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Macrogenics Inc (NASDAQ:MGNX)
Q3 2019 Balance Call
Nov 6, 2019, 4:30 p.m. ET

Operator



Good afternoon. We will activate the MacroGenics 2019 Third Division Accumulated Beforehand and Banking After-effects Appointment Alarm in aloof a moment. [Operator Instructions]



At this point, I will about-face the alarm over to Anna Krassowska, Vice President, Investor Relations and Accumulated Communications of MacroGenics.

Anna Krassowska — Vice President, Investor Relations and Accumulated Communications

Thank you. Acceptable afternoon and acceptable to MacroGenics’ appointment alarm to altercate our third division 2019 banking and operational results. For anyone who has not had a adventitious to assay our results, we issued a columnist absolution this afternoon analogue today’s announcement, which is accessible beneath the Investors tab on our website and Media You may additionally acquire to this appointment alarm via webcast on our website, area it will be archived for 30 days, alpha about two hours afterwards the alarm is completed.

I would like to active admirers that today’s altercation will accommodate statements about the company’s approaching expectations, affairs and affairs that aggregate avant-garde statements for purposes of the Safe Harbor accouterment beneath the Private Antithesis Litigation Reform Act of 1995. Actual after-effects may alter materially from those adumbrated by these avant-garde statements as a aftereffect of assorted important factors, including those discussed in the Risk Factors area of our annual, anniversary and accepted letters filed with the SEC.

In addition, any avant-garde statements represent our angle abandoned as of today and should not be relied aloft as apery our angle as of any consecutive date. While we may acquire to amend these avant-garde statements at some point in the future, we accurately abandon any obligation to do so alike if our angle change except to the admeasurement appropriate by applicative law.

And now I’d like to about-face the alarm over to Dr. Scott Koenig, MacroGenics’ President and Chief Executive Officer.

Scott Koenig — President, Chief Executive Officer and Director

Thank you Anna. I’d like to acceptable anybody accommodating via appointment alarm and webcast today. Acknowledge you for abutting us. This afternoon I will focus my able animadversion on our added avant-garde programs and the abreast appellation milestones accepted during the butt of the year. But afore I do so, let me aboriginal about-face the alarm over to Jim Karrels, Senior Vice President and Chief Banking Officer, who will assay our banking after-effects for the quarter.

James Karrels — Senior Vice President, Chief Banking Officer and Secretary

Thank you, Scott. This afternoon MacroGenics appear banking after-effects for the division concluded September 30, 2019, which highlight our banking position as able-bodied as the beforehand we acquire fabricated over the quarter. As declared in our release, MacroGenics had assay and development costs of $44.9 actor for the division concluded September 30, 2019, compared to $46.2 actor for the division concluded September 30, 2018.

This abatement was due to decreased development and accomplishment costs for MGA012 and flotetuzumab, partially account by added analytic balloon costs accompanying to our MGD013 study. We had accepted and authoritative costs of $11.8 actor for the division concluded September 30, 2019, compared to $9.6 actor for the division concluded September 30 2018.

This access was primarily due to consulting costs and added able account fees. We recorded absolute revenue, consisting primarily of acquirement from collaborative agreements of $18.7 actor for the division concluded September 30, 2019, compared to $20.8 actor for the division concluded September 30, 2018. The abatement was primarily due to decreased acquirement accustomed beneath our accord and authorization acceding with Incyte. This abatement was partially account by an access in acquirement accustomed from the deferred upfront payments beneath both our accord and authorization agreements with Zai Lab and Servier, as able-bodied as acquirement accompanying to accomplishment casework performed beneath our analytic accession agreements with Zai Lab.

We had a net accident of $44.6 actor for the division concluded September 30, 2019 compared to a net accident of $34 actor for the division concluded September 30, 2018. Agenda that for the division concluded September 30, 2019, this net accident reflected added costs of $6.7 million, which included $7.6 actor in abeyant losses accustomed on accumulated disinterestedness antithesis held. And finally, our cash, banknote equivalents and bankable antithesis as of September 30, 2019 were $254.4 actor compared to $232.9 actor as of December 31, 2018.

And now I’ll about-face the alarm aback to Scott.

Scott Koenig — President, Chief Executive Officer and Director

Thank you, Jim. Let’s activate with Margetuximab, our investigational Fc optimized anti-HER2 anybody actuality evaluated in SOPHIA, our Appearance 3 balloon in HER2-positive metastatic breast blight advised to analyze margetuximab added chemotherapy adjoin trastuzumab added chemotherapy. We acquire advanced appear that progression-free adaptation in the margetuximab arm was abiding compared to the trastuzumab arm, affair the study’s aboriginal consecutive primary endpoint.

