Earnings call transcript Q2 2023

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Operator

Good afternoon, and welcome to the Cyclacel Pharmaceuticals Second Quarter 2023 Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. After today’s call members of the financial community will have the opportunity to ask questions. [Operator Instructions] Please note today's call is being recorded.

I would now like to turn the conference call over to the company. ahead. go Please

Grace Kim

and to everyone, for for today's joining second Good Cyclacel's thank financial call discuss of highlights results conference quarter afternoon, XXXX. you and the business

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

in set and involve which those Commission, the As XX-K. and the release, risks with and our Exchange XX-Q including forth press company's include, forward-looking among uncertainties discussed prospects, affect filings and statements in other our that things, may Securities Form business our

our our other information. and of responsibility projections today, of take represent such to does update as statements Cyclacel forward-looking judgment not any and All

followed Officer; Executive Senior With Paul Finance Spiro and us President Medical Chief with Executive Chief will Operating today Dr. Spiro Officer. are of begin McBarron, President, Mark which Vice our President provide highlights and progress. programs, and and quarter Mark Officer; Rombotis, strategy the and and details a by Chief Vice Kirschbaum, financial provide session. an overview second Cyclacel's of Paul on be business will will Q&A will for clinical XXXX,

time, this over I At would Spiro. like call to the to turn

Spiro Rombotis

coming everyone you well. with readouts for on today progressing months. the us and to are our update. joining plogo Grace, fadra or key fadraciclib programs track for and Both we data business you, clinical thank plogosertib over Thank And deliver are quarterly or

XXX-XXX dose study, RPXD. the lymphoma. in data data, patients solid its and complete further dose recommended elucidation epigenetic the And with with in We Phase fadra and dose plogo fadra report In determination mechanism. escalation expect novel of study and tumors escalation the of or X to

Pharmacodynamic data the level the dose our that to is at patients this from task engagement and this to determine are target very levels close the dose level recommended above achieving achieving And goal. predicted RPXD. X on we're initial Pharmacokinetic immediate dosing. Phase suggest Our or daily we

to the expect In increase in of which may RPXD, the we histologies selection Phase another chance see success in is X that anti-cancer activity. the may addition of to choosing parameter

As and patients previously all seen reported, T-cell have Demetrio ovarian including disease and women's PRs also in cervical we cancers, on with stable fadra and cancer, pancreatic monotherapy. lymphoma, and

of thus administered their we that class strategic Our they after in terms RPXD of three Clinical discontinued reported a or profile from proof-of-concept Of of they Phase POC date, been to is molecules AZDXXXX in have other we a X label and collected reported and data intravenously fadra’s notes, study. to available. become activity POC is have a Phase its portfolio of this competitor candidates, clinical a far. declare are the anti-cancer believe differentiated that once trials X the CDKX/X AZDXXXX participate a they Based stage with and as to sites totality from this will selected once mind in on data CDKX elect ready start safety week. inhibitor recently be stage disclosed open prioritization,

administered to on CDKX/X We required tablets a CDKX is and schedule. Accordingly by daily continuous fadra enable believe apoptosis. a is CDKX that targets on inhibitor pressure oral

plogo. not to turn us Let

ovarian non-small cell lymphoma. lung, early and biliary has plogo with advanced inhibitor at with shown In now low doses, plogo study, carcinoma, in our that adenoid novel excited of we evaluating cystic activity solid tumors anti-cancer epigenetic emerge cancer. signals level in five activity. are XXX-XXX very patients patients as at and concentrations for are plogo We is could PLKX a dose treatment with a escalating tract,

further novel specific findings, cohorts data, revealed basis Our more the differentiated of concentrations. A will on or biological selected enroll plogo’s may epigenetic at patient elucidate corroborate program, aiming has these biomarkers. profile the to future, low preclinical in activity one

over will recent call turn I data. now Medical Officer Mark provide clinical to to the Mark? Dr. Kirschbaum, Chief details on our

