- Earnings call transcript Q3 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals Third Quarter 2022 Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. [Operator Instructions] The company will also be accepting a limited number of questions submitted via e-mail to address ir@cyclacel.com. [Operator Instructions] Please note, today's call is being recorded. I would now like to turn the conference call over to the company.

Irina Koffler

thank Financial joining for Results quarter XXXX. and to conference the everyone, of Cyclacel's discuss and afternoon, you today's for call third Good Business Highlights

Act to over forward-looking Litigation call, made Reform XXXX Private and safe by of to XXXX I Before harbor this intended statements to Section are Act the within the that during of call would turning Securities amended. XXE Securities like fall remind management provisions everyone conference the Exchange management, as of the of

As in available and other those among the forth the from and the our set with statements press our include, is including involve uncertainties company's things, SEC or release, our risks discussed prospects, affect filings which forward-looking in Form our that website. XX-Q. may SEC, filing business This

and and and Chief Officer; projections Senior will any for not does Medical of forward-looking President call session. At which begin like Operating us turn business, to program today I’d strategy financial to Vice Rombotis, other and Spiro and with Mark Finance our are provide and such With Officer statements will Executive the take today, of Chief and Chief over progress will judgment followed Kirschbaum, the clinical Cyclacel’s information. third Executive our of Dr. Spiro of by Paul Q&A and overview All highlights on an Officer. quarter McBarron, be our as XXXX Paul this Vice time, Cyclacel President, responsibility update to represent President Spiro?

Spiro Rombotis

business everyone our update. for Irina. joining you us quarterly Thank you, for And thank today

last and and solid or oral Triple Phase fadra designed Last lymphoma. provide ongoing were tumors fadraciclib excited in data fadra study, XXX in which in clinical and exceeded also and month week, We or we reviewed have excellent Phase study or ENA progress with to at I/II day. our oral clinical in with expectations made dosing. programs from R&D primarily new to We and patients with a XXX XXXX CYCXXX our preclinical fadra safety data Meeting I our optimal

the T-cell to Mark on of challenging addition for hepatobiliary several dedicated for our Kirschbaum the landscape lymphoma will cancers own reviewed indications later In have our be Each study principal interest and II in data for of investigators two treatment these cohort cancers. our reasons. its by clinical summarized fadra of and which Phase

One lab from important our cells cancer reasons which Hospital to by tract type. data world obtained drug cancers. for was hair in The of biliary in this biliary these preclinical in in investigator the University potential patients clinics suggests presented showing from specializing from largest tract in her who National the shared Seoul one the sensitivity who fadra are cells cancer

PRs patients peripheral see of which were As treat. to for in T-cell both in Hope lymphoma is and These we by cutaneous explained mono-therapy included investigator difficult to of lymphoma. very from angioimmunoblastic a PTCL the as City type PR excited with the

its of of on evidence reported including biological XXX differentiated and program, We new also our activity exciting early from signals clinical profile. findings further

For are website. our the available a our to of including those event Day join key is on leader you unable R&D who presentations opinion replay the of

study dose in the level registration-directed by approaching data XXXX. XXX stage. Dose with proof-of-concept part Initial is cohorts middle sites from expected earlier of Phase the slots completion escalation fadra multiple stage are if the from the dose a for bit months and X multiple Phase a submitting XX in escalation readouts around X. patients for are this of is currently histology enter Over expect soon next and data fadra The will we the studies XXX. the X/X study

XXX initial We from study in mid-XXXX well. data as this expect

drug recognize company two molecules developers to like institutions. our our would I and bringing our Mark, The of and technical to of at to stage to is scaled over within strategy team tremendous the committed pool proof-of-concept handing Before creating the collaborating value. talent shareholder

we achieving are on the be will for soon potentially We with Officer, and in other may way to kinase that XXX. data. provide classes respective Kirschbaum over their recent do medicines with in fadra differentiated well a clinical on position our inhibitors best-in-class. I our now same Chief to to Mark? call our which We to that turn details believe properties, from will are be our the Mark Medical Dr.

Mark Kirschbaum

Thank you Spiro.

