Earnings call transcript Q2 2023

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Operator

Good morning, everyone, and welcome to the Summit Therapeutics Second Quarter 2023 Earnings Call. Please note that this call is being recorded. [Operator Instructions].

I would now like to turn today's call over to Dave Gancarz. Please go ahead.

Dave Gancarz

you us. thank and morning, for joining Good

replay Our is our available was on issued our an website. later made morning and earlier this archived and on webcast call website, being press also today is be available release Today's simultaneously will the www.smmttx.com. homepage of

and Officer today Chief Bob Executive Zanganeh, Maky Welcome, Officer; our on Allen and Ankur of our Chairman Dr. Executive Dhingra, President; me Officer; I'm Allen. Head Joining introduce is the who the Financial Dr. our our call is Development. Duggan, of happy Board Co-Chief Yang, Co-Chief and and Research to new

results we management in today considered filings Please statements forward-looking Before materially may undertakes that differ that as our team note and from update to current no uncertainties to about obligation information statements based for to indicated some risks may be on questions those and refer would statements, Summit law. forward-looking statements, to started, these make these get cause uncertainties. and required our cautions responses that like except forward-looking we are risks by some Summit statements. statements expectations. forward-looking to made our actual these to subject the I that by SEC

Following comments will we from Bob, Maky take questions. and Ankur,

I the with call turn will And that, over to Bob.

Robert Duggan

has regarding Anker our team and us and like to to color provide financial I'd amazing today. say will over to then Dave. you, joining hand add words Thank morning, more some Good about few for Thank updates outlook. positions Maky I then it what you everyone. a our will accomplished,

time, all closed patients in efficiency, of XXXX, with Phase work to match lives output X terms Team of the trials skills transaction in-license and Summit since quality Akeso can In improve you clinical speed. intent, to we with Summit. that And the the In ivonescimab. alignment blending with mission speed due our launched most registrational with with we of III both high-quality and the importantly, statement have January our of

As of development beneficial Summit we Europe last their full States, Canada, in pipeline Japan, Summit the ivonescimab the in foundation the at takes United the and I product Team and take betterment all chose that ivonescimab and lives. end and caretaker impact the the significant XXXX, the maximizing to commitment. in of of our significant major developing our be markets. ivonescimab business should United spoke patients premier Akeso treat. chose as in while full quarter moving of candidate Europe is difference States, Team responsibility This for lives the all about Japan, for making we We the of Western in for forward in the process patients' responsibility difference make Summit

and the We continue and success continuing by patient established upon to results created build Akeso.

made meaningful to Akeso second most to over visits and past Our person past our in the team China has multiple recent leadership Akeso's quarter. time months in the including trip the with during year, few spent

work to we best to our together results of As we realize potential the continue and propel collaboration forward, possible the achieve ivonescimab.

changed the positive each manner, coordinated map. and in patient Our day. for partnership Akeso care actions of the allow continues specific within missions, patient improving business in clearly-aligned this lives, we every as which a highly the patients cancers In paradigm focus on make and of curate our of to needs Team progress future has our

underway, III Phase second Summit clinical with are this multiregional to our Continuing multiregional has trial. Phase X trial dose we about the Team first patient and trend, in III

us. have to to, trial in own the China. they've as dedication commitment not they stakeholders. they second carcinoma working participate company the their setting that, to best collaborated as their to it's possible. ivn This but Akeso Phase the all cell similar their becoming interest to because we demonstrates first-line well. a trial as many wanted as squamous worldwide with in partnership, But multiregional lung, chosen with patients patients work alongside trial we to in possible for specific biopharmaceutical have to of Summit-led chosen to our trial III bring have because each had In to and participate to as their quickly desire fully And We enroll in in a and and

ivonescimab partner, couple as with We And a believe they pretty intent good the -- to we we well. our and right years. excited coming what of chose intent chose X are in accomplish the about

over I would accomplishments context that, as and With next additional provide Maky? to like steps. our it to to Maky hand to

Mahkam Zanganeh

Bob, and you, and about incredibly ivonescimab, what already potential I'm good have we its enthusiastic morning, Thank accomplished. everyone.

cancer the in X since non-small including meetings, interactions, indication. we past In closed months we X large deal the with our lung held have Akeso FDA surrounding separate January, X cell with

and In major bodies in other authorities licensed and with Europe, other our regulatory addition, of communicated have health territories: Japan. we Canada each

a cancer patients launched States, year. clinical X the have second next soon in and trial clinical We trial United Phase in ivonescimab Japan early Canada Europe, dosing and for with to III in we Phase non-small will plan patients and III treat begin cell lung

trials X for clinical have We Phase III ivonescimab.

