Cyclacel Pharmaceuticals (CYCC) 14 May 242024 Q1 Earnings call transcript

Good afternoon, and welcome to the Cyclacel Pharmaceuticals First Quarter 2024 Results Conference Call and Webcast. [Operator Instructions] Please note, today's call is being recorded. I would now like to turn the conference call over to the company. Please go ahead.

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the first quarter ending March 31, 2024.

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

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

overview Dr. our highlights Spiro McBarron, Brian Executive will of business Officer; such Chief then by first Medical will followed to of our progress. Officer. update and Paul will and Cyclacel strategy Rombotis, represent Executive program, Spiro Schwartz, of With XXXX, Officer; any statements judgment today with quarter session. today us Chief the Chief President responsibility All information. as and be a Operating will financial details and are provide other does clinical projections on Vice forward-looking of Paul Q&A and and not and Cyclacel's Finance our President, for Brian provide which an begin take

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

joining for our Thank XXXX everyone, update. and us today for you, you, thank Grace, first quarter business

begun of abnormalities, of with in loss per and/or part deep for rules. including dosing X have function. deletions have financing Phase fadraciclib placement proceeds or closed II in $X our we short in at XXX-XXX chromosomal a As the proof-of-concept resources place, patients study, With priced NASDAQ in reported, market million of private previously CDKNXB patients or in CDKNXA additional more for the we the fadra gross evaluating

abnormalities data, a findings are and/or which X and/or II we for approach solid our clinical potential recall enrolling patients. precision inhibitor preclinical following lymphoma those In are for and or evaluating will I fadra. hypothesis the with patient more sensitive that with in oral patients an pursuing mutational initially these tumors multiple selected of activity CDKX/X abnormalities to that one Phase medicine in maybe various suggests chromosomal cohorts, based lymphoma. we the I and and We're You fadra, also part, Phase anticancer CDKNXA Phase their including in observation CDKNXB on activity, T-cell responses patients of profile

cancer these glioma, T-cell certain that co-deleted. on squamous, there solid and We several great the and pancreatic melanoma, abnormalities, need lung, identified bladder, head breast, lymphomas. populations medical in neck, in in and endometrial, are is esophageal, believe closely which by occur gene industry deletions hepatobiliary, are ovarian, patient unmet also including located CDKNXA including interest often and tumors, X chromosome

drugs CDKNXB and breast, B including glioma, endometrial, no esophageal, with are head deletions approved and There pancreatic solid melanoma, others. patients lung, several occur in abnormalities. hepatobiliary, and cholangiocarcinoma, mesothelioma, tumors, squamous to or including CDKNXA neck, treat bladder,

study this the the this in and weeks a study presented fadra the on data year. part readouts of Final the dose clinical support X expect We for of activity initial escalation in the II few second to ASCO key the part XXX-XXX Meeting Annual data from year. of proof-of-concept from XXXX at be Phase half

and to our our study. will fadra to some Brian call the progress results discuss clinical review Brian? over the I turn now of in

recommended we study, our determined dose Thank fadra. you, XXX-XXX recently Spiro. the completed for II Phase In

cycle. schedule. were As in days a observed No toxicities XXX this week reminder, the X on X-week milligrams BID per is dosed orally, a dose-limiting

CDKNXB II. alterations. cohort the participating with first of study the in we Phase initial the CDKNXA up to part order X sites up focus We proof-of-concept with II patient the in In have or the to speed additional of now the in have dosed patients enrollment, Phase opened with

results We initial the half expect to deliver second by of XXXX.

for As study, through our strategy. clinical rationale we me the let progress summarize the Phase II

We unmet from cancers. CDKNXA in CDKNXB I lung, Phase associated loss have with testicular patient multiple, clinical a often including monotherapy. who and gynecological, of and have function included patients with These outcomes. alterations, pretreated recently pancreatic or observed are These hepatobiliary, poor various fadraciclib benefited groups high need

post target deletions excited cycle a squamous illustration, oral X to fadra patient have on experienced X. recently therapy XX% clinical with of analyzing total treated we standard-of-care enrolled a patient patients monotherapy benefit CDKNXB chemo a who cell target sum a fadra the cycle see and and all all immunotherapy. lesions to X found X I years Cycle the in were IV XX% as endometrial After the non-small now the lung sum first patients continues subset treatment shrinkage whom of and of with of cancer advanced achieved of study retrospectively all an an cancer found with previously As of included we of achieved CDKNXB a testicular lesions in loss. and of patients, CDKNXA or alterations, was These surgery monotherapy. in to CDKNXA and of refractory after A the monotherapy CR in cancer previous Phase CDKNXB on over patients fadra reduction

patients, Phase X loss had our activity in I CDKNXA. of PRs including one also whom out treated, observed by patients lymphoma who T-cell encouraged X are in of We of anticancer

of of a large loss patients percentage lymphoma Literature suggests that have CDKNXA. T-cell

evaluating these Paul X to study. are part our review will of call limited now results. turn generating proof-of-concept the in data types over to quarter with Although data first II the Phase Phase I be believe the we cannot and cancer generalized, supports the hypothesis that patients

you, Thank Brian.

claim this credit for million tax cash As United and of and the XXXX, private the March XX, received million, for placement cash and which XXXX. second final $X.X $X.X part and research month's forma pro from equivalents cash includes proceeds Kingdom of development totaled

in million in XX, to XXXX. XXXX, December to and part million to as Net tax Cash equivalents million of March includes $X.X in March period ended used of XXXX. million the million XX, for $X.X cash compared first $X.X $X.X same months of activities R&D respect March claim was for XX, cash compared XXXX operating credit as the X totaled XXXX, the received the which of $X.X

$X.X million the R&D and expenses XXXX, Research X were R&D development same for XX, the X for or months to and XXXX R&D expenses $X.X as March $X to million in ended were fadra same XXXX $X.X the to ended March million period for months for and expenditures. as other to $X.X to XX, the period compared the million XXXX. plogo XXXX, compared the decrease were XX, million X relating in expenses million a a due related compared clinical in in to ended decrease other same as March in expenditures. due for manufacturing $X.X months nonclinical for period to trial nonclinical XXXX,

Expenses XXXX. XXXX the new greatly XXXX, reduced expenses becomes salt plogo at related study formulation XX, March paused remained while X and to relatively will for available. have and as flat administrative a months be we General approximately in each of ended million the XXX-XXX $X.X

XXXX received United XX, research we million for were XXXX, the were $X.X the X and Total million, claim XXXX, year. months which, $X.X the the year $X.X expenditure. related now for development have Kingdom compared mentioned and million compared million of X to development the March as and to includes same credits to I the previously, are research the XX, directly payment, previous other tax $X.X to same million period net ended ended March for of period correlated expenses, previous which for $X.X months qualifying

Net $X.X loss months million million expense for $X.X XXXX. March for in ended X compensation million, XX, including to stock-based million, stock-based of the $X.X same of which XXXX, were the $X.X includes compensation expense period compared

that Phase quarter concentrate specific in we patients the to our fund our programs XXXX we study, XXXX. resources current currently that fourth continue resources will As of in recruiting decrease. its on The expenditures estimates into in fadra cohorts planned will II the company cash anticipate the

now questions. Operator, ready we take are to

Ahu Thalmann. [Operator Instructions] question with Ladenburg Demir from Our comes first

Two from us.

we we are helpful? XXX ASCO see and to the any color? you fadraciclib expecting very analysis additional are at Could would to subset provide is one patients from going information First more How be many what study? see

for ASCO Brian to will answer I the question, Ahu. to the content. question your on turn Thank over you

the planning we're safety PD basically the The ago, weeks to be data of seen Ahu, of was portion, efficacy There'll the and also couple both present included. set full and study. the I cut including almost a should portion so data Phase dose have the dose escalation totality PK around we far. escalation of but

study. have the proof-of-concept I II question Phase the is of Another portion same on

sites many When thoughts enrollment? line? expecting what are are going are is that to forward? what present? to Curious, And fast see We currently, later on this might And how time data are you move open? the How your year. the

Brian?

slightly Phase sites to opened We've the already just open sites, sites. tumor different X starting T-cell from site. lymphoma I had the solid enrolling. we The tumor solid We're

opening just it's X. an So additional

frequency. terms identified. cohorts. by the known encouraged at probably being determine of enrolled We we're we've In are year, the of difficult most But these sometimes moment to of both patients quite timing, the the mutations anticipate end

that treat the Let color, company need panels. a standard Brian's patients, to of diagnostic the readily to mutations do Ahu, although add as We identify these part me companion are available they not also available and the once patients no there is they're regulatory with abnormality. these discussions, drug important are collecting is the but data approved for to future that amply identified points

this queue for to the questions or We like in the no now at additional I'd over any call have today's remarks. time. further back closing speakers turn to

joining the Earnings with anticipated the Fadraciclib proof-of-concept strong all profile II of comparative in you, patients a to XXXX its Phase dosed class. in you therapeutic has achieved Cyclacel's operator, for with XXXX milestone key thanks catalysts Thank important First in and stage Quarter a first and Call.

advanced open-label, oral XXX-XXX escalation further XXXX tumors our to key in and data fadra of hope upcoming XXX-XXX reminder, the you stage II, patients from meet a in oral report are: lymphoma the study at of conferences. patients advanced Annual ASCO look data of Meeting, fadraciclib and updates in the initial solid with with with you some with dose As upcoming cohorts of and tumors to We Phase lymphoma. at solid forward from interim study providing report part milestones proof-of-concept

this call. end at may you Operator, time, the

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

any at disconnect may time. You