Earnings call transcript Q2 2023

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

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Onconova Therapeutics Second Quarter [Technical Difficulty]

Dr. Steve Fruchtman

Sarah, excuse me, you are coming in and out and I don’t know if other people hear.

You coming in and out.

Operator

Thank you.

restart. me Let thank gentlemen, standing by. Ladies you and for Quarter to and Results Onconova Second the Therapeutics XXXX Business Financial Welcome Update Conference Call. all time, this participants a in At listen-only are mode. hold prepared question-and-answer we management’s will following session. remarks, a Operator

At to this call ahead. to recorded XX, would As a of this call LifeSci is I over reminder, time, the Mackle today, being August XXXX. Bruce turn Go like Advisors.

Bruce Mackle

issued Earlier results welcome press Onconova Thank Onconova’s financial update to its And reporting results a XXXX everyone business and you, this conference financial call. Operator. quarter second business progress. afternoon, release and

you release, and not in at If Media have is Investors yet seen website press the company’s www.onconova.com. it this section the of available

from Financial Affairs and my Onconova’s the and Victor also prepared CEO, remarks. President Regulatory Moyo; and Fruchtman; Officer, VP during Operating of Fred Officer, following Assurance, Following be hear Q&A Dr. and Officer Mark available Dr. we the Chief introduction, Guerin. Chief Onconova’s will Frullo, Consultant will Quality Steve Chief Medical session

Before actual conference call materially. like we XXXX, risks that this Safe forward-looking Act under statements Private Litigation made include Harbor cause differ Reform and to that the statements involves Securities begin, can of remind of will results during the everyone to which I provisions uncertainties would

Onconova Forward-looking information, law, future facts disclaims made of circumstances. reflect any and these statements speak to statements as the or underlying to by only obligation are as circumstances Except the as date they required may forward-looking events change. update

please and the risk company’s For SEC the review disclaimer release on press factors more the information forward-looking in statements, in today’s filings.

and CEO, the call turn to Dr. I President will Onconova’s that, now With Steve Fruchtman. over

Dr. Steve Fruchtman

investors and listening who Bruce, are analysts thanks and Thank to all our you, today.

pathways differentiated patients dedicated enable act Onconova that to cancer important cancer some of developing is that know, the to you cells therapies most for grow. novel by targeting with As

rigosertib a in outlook two and cell-signaling programs We about a proteins inhibitor, targeting involved encouraged involving are multi-kinase resistant CDKX/X lead narazaciclib, our very for pathways the differentiated inhibitor.

and quarter, I both Over Phase advance the product studies trials. diligently regulatory each development II last investigator-sponsored guide for strategy Phase have we worked these to the company and will from and clinical of the multiple in programs candidate. Data

of Over and important including have warranting on also meetings. by AACR rigosertib, at Presentation and recognition several presentations. data medical program each data encouraging and quarter, prestigious community presented preclinical the very is and course proposition the affirms value data scientific clinical from of we narazaciclib the the meetings, these rigorous preclinical ASCO the the these

the related we for In the addition, with FDA, and squamous cell requirements rigosertib an to for a of dialogue regulatory the path ultra-rare opened constructive for carcinoma. in an important indication RDEB-associated approval

into XXXX defining on rest narazaciclib, Looking or program studies. ahead dose the we and and the one II advancing to will XXXX, the monotherapy, randomized of more for be Phase daily early focused

will be have at out patients squamous rigosertib, on study the mapping based that with seen refractory For focused responses on the major agency, RDEB-associated and a cell meetings. impressive clinical we registrational very previously medical discuss presented plan in been to carcinoma

combination studies inhibitor rigosertib advanced non-small also and lung We cell with cancer checkpoint ongoing melanoma. investigator KRAS the to in support sponsored continue mutated malignant

the Importantly, lung non-small cancer mutation in malignant KRAS melanoma. in cell

with in that fact, should mutation. And lung cell KRAS responses to our KRAS reported And welcomes advanced of combination patients in non-small now the and any seen with clinical be are to agnostic be cancer no responses that the trial cancer rigosertib and hypothesis present. appeared refractory Importantly, lung mutation nivolumab. support effects KRAS KRAS data the matter