In October, we appear abstracts from the added pre-specified acting assay of all-embracing adaptation conducted afterwards 270 contest acquire been reached. The abstracts showed a trend in OS in favor of margetuximab. In the Absorbed to amusement population, the average OS of patients advised with margetuximab and chemotherapy was 21.6 months, compared to 19.8 months for patients who acquire trastuzumab and chemotherapy, a assiduity adaptation of 1.8 months. The hazard arrangement was 0.89 and the p bulk was 0.33.

Margetuximab optimized Fc arena binds with added affection to CD16A, including the 158F low-affinity allele agitated by about 85% of the animal population, In the pre-specified basic assay of this above sub-population of genetically authentic patients in SOPHIA accustomed the 158F allele, average OS was 23.7 months in the margetuximab arm compared to 19.4 months in the trastuzumab arm, a assiduity of 4.3 months. The hazard arrangement was 0.79 and the p-value was 0.09. We attending avant-garde to presenting added capacity of the added acting assay at the San Antonio Breast Blight Symposium on December 11. The final OS assay is planned afterwards 385 contest acquire accrued and is projected to be completed in 2020. We acquire that patients with HER2-positive metastatic breast blight abeyant to new therapies. Margetuximab, if accustomed by regulators will abode an important unmet charge and could become a admired assay advantage for patients active with this adverse disease.

Therefore, we apprehend to abide a BLA to the FDA afore the end of the year. We additionally seek to abode unmet needs of HER2-positive cancers above breast cancer. At the ESMO Congress in September, we presented adapted abstracts from our advancing Appearance 2 abstraction evaluating margetuximab in aggregate with pembrolizumab in added band patients with HER2-positive metastatic belly cancer. This abstraction testing a chemotherapy chargeless regimens for patients who had accustomed above-mentioned first-line accepted of affliction assay with chemotherapy in trastuzumab.

As a advertence a acknowledgment bulk of 47% with a average all-embracing adaptation of 13.1 months was appear from the aboriginal band chemotherapy and trastuzumab in the ToGA study. In our Appearance 2 abstraction in added band Belly blight patients, who are HER2 IHC3 positive, we appear a average all-embracing adaptation of 16.8 months. Furthermore, in the HER2 IHC3 added and PDL1 double-positive patients, we observed, the average all-embracing adaptation of 20.5 months and a acknowledgment bulk of about 50%.

Notably, the assurance contour of margetuximab and pembrolizumab empiric in our abstraction was agnate to that of pembrolizumab monotherapy. Based on those able second-line data, we acquire avant-garde a chemo chargeless dieting of margetuximab and MGA012, our anti-PD-1 mAb into a Appearance 2-3 allotment abstraction alleged MAHOGANY, in first-line patients with belly blight who are HER2 IHC3 added and PDL-1 bifold positive. The aboriginal accommodating was dosed in October. This chemotherapy chargeless allotment of the study, which we accredit to as bore A is advised as a single-arm abstraction to abutment a abeyant accelerated approval of this dieting in the US based on the primary adeptness endpoint of cold acknowledgment rate. We acquire there may be a cogent befalling to change the treatnebt archetype for some patients active with metastatic HER2-positive belly cancer.

The added basic of the MAHOGANY study, which we accredit to as Bore B, is advised as a randomized controlled balloon to appraise the aggregate of margetuximab, with chemotherapy added either MGA012 or MGD013, our PD-1 x LAG-3 DART atom compared to trastuzumab and chemotherapy in a broader citizenry of patients with HER2-positive belly cancer. The abstraction advised to appraise all-embracing adaptation as the primary endpoint. We apprehend to admit Bore B in the aboriginal bisected of 2020 and plan to alike the all-around efforts with our accomplice in Greater China, Zai Lab.

Turning briefly to enoblituzumab, the best avant-garde in our portfolio of molecules targeting B7H3, enoblituzumab is an investigational mAb into which we acquire congenital the aforementioned Fc mutations as margetuximab. We are planning a randomized Appearance 2-3 abstraction enoblituzuma added MGA012 with or afterwards chemotherapy in patients with first-line metastatic arch and abutting cancer. We apprehend to admit the abstraction anon and plan to alike the all-around efforts with our accomplice in Greater China, I-Mab Biopharma.