As our single-agent encouraging in progress very Spiro we the X with mentioned and with pleased the are fadra studies. Phase we XXX of activity are seeing

aggressive the X the dose study of X part are longer objective their disease is of the a whether XX specialized course illness. determine responses or to stage out responses of determined indications fadra centers X such study achieved Two dosing of study Phase the for review best briefly study RPXD response. tumor disease stable and to is X It stage patients Phase ones of in is broad and as partial the anticancer choosing patients These pancreatic of with me development RPXD no lymphoma. Phase optimal the The with in be ongoing tolerated maintains objective. into patient an liver, Patients primary X/X are stable schedule. in lymphoma difficult cancer with proof-of-concept see target their to relevant treated Phase angioimmunoblastic Phase types A ovarian move is They world. or cycles treatment. in where our with standard it to subjects recruited the top treatments. lesion have referred sites XXX-XXX of to among earlier are primary of XX thus cervical, Once of early predict phase the of which the safety. recommended disease three in advanced endometrial, five study including and which form into will patient as be immediately responding deeper the designed the participating will generally are achieved exciting Phase X fadra PR this in Let objective termination been activity. will has response with drug X reductions promising of Phase or is oral Phase T-cell the the T-cell with to very and treat X the population; activity a

side Friday considered four-week We no of XXX twice are to dose-limiting out data have quickly is nausea and to including one the is four well a tolerated of BID at to to we dose able Overall, five four. Monday pleased that report study This escalate we that of daily five on been toxicities there the weeks can on thus effect see level manageable fadra schedule are be collected which far drug. dose through dose levels drug. and XXX-milligram only related for milligrams is safe. Based completed as from the dose primarily level consistent completed from

Correlative XXXX dose results with also at studies achieved CDKX predicted of have the the ENA per fadra the is preliminary The good dose approximately four plasma to levels of and day. the proportional molecular target of at still as on we preliminary activity reported and drug. twice and pharmacokinetic such from targets seek Because dosing. results studies dose engagement per dosed RNA in fadraciclib correlative concentrations We so daily CDKX the and five molecular coverage for results threshold studies of seven of cross consistent while the higher continuous five are hours patients from XXX-XXX. show levels

believes tumors concept proof sensitive with As of and and of be identify to of fadra to to we enrolling initiate syndrome, study in acute lymphoma and initial are PLKX including end of second dose trial, X myeloid is XXX level types of RPXD Phase the Monday leukemia XXX-XXX, also our currently forward -Friday inhibitor. on XXX-XXX the Day, oral our of BID the trial update myelodysplastic results solid XXXX. near on at The the reported levels a enrolled Phase six cancer we in XXX-XXX ovarian, one to escalation tumors on XXXX part to With R&D are patients breast, colorectal, from uterine XXX in study lymphoma. dose four, weeks the XXX-XXX which through endometrial, three We evaluate two. look advanced we XX-day one and encouraging recent regard X/X providing is with we an Tumor study, in expect patients interest. at patients in dose cycle. and fadra oral activity At hepatobiliary, early to our milligrams

an ovarian nanomolar lower higher-dose pulse continuous five PLK As We be doses. as XXX, suggests one cancer, cancer PLKX study two traditional, at thus stable strategy. toxicity in documented strategy are six potentially effective inhibition BRDX. that to as non-small it study given for well favorable at inhibitory patients, has pleasantly this metastatic this early with cycles. as for were administration is lung low for metastatic level one human minimizing Published have shorter stage a first through cycles and therefore, inhibitors evidence, that level dose more one who surprised and true as started preclinical profile as we particularly a went in and half-life the disease dose oral the may the for is XXX, This cell type of well low in observe is

cancer in a oncogenes central process. is of BRDX role the regulation an important in target, the plays which many Now epigenetic involved

activity target may several is squamous important esophageal, Our broad non-small single-agent show was ongoing cell across activity. carcinoma. Phase drug's tumor X/X types gastric, observed models ovarian XXX multiple trial the to lung, This where cell including breast, of preclinical and designed

evaluates our for best or financial now of efficacy efficiently these tumor review chosen so schedule can cohort over third Paul the to call study the and to the both will the I that types. quarter Our in schedule results. study turn dose be and dose stage

Paul McBarron

Thank you, Mark.

