Cyclacel Pharmaceuticals (CYCC) 14 Aug 242024 Q2 Earnings call transcript

Good afternoon, everyone, and thank you for joining today's conference call to discuss Cyclacel's financial results and business highlights for the second quarter ended June 30, 2024.

Before turning the call over to management, I would like to remind everyone that during this conference call, forward-looking statements made by management are intended to fall within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended.

As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the Securities and Exchange Commission, which include, among other things, our Forms 10-Q and 10-K.

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

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

its wise abnormalities, fadra, on Recruitment strategy including our clinical report including NIB to our prospectively presented which that testing function. with in for deep endometrial on study was Phase occur X [indiscernible] this of well. tumor solid with often great medicine lymphoma. Retrospective in tumor population specifically population. Clinical at I CDKNXA and chromosomal located our or CDKNXA genes, in patient Meeting class. or enriched pancreatic and analysis tumors, and/or is endometrial, available chromosome on and heavily melanoma, lung, believe the has squamous is CDKNXA CDKX/X including We formalities head bladder, ASCO that are pleased solid data, and in monotherapy In melanoma, endometrial, and/or suppression lung, several hard proof-of-concept in patients loss there may hepatobiliary several patients CDKNXA need KXB and fadra T-cell of deletions cohort, from highlighted deletions glioma, oral the head tumors, we occur this unmet in co-deleted. ASCO breast, progress deletions medical are be with a Phase also others. Based competitive esophageal, data suggests which certain lung, currently types, in including in pancreatic associated and alterations inhibitor, and Annual a believe are precision evaluating esophageal, II and pancreatic we're cohort closely bladder, glioma, including mesothelioma, CDK as by going gene part XXX-XXX the certain in in We neck, cancer pretreated the that industry on cholangiocarcinoma, including The therapeutic are strong June. hypothesis T-cell several activity lymphomas. in identified benefit with was or monotherapy breast, preclinical at which neck, an observed the ovarian, and CDKNXB. profile ovarian, unselected evidence built we evaluated interest fadra hepatobiliary, squamous,

of study to clinical our clinical review expect results Brian? will discuss proof starting We of parts to over the quarter in some of program. this and of progress II initial the in the report the now to Phase concept fourth fadra Brian I activity from call the turn our year.

Thank you, Spiro.

fadra dozen the encouraged in of pace CDKNXA patients PLC recruiting around the end from reporting the mentioned, the a enrollment, results investigators of we As clinical our well by with and of XXXX. cohort. anticipate on initial are very patients I'm Spiro enthusiasm we study, of about by enrollment Based

with T-cell lymphoma. patients this including patients Phase the have with activity, signals We I lymphoma, X X of of cell in recruiting cohort, responses which based second opened was a out is T also on partial

a were concept the data X from X. study, twice CYC-XXX-XXX adverse There ASCO data out presented progress fatigue part X the strategy. The XX% included of summarize of patients most between was we baseline. fadra were Dose part at population. of total heavily patients, hypoglycemia. of study, the XX with of selected clinical X evaluating the median were a and the our nausea, no treatment-related XXX patients reduction dosing of The study. X with in target therapy. hypoglycemia and in fadra well vomiting, X. were generally Fadra T-cell in this lesions as common received decrease CDKNXA in reported whom A a Phase different measurable monotherapy level at lymphoma, escalation milligrams me a [ II X rationale non-small in for weeks X in reported tumor dose were of burden events prior week, patients and of patients. Patients having lines with drug-related cell the dose squamous were A in CDK SAEs total Phase II ] partial several overdose diarrhea, days As level account drug-related weeks. were dose loss proof of X lung achieved let XX had ASCO responses I tolerated a compliance Most with reported accidental patients commonly daily, CDKNXA Two was Phase at SAEs the loss, and for platelet one cancer unselected at pretreated, X good had set schedules NTB and XX X level. X

clinical was a in Phase who previously addition, analysis X over years response a with CDKX cancer, reported In identified patients previous NCAP endometrial loss. treated and in monotherapy A benefit and X ovarian complete X Padra patients achieved found with in retrospective cancer. each was endometrial I of to a pancreatic of study CDKNXA intravenous have patient and treatment cancer

we the to part believe look in the to initial support POC the patient data I types X the turn call data II reporting results. generalized, be quarter now in evaluating Phase specific of Phase forward that months. cannot study. I the upcoming are will review second and over with hypothesis-generating the Paul data cohorts to cancer We limited the Although the