deal just the ivonescimab our III the half this patients true in Summit at with unmet after year, second mission, would difficult we to quarter, conviction odds United second up power running to Phase trial in trial Team benefit over of by purpose, treated any, in first accomplished few, are in months biotech previously belief We our States second and month. medical the Phase space. patient our incredible a in was patient during announced open of first needs III comes the working sites closed. facing treat the X actively the next within accomplish the the that speed if in to help we With our first The and

payment were to million volumes through ivonescimab. in Akeso we belief working Obviously, and since our place of due our $XXX ivonescimab in spoke conviction on been and about has conviction diligence Our upfront our Akeso.

displayed. ivonescimab for study, for However, II in in patients year in at lung that over cell months. amongst follow-up non-small treatment ASCO the Phase year, plus of data who was conviction updated ASCO this XXX data chemotherapy ASCO frontline that data of with patients June, median display Phase Last a was at the II XX to received up released. XX was XXXX, for cancer AKXXX-XXX time of data, XXXX, At some to results data other China backs

over single-arm Australia, to study have a patients into of the good ivonescimab. a to in While patients received over this ivonescimab larger clinical XXX potential XXX a was speak studies of look these and well in China in subset

and this received responded a this median II and of patients survival months. patients XX months. Of of survival combination was XXX to control the from cell the disease there duration had XX% of progression-free months. XX rate combination, treatment-naive months The response the X.X progression-free XX in rate. for Phase X/X range patients and chemotherapy. these treatment of ivonescimab the the experienced who was of Of carcinoma the XX.X to a interval study, The confidence the Phase was study, II for median a patients XX% patients XX% XX to in squamous response lung

median not XX.X%. XX rate survival overall survival XX.X yet patients for overall of time was a estimated months reached after months, was these While follow-up X the

our the safety thus this loss adverse been believe and plus profile being chemotherapy hair current considering study of population. this most counts common data promising directly with acceptable, chemotherapy, Phase forward far second -- to move We the pembrolizumab neutrophil has therapy plus We trial when believe ivonescimab anemia, standard helps with clinical the events first-line care, decreased III treatment-related of our decision very support and trial. in into that

continue extremely patients is our based ivonescimab a difference on and by we what like. make on the see potential to with ivonescimab, our significant encouraged in to We continuously-growing for conviction are speed

expression with believe and profile presented XX.X months PFS with are well combined, The was study. Grade for XX.X including progression-free expression patients or safety XX the by ASCO, We all confidence those these PD-(L)X, of cancer low lung median with scores, observed with was PD-(L)X Across did We as TPS the not that chemotherapy data cell Phase acceptable non-squamous ivonescimab a in in high treatment-naive, non-small express to XX% months. II survival higher events treatment-related those interval with patients other X.X receiving histology plus meaning encouraged tumors X from patients the reported. months. the median XX% range adverse at

patients and therapy PD-X and addition, or updates the remain therapy cancer XX provided second taking associated II progressed in on EGFR who at patients months. their after like progressed of In XX XX%, or with for patients with lung who patients this mutant received the who Phase later who cohorts. after by encouraged targeted were in data respective had Of a line We treatment XX% ivonescimab initial line these are chemotherapy had X maturing data remain disease pembrolizumab. later brief note, patients their cohort plus second receiving therapies XX for respectively,

and builds upon to an an continue believe the ivonescimab. data the back antibody to anti-VEGF. for be that the of first-in-class designed that an mechanism observe We is continue cancer anti-PD-X we believe Ivonescimab mature action this X to encouraging be to innovative, we and that to administration relates then the same potentially Ivonescimab not as what that of bispecific target. is established

referred nutrient but cells inhibitor, as cell that a attaching culling blood T assist cell, in with VEGF believe break. act therapy Anti-PD-X part prevent stops helps and therapy cooperative the -- it actually from in supply the VEGF. the system tumor. to we checkpoint a its T the with of T allowing tumor that Anti-PD-X binding therapy cell do tumor, hence, we by its build the to to the ivonescimab Anti-VEGF deplete therapy goes doing without is the new the also helps in what checkpoint immune job the T blood allows cells and immune the build job cell the the further blood first as to to place. fight Anti-VEGF the of binding. in by better checkpoint to system to refer or to tumor

