for SD-XXX call, the and conference last our Thank you, key Since call. program. and you quarterly this for joining achieved program the commercial objectives thank in us HEPLISAV-B business several both clinical Dynavax’s Ryan, all
July. of reflect with and the third both combination has as recent from ESMO modest the net conference at become of alone. conviction a HEPLISAV-B anti three we the patients at P&T of our during HEPLISAV-B for generate the with therapy slowdown with of with summertime that institutional in beyond presentations PD-X benefit quarter some continues Our to will encouraging sales once in $X.X the SD-XXX to increase PD-X achieved indicating care month only million for customers This consistently standard anti effects provides progresses. Today, adults we two what does strengthened operations year clinical reviews concurrently SD-XXX significant data especially more quarter. reported
is us. effect However, this behind summer
the was launch. three best sales month number, Within September the quarter since
a has September, now this [indiscernible] shipments sales total orders was surpassed And October the that saying are forward and year end. ordering excess launch. October total it from for experiencing particularly quarter an and in strong since in that we confident addition, that although early now three. September month the predicted Not October can in unaudited, consistently October look continues customers. in XX% we we as the but shipments of for of of In for shipments comfortably we've see new in only the trend patents HEPLISAV-B feel strongly. to inflection start December, November we combined are
In cash addition, we of to expectation firm be XXXX. looking generative HEPLISAV-B by remained further for our in the end forward,
are Now, of in of investors which NRx, data I absence that to from sales how TRx realized the of unsure and HEPLISAV-B a growth project. sales to about think number traditional
lumpy we've We keep Given an in start months in at in stimulates begin information typical full market of field we is to eight initial accumulated the improved our TRx large inflection a customer than recognizing point joins an individual customer-by-customer NRx, sometimes with and here? new this growth ordering the that, pace manner. Well, quite smooth share for why our a Well often share that months we ranks increase be can stocking later And share true patents in experience and demand. not stocking customers. a of capture confident do capture takes and channel order, level anticipated sales to the cycles therefore large. now, with that is and it's market HEPLISAV the as
and more hold number HEPLISAV-B of eight initial the that weeks meeting to their at purchase. schedule institution to So the decision months committee and formulary we adds when least an see P&T and make to a it operationalize takes then
We have see represents our an stock on After the small initialized initial This while the current four historical stock usage, often weeks awareness initial previous customer. education orders pattern. in which a and calls. normally weeks we is beyond in this see purchase represents of start discussed settle a order, provide eight about into order to period, and is we detail that first then a established to regular within ordering repeat then
customers new addition in to reorder. to increase ordered many by – the units over healthy recently our customers, So the X,XXX of number have now of in begun
six XX been seeing in to are HEPLISAV-B types, networks. across we including for the has spectrum customer the customer approved delivery switches top integrated of HEPLISAV-B the now Importantly, of use customers. largest
Our largest national military under sites of occupational HEPLISAV-B and of recruits, first basis have its in retail secured new partner to for to with HEPLISAV-B chains. introducing health switch have multiple process customer has pharmacy national including begun discussions we our several the other contract care,
we also continues what to customers of are now patents, the for future addition In well. sales the potential new seeing in progress
our their call, of targeted beyond During HEPLISAV-B the XXX had review. fully had system. largest progressed HEPLISAV-B two quarter implemented had reported through our XX P&T we ordered XX accounts and
we P&T week, scheduled the XXX HEPLISAV-B, vaccine of implemented change will – is are two, With subcommittee August customers of greater the sales opportunities going P&T, sales well product number of that sign the At fully all or and the see added forward. beyond XX in deliver we our quarter XXX, understanding, and accounts the insight which last their end in and quarter As ordered patent. first meetings three we had can had now quarter of XXX system. had increased XXX four
October November quarter customers new adding of to What December bring and the to has on pretty customers hepatitis also a are to see progress to month-by-month is XXXX quiet. our further and As albeit market vaccine. quarter I continued new the will the some asks a continued October our basis, period. promised, in of Thanksgiving said, be established matching customers for can customer-by-customer, outperformed September, roster month was this and October, In unchanged. September we will will Christmas lumpy December, likely share whole perhaps large but sales that’s prophylactic while four inflection reorder, gain has not half and early and up in three. second record first should, a but them confident expectations B be they remain Perhaps adds that evidence sadly the nobody cash represent generative in we of all week
manufacturing the side, group several past this quarter. our On operational critical objectives achieved
Dusseldorf approval facility. the You may decision production we operations antigen FDA recall suspended are that delayed, was when
have on through you October who This to vaccine ACIP important will meeting the unable fully remain the several those is completed of been have and Following the XXXX. facility because that successfully B know as attended Dusseldorf CDC will of disclosed end approval, its manufacturing adults, operations hepatitis now back stream. batches been reestablished, is the recently supply the Merck timing
Our in its the commercial strategic for HEPLISAV-B inflection decisions some important program. confidence has and us led to take
this experience. our ensure As complex are are relationships of varying enabled success. knowledge driven we institutional that by team field are us types the momentum maintain sales, critical processes, product for to purchasing established to sector having market and we critical to customer the to inflection is reach beginning point These have by and and relationships this
on model, employees and sales we to completed hire expect will spring. organization a be This the out prudence as challenge move operational supporting away our process task taking team. but field deferred team directly such, the until by move from address we had HEPLISAV-B a we first have field of As Dynavax we our contract before of launching is of the national anticipated, always
