TCON - Earnings call transcript Q3 2019 | TRACON Pharmaceuticals, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals Third Quarter 2019 Earnings Conference Call. At this time, all callers are in a listen-only mode. After the speaker's prepared remarks, we will conduct a question-and-answer session, and instructions will be given at that time.

During today's call we'll be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, future expenses and cash runway, and our development plans and strategy.

These statements are subject to various risks that are described in our filings made with Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent quarterly reports on Form 10-Q.

to disclaim reliance such any not statements, these statements. cautioned we and obligation are place on undue forward-looking You to update

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

Charles Theuer

for you call. financial and conference TRACON's third will recent our pipeline begin with activities. thank results and quarter business and afternoon, joining Good on update I XXXX an update

Scott months Following the Brown, September Chief that, Officer, will for nine Accounting financial three our XXXX. and ended review XX, results our

Finally, conclude will by we taking your questions.

centered Our to three continue efforts be on value propositions.

continue a to First, of we develop clinical stage assets. pipeline robust

clinical Second, tracking in are of of the XXXX. IMF's pipeline intent multiple for preclinical selecting at we of development progress antibodies one with the biospecific least of assets these

external that assets our significant evaluate expertise. U.S. potentially key drive and Third, long-term to to in us to will platform to leverage We shareholder new XXXX our continue our development and establish partnerships we development includes continue clinical that product stage platform pipeline value. will XXXX product to commercialization allow believe independent additional CRO add

clinical providing an clinical Let's cash four to this by If at runway important we data financial resources begin we XXXX our for facility extend of into points transaction us time with which Capital at the each estimate sale. prices our utilized, with the into QX XXXX, remains significant would of fully to with requests continue time registration in at $XX follower establish entered development leverage related best-in-class We to assets. Aspire development, financial and the new Aspire a goal our platform. committed on million With the date or or statement during product and partnerships fast corporate to to the purchase a time about respect October. XX stage stock the first-in-class, market to business around financial our flexibility to TRACON's up executed of an effective from agreement common based on month period price beginning to transaction

four with the unmet Let's assets of there experience inhibitors, ophthalmic improved essential like to VEGF in we combination begin a believe stage carotuximab. with Because AMD. to not patients agents formulation VEGF substantial meaningfully wet target do is treatment turn our vision be need and majority now upon endoglin, angiogenetic the that clinical DE-XXX, for clinical with pathways, inhibitors in single-agent developed of

randomized single-agent Lucentis with doses Our compares completed three-arm Lucentis. Phase licensee, with that in different Santen, last to AVANTE two treatment enrollment with combined DE-XXX treatment quarter study the II of

U.S. six The XX patients milestone data, clinical of in trial the visual in expected XXXX. expected at sites significant be the is This endpoint first-half our of the months first are to accrued acuity XXXX. corrected best following including and primary dosing of top of line

to financial success milestones significant $XXX low including a high sales. in and regulatory, net DE-XXX, teen retains remaining based to on TRACON global million developmental, royalty rights and commercialization single-digit

cell reverse a focused DNA on NCI repair to resistance that now or four is Phase the that to Phase second TRCXXX, mesothelioma I stage the novel, trials lung non-small is turn to of chemotherapeutics. small-molecule asset by sponsored excision in that We'll intended base are clinical patients continues pathway II Enrollment cancer. certain inhibitor with or our

in TRCXXX with that response. ongoing gene Phase from well to correlates patients as glioblastoma tumor As specimens from specimens trials II well, with goal the profile identifying a biomarkers tumor as continue in expression our clinical academic trial, collaborators in protein completed treated of evaluate or the

clinical We presentations TRCXXX XXXX. in on expect multiple data

another more month, to XX studying sufficient Xtandi cancer prostate prostate with resistance FXXXL we or receptor profile a another basis trial or to Earlier in that patients: those determine have Erleada. to with We'll those those in risk-benefit Erleada. treatment asset for than now move Xtandi clinical third with mutation, with enrolled with I/II TRCXXX on patients Janssen an androgen resistance are developed our stage TRCXXX, who this three we're mutation, of cancer, to acquired agreed in patients Phase castrate-resistant with metastatic undisclosed of the point cohorts and that