late the following remain Dr. to Medical a It physician the as thank the Officer, will to to an Chief advanced health his researcher Dr. join leadership. successful our Victor dive is and Michael company. a and you Before Gelder each Chief fine consultant service honor his into such have clinical for professional, for of trials Medical details to we program, Saunders. Michael I the Onconova’s Consulting to would Onconova, to under entering the Michael like Chief introduce with service Moyo. untimely and Medical passing We Onconova our extraordinary Officer, of Officer, patients Dr. Interim cancers Mark our global

in ground industry. Victor from clinical has efforts. hit his great important work in is decades XX contribution an brings the of clinical research, running more already and than Onconova’s three experience a Victor of development the making years biotech to including depth

Victor trial alpha have erythropoietin a Onconova advanced warmly leading more the other approved well him held personally Centocor is Biotech, Ortho we and and has DOXIL lead ovarian and drugs and both years, was J&J., in Biotech as were roles and at as he welcome as Victor Biotech. startups. leadership subsidiary in responsible Obviously, Ortho team. cancer. trial emerging as XX together programs the for we confidence than the that He as at Pharmaceuticals, alpha myelodysplastic well multibillion-dollar I with known I great for It to of the Merrimack Ortho these are syndrome, franchise with erythropoietin working

will narazaciclib, their six in would this two progression-free by progress class survival. the of be sales we driven first improve our billion topics. our efforts to the dose or topped RPXD. $X drugs today, Worldwide focus of recommended XXXX, the with primarily II define in topic update on our Phase to Starting For ability top CDKX/X a inhibitor,

We based a development of pathways. of importantly, risk believe involved has safety that the and lower by entrant improved differentiated potential resistant profile, entrance these on into protein totally an the resistant the market narazaciclib this be targeting -- in to

registrational to year last support defining evaluation Our recommended with to and I with dose dedicated II of trial been Phase combination and intent. narazaciclib a letrozole efforts the Phase the over completing program have a

patients escalation one trial LGEEC. endometrial clinical as The two low-grade program Phase patients monotherapy with dose and tumors letrozole endometrioid cancer, studies combination also in includes I Phase I/II in with with in known solid

Phase and from results the studies, II this year. anticipate in pharmacology of Patients topline continue dose quarter trials including the fourth recommended the onto these reporting safety, to be a of entered we and selection

seen identified. will and this a the LGEEC additional XXXX. information Based on trial narazaciclib We half to is the combination the initiating other use initiate progress of to-date, randomized indications in we in in studies anticipate dose define first once

on to rigosertib. Moving

second for will registrational rigosertib. related of to topic The the plan development a be

we you had B a may Type As with towards meeting know, the FDA June. of end the

and on tremendous and with and have responses at from clinical feedback need, previously refractory constructive we unmet Based medical this meeting impressive patients clinical meetings the the in our seen agency major a these presented data. medical

to in a protocol develop carcinoma. RDEB-associated rigosertib squamous registrational with with trial intend patients We cell a for potential

the an XXXX. We will steps first provide of update on half in next

invite introduction, both you latest give and narazaciclib insight to take overview Victor Victor? you through and I rigosertib. more that the and With will updates on

Dr. Victor Moyo

believe Onconova join potential Thanks for Steve. I the have the very that people excited assets two improve our am introduction, cancer. the care to to and with of

narazaciclib. start with So an update on by providing you I will

improve with We potential in differentiated to and even other inhibitors that less potentially the neutropenia narazaciclib than has it believe CDKX/X has than its safety Number of a care class. this because the more drugs myelosuppression profile attributes. one, unique other

bone other be have required Thus, that for we and drug of and need narazaciclib which can is inhibitors CDX/XK every administered there cancer already is daily to two, by once a marrow replication demonstrated no may permit feel holiday day. and cells. confident that meet recovery Number

thus, and activity contribute immunosuppression overcome development of overcomes And kinases. resistance. This to Number inhibition three, tumor tumor growth it could enhanced microenvironment. in the the this treatment multiple inhibits

milligrams quarter our achieved schedule continuous first safety patients target dosing the of solid indicated from daily I that narazaciclib we During a call, XXX of tumors observations Phase study with reported that acceptable engagement an with at profile.