strongest binding enables vitro the to structure and macro that may to preclinical VEGF, tetravalence presence Ivonescimab compound presence binding actually such may that tumor the in and cooperative to than designed is in together. affinity both was and of targets tumor like the stronger its between in the parts. where have novel anti-PD-X are therefore, saw of metastasis separate just In have the designed VEGF PD-X tumor compared PD-X affinity the PD-X Ivonescimab binding greater VEGF. the of as VEGF over targets, dosed compounds both of have cells. The and is found experiments, and anti-VGEF the environment. focus Ivonescimab's in higher is ivonescimab's target to ivonescimab different we has binding to potential X side molecules. the both the also targeting the binding of PD-X and antitumor of activity advantage operative over with It sum individually XXx

With from to that expand in continue plan we here. clinical development to program our mind,

we announcement our in lung cell As stated have are since in cancer, start the of actions ivonescimab. for X trials conjunction with step and non-small deal our into commitments first following plans these clinical to through only this of the our the

indications in We ivonescimab cell to expand additional tumors life development and non-small in the cancer have lung to confidence continue other during solid its both in cycle. within

potential indications constructed scheduled was the the of this We as be potential for to evident milestone. is believe of well from number the of deal with are as which ivonescimab. milestones mindset, regulatory paid size strongly the Our in as

strategic plan of key programs. will engage the studies to of be or A ISP our investigator-sponsored broadening ivonescimab for in value part

aside to enthusiast As cancer. higher a key lung with SMTXXX our of for leaders, what and opinion we to are we broaden ivonescimab related physician do message can experiencing continue leaders

for beginning. will multiple related continue as to information received potential share programs additional we have be addition that consider uses are move forward. excited the examine can and consider, the This potential We to coming to in inquiries just to to we sponsored that studies in is we continue ISP additional we quarters, ivonescimab. This

on let financial our some outlook. details will I and Ankur? Ankur more position Now, give

Ankur Dhingra

financial of front a Maky. team. you, with you opportunity the of the made the in as the developments an optimistic great end as I'll of quarter the the and Thank our with during financial have we progress ivonescimab us give that update we on and incredibly quarter. position I'm have

the was a in compared XXXX. for About loss Net $XX.X the net loss million of million quarter $XX.X P&L. of to second quarter the

to majority extend well and are possible. we now Phase remain mentioned, continue time, spending that in our have of clinical ivonescimab, this As long development in we X and molecule, our At as III with disciplined engaged of ivonescimab. for the reflects as spending our same cash to focused trials investments ensure we runway

includes operating and is currently as setting initial the for we clinical up second an million in working executing team into receivables. trials to investments SMTXXX half our Speaking of We about this ivonescimab capital the our cash development and appropriately capable experienced $XXX and as XXXX. well This going fund of with planned trials needs multiple our oncology cash, believe with quarter investments for building position, manufacturing work, to the in begin large clinical exited cost territory.

loan $XXX repay have capital balance in complete of September we becomes a and the ability We September if raised on a to prior due sheet transaction million our XXXX. in certain to that scenarios, XXXX

and are and held highly-liquid equivalents on market in investments cash short-term money U.S. Our highly-rated treasuries. funds

the position reputable large, banks. and European very U.S. in held at about financial I feel is cash good overall our company. Our

to back Dave. that, I over with it will And hand

Dave Gancarz

Maky transition will received it of back open as the live may then from session. number questions And the Ankur. you, already. can now into will I I operator there, Thank a the over participants. start, Q&A who and Bob, for We line we've to hand

Dave Gancarz

respect completion time we some give question updates on comes on enrollment when will our in expected to First progress progress Phase enrollment of trial. enrollment and take clinical the III Could the place? with

Robert Duggan

Dave. take I'll that,

of of specifics give yes. in say don't well next to the plan. I the XXX is then numbers, we that the year. So enrolling the on study, completion but enrollment half And first be will This study will we're

Dave Gancarz

for next enrollment. the Yes. should carcinoma, completion for United When to year trial later the Phase We're of expect the investors States the of in HARMONi-X, of in first-line the half XXXX -- III clinical calendar off targeting squamous to and end cell Europe? first the kick

had we half Maky at towards mentioned the as guiding second earlier, XXXX this so are And of point.

more up and other given and we're haven't that than activated perspective. quickly guidance, getting on very track from We specific are sites

financial. The next more X questions,

pembrolizumab carcinoma, the HARMONi-X the well Phase is financing As which over cost of as XX potential clinical head-to-head to of and in cell supporting first which months is expected against trial that The continue III squamous next the study? chemotherapy?

