TCON - Earnings call 4 2023 | TRACON Pharmaceuticals, Inc.

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

Operator

Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals Fourth Quarter and Year-End 2023 Earnings Conference Call. [Operator Instructions]

During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, financing opportunities, our development plan and strategies, potential cost savings and other benefits deliverable through our product development platform or PDP, ability to enter into additional license agreements and expectations regarding envafolimab treatments continuing to generate a double-digit objective response rate. These statements are subject to risks and are described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2023, and subsequent reports on Forms 10-Q.

You are cautioned not to place undue reliance on these forward-looking statements unless required by applicable law. to statements. obligation any disclaim update such We

Now to CEO Dr. like to of call over turn the Charles begin. Pharmaceuticals. Theuer, I Dr. would TRACON please Theuer, President and

Charles Theuer

TRACON's afternoon Fourth Results Good Business Call. Update you thank for and Quarter Year-End XXXX and and Financial joining

our begin update review will pipeline and on I activities. our with then an recent

that, Brown, our ended the the for results XX Scott Chief months review Following X XX, December XXXX. financial Financial Officer, and will

an by single-agent blinded adverse pivotal patients Finally, and our your XX% we taking update X.X% well enva review and we enva treatment. was with ongoing central Enva single independent ENVASARC on investigator from in progress begin II drug-related was serious reported event. conclude single-agent of initial trial. the objective with The XX will rate C efficacy with data in by safety by continued response or questions. I'll December, without a generally cohort the monotherapy updated X Phase review interim tolerated responses. treated XX In patients

Importantly, central greater months. X review median by than is response duration

on and are updated to to We of end data ENVASARC of to this response prior thereafter the expect shortly and report this later quarter. complete pivotal trial the track quarter accrual

MFS, to primary key than or response exceed endpoint. XX is XX.XX% Median months confirmed of show only or must objective response with in endpoint response central patients an a the duration X out objective secondary greater X reminder, responses As in a in order of review. the rate patients by UPS objective of rate statistically refractory Votrient, the X% FDA-approved for ENVASARC treatment

drug be more Votrient, enva ENVASARC efficacious in goal warning liver to demonstrate a that black-box safer and potential a fatal is for both toxicity. than Our has with to

checkpoint BLA strategy FDA rate to as refractory XX% as discuss other the we determine Furthermore, in Based or single-agent are we a filing for to of plan approach inhibitors UPS the response targeting X responses. MFS, from enva. trials on data we soon

in therapy the that on observed drug and a received As that might based of we sarcoma regulatory activity of These MFS in have X tissue advantages reminder, subtypes progressed prior salutations ENVASARC. sarcoma designation for provide soft review or lines on X received orphan expedite UPS enva in designation enva. and Fast important of Track have

sarcoma ENVASARC is UPS refractory and designed to data the subtypes MFS. safety efficacy in provide and of

frontline is the MFS, and BLA We submission, initiate setting ENVASARC sarcoma also subtypes, doxorubicin of strategy We in the have subject pursue including results treatment of pivotal the common a in enrollment completion to the a therapy the for from in to of prior the approved therefore and and the positive trial of of Doxorubicin plan frontline trial common enva patients. approval sarcoma diagnosed ENVASARC. expected to enva the used to sarcoma. following UPS most newly

The be of goal the respond of sarcoma doxorubicin. to determine the subtypes combination of that trial and will best enva to that

require to in results randomized survival benefit. demonstrate FDA we positive a trial, a will the the Assuming pivotal trial expect ENVASARC

doxorubicin to to as single-agent with trial and survival other with expect MFS and This the We as doxorubicin expected to UPS endpoint. patients well to expected compare sarcoma with post-approval be trial with III potential subtypes enva Phase enroll will doxorubicin. respond enva as this progression-free would therapy

the for of in to ENVASARC from design submission of review We time refractory with meeting pre-BLA expected our frontline accelerated the approval the a at discuss to expect trial sarcoma. expected of of the potential FDA enva data