$X.X of the same million study. and the $X.X professional clinical is ongoing Total to research XX, and a in period $X.X XX, CYCXXX cash September months million each the Phase the ended year activities ended development for to the September due to the million legal period as three costs equivalents million XXXX three same operating totaled $X.X December available directly tax in General in of in $XX.X ready in Operator, ended foreign million same to to of to exchange XXXX. the September million in $X relating $X.X United for XX to September XX, ended months XXXX XXXX. million for for XXXX, compared net September months million three for September the million of we will ended the million R&D $XX,XXX fadraciclib XXXX. administrative previous or the estimates $X.X loss September cash of associated XXXX end September the trial credits studies $X.X September income R&D were increase ended to the correlated period months related three XX million period XXXX. development was XXXX expenses for and gains. costs and million increase to to as period expenditure. XX, for the for period for trial now and XX, X/X million associated ended The expenditures. related research three three months for X/X a and $X.X nonclinical to compared to were in $X.X same Due was Net ended the million to $XX.X of an company three nine programs expenses ended compared expenses for Research decrease same the with clinical for million XXXX months $X.X costs. same $X compared cash Kingdom months XXXX million in of compared As compared The expenses qualifying $X.X for XXXX were period and were the $XX.X of the planned and compared three XXXX. for months cash was million reduction previous take $X.X year. Phase of XX, questions. development months XX, to the to XXXX $XX the as and September currently due XX, for other the compared used XXX-XXX XXXX same to $X.X with XX, are XXXX. million XXXX September as Net for are million of XXXX that fund were R&D The its primarily the and XX,

Operator

[Operator Ahu Demir Instructions] Ladenburg. from from First comes question

Ahu Demir

congrats first also the evening. taking made so on you for on six you course and Good be months Thank the progress have of questions much question XX program. will to my fadra months. the over My

XXXX? there are plan you of for first you the proof-of-concept Given indications and particularly pursue stage, that there for or be the indications that half combinations interested any are are to multiple will prioritizing you

Spiro Rombotis

Thank you, question. your Ahu for

at any because We time. all they indication one are not come same prioritizing the

with However, it sites about investigators far. seen you II is indicates so women's based get the the But highest obviously, interest the both need have reflecting activity obvious disease enroll, state. dialogue we as The on as people feet have and Phase initial relevance to that cancers. two lymphoma the voting as and with will drug for study starts well of unmet their medical clinical

Ahu Demir

time publicly My question public. it? helpful, then for you potential the I know I yet second is but known will to The what the any new line information you to That's pursue curious combinations be Spiro. provide disclose? you indications information BRDX XXX and will know on and inhibition would and not the program. be it's a

Spiro Rombotis

Yes.

scientific I'll of and back on aspect address time lines. Let medical come to the me you. the Mark Mark question. ask your to over

Mark Kirschbaum

early study ascertaining the the schedule. we're and We're still Hi. in very dosing

really So of replicate that of to but kind types hoping to the our are as number it's we're past been going activity to go predict responsive combinations hard single-agent therapy kind of step. first in we're what and at there have a to tumor

Spiro Rombotis

Mark. you, Thank

timing, So the already in not assumption at is below Phase at level, explanation more that clear on is up we Essentially, expected question of this a the we the possibly Day, a to four, has have activity drug need low active the may for you wrong level study. the answer. would we three, in we typically It's we're five see dose escalation is and which go before provided dose the I of to perhaps the window. therapeutic first Normally, that some expect to heard. Mark which escalation, complete that an need R&D know levels,

to this first within happen of the expect XXXX. We half

entry to Phase continue that see of II. speed into up to could and need then You course activity things

mutation which to on recently at the non-small with attention had to addition the In discovered encouraging six who first have activity, G-XXV BRDX cycles, turn very still cancer. Ahu, He's people registered I lung so dose would was KRAS after patient highlighted you like to we that cell level. the study

know mutations. sensitive to we inhibitors are PLK KRAS that As

our but is there you GXXV, for has. is one GXXC is the one As approved need huge many medical know drug drug no approved other of for a which KRAS and unmet there including that patient mutations

expect exciting dose patients to study and investigation to see colon is KRAS with as we avenue like lung, pancreatic, be this So going tumors in forward a other potentially earn very would relevant and I to escalation. our wishing slots move in

Ahu Demir

much helpful. Very you my taking Thank question. so for

Spiro Rombotis

Thank you, Ahu.

Operator

comes Our next question [ph] from Brookline Capital Markets. from Shumbendu Sendhwa

Unidentified Analyst

for question. my taking you Thank

level X? regards many in it? with fadra for planning the X? dosed you – to thinking And are you have are how also level you dose patients So trial, those How been you. enrolling are Thank about

Spiro Rombotis

is Shumbendu, a I this Mark. think question for

Mark Kirschbaum

mean in we're process in it's way I now. But time level information. Hi. accruing It's of -- early just in – now. really real X, with too the to any it's disclose ongoing that's

short in while. we'll update that So, a

Unidentified Analyst

And are trial. dose level XXX you in the and X. moving level dose X enrolling to Okay. for Currently Thanks.

schedule you the elaborate are how please Could to So on there? planning escalate? you dosing

Spiro Rombotis

sure. Yes, Mark?