Mark Kirschbaum

Spiro. you, Thank

As in both accruing fadra in are clinical you well, plogo studies. programs are respective our important their and and the heard, stages

cycle Regarding we recently fadra, enrollment T-cell reductions tablet is of the lymphoma which very form as we that expect XXX-XXX and and all endometrial peripheral previously dose completing best The achieved target documented three the like of I XX after commercial select summarize levels six, PR, may were would study. achieved of pretreated eight, out their patients launch. dosing patient tumor we lymphoma. in a disease was patients has RPXD. with shrinkage are the fadra and support have using to Of seen in note, XA to reported including eventually of ongoing. aggressive cancer at angioimmunoblastic what oral cervical two endometrial with liver lesion shortly T-cell We level now heavily XX form a with cancers stable ovarian one with dose patients response. patient

of manageable phase for In five be in The promising is maintain to discrete testing of other. and and The X X. toxicities have we continue to major us safety for of cohorts, disease reversible. predict patient thus responses are each pancreatic in the assess relevant primary in clinical nausea and of far objective tumor parallel types. this Phase directed seen registration activity stage independently Phase and determination of These to which types treatment. follow study may each RPXD running and design this to recruit stable and tumor of hyperglycemia, cycles allows deeper The different fadra’s were the responses

of plogo, in turn solid XXX-XXX and plogo inhibitor, with in advanced tumors study PLKX lymphoma. the oral Let's patients to our now

cycles. level at early biliary intriguing patient and low four ovarian dose dose cancer cystic three three disease cancer in one a for with cycles non-small for a with at eight stable level in with concentrations and cell We dose these for dose five adenoid have cancer patients cycles clinical patient continuously. included two observed two and given These a activity level at for lung carcinoma tract cycles

Approved data are refers currently have epigenetic control We shown dose far. way to plogo No mechanisms epigenetic activity cancer the DNA low thus epigenetic typically work have deacetylase as to with Preclinical or agents such therapies. traditional that reported five. Term drugs had methylating enrolling at histone gene chemotherapy as concentrations, cell level changing of opposed inhibitors hypo sequence. SAE other mechanism. without forms been and

in colon, These cancer epigenetic lung target and single possible correlative preclinical in biology investigating actively designed preclinical clinical models several setting well types our are lymphoma. The potential as XXX-XXX with study. as study We suggests and to is mechanism tumor this important include agent activity. the

updating as designed dose RPXD schedule we stage both of our is evaluate evaluation We efficiently and p forward to you cohort proof-of-concept study fadra Our or to look study. optimize and for to of progress plogo. the the

I quarter will second and now review turn our results. the call to Paul financial over to

Paul McBarron

Mark. you, Thank

end total currently the As $XX.X same cash million $X.X cash planned June equivalents $XX.X compared company of The months six used of the XX as XXXX. XXXX, its estimates operating million XX activities XXXX. XXXX, million million XX programs of was December through available period the fund for that June compared cash $X.X will ended of for to in Net XXXX. to

extend liquidity not expenditures, incurred However, into of have could the the requirements plan operating which our includes quarter XXXX. second discretionary

June in Research three fadra $X.X period $X.X expenditures. to associated R&D the in for XX R&D XXXX the $X.X as in non-clinical same for period million months XXXX increase for XX progression ended due due and compared June compared the XXXX, development XX million expenses to $X.X ended the or million were as expenses costs months three $X for compared XXXX of to the the ended million R&D XXXX expenses XXX-XXXstudy. $X.X period relating same three million in for months with trial as were same clinical XXXX. for were the to to plogo to related to million June the

XX same the months and June XX of the million of tax to compared credits XXXX United expenses June credits General the and decrease XXXX effect the XXXX rate for and flat Development period are relatively year. $X.X expense XX of was for due April $X.X income research of other to three remained months tax a directly net to million. for three the took expenditure. were and XXXX correlated and $X Research million ended previous in three credit $X.X to period at the year, that $X.X for months for ended previous in June development this Total the qualifying Research million same administrative tax Kingdom an the ended million, compared year. development

Net the three the loss compared million, XXXX to period $X.X XXXX. was $X.X June in ended for months million same XX for

now to take are ready we Operator, questions.