Ankur Dhingra

Sure.

address both. me Let

So regarding lung Phase Europe it U.S. in the space. but and the cost, not cancer specifics, a trial provide in is the the III

it's in trials broadly, the there As space going not be several know, materially you to cancer are that, so lung different. happens,

So in about estimate III the you lung clinical trial. cost can patients XXX our for cancer Phase

strategy trials which some program receivables of the have We've development end at in we XX $XXX least and question, continue announced. cash fund is more, I our just is the financing that as for next X to that the mentioned, sufficient to expand months. announced the Regarding ivonescimab we beyond the also mentioned million for we and trials at that our have to the have quarter, both

and any other plans consider have So we any financing make trials as well discuss will we as and accordingly. decisions for will both that plans we'll ivonescimab, these that

Dave Gancarz

more in The relates, Ankur. little bit English. you, Thank next question a the maybe really plain

data? has feel little a maybe to respect reached, as Allen, give to been just bit comment overall median then statement? plain how So survival that that's English context we not And that in, that -- data is yet that Or our about looking we're bad the thing? come do at of you could with a specifically

Allen Yang

reasons sort excited so the the molecule, that we're why of very excited. and very about doing Yes. I for clinical The studies. conducting think asking are is alive these X joined right decided this FDA. looked ultimately the But patients was scientific Phase a now, I by rationale And of we're when fact the I'm is terrific data, that's that's and studies that good approvability I product, still that There's the about of this the I III of thing. Summit at you're performance X

Dave Gancarz

to Thanks, questions then couple specifically, have size study with a of come reminders in Allen. the And overall.

in a give III we could of patients we enroll So our plan to little respect X many how bit context clinical Phase with trials? to

Robert Duggan

for XXX? disclosed patients. study, the for squamous our And and non-squamous cancer study, the we in cell enroll line Europe, XXX -- have the then lung planning it? the Yes. sample in front North first non-small publicly So XXX, XXX, size, the which region III, to America Phase is we're

Dave Gancarz

the FDA? in that generated with And that then second is Is can Australia. submitted data to to data respect that being Akeso the by to last be question,

Robert Duggan

Yes.

So was ultimately Akeso-run the referring was that X think data. run Australia. so study, I you're to control in that That Phase and they an

of some as form. However, the see in that see part an FDA in my package, experience, all probably and FDA want the to to data will they'll want so

Dave Gancarz

little you're ivonescimab to of respect of bit the spoken And to level why prepared a had and Allen, with mechanism you X it? But a then excited action this final the could Maky give during high remarks. about question,

Allen Yang

a is experience X is of lot Ivonescimab Yes. X bispecifics. molecule. This have validated unique. a with targets, and PD-X I VEGF. exciting really takes It

oncology. So if pembrolizumab they you bevacizumab, targets think in and are well-validated of

I between don't sites. that target there's binding people -- is don't what realize cooperative the X

So finding of other the of ligand. X ligand increases the binding affinity

So PD-X at targets what affinity you both when that is binding for where have increases expressed binding many fold. be highly means highest or places the are targets will binds, both about. That VEGF

exciting really the that's So in MOA.

additional it exciting. and the we will comes out, very other MOA data on disclose have as information that's also We there's that

Dave Gancarz

Thanks, Allen.

live call, covers that , so questions number our those turn I'll to questions. to received for now that appreciate operator, been of prior questions it And over so the in. coming I have any a additional

Operator

Thanks, Dave. for call the I Dave questions Seeing [Operator to Instructions]. remarks. live come back no closing turn in, will

Dave Gancarz

to this morning. I much for very thank call our want everyone attending

webcast very your participation, website, day. earlier, you will hope remain of the As rest available you for of www.smmttx.com. I enjoy your and this on an mentioned much our archived version Thank

Operator

This call. today's conference joining will us. for conclude you Thank

may You disconnect. now

Dave Gancarz	SVP, Stakeholder Relations, Business Development & Corporate Strategy
Robert Duggan	CEO & Executive Chairman
Mahkam Zanganeh	CEO, President & Director
Ankur Dhingra	CFO
Allen Yang	Former Head, Clinical Development & Acting Chief Medical Officer

Summit Therapeutics (SMMT) 9 Aug 232023 Q2 Earnings call transcript