The abutting program. I will altercate is flotetuzumab, our investigational bispecific DART atom that recognizes both CD123 and CD3. As we appear this morning, there will be bristles presentations on flotetuzumab at the ASH anniversary affair in December. These accommodate to our presentations of adapted abstracts from the Appearance 1 monotherapy abstraction in patients with relapsed or adverse astute myeloid leukemia or AML. The abstraction enrolled a absolute of 50 patients at the recommended Appearance 2 dose, including 30 patients enrolled with adverse AML, that will be the focus of the ASH presentation.

These patients represents an acutely arduous citizenry to treat. Area based on our data, we acquire there may be an befalling to abode an unmet need. The added presentation will alarm abstracts suggesting in the beggarly signature associated with patients who are acceptable to acknowledge to flotetuzumab, acknowledging the apparatus actuality exported by this molecule. We acquire accomplished discussions with the FDA to ascertain a abeyant allotment aisle for this atom and advanced accouterment added advice aboriginal abutting year. We acquire additionally accomplished a aggregate abstraction of pertuzumab and MGA012 in relapsed or adverse AML accommodating at abeyant actuality to both augment and amplify the continuance of acknowledgment of AML patients on flotetuzumab. The aggregate is accurate by a able accurate rationale, based on abstracts that we acquire advanced reported.

Turning to our PD-1 programs, the aboriginal and best avant-garde is MGA012, which as you apperceive is abandoned accountant to Incyte Corporation globally, although we retained the rights to beforehand our action molecules in aggregate with MGA012. Incyte is initially advancing development of MGA012 monotherapy through three potentially allotment directed analytic trials.

One in MSI-high endometrial blight and one in Merkel corpuscle blight with antecedent abstracts advancing in 2020 and the abstraction in anal blight with antecedent abstracts accepted in 2021. And afresh there is about Incyte and MacroGenics are anniversary belief MGA012 in assorted aggregate trials. In total, the accretion development affairs for MGA012 includes about a dozen analytic studies. As you may acquire apparent from the abstracts we appear yesterday, Incyte has several column the presentation at the SITC Anniversary Affair demography abode this week.

As a reminder, beneath the acceding of our acceding with Incyte, MacroGenics is acceptable to acquire up to $405 actor of potential, development and authoritative milestones and up to $330 actor in abeyant bartering milestone. If MGA012 was accustomed and commercialized, MacroGenics would be acceptable to acquire royalties tiered from 15% to 24% on approaching sales of MGA012 by Incyte. Our added checkpoint atom is MGD013, a first-in-class investigational DART atom that is advised to accommodate co-blockade of two allowed checkpoint molecules bidding on T-cells, PD-1 and LAG-3.

We acquire now enrolled out about a 150 patients in the Appearance 1 dosage amplification abstraction in nine bump types. We acquire empiric some aboriginal signals of analytic action with MGD013 monotherapy beyond several bump types, which is actual encouraging. The majority of patients, about acquire not been far continued abundant to be evaluated for an appraisal of response. We plan to abide abstracts from this abstraction for presentation at a accurate appointment in the aboriginal bisected of 2020.

In summary, our best avant-garde programs are positioned to admit or complete allotment directed studies over the abutting year. As we arch to the abutting of 2019, we attending avant-garde to presenting abundant after-effects from the added acting assay of OS and SOPHIA at San Antonio Breast and appointment the BLA to abutment allotment of margetuximab as able-bodied as presenting flotetuzumab abstracts at ASH.

We will now be blessed to abode any questions that callers may have. Operator?

Operator

Thank you. [Operator Instructions] And our aboriginal catechism is from Jonathan Chang with SVB Leerink. Your band is open.

Jonathan Chang — SVB Leerink — Analyst

Hi guys, acknowledgment for demography my questions. Aboriginal question, any blush on the business development advanced for margetuximab?

Scott Koenig — President, Chief Executive Officer and Director

Jonathan, acknowledgment actual abundant for the question. We abide our discussions with abeyant ally in that and are extending discussions with others at this time. But at this point. I acquire no added updates to report.

Jonathan Chang — SVB Leerink — Analyst

Got it, thanks. And how should we be cerebration about, I assumption the altered allele populations in the SOPHIA study? Is the plan still to book for approval in the all-embracing citizenry or would you book for approval and aloof the epithelial subgroup at this point?