Operator

Instructions] [Operator

Demir, Our Ladenburg. first question comes Ahu from

Ahu Demir

side. my taking questions. Hello, you thank much Three our very on for

the of PLKX will in disclose developments First PLKX compared profile more you to to be you given recent this one plogo but mentioned much us. the however, action the disclosed and on and Could time names I differential inhibitors? some would can week. know just in mechanism curious, later of field details other be elaborate

Spiro Rombotis

that question. other in with the you time, have cancer tested mechanism potential the you always that the the two that only cancer, clinical has a week inhibitors a Ahu. PLKX patients. tested But presumed not. change in has of we developments does have target will Last seen molecule as we an is epigenetic been agent of mechanism. the in by molecule clinical several details when classification. BRBX, is plogo’s relates importantly, excellent the activity as in protocol. have part same of of That's frontline never combinations. molecule Thank disclose we It's cross mentioned, emerge other is other that a and us, believe evidenced an agent reactivity plans, of Very plogo epigenetic There which trial story validated is we molecule interest are the question, the this your epigenetic certainly is colorectal between for been full with as that in stage difference single a a single to to the where At we year candidate

have functions. versus a on we chance indications believe potential should XX but on to the about make of molecules that biological We consider XX given we is here have best-in-class the different Last it were one point market based drugs molecule. both different both to without believe hours, I very around a orally, half-life these have

Ahu Demir

-- what see up you Thank be are follow greater you're when there would clinical question trial? you, And plogo in a a that indications Spiro. efficacy trying any of a

Spiro Rombotis

think the tumor exciting any dozen importance oncology, as which Well, different cell of These new very it's is still are cystic tract obviously Mark patients so early seen far. biliary adenoid activity carcinoma, and in have cancer, drug, a reported to I in ovarian given lung and market four types about so in we days, cancers. this non- small or also

us for have seen the reasons as to potential interest So is women's great the that activity cancers this class remain in of for before in we lung.

We our have so course triple is patients cancer of and change colorectal negative also and believe may not far We picture. had that bladder enrolled possibly to any sensitive inhibition, breast. PLKX change then will

enroll if of to that cohort on is fully the patients the course, that in fully plogo tumor So to it agnostic, as because what to may be that But the which choose intentionally story and mutation. the we this based and here remains with sometimes In a the epigenetic mutation story matter could chemo specific words, be next the able mechanism a the other can a enroll profile tumor tumor enroll unfolds. quarter More tissue selected regardless is originated of of patient only driving unfold. patients. patients corroborated, on in is of type

Ahu Demir

And Spiro. is the When sense, any timeline my data plogo? from efficacy the Makes when will -- expect look we like? be should of last programs what question fadra or any

Spiro Rombotis

mentioned a fadra possibly Well, this report should come will bit of full by results that XXX-XXX first X the the study, Phase sooner. the in the we end be this for year

at prior it should follow extensive complete aware worked in company patients of X, that up. preclinical clinic their soon beginning moment, will by the this fadra data Cyclacel that on which us the we're to last the go be unfolds You complete as as to as itself, collaborators ready Phase and story of being the

course, complete In end will this of sets year, of the have we studies, would first for cohorts need case to least progress, doses but of two have conservatively, towards in plogo we of disclose or clinical the expect are to assuming early we at additional plogo, expect confirmation three results mechanism sponsor data year, which the next take us the December, more collection. we before in by and

four products next these of data both will So over a have flow three the quarters. to

Operator

Oppenheimer. from Our next Jeff Jones, question comes

Jeff Jones

And the guys. for afternoon, thanks questions. Good taking

on Ahu’s your level take to to to And have of call you RPXD. RPXD? look study. I And for timing follow couple be does that at you enrolled Do able a Just dose confirm fadra. the there just ups like six is start patients from wanted what need it long X how to POC then the call this point? Phase to enrollment from XA to

Spiro Rombotis

your for question, you Jeff. Thank

Let Mark part Mark me your first completes the of ask to when Dr. the Kirschbaum talk question. come to back and answer I'll X about response Phase and and question,

Mark Kirschbaum

Sure.

the few have last have day are start We expected and patients consented any now. to

Jeff Jones

So that RPXD, to achieve Mark? time a

Spiro Rombotis

So with this time protocol a asked. follow up Jeff that

Mark Kirschbaum

So the technically, cycle. period DLP is one

days. that one for in we could activity, safety one obviously we safety, the month will it early through to of get following they but them declare terms of if be it, part be month XX for So is still