we positive first can AACR the combination Phase cancer that the in also and XXXX data of at in initiation additional effectively recurrent patients I/II LGEEC We demonstrated endometrioid the endometrial with study that and of preclinical and agents narazaciclib letrozole with synergistically other narazaciclib reported combined evaluating be low-grade abbreviated reported indications.

data first ideal combination an that improved for off-label is inhibitors indication LGEEC. CDKX/X suggests recurring the LGEEC in believe we progression-free letrozole narazaciclib. of and survival use Comparing So

negatively treatment need an However, of and resistance, issues new tolerability impacted safety, these be to regimens therapies. creating by unmet for appeared

BUBX compendia support BUBX. potential narazaciclib CDKX/X, on indications. poor and linked including and positive and other Over inhibiting expression Together, action beyond of to data tumors, addition, a targets the impact in protein breast narazaciclib for cancer. LGEEC endometrial to a uniquely make the called BUBX is In outcomes

XXXX, least combination into at provide additional we and a indication details study different we a in intend clinical one to will finalized. once begin letrozole of Looking is narazaciclib additional and protocol

about to path Next, I’d speak registrational a rigosertib. our plans like to define for

agent combination with have compound a in checkpoint the separately and potential for We as cell in inhibitors. RDEB-associated indication single carcinoma ultra-rare lead squamous of the evaluating been clinical this

carcinoma cell cancers Bullosa patients ISID, Symposium, During skin at we International -- a of with lesions. all our reported quarter first achieved the International responses and Society complete presented the data that showing Epidermolysis RDEB-associated the refractory cause clinical of squamous Investigative Dermatology lesion call,

durable and that our this either continue for been We enthusiasm new toxicities also treated patients develop rigosertib responses disease supports enormous that this additional experts the experience The interest IV with indication. important had to well from in no observed oral tolerated international the indication. in with to rigosertib or rigosertib

I the death squamous develop options. years RDEB no mortality effective mortality has cause is two a this and is with half are carcinoma and Patients in RDEB-associated and will therapeutic there most a cell point the of common the XX% patient. squamous could out associated this that -- within is carcinoma cell high and very most

urgent unmet need, we meeting and Type with June. completed and Because B requested of high FDA this a in

strategy is constructive, registrational discuss As discussions, the on review. our and goal for with meeting a to mentioned, Steve our the and FDA their trial based a and protocol was develop

inhibited squamous a more indications the positive RDEB-associated key have in PLKX, as overexpressed that is kinase potently cell cancers a disease carcinoma other rigosertib. may into driver and read in results rigosertib’s Notably, of through prevalent by is

collaborate AI response company to rigosertib. could to a to continue identify biomarkers We that predict Biomed, Pangea an

combination In addition, or to studies investigational through inhibitors to with sponsored potential we the in IST. checkpoint rigosertib continue combine two evaluate

the Mount investigators being The in I/II cancer a Sinai inhibitor. PD-X of have study KRAS-mutated Icahn nivolumab rigosertib and at York. conducted in first of patients checkpoint therapy is prior with Phase evaluating at School This non-small with New failed Medicine is the by who lung combination cell IST

Patient We provide the As be end protocol reported quarter, and trial complete dose on at the to year. an was last intended the rigosertib. to further allow the safety of based of investigators efficacy is in the XXXX. accrual data, acceptable expect escalation would update of to data amended encouraging

in This being IST The rigosertib patients evaluating with time on melanoma. design University II two-stage KEYTRUDA in with combination initiated is Vanderbilt in at second and metastatic Phase conducted is enrollment May. refractory

And portion hand call of it and over with I the to conclude Mark. that, will my

Mark Guerin

sufficient be of XX, December believe XXXX. and of fund million Victor. Based ongoing second XXXX and $XX.X our into you, as our cash second position million, that closed compared will projections, business quarter cash equivalents cash the of quarter on Thank of to we the with to $XX.X current our trials clinical Onconova XXXX.