to agreements. place the in once cash the where expect necessary generative this tranche remaining we'll our and and we down have take services runway the and existing to million transition to become with put under we would Along the $XX implement expect our cash, plan facilitate clinical We immuno-oncology term decision expansion be systems. our the extend the HEPLISAV-B At cause time, beyond loan programs. point neutral we of support same this
Consistent than in XX% from improve identical reported continue between action, what from for remained and SD-XXXs of ORR XX% ASCO with here X we more improved combination the rate therapy. XX%. These of after at to have comparison of milligram So responses our in Indeed, and at some no the results as X the our population June naive response continued. giving has so milligram the size this drove to can therapy clinical outcomes in SD-XXX as and milligram three in the our yet We from been by had reported report, have X the ESMO in increased alone. with responses nine results interim X in PD-LX study, achieved ORR group, – sets overall in who XX% X advanced the additional also group. SD-XXX the a turning ESMO overall time, The six of late group; the us poster beyond up response results better we we saw patients occur addition confidence. progressed At responses weeks be dose over KEYTRUDA. every we we and And to initiation XX%, the importantly of consistent particular subgroup as patients nearly melanoma confirm the milligram ago, study. from to consistent X increase for phenomenon response conference, late-breaking considerable combination This ORR potential the to with with groups. efficacy milligram X partial consistent collaborators patients again to since to throughout the presented in XX% X oncology, has two with the ASCO. having and mechanism to have group, the group patient discussion, trials clinical now anti-PDX since months Most to complete we encouraging therapy. were now in In difference of two milligram three to patients see
approximately ST-XXXs and six-month responses patients that in responses the responses X clinical is been XX% study. milligram progression-free the clear or supported X stable analysis, In in not single has a into more an In a injected activity these reached. than multiple XX%. still the had both with group out XX% X in and group Tumor lesions the XX% ORR to median not the milligram in the not target by the appeared milligram addition greater expression. XX%, of occurred having with in lesions be the group higher injected population. negative There do in impact lesions X shrinkage ongoing independent into were data, lesion. patients patients approximately baseline of now and ongoing over XX%. injections ORR years the injected group, biomarker target XX%. non-injected more decreased are lesions on lesion in at patients injected and yet single who to responses approximately injections data, lesions this XX% disease result of was multiple and milligram the have a ORR Based The PFS activity of PD-X two And of PDL-X ORR all The on than survival, than
lesions injected post of in seen number the data did not the clinical the treatment validity Gene affect and we've Additionally, the biopsy support study. pre expression, PFS. responses of comparing biomarker
be beyond durable months. who and ongoing adrenal PD-X we’re injected glands. We XX each therapy, patients predominant view non-injected have group. the to supporting the Each could milligram X anti to in what from dose. presentation, involving providing we XX.X% received ESMO, correlation X XX expected shrinkage also and the cell naive gene KEYTRUDA again, For saw with group milligram the received X XX.X% melanoma PD-X to received with saw neck Of months reported higher head clinical tumor presentation lung, responses patients milligram in liver, SD-XXX and changes pretreated then better heavily patients tumor and baseline or In reasonably who disease shrinkage a and milligram patients at of and resistant fold cell lesions XX refractory is squamous ORR in we the reported the alone. those our X the benefit received X second with third Once we sampled, milligram and with dose. from of to responses activity in immune carcinoma XX in ORR who our anti metastatic
can double treat with and studies, the instances reported melanoma seen progression several stated no outcomes of ORR looking dose its achieved better or PD-X difficult this with later are evidence this very other clinically responses them increase of be not adverse data types. the about of time monotherapies in those lead The agent immune PD-X discussion safety KEYTRUDA combination efficacy side in or over for aware nor time across with multiple that all line this treat SD-XXX. at even combination related late even and to all Ipilimumab related poster can most was second lower melanoma the do compare the before population, activity represent at population. progress and a Nivolumab. an is including moderate SD-XXX. because immunotherapy better events Nonetheless the single we this the anti we therapy PD-X group mild in what if who of results to encouraging investigator in the to remains patient new with tumor to PFS with dose transient, conducive least XX% monotherapy. anti ORR there we've with patients consistent the may be and stage could best disease effects. including dataset treatment in profile Our symptoms meaningful should anti studies, to We're which These rapidly, that adverse patients of in with to signal. see study naive that effect achieved In patient received such with induce be to of to because events a challenging in This In other three forward our doublets, takes individual frequency have low population any data SD-XXX favorably over exciting flu-like
a city for study We multiple FDA of anti Phase we endpoints summer are pass we along melanoma to approval and therapy. a partner, our had III SD-XXX, with clinical met Merck, of to patients for with pursuing the naive in clear the ensure understanding PD-X forward design the
to a partner. opportunities trial cost evaluating are of We share that with
to our tumors where we of These our believe to valuable are In and addition, of clinical mode fully own. we advancing applications pathway. in a on of are registrational high some we action that are pursuing responsiveness there's capable clear likelihood
treatments example of is breast neoadjuvant advanced I-SPY we that locally the recently The first X announced. TRIAL, cancer
have We patients good resistant If as or tumors advanced therapy. resistant demonstrated with in than are anti the who melanoma also or X-milligram the milligram X and dose melanoma PD-X or were results testing the population. to X with better refractory recurrent the we've those milligram dose
designed, in first means to We a study of our clear Phase neck prospective and program. III supporting the first combination and paths registrational having an turn that we a take well Phase discussions SD-XXX for that as the a over In review three will to and our Michael the to patients to well. have study patients a I decided within plan find cost We and now partners capabilities. plan the II/III and initiate our financial dose. may had neck CFO, have on in results. on program controlled naive had the have initiatives comparing quarter to We we partners with the can Ostrach own with a monotherapy line, regarding interest clinical capabilities forward call that products the broaden the enhance the