Brian. Thank you,

months due for expenses expenditures. XXXX. R&D million topogezotitib, [indiscernible] the decrease to as and the decrease programs X to months activities trial the for million months million to $X.X X to same Net in June million June The million months expenditures. $X.X inhibitor million Net June of million equivalents the ended and and $X.X $X.X $X.X $X XX, each used of in $X.X and same were million $X.X financing was cash General period X in of for from of other for securities to result the fund same a in as X cash June ended XXXX, were XXXX in activities expenses XXXX, XXXX. same XXXX, ended development compared December of a million stock into million months Fadra June approximately the cash XXXX, and $X R&D relating to fourth each PLKX the cash XXXX. of other operating as quarter months XX, costs planned provided XX, for as XXXX, Research compared expenses of period was administrative the X to X June compared of XXXX, expenses X June and common due the the XX, for to current XX, issue Total of million at XX, for under estimates the months a XXXX, ended clinical that nonclinical compared expenses our million period for warrants company agreement. for XXXX net The million or manufacturing for totaled $X a XXXX. and compared XX, resources in the receiving $X.X June remained purchase were $X.X period $X.X ended $X.X The XXXX. the for flat XX, XXXX R&D net other ended by nonclinical expenses As as ended approximately XXXX. will million its

was R&D period million including the compensation credits United for X months to June compared same XXXX. Net Kingdom the expenditure. stock-based for ended $X of research $X.X million, questions. months directly and for the of of qualifying $X.X compared million compensation tax same we $X.X Operator, million XX, now XX, period for million year X are previous June including $X.X $X.X expense to of development the to XXXX, and take XXXX, are ready to loss or correlated million, the stock-based in expense

[Operator to Instructions] Ladenburg go Demir We'll Ahu first at Thalmann.

couple. have We a

the this this First would what of you program? is the of is what part disclose on success is year. the and the be half in based other And consider -- are the the plan data the to the would target you And NXB question program? for would CDKNXA, for scenarios that second question what what be benchmark enrollment that

Thank for your you question.

I over to Brian, Brian. for this you. is think

I'll is take study. of XX a at XX approximately responses. where the process. And move look next to it's of is question sort the need first phase to X Ahu, to then would X-stage on you than The the patients, X Stage to you more see

just be those success in I patients. XX that the phase for responses would cohort. recess clarifies the next a confirm first confirm XX the be in bigger in responses first to at least part So to hope that just will X

And of many patients how the many Yes, to what that's target Brian. data half for you And enrollment helpful, year? show is second program? this in -- from the how are planning this

required and patients screened. we good, need been the -- have has Accrual that been

anticipate reasonably a we the of why present -- of just be patients So able that's around to the dozen end we'll least data confident response year. at by we're worth

remind everyone, here to every Just we scan months. X

on August, in get second efficacy be X scan months that the would sort already the to from X data for months it we're So the first and of scan group.

think I to question question, ask would as could If that well. Brian, I I one more that you refer

these or inside the to ANI In is the is to reason do CDKX, in disclosure status there terms be potent any see other we what second more would the operations any data the of think of And it these? half, could mutations of be with form -- and alterations the operations? of of loss be would the different able

our the from from leasing to far the be different XX, be get way point there old we'll a in over You we've to are interesting would sensitive at that's patients is seen is so plus more patients terms least mutations that see different which bring new to of a think specific treated the I present alteration really up [indiscernible] -- XX a feel drug. the able either what or

hold an get hopefully, even from able There bit little that numerous down different we'll be we'll idea. more. So it a to ones. are analysis, And

Instructions] sir, turn afternoon. it for any further Rombotis, closing [Operator to have questions gentlemen, I'll back no And you, things comments. this appears we Mr.

Thank Earnings Cyclacel's to you for all Second you, Bob, and joining XXXX of Call. thanks Quarter

initial We cohorts with may Phase and fadra stage forward interim study important data key dosed We and you forward updates at solid with the advanced with in end call. the in II at the reporting fadra have of and time, with open meet this II include from These proof-of-concept of some patients for you to to concept the you further XXXX. in Phase hope Operator, catalysts stage in achieved providing oral look tumors lymphoma. multiple to look milestones conferences. XXX-XX patients upcoming

we and ladies Rombotis. conference Mr. you day. great that joining everyone, will your Cyclacel's gentlemen, conclude all Again, for a you, thanks and of results much call. Goodbye. Again, wish remainder Thank so us, financial