLKX have and to opportunities intellectual hear into later expect of explore

X therapy inhibitors. first combination objective from to third Breast the with Antonio The strategy of evaluate and I San after paclitaxel or we onvansertib of breast positive December, therapeutic our in program. hormone receptor reporting a as CDKX/X at on breast patients Symposium In for was our potential presented cancer Cancer HR-positive the poster progression endocrine Now the presentations cancer preclinical move poster item will agenda. to data

exhibited models onvansertib cell paclitaxel cancer antitumor lines. xenograft vivo, demonstrated combination synergistic HR-positive or with the robust breast In in patient-derived activity resistant In therapies. X first-line activity and vitro, to PDX

enhanced in antitumor displayed evaluated activity and ENHERTU poster combination PDX was combination compared breast monotherapy. overcame ENHERTU second onvansertib HR-positive to of onvansertib the The ENHERTU each of The tolerated, models. cancer and drug-resistant resistance plus well

therapeutic represents currently are therapies. Overall, evaluating the first-line cancer with the patients a promising HR-positive broad through onvansertib, some our breast of for to of posters resistant believe trials. these investigator-initiated potential combination we of which highlight ENHERTU We strategy onvansertib

item, For quarter our to Jamie? fourth financials. talk I last to Jamie over turn will call the about agenda our

James Levine

Mark. Form with Earlier issued XXXX. press we you, results a the which full today, filed XX-K December our contain financial SEC, ending XX, Thank and a release the year for

our balance proceeds successfully with raise to health in as Turning December new capital XXXX, investments of net completed includes million the existing $XX.X and million, the we December institutional sheet. Cash which $XX short-term investors. and totaled of dedicated care XX,

runway was on the forecasted the QX burn. believe of with provide our that ongoing for clinical quarterly Based cash cash operating in into programs, typical current Our activities XXXX, our XXXX. in line quarter in us spend cash $XX.X million used resources which first our we cash with is

was Finally, our I'd S-X, that out previous shelf Form maintain for shelf been on issuance in the this which practice today, And to registration point not shares. of did we always April like involve today we to statement. S-X clarity, our filed that replaces has active any year. of an statement expire registration also shelf due to filed a It the

Mark. I'll turn call to over back that, With the

Mark Erlander

Thank Jamie. you,

trial highly half hear of you the in the and shared remarks encouraged the from look results year. first trial December, and forward additional to updates could in today, that efficacy are As this CRDF-XXX we by we we from sharing our from the

a like I their to moment the and that, families, enabling is would the thank the whose efforts. our importantly, in With to clinical patients investigators take clinical participation and trial development

year. for that, the With treatment will paradigm believe has now potential to the up to large questions. with that onvansertib patients, the of change continue open We mCRC diagnosed call who for each the are RAS-Mutated number Operator? I

Operator

Cowen. Our from comes Instructions] Frahm question with first [Operator TD Marc

Unknown Analyst

Mark. This is Alex on for

do us how in half the when is PFS be? update and do to in exactly ORR? So of that can then And evaluable how any new first what for that you many in you expect expect update, you become sense also data will those curves mature context? And coming patients give

Mark Erlander

question. to the and really -- goal that since more substantive point update. in is give next At a mature our for what this XX-patient Alex, update update, actually time, to to our Thanks,

So -- for is that's this that year. this to this it we something half at When obviously, this early at think first that's comes PFS that point, -- within of the first early this But I what we updating will to really do. that, half have beyond probably too planned half. -- PFS, be

Operator

next Catanzaro question from at Our Joe comes Piper Sandler.

Joseph Catanzaro

whether you you converting selection XXX Maybe around registrational sort a a couple of come the decision the will me together and dose just that speak here. FDA for interactions trial. with with thoughts Can and will your potential to make your to when

I cadence sort those of decision Just through a maybe walk have the follow-up. points? And then of

Mark Erlander

Project is topics get we be of our Optimus. as possible. the about. as goal, is our Really, soon CRDF-XXX question. that really for there's is FDA that on you the to in this -- Joe, X really FDA talking based goal And to know, the front as will Thanks, And

first, then the which the course, trial design for really the is XX second is XXX. versus registrational of And finalizing the XX. the The dose, is the -- really trial,

from of may soon is patients. goal may point all I get not to It be our XX So or less. be as could This possible. mean, our as to view, FDA the

looking depend course, the that signal and on XX will at Of XX. it with

the give meeting So are us And after that and of FDA, course, that's will right with going be that we now. registrational the gating factor I into XXX for that that, really, where will -- that clarity think the trial.

Joseph Catanzaro

Got Okay. it.

here. Mark, follow-up BREAKWATER my the of head the terribly trial data encorafenib. top my on Not your So to off relates with the comments, of familiar

trial study? my seen observed in accelerated with the approval So far rate they that in that whether that what response XXX question is thus supported the you've delta aligns an

Mark Erlander

Certainly, XX%. was XX% great consistent. question. ORR is Certainly Yes. versus Their Joe,

consistent shown the XX with that we I patients. far have So with first certainly think it's what so

Operator

at comes Our William next Hsieh from question Andy Blair.

Tsan-Yu Hsieh

evolving me, don't size really tumor velocity of if terms thinking for of is One of reduction. in your X you kind the mind.

And the one the So of relatively the slope observations and flat on most you deepens, as really control December alluded basically, it to, at milligram. Mark, is time. of obvious arm the the XX is over the data, XX-milligram for then call, looking

curious if some de-risk prior So PFS about that how think endpoints based such as could the OS. you on inform of endpoints, and CRC I'm or experience data approvable

So that's #X. question

do to BREAKWATER. with also has #X Question

number that patient the the required patients that's XXX arm. each about approval in for was trial, So accelerated

potentially could discussion kind upcoming I'm form that the context of -- the curious, pathway. of that's your the accelerated approval with if of FDA the framework in So

Mark Erlander

for one, OS. in data questions. greater there are responses and clearly, PFS been and going responses a showing first -- Yes, after deeper earlier both have has with line Thanks, that those associated that in first trials CRC Andy, of correlation and previous

is known. So that's something that

And well, Certainly, went arm we their was what moving certainly, looking per I think XXX interim. their on for the BREAKWATER, at are they to after that.

to the the when them. specifics around of is for talking course, our good are we one meet and of do assumptions FDA to trial was fewer and, course, be, BREAKWATER design, is Andy, you which certainly, finalize point will full that approval. We the accelerated needed one, showed that the what our with a patients make, that But

both you questions. So those for thank

Operator

Robert Our next question comes H.C. from Wainwright. Burns at

Robert Burns

And last amazing me. I again, just congrats the for you that reported follow-up year. late data one on guess

although we as especially And being GXXC you trial. that the get about that [ in developed agents So pan-RAS cancer, also thoughts also to to are minor obviously, your know a the is agent, code ] XXX space? in I colorectal the wanted break how component view KRAS

Mark Erlander

drug an the approval of a up small The just which you is for X% inhibitors, really mentioned, course, year, about RAS-mutated of of KRAS GXXC, those but patients. -- line. about is RAS-mutated It's makes last thanks GXXC of that And very sliver second questions. both patients. that, Robert, as Great. Amgen's was with and is there the in know you

what So look too it's first that trials. -- small. we second our in line line, they and not patients within from impact with doesn't we're also those at really it's think are we mutations what a mutations, And in really -- since do there, have such it doing I really GXXC

or well as -- in the RevMed, GXXX with the is the pancreatic clearly, that's the the signal non-small PDAC. So program, as cell the the

what with what for in in agents And they're as don't colorectal, doing but so much reported are certainly activity keeping and the eye space. we an their progress this on we see they've their

Operator

next from The comes Craig-Hallum. Lowe question with Albert

Gum-Ming Lowe

to see the is complete I was enrollment going to great over it's weeks few wondering, just here. next the

be able first think XX of all update? included patients you in we'll do the to this So see half

Mark Erlander

XX December for we're out patients, scan. you XX which that are We when very thank really that in we pleased X of reported the we finishing Yes. dosed a least Albert, question. excited within of couple patients the post-baseline -- Yes, weeks had did and by enrollment. have at

out our update first make substantive -- treat these update more goal half And the and And really so this is from we continue next to really and continuing sure a really reporting patients. for to be to we'll it's obviously, trial. the mature

at leave we at this it So point. that

Operator

[Operator no other at Instructions] time. All right. I'm questions showing this

now So for Mark this I session. will like remarks. closing conclude to turn would back the to question-and-answer it

Mark Erlander

Thank for and again this here you -- afternoon for operator, this thank for joining us you, all call. everyone

Operator

Thank does conclude now conference. you today's may disconnect. the This and in for participation your program, you

Cardiff Oncology (CRDF) 27 Feb 252024 Q4 Earnings call transcript