andro indicate While lower and mature, mutation. and therapy the available not patients the data early initial with the lower to of in prevalence that expected response than data than expected a rate mutation FXXXL receptor

they II Phase million in in II independently payment, not Janssen $XXX.X the if on we low entitled a data, right the to of TRACON to enrolled from re-acquire proof-of-concept half sales. completion the TRCXXX to TRACON opt-in to patients is a success-based their to Janssen upfront TRACON partner and currently the the on can data receive If Based all accrual, up expect now license Jansen on first XXXX. Phase does from TRCXXX royalty of million a proof-of-concept exercise deliver or in that and opt-in, Recall and asset single-digit advance with abroad. milestones $XX U.S.

a and developing in marketed first from Our this trial and presenting X in top is half fourth the supplied of completing by we escalation studied TJXXXXXX and Through I-Mab TJXXXXXX, second anticipate being X We're with PD-LX dose collaboration Roche. our with is in Phase line antibody XXXX. antibody study clinical agreement which agent Biopharma. dose in them being single as Phase with combination the escalation CDXX a asset stage Tecentriq, a data

a of of in TRACON collaboration, is and the and And out U.S. development payments, TJXXXXXX to Europe. responsible portions party. this if the escalating TJXXXXXX I-Mab TRACON elect In and royalty for is clinical non-royalty regulatory to third license

a multi-product tumors exciting agreement believe to that approaches hot to T-cells that for second to bispecific is We most the cancer potential have micro I-Mab's America. make words in tumor of with direct North bispecific collaboration environment, antibodies, or antibodies cold five to in up therapeutic those especially the the treatments. other Our to one develop I-Mab

advancing At innovation. has time, source their continued our Further, access of I-Mab antibodies. pipeline multiproduct a this we disclosed as view bispecific preclinical to a viable seven

bispecifics expression of I-Mab one an the in including the targets PD-LX XXBB interested associated engage through through tumor expression that receptor, T-cells targets another T-cell undisclosed particularly that tumor and the that antigen. tumor through the are We

For clinical U.S. U.S. to the for from will trials. subject bear the share of will I-Mab the commercialization companies and and for in the phase more U.S. will collaboration. TRACON any cost and bispecific costs lead development development and and share clinical TRACON becomes early commercialization also commercialization. equally two antibody the stages profits advanced in

TRACON's element collaboration becomes study. of from Another to in prior is right each the license any to at pivotal that bispecific worth conclusion the agreement subject time this to antibody of noting I-Mab

Greater escalate to reflect opt-in all development. phase would payments of the China. The territories option advancing this Exercising expand rights our include outside of

an due of IND exercises its to example, option $XX payment For opt-in to studies. million prior enabling is TRACON

the an IND the in first I-Mab XXXX. bispecific antibody file U.S. We from in expect to for

XXXX currently From fund the of our our resources expected potential operations clinical third through financial perspective, milestones. bad capital quarter our planned sufficient development and creating be into multiple are to and to business

our discussed through rate equity Capital. we the with further be of line Aspire established run use extended recently may As

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

Scott Brown

comparable September nine the and zero collaboration $X at to good revenue afternoon for three you Thank respectively. TRACON for reported XXXX and periods XX, compared the ended million everyone. months no XXXX of Charles

Ambrx in no million in with compared $X due was the to was connection received payment XXXX, to revenue the upfront decrease XXXX. corresponding that revenue recorded agreement The in as

clinical this months September and attributable expenses million $X.X nine were expenses related comparable million trial development ended $X three and periods XXXX, to and million respectively, $XX.X million and the year decrease lower and for manufacturing earlier for of of the to XXXX. primarily program XX, the $XX.X termination The Research to TRCXXX the compared was

General comparable and $X periods respectively, for administrative $X.X and of million expenses ended three $X and to $X.X million months, XX, XXXX. XXXX, the and million for were the nine million September compared

periods $XX.X $XX.X XXXX. to Our September million XXXX, the and was three comparable months and net million million nine loss $X.X for $X.X the compared million XX, respectively, for of ended and