MFS. anticipated refractory in enva the sales understand million UPS following in peak to is in at parity $XXX potential important and is sarcoma solely the It revenues not pricing with forecasted annual approval

neoadjuvant to create in and the settings benefit supplemental broadly patients frontline, with to opportunity development clinical the is BLAs. enva adjuvant Our strategy sarcoma designed by for seeking

Phase inhibitor, repair adding Institute. damage of the DNA current is The followed trial supported the treatment our to to NCI durvalumab designed with The turn endpoint standard-of-care is of by National primary survival, maintenance radiation and pemetrexed, a randomized TRCXXX agreement ongoing and X-arm program consolidated to patients cisplatin is trial research therapy, treatment. now survival of II in with Stage results TRCXXX, are improvement that nonsquamous, U.S., a enrollment at and will to enroll assess trial in the combination XX% development the in the in through XX XX%. X TRCXXX assessing are the progression-free Cancer expected radiation. XXXX. an year and an financially detect from is now open XX to lung III chemo trial The sponsoring sites final cancer progression-free non-small in cooperative benefit will We cell for

clinical now our of PDP, November of discuss last will pipeline or of an value operations of expected to clinical a independent approximately implementation recognized shift license patient. development per that our payment of update PDP in research. enjoy independent of clinical license $X to at as is product to them its The We PDP trials for platform, reap do that from trial we for of I biotech $XXX,XXX TRACON. million the TRACON the upfront company cost the benefits executed allow a estimated of to CRO internalizing CRO at run to our we an year

licensing speed patient, to be for at we our TRACON our increased million trial to more execution CRO team. our pace charges potential of in per trials of expected on up savings of that by could the $XXX,XXX PDP trial $XX approximately using a enjoy and advantages XXX-patient typical a enrollment from partner As running the or addition in-house

efficient our nondilutive expect enabled PDP that CRO to as our independent in noted most the through capital we us through cash positions one clinical of believe position the As for opportunities we we organizations. supplement further have development past,

our ways capital to We expect platform to TRACON. provide to leverage continue potential for nondilutive that X in

our This the aligned past, a using example, we First, drug to clinical lower an still TRACON cost & to used to we Johnson. pay-for-performance but to evaluate with at in premium a compared model. for plan fixed where performs structure CRO trials candidates Johnson continue a cost a at is

Second, proprietary to execute capabilities independently our and PDP, paid our clinical avoid we to CROs know-how to capabilities enable these nontransferable to to contracting trials. share continue clinical plan another licenses to internalize company and operations with use whereby to are to execute new we

TRACON, such the As at can an experience we result investment time for has partner. believe savings our been in cost substantial and

conducting as become compared that wish has at at CROs. rewards believe over We faster to reap for quality contracted and companies time, trials the CRO-independent lower our earned to credibility strong who PDP compelling cost a of typically higher to trials solution and

provide our on Scott will update financials. At this time, an

Scott Brown

Thank you, Charles, and good afternoon, everyone.

$X to December X for X months of period revenue $XX compared ended increase and comparable to was with arbitration in the for license PDP XX, the I-Mab. Revenue XXXX, the and $X XX is the million in the to announced for in the the periods million, XX-month million is for increase previously due TJXXXX X-month period The million the conjunction the prespecified license outcome related and fee XXXX. for termination $X with