Spiro Rombotis

of Phase to second obviously, as explained. Mark one declaration question when Jeff, Mark. is are going start we you, prerequisite X, Thank RPXD Great. was your

the is strategic to X, other stockholder that board into section parameters both all start balance options, end and Phase explained make will corporate of The to QX. one as value, initiatives of sheets the our remarks the way in toward so pursue his of and these and decision

Jeff Jones

Great. Okay.

you solid tumor follow the escalation the patients. on mentioned presenting up, one data dose the lymphoma, Just in

are the sponsored company conference, through X you thinking you a that of to totality a that? event all data about are walk about at end, that the So Phase year towards How data? or thinking

Spiro Rombotis

company do Antonio with have are announcement us Obviously, you, some all past consider con early to therefore, conferences deadlines like first, have above. We submissions the we'll year there end to and [inaudible]. for at like or for

Operator

Markets. Our comes Brookline Capital question Dolliver, next Kemp from

Kemp Dolliver

Great.

spending So are second the into when thinking with timing talking? what's likely where with you're to about about runway discretionary regard s, given the discretionary You're your quarter? talk you and amount data you resources, of of dollar extending

Spiro Rombotis

Kemp. this one Paul. think Thank you, for I is

Paul McBarron

Thank you, Kemp.

at moment. would at referred what expenditure So That's discretionary. clearly the I the what think look we we by is uncommitted

it limiting I R&D us of UK our tax that allows that part bring cash think the That's important the into which spend, uncommitted some prepared to dollars million number fact into company, of to early that QX remarks. the in $X.X about that by then in is extend flow credit. I us allows XXXX XXXX significant a the of mentioned

Kemp Dolliver

to over a Got still too And interesting much on you if it. like this. Is to fadra choice. more plogo, not But program, fair? looks had focus the make that

Spiro Rombotis

asking they with fair data. has liked question, a is That as And it's It's certainly which most. excellent parents generation of almost the children said compound prepared field opinion, our and active the as advanced two the fair lost value safety record. the to most who and for And we the if an actually clinical momentum next and stockholders. exit our potential the an competitors terminating in have remarks, most programs, fadra’s seem had two CDK in increase in not value scarcity and we

Obviously, is interest in a these compounds itself The that there strategics. attention Kemp, our will developments the alignments. investors dimension corporate can those other in in of well explore forward should other various as which come lot molecule manifest need And initiatives, to you in dictate your course, from fastest. of bring could that and the to to question, parallel of due we that as interest

as became For or funding develop you theoretically of inverse transactions non-dilutive could fadra. fadra out capital opposite plogo could action are And about the non-dilutive license as of from the we plogo excited were with to mechanism coming parties support from happen. the example, could therefore, fadra plogo, if as

fadra time, X X end to and both relatively drugs Phase of the are is for committed the at at plogo, Phase we taking to ready. to this modest even forward So get get spend to

value in company understand all hope exploring So this difficult maximize available that avenues capital is stockholder to you in the time the markets.

Operator

to We in turn over queue. At back further like to call the have time. speakers. today's this questions no the I'd now

Spiro Rombotis

programs catalysts profile Both Thank And earnings us classes. important everybody call. you quarterly the much, with approaching a competitive today of in operator. you joining very our our therapeutic strong thank for for are

determination are, XXX-XXX dose tumors the reminder, in for upcoming and advanced from key escalation patients with from oral RPXD and our study for a As stage lymphoma. data report solid milestones XXXX final fadra

in patient dose X oral tumors XXX-XXX study solid solid novel proof-of-concept advanced in with Phase XXX-XXX and plogo oral of with of plogo. data from X, and patients fadra advanced with action Phase lymphoma. tumors First study in Report of of lymphoma elaborate and patients mechanism

at may this look the at to outlook time with upcoming meet further conference. you forward to hope We providing you you end call. Operator, with and

Operator

This today's Thank does conclude for your program. you participation.

You any at disconnect may time.

Cyclacel Pharmaceuticals (CYCC) 9 Aug 232023 Q2 Earnings call transcript