and Research XXXX. the and $X of expenses to for were million, same in quarter General million for expenses XXXX This were for in same $X.X compares period the the period quarter second XXXX second million. with $X.X XXXX. the administrative of development $X.X for compared million

Net XXXX second clinical quarter $X share weighted for period. of $X.X in of with loss of expenses compares share for increase compared on weighted the That outstanding. per quarter narazaciclib loss $X.XX result manufacturing with the primarily in XXXX XX.X loss on second XX a a XXXX was and outstanding. of was of $X.XX per The million net the shares or or the XXXX million development quarter second net million shares XXXX million for

With concluding my remarks. for now to I the Steve financial hand back his overview call complete, will

Dr. Steve Fruchtman

observations, and compounds, to and lead two both, signals for supporting conclusion, review. that our health approval preclinical authority safety because along the of optimistic are compounds. Victor, we of outlook Thanks with the Mark about for clinical our In promising our strategy eventual for data, very

and compound reduced believe provide pattern kinase the on bone wider a improved scheme. administration marrow efficacy and For narazaciclib, to toxicity, we and potential an the of based addition differentiated CDKX/X safety

permit target cancer engagement a bone dosing without but that drug we neutropenia, recovery, for regimen, the permits development a permits cells To-date, [inaudible] may to have and need proliferate. which marrow once-per-day the seen also of mild

and to expect and of pharmacokinetics Phase combination dose. I/II Phase study of monotherapy recommended topline We letrozole the from II I the fourth year. safety, with a report definition readout this The in will results Phase quarter our include

results in ahead, in of cancer half randomized to presented to combination other intend to narazaciclib, advance with studies the into endometrioid Looking define further We or studies patients an indication. the compounds a endometrial combination of we XXXX, letrozole second with in low-grade the first letrozole XXXX. preclinical additional trial quarter in the plan the leverage

We the signaling cell carcinoma. Type believe safety of agent. attractive RDEB as for including by the an with meeting squamous pathways, rigosertib’s a with to in action an constructive indication monotherapy of profile, continue B ultra-rare mechanism cell position we lead rigosertib, anticancer For unique that FDA KRAS on could had complicated discussion mutations acceptable rigosertib it of the combined

Based on to that look an after plan half update a will design with dialogue provide continued the registrational to on the meeting, trial agency we in and next XXXX. I of steps first

believe we to that enhance and act synergistically rigosertib inhibitor the with inhibitors checkpoint rates continue to In potential addition, response overcome has checkpoint resistance. to

have using strategy an We approach. IST been evaluate this to

with rigosertib are cancer. non-small studies melanoma evaluating with patients Two and KRAS refractory thus cell inhibitors mutated underway, lung checkpoint in

an cancer XXXX. on quite the in the completed end While started enrollment study the this can update expected and provide enrollment at in of the trial year lung the is be melanoma in to recently, study investigators

management as clinical partners bring our dedicated in who our patients Onconova. investment the and entities providing and you new trials We employees, thank brave on medical support patients company’s to to progress. of your our team, updates as want I the ongoing look to the investigators, closing, to community for forward experimental well efforts and participate In at

begin we today’s Q&A will that, Operator? session. With

Operator

first from Our Charles Instructions] Zhu comes with Guggenheim. [Operator question

Edouard Mullarky

of on Edouard an combination narazaciclib to the what’s still maybe taking kind have Charles. the be done are escalation. there? cohort? you wondering is you for for sounded This first on you establish mean And of our follow-up question the dose like on kind just a cleared letrozole question close? LGEEC. for to dose Are past I It am status patients, Just with on guys. another I Thank as for Hi, that the getting you pretty enrolling then remains RPXD. what monotherapy you question. call a

color there going? you. any Just that recruitment, how is on Thank how trial

Dr. Steve Fruchtman

this predict these question, first for XXX cohort. cohort the hard milligrams we milligrams. in mentioned past if It’s I additional will are we and in DLTs, patients at we currently, DLTs the you has as and the on middle every know, at depends to have are be that XXX So, the think, expanding next day of of number seen that, the no

us proliferating believe shows proliferating close target narazaciclib. marker PD-X dose marker So of that we whether on a are of that not are proliferation not at engagement we are is and or current cells based evidence cells this

could also seeing neutropenia, have mild we are We expected. which

at we is II closer. we on next sometimes would getting two this predict. We believe XXX XXX, we toxicity few dose those limiting the milligrams have another the are cohort which based So the observations, anticipate we knowing hard and dose to But months. how at be to expand or case, in may to may close XXX in Phase recommended be

what? was Edouard, question, second The

Edouard Mullarky

combo, Thanks any letrozole Yes. on for progress -- on color. is that how just that going, trial? how that the Maybe on color combination enrollment just