Cohort development ENVASARC comparable enrollment decrease the million TRACON's ENVASARC XX, XX only of XXXX, and million X C in were the research of and and XXXX. $XX.X was $X.X million of and the for months for compared of due D The million pivotal $XX.X period $X.X to corresponding and expenses termination to the trial. cohort ended December

million comparable compared the expenses and of X and the to December lower XX, administrative and legal XXXX, XXXX. $XX million General million XX $X.X was months $X.X decrease for The $X were for million due ended periods expenses. to and

of months was XX our was net periods December quarter. comparable the ended income $X.X due the of arbitration the We the compared net $XX the for ended XXXX. net other being December the XXXX, loss collected award income Our XX, XX, $X.X million million XXXX, months losses million third $XX.X XX million to months for and $X X in ended in recorded million for December XXXX, of and to XX,

restricted XX, the cash balance XX, I our $XX.X totaled Charles. million to XXXX, to December back compared and December million call sheet. at that, cash $X.X will Turning over to turn XXXX. With cash, the At equivalents

Charles Theuer

Thank you, Scott.

recap is me as key have expected As planned. corporate events. proceeding our heard, strategy Allow you to X

response the data pivotal from First, later we trial. ENVASARC to report expect this quarter, updated

compared Second, by partners and executing to at a for product nondilutive platform to either license an generate but a development you cost we to are available additional now a answer leverage our we replacing continue through model. Thank or trials clinical cost your at CRO a captured lower pay-for-performance using capital premium still to attention, questions. and a your fees expect to and our to through CRO for time

Operator

from first Instructions] Research. [Operator Soumit the Roy with question line Our Jones will of come

Soumit Roy

would some market you drug? profile safety color to helpful. this really of doing lower adoption and started XX%? on rate what response expect infusion? Or the XX%, approval you research faster response rate rate -- would have or -- trial, take Do of this response physicians proper cause rate willing would to a what be because better greater be a are better be ENVASARC on the Any than On

Charles Theuer

Soumit, question. kind order yes, to refractory it's I I of important treatment in understand where stands. thanks think the to the sarcoma answer for your think Yes, for question,

or treatments MFS, As the like liposarcoma, there line leiomyosarcoma second UPS discussed a approved rate. X% In like as of diseases Votrient, -- case the approved response a we've like has has subtypes of and for an and that example, of are epirubicin X% standard care, rate. response

you significant response which market is have in therapy. rate, sarcoma our for about adoption consider rate, for which example, rate refractory on doxorubicin, XX% XX% almost based profile, a expect a XX% target product actually of the is our response achieving response So the And high that sarcoma. research frontline to we as of is as in

different to some has care. significant how larger in the about think effective that standard been approved line very doxorubicin there drug when in I in I think board a the guess that mentioned, has only across And So much setting, think and still rate. in a most you the been than response it's of therapy fact as tumors I dynamic about advances to consider frontline is progress for the bottom XXXX. slow sarcoma. the response rates, XX% a was even And where sarcoma more It's sarcoma have is

I U.S. profile, that our investigators with big would trial feel be on the significant in clinical almost drug, The the which that are field that therapy think, by trial, positive adoption potential currently XX have we're our also in another based fact they advantage a the adopted and of experience in the the would target opinion and in envafolimab with achieving So the this every market product leader of using sites enrolling terms do research be for it we us. commercially. key is

Soumit Roy

really helpful. That's Great.

BLA. question the on on the discussion the Second FDA with

that to control a with run arm? been the filed? if the be only one has can like before trial would is III a Or the FDA what this trial from Phase conversation Now arm, you has larger --

Charles Theuer

Yes.

Cohort based data to initially, D, single ENVASARC to So with clear, envafolimab, which there is of our the the study be combination is you single-arm with were a designed a was achieving endpoint with there discussion And the a accelerated respect arm And trial was currently. C FDA combining the Cohort primary envafolimab on approval. file to was with ipilimumab, know. as which as the way

if see achieved potentially to the clearly XX.XX% D of opportunity for had have only achieved to Given both independently in C, superior that took we was cohorts endpoint D Cohort responses study outperformed to approval. of Cohort the rate. and those primary Cohort have C would D D study. having dual Cohort Cohort Cohort response the compared had But clear, the been in down in But didn't we be

Cohort change the opportunity that based to increased did C primary achieving fact on and Cohort the the approval not So respect for doesn't D activity with endpoint. show