Turning December balance June the and sheet, $XX.X at September $XX.X cash million equivalents, XX, to and short-term and $XX.X compared XXXX million XXXX, XX, our totaled respectively. cash, XXXX to XX, million investments at

use our be the Capital. operations current line to fund into sufficient may Charles of third planned through resources we with XXXX, Aspire the As expect extended said, of quarter which be further our to equity capital

the Charles. With turn call to that, back over will I

Charles Theuer

To Scott. forward built that to have four broad milestones a and value-creating we look potentially pipeline, you, clinical XXXX. the recap, are Thank expected in

wet top AVANTE in trial in First licensee half of AMD results our through first Phase year. line the Santen X the

partnership the proof year antibody first year, with first concept Second, half second Phase the in antibody IND our the data top right half of pipe for TJXXXX, which trigger bispecific will for the the Janssen broad cancer, of in line and from filing X reacquire of and to I-Mab. Phase data CDXX the our nomination prostate then and for X in TRCXXX

which The runway. success first result XXXX would our further clinical cash extend could of the milestones expected readouts in in half based

on have plans providing further we or the and strategy updates to first-in-class, that corporate for We months in and the also and We remain assets, TRACON a platform continue best-in-class development right through look patients who would coming new fast confident development the shareholders. our with place benefit to from identify forward product accessing in benefit the collaboration. follower deliver to ex-U.S. companies business of clinical-stage

and you attention are answer your available questions. your Thank and we time for to

Operator

Thank Maury first Raycroft Instructions] from [Operator Our Jefferies. comes with question you.

with You your may proceed question.

Unidentified Analyst

has My for taking those is Maury. Hi, first And questions. for the for on reviews? a reviewed feedback study so on Mitchell that any study there. gotten you been This have is Thank DSMB? by if you DE-XXX question our

Charles Theuer

interim Yes, there's question. your appreciate I no study. that into look DSMB

not we until the of in will which at look is first next we expect final have data the So day year. an available, interim the half

Unidentified Analyst

prevalence Okay, FXXXL? are higher thank versus you receptor TRCXXX, you then androgen And a mutation that mentioned you. that seeing for of

Charles Theuer

third patients as looking point undisclosed in resistance. FXXXL we seen and a are clear, where mutation And cohorts trial defined at so fail second mutation a prevalence. has higher the without a the yes, three yes, There's cohort for the exploring. be are a FXXXL So those are basis receptor point that enrolling currently that a lower to than then prevalence that of expected we've mutation and than though we're point patients the we're

separate those of first we'll year. cohorts next that data the so on are half report And three expecting

Unidentified Analyst

Okay, great. Thank you.

Charles Theuer

Thank you. Appreciate the questions.

Operator

Instructions] Bert Hazlett comes BTIG. [Operator with next you. Thank Our question from

with proceed question. your may You

Bert Hazlett

us the the how by remind the Thanks. with intrigued Could to really and you program. update, Charles, – comments the pipeline, I-Mab decision those I especially how regard programs X-XBB the process works but us those remind discussion you I-Mab, of there's move bedding could to that how they works? antibodies with between forward? I regard how know some selection and and you the appreciate

Charles Theuer

Sure, I part an the our such appreciate really long-term terms important It's to that access of future of Bert. pipeline. the question. No, in

manufacturing we to those year period they reach of a TRACON. start presented IND-enabled they five point enabling into do and that that are come data, carefully currently continues the that and bispecifics make and that we our targeting dominate two way X includes the where assets, can over is, enough that one So it preclinical assets existing of at future data to to that over compound. pace IND-enabling moving to up an any the to stage data times time. seven advance collaboration, process are we also years formally evaluated based works that to listed as on including IND the entitled the five asset per up through year a next are to At assets that that there's of the stage the And where listed, X-XBB and to kind