Dr. Steve Fruchtman

Yeah. Right.

believe and you going. the number trial. We had we NYU, So a that accrual others. MDN a of including of amend the is trial while open the took It country, at get across some sites to

thing eligibility narazaciclib the decided, a the this and key was bit and combination to trial the about dose of of criteria letrozole. get is Our we strict

the again, on we amendment, increase, question. based end combination before the Did So has Phase that our and specifically the this the of we of recommended answer combination should an that will been dose trial and that the studying the before year, end monotherapy letrozole of narazaciclib accrual and we believe which prediction year. trial of this II our LGEEC have your always anticipate, the of

Operator

next from Demir Thalmann. comes question Ladenburg Ahu Our from

Ahu Demir

and combination I as of there full-time questions, you congrats Thank CMO. a safety quarter. the taking for cancer highlight that could letrozole also, on have position the this on in two congrats signals for for Are progress overlapping terms one taking signals? on question Good the endometrial afternoon. comment on the us? Victor, in you Could any and narazaciclib. anything safety the you my actually

Dr. Steve Fruchtman

Sure.

will I take Ahu. that, So

a explain why are your finishing to We with to question. with trial has on mostly exactly you focused I agent will but narazaciclib, monotherapy the and do it single

there the core and no antiestrogen. combined the and letrozole typically is to inhibitors a that or inhibitor -- antiestrogens between All of multi-kinase toxicity an well. are we CDK as palbociclib And CDKX/X CDKX/X do as with narazaciclib plan [ph]

the So will combination anticipate we be safe.

trial, permit a of the the in trial will combination, patients few the on key will early open We show safety the randomized be thing to us but a XXXX. have which will to

So the combination in monotherapy study the cancer of trial with low-grade letrozole. specifically and this endometrial

year, in a I endometrioid which think will randomized those of be two this our end into should studies, finished trial by low-grade cancer endometrial goal. and that’s the lead which

Ahu Demir

enrollment, the that’s are will data question be indications Steve. you, any would any dominating particular Thank narazaciclib on? trial, tumor solid the the be in indications more there follow-up And

Dr. Steve Fruchtman

catch didn’t that. I

asking were cancers your about or to are type it? being repeat that trial. the that? You What of you Was on monotherapy could put question

Ahu Demir

what any In that enrolling Yes. numbers the indications? correct. you is see you solid that patients I more of tumor -- indications indications we in data narazaciclib those that mean trial, of also are will and trial enrolling from see more the

Dr. Steve Fruchtman

the trial and that is type cancer, the lung prostate bladder end-stage So cancer cancer, end-stage There’s very It’s of cancer, cancer. open dominates. is typical one that patients monotherapy could to cancers all ovarian no variable. include

So no diffuse it’s that there’s dominates. and indication single very

and think don’t patients any their have don’t we efficacy expect diverse signals. than cancers. Ahu, and don’t are I The other regarding to I anticipate very safety, their So indications

and the a it and the recommended of endometrial goal anticipate letrozole approved the any as like on running combine The just to with be the I trial. of recommended time inhibitors safety is monotherapy studies dose added cancer just and think recommended it to the issues is to with narazaciclib and already CDK which the Phase Phase going generated I Phase study, is toxicity like CDKX/X monotherapy of II be safe, most competing at dose don’t combination, to letrozole II the dose kind from the up Phase II I establish it’s same said, anticipate we we will completely of the

Ahu Demir

you, Thank Very helpful. Steve.