Soumit Roy

Right. be, data that data of at patient And give the details could us you many will quarter, and provided? upcoming color end any how what of kind will on this the be

Charles Theuer

Sure. Yes.

response December respond of providing to X enrolled is follow patients time. we for that And data months that announced to enrolled each the to So excess we at updated them in our therapy. that for opportunity rate XX had patient at opportunity in want least to we give an

expect an would on patients. approximately XX we time, this at update So

duration a patients the to opportunity of in for that finish total at we beyond least that to X the XX thought, to to Soumit. rate response whom patients additional also we update expect have So potentially the December evaluate would months. would And and mean response, XX-or-so in

Operator

H.C. White question Wainright. from next the going of line come Ed with is Our to

Unknown Analyst

on This Ed. for is Steve

half. study, So used first mid-XXXX now be ENVASARC to expected from I the for data and think second question, final in that it's the

about wondering just was So the timing.

Charles Theuer

Yes. No, question. good

objective because So call, mentioned the part we key means the other response key do median just X the I duration we there of rate, just as should response response mid-year. endpoint is We being than mentioned the more trial for accrual the goal. expect data of full as quarter, response with but not months of that quarter have this being also by a the third duration which endpoint

significant for in at have expect third accrual to order we then be patient each this in data full feel months X we So quarter, quarter would trial being given XXXX. of on that least data

Unknown Analyst

makes through would future that deals And how right product for you platform, worked have sense. Yes, Okay. like? do for your any being pricing that deals are And development look now? then

Charles Theuer

question. great No,

upfront. So a I on November. And in technology transactions. can't would the the license X through ways. comment was One fact that past we through reiterate on we've clearly X the actual PDP But just for million or now specific accomplished that potential is I that licensing in monetized nontransferable $X the

company more be give make TRACON, if clear typically for I platform. $X $X it's $X Phase can let's trial, guarantee study a XXX-patient million we is final come won't CRO price, Phase that TRACON than charge mean again, at or it that so it's potentially at substantial what be potentially know bigger the potentially even million, to $XX $X we to we say, can say, be trial a that the a bid might a example, more, think to to partner I them $XXX,XXX and, that's $XXX,XXX the do to will at, that. a which million, it's replace XX-patient our in patient, access charge for to TRACON. If a patient, million CRO a at study likely, a actually would to potential revenue a and can I and do in-house the performing cost and services more, CRO And more we study a million would

to potential $XX about talking at can that's guarantee we that go and see cost-plus. $XX a do million, say, we million we're TRACON. for knowing it at the substantial can can you we'll So company If million, price $XX revenue

of So are the both that gives each some of potential potential opportunities opportunities. those TRACON, for idea and those around you economics

Unknown Analyst

And Okay. runway efforts? how the any going about can this and you forward? And cost-cutting is SG&A provide cash just

Charles Theuer

Sure.

think guided you've to And these think, this Just I I seen, think as decreased year. X we -- so expenses, I related mid we've things. definitely to have

a years. significant fully have as second of I that So expense ENVASARC is related longer no all, one they the the expenses last X to have, almost enrolled arbitration the And was we trial. mentioned,

expenses in forward platform point through future and result the also X in So net well. And as revenue quarter going both related that I quarter or were to And licensing income-positive. out, decrease platform. will the we're potential leveraging could the in X leveraging would we quarters actually further income-positive where

Operator

And And no time. Instructions] over for Theuer turn this I'm showing I back [Operator like Dr. would questions closing to further at the remarks. conference to

Charles Theuer

great Well, and to Have and thanks next day. for many And you the forward to updating you quarter. attention, for a your time thank we questions. the audience look

Operator

call. conference for Thank today's you This concludes participating.

You may now disconnect.

TRACON Pharmaceuticals (TCON) 5 Mar 242023 Q4 Earnings call transcript