Mark Kirschbaum

Yes.

So, certainly.

it's pretty It's essentially dose So, increase, X-milligram ahead. level. to a straight each

We have and scientific pre-clinically. pulse both continuous schedule, higher that dose have that shows in dosing low a then evidence doses type activity a in schedule

as schedules we dosing looking and go at of regimens we're both these So along.

weeks with So we X-milligrams started continuously. three

week three So, it's Monday Friday, a of five four. for to days out weeks

then Now is as next a week-off, this XX-milligrams, dose three tolerated. week-on level that will be weeks at we're it's and the continuously

history of how have along. faithfully, these doing kind because a We're drug past will the in and go so. drugs So the slow that's it

at seeing joy to this in this of as heard And great time. two three kind our you of activity. point toxicity the we're first actually, of clinical Fortunately, out patients, any not showed

us we for of multiple treat combinations. ultimate schedule give go to kind patients this forward, So hoping as think story we ways various may

Unidentified Analyst

Okay. color. Thank additional you for

with thoughts about addition What possible like were maybe you even that? finally about therapies. Now are your what may, new if with combinations targeted therapies the XXX, or I thinking [indiscernible]

Spiro Rombotis

Mark?

Mark Kirschbaum

are fashion, see Again, of we allow is the that will if have where dose Think up the this that low do dose. approach a to we where lot it's in about active to holds will it predict with would regimen. simple lot. a of with go very too a really kind thing be major Obviously, these combinations really because we non-toxic early to of But kind a it exactly this.

think I going. getting we're just

Spiro Rombotis

how We Mark's asked. single-agent this that the are of may This also correctly are higher inhibitors to has default you molecular to remind be of a profile audience other end as in single-agent time that the response. of activity. important. gives should other an to support to it -- enhanced the of show bend we important for an It as a going our chance is strategy single-agent us combinations activity part PLK compared good it think discovery the BRDX drug this very chance it clinic explanation To

a safe from very can. allocating pointed Phase to if drug agent out to registration is but course for provide important. single-agent a a to I our if as certainly of combinable mechanistic single activity earlier business look irrational, will test Mark where be So we They exploring bias And and in as its it have capital we combinations is perspective we access opportunities.

Unidentified Analyst

taking so Thank Excellent. you my question. much for

Spiro Rombotis

Thank you, Fernando.

Operator

question from from [Operator Jonathan Capital Partners. Instructions] We'll next take our Aschoff ROTH

Jonathan Aschoff

you, Thank guys.

million G&A Just grow brief this a number, roughly is a or outlier? bit an we little $X that from housekeeping. Should of

Spiro Rombotis

Paul?

Paul McBarron

Jonathan. of bit a an It's outlier

that we've in So had prior the quarter. I would the with stay trend

Jonathan Aschoff

great. Thank guys. sounds That you very much,

Paul McBarron

Thank you, You’re welcome. Jonathan,

Operator

remarks. have I questions to this turn or any time. over back call at further we company appears the no will closing the it now additional And for

Spiro Rombotis

fadra, earnings clinical reported for recently you on based XXXX may IV into we of oral success new all clinical the with plan. data began tremendous the execute for clinical as are work joining call. and to thanks third we and fadra our largely We highly promising earlier Gretchen clinical translate quarter you, promise with development Thank Cyclacel's

anti-cancer is a activity tumors as builds asset our by similar means of and low programs heavily second trajectory potential key providing two this signs hope of important with industry early medical to the Operator is XXXX pretreated forward XXX in some clinical doses the end Our of becoming following on tumors conferences. time meet with and solid of apparent and is momentum lymphoma. was may solid clinical and at lymphoma in agent pipeline therapeutics circles. at progress single takeaway you that at oral look you We updates call. clinical fadra to upcoming becoming to further throughout our patients The in

Operator

Thank you, ladies and gentlemen. This today's concludes conference.

may You now disconnect.

Cyclacel Pharmaceuticals (CYCC) 10 Nov 222022 Q3 Earnings call transcript