Operator

from next comes from Our H.C. Joe Wainwright. question

Unidentified Analyst

This for questions. questions. is Surendar two Thanks Joe. I [ph] taking our have on for

narazaciclib, for question efficacy first XQ? in the The data initial anticipated we any expecting are readouts in

Dr. Steve Fruchtman

So I will take that one.

So and important These way. question, that’s the very questions. the a inhibitors great are by CDKX/X

who and these how probably So community analyst the understand the drugs investment already work.

on they cytotoxic CDKX/X prevent you are the These at drugs authority the drugs. all And endpoints. were class based look if of health inhibitors, These tumor approvals for not three proliferation. approved two

first second is and is the survival overall The survival. progression-free

they for not many you cytotoxic, see reason that because do is the are not And responses.

see periodically digits. but may it’s You in a single response, probably

these way by the So overall prolonging PFS survival. drugs to prolonging patient’s lives work improve and

And thus, controls control historical to arm, intelligently, you really you a by use but evaluate all means. that could need

We arm once plan with improvement to the The open established in PFS to control to or Phase either hurdle for and on LGEEC is a XXXX we randomized in remain early target in plan. be really trial are way we is that modern in the and era. a that and OS, II the that do thus, trial, recommended will next show our

Unidentified Analyst

Got could for Phase enrolled in question have it. RDEB. us provide be it. missed patients many are in it, And you Got on the but may II still if trial. pending I one to rigosertib how more an update

Dr. Steve Fruchtman

trial. as Dr. Austria. we in One two So Those where ISTs Johann cell Bauer South sites. of this also resides, Dr. international two in in Andrew is primary Thomas squamous -- at RDEB have one experts Philadelphia, are and in Jefferson world’s sites the this participating

travel do as may trial, or will Onconova major presented, have doing RDEB we is the the to on site once with in in in because And now appear these have Israel, they compassionate sponsored to ultra-rare it patients are treat and of then because we squamous with are up asked cell. open use anyway, the perhaps to medical these -- discussions it may again, trials been approach. and Paris, requests the agency a to trials patient an these us one of a Since world, transition and a are would in we Chile expert a identified we centers specifically, patients that and patient the in anywhere patients France, agency can we have results the

been responses the meeting. So a have reported major medical at

think the complete remissions, in those use have also We the impressive on presentations what we now cutaneous number is trial approach. very are patients since a of compassionate

but trial there’s the and at are too either efficacy we intravenous another they put that protocol see we efficacy in squamous I of buy-in trial, a look get or forward an a rigosertib on said, patients on Victor plan, potentially their recently to continue Thomas cell early patient oral an believe and those the continuation Onconova Jefferson, sponsored of RDEB more on a number signal to larger but rigosertib for patients. in go interim, the back In to create agency carcinoma. as evaluation,

Unidentified Analyst

Thanks thank updates. for for clarifying, Steve, you and the

Dr. Steve Fruchtman

Surendar. Pleasure,

Operator

Noble question Robert Capital next Our Markets. comes from from LeBoyer

Robert LeBoyer

details the afternoon. Good ahead? at has the or made that’s on I was any or do question could if any patients number particular be my And to Vanderbilt. might the you wondering give progress trial And as to been data melanoma going points that additional with of

Dr. Steve Fruchtman

cohort. how many to that is first it’s that not next So that the have completed. the a stated bit in early almost I believe, publicly too patients I is, first little three trial. mention to so will and cohort at patients up are efficacy, cohort evaluate Maybe we enrolling on

obviously, there’s trial the been rigosertib, of cohort, melanoma its next and in be quite far, concerns the dose is no So a would malignant progress. but early safety in higher that at

Robert LeBoyer

you Okay. much. Thank very

Operator

the no to am turn remarks. for time, call I this closing like queue. further back showing I’d questions any to in the Steve At

Dr. Steve Fruchtman

Thank you participating you for all thank call. again, Operator, and today’s of in

excellent your are to look for you and our mentioned, important Thanks wonderful Thank milestones as a additional approaching and providing pipeline for to forward evening. updates they participating as pleased again questions again. have are we and be achieved. We across

Operator

for call. concludes you This all in participating Thank event. today’s today’s

disconnect. now may You

Traws Pharma (TRAW) 10 Aug 232023 Q2 Earnings call transcript