IND-enabling and the responsibility full the we filing and BLA the the responsibility it X and only part activities, Phase the trial. And of the the And you also nominate up manufacturing by that, until spec of the the to commercialization. then we forward through with Phase response I-Mab to We IND on perform the continue of trials, including then running IND file once continues move as is X whether take studies. filing not clinical then which but initial assemble time

the Phase the that profits With commercialize the equally commercialize are drugs, bispecifics in the they for to time entitled bispecific, we in cases all we China. trial we and and the that At X many own commercialization fully U.S. then in costs thought data with approval. the being split on split their the actually sufficient the maybe

works. the to JSC So of that's And general relationship kind of how of monitor in stay terms we with in close quarterly a touch overview do bispecifics. progress meetings that I-Mab of

Bert Hazlett

lifted it there's That's data has that target. that helpful. specifically, that has risen X-XBB been to And particular some with has others then you? intrigued with intriguing What regard above really

Charles Theuer

No, a Bert. great Yes. question

another – tumor broad is play tumor prospect. So, with there receptor like I in receptor. trying truly I at through cell when turn a exciting look a to to my bispecifics hot through either bispecifics, in and think bring a the T-cells categories, cold X-XBB two truly would the or a very CDX that so engaging But be view

are instance TIGIT other receptor say for class two receptors – and separate PD-LX checkpoint engaging The bispecifics instance, of receptor. is the like for another immune a

those are with really case that is prove when engaging that a those separate attractive in targeting just Whereas because recreate have individually can't you receptors a either there, you're me T-cell, separate superior two And to paradigm less inherently you to of antibody. you're to antibodies. the monoclonal really that with creating a bispecific

why to engagers sense me cancer immune two separate as as to true that's targets. bispecifics therapy more So inherently to T-cell make are opposed the that checkpoint breakthroughs potentially

Bert Hazlett

in that TILs you of the might microenvironment? So potentially there patients able group target with antibody with to tumor those of that subgroup you low that enrich be are a –

Charles Theuer

to I antibody, mechanism definitely with you definitely for I Yes. respect patients. for as tumors about you responsive instance think profile PD-LX/X-XBB more could for PD-LX could one for bispecific, strategies, enriching think mean, expression those enrichment

For antigen, a target that's second – another is target tumor there now X-XBB I-Mab that is bispecific developing. for associated an right undisclosed

that look for enrich as you bispecific. on target that patients might way example, could respond to for the for to immunohistochemistry tumor So another by that

an prime a of is enrichment difference therapy the between a successful biomarker that clearly unsuccessful make bispecific of and So focus a therapy. development could

Bert Hazlett

other Okay, on Phase on thank one XXX. you. just X And data follow-up the

you response as is you that the What's set of resistant that at that think patient Just the expected lower due response? driving Do to the initial – look trial? to criteria Is selection? due rate?

Charles Theuer

No, question. great it's a

drugs therapies, when heterogeneous think didn't you cancer, FXXXL rates and I Erleada the look you get the all basis mechanisms resistance was are to also and back that you those resistance. be for you tumors about XX% mechanisms elaborate response where that to one maybe may for Xtandi you as are saw for on resistance, think when will and for if those who patients instance, those likely – FXXXL prostate we naive And more mutation, saw higher. the more of point type there mutation, PSA instance based androgen so and other to are wild receptor, of basis to

Xtandi, AR seeing that patient an data Erleada expected So on response in PSA mutation we're rate not clearly XX% for have you than wild-type in would FXXXL patients. instance based the

Bert Hazlett

the That's get Thank you. I'll queue. Okay. helpful. in back

Charles Theuer

very Appreciate Yes. the much. questions, you Bert. Thank

Operator

Thank this call Theuer time. not over showing at remarks. for now any like I turn would questions you. any am And to I further back the Charles to Dr. further

Charles Theuer

your with attention Well, we look for a to next thank forward good day. you again and you speaking Have quarter.

Operator

and for Thank you. call. this today's concludes gentlemen, you participating. conference Ladies Thank

disconnect. now may You

TRACON Pharmaceuticals (TCON) 5 Nov 192019 Q3 Earnings call transcript