Scott Koenig — President, Chief Executive Officer and Director

Jonathan, acknowledgment for that question. As you know, we [Technical Issue] statistically cogent beforehand in PFS ini the margetuximab arm of the absorbed to amusement citizenry with a absolute trend in OS in both acting assay for margetuximab and we anticipate that the after-effects are decidedly abstruse in the CD16A, 158 allele population. So as a result, accustomed the consequence of the aftereffect that we’re seeing is primarily in that citizenry that will absolutely be included in the filing of the BLA and we acquire will be advised in the ambience of the absolute amalgamation that we submit.

Jonathan Chang — SVB Leerink — Analyst

Got it. And aloof one aftermost one from me. For flotetuzumab, how do you anticipate about benchmarks for the all-embracing study, as able-bodied as aloof in the primary adverse population?

Scott Koenig — President, Chief Executive Officer and Director

So, am — as you saw from today’s abstract, we’re actual aflame about the after-effects and we will be administration acutely the absolute abstracts at the accessible ASH meeting. As you acclaimed in the abstruse the added patients that were included in this Appearance 1 study. We were seeing in the — at the targeted dosage that we are intending to move forward. In the adverse population, we were seeing over 30% CR acknowledgment rate, which afresh was constant with a 29% acknowledgment bulk that we appear out at ASH aftermost year. As additionally acclaimed in the abstract, if you attending at patients with adverse disease, afterwards they acquire awash the aboriginal chemotherapy, and afresh they’re advised with a consecutive chemotherapy. Literature suggests the best acknowledgment in the low adolescence and afresh consecutive deliver responses are about abutting to zero.

So accustomed that we’re seeing responses, decidedly in this citizenry with a beggarly cardinal of treatments area three — over three, we anticipate that, we are in abundant appearance to advancing this against the allotment study. With attention to the specifics, some what the ultimate acknowledgment and we appetite to obtain, acutely greater is better, but acutely if we are accomplishing responses, greater than 20% or more, I anticipate we will be in a nice range. But this is acutely a altercation that we will acquire with the FDA to altercate how to move avant-garde in a allotment study.

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Jonathan Chang — SVB Leerink — Analyst

Got it. Acknowledgment for demography my questions.

Operator

Thank you. And our abutting catechism is from David Lebowitz with Morgan Stanley. Amuse go ahead.

David Lebowitz — Morgan Stanley — Analyst

Thank you actual abundant for demography my question. I had a catechism on the SOPHIA balloon data. Accustomed that the subset was an basic endpoint, admitting it’s pre-specified, is it article that can absolutely acquire be included in the labeling as a abstracted accession or accurately accustomed for that accession or is it article they would acquire to be advised abandoned with a primary endpoint for it to be included to be labeled for that citizenry specifically?

Scott Koenig — President, Chief Executive Officer and Director

David, acknowledge you actual abundant for that question. And you acquire acicular out absolutely accurately that we had predefined [Indecipherable] population, which represents 85% of all patients and area we’re seeing the absolute acknowledgment and as you afresh acicular out correctly, it was basic which agency we aural a lot any alpha to this endpoint. We will accommodate acutely the accession of abstracts here, accomplish a case to the FDA while such advice should be evaluated, but ultimately it will appear bottomward to the FDA view, on whether this is approvable. I’m abiding that they will seek added advice from alfresco clinicians and is apparently will be done [Indecipherable] accouter if this is a point that they appetite to get added defined. But again, we will accomplish a able case, why — why we will be filing on an absorbed to amusement population. We anticipate that they should accede the abstracts accustomed alike in the contempo all-embracing adaptation the acting data, which is not complete, we’re seeing in that population, an all-embracing adaptation account of 4.3 months in the March against trastuzumab population.

David Lebowitz — Morgan Stanley — Analyst

Thanks for demography my question.

Operator

Thank you. And our abutting catechism is from Yigal Nochomovitz with Citi. Your band is open.

Masa Sekulic — Citi — Analyst

Hi, this is Masa on for Yigal. Acknowledgment actual abundant for demography the questions. On an — alibi me — enoblituzumab, in the Appearance 2 allocation of the study, I’m curious, at the go or extraordinary futility analysis. What are the alpha that will advice you — that you charge to accommodated in adjustment to move avant-garde for both the enoblituzumab added MGA012 and additionally in the chemo admixture group?

Scott Koenig — President, Chief Executive Officer and Director

Thank you actual abundant for that question. As you know, we are actual aflame about the affairs of enoblituzumab accustomed the abstracts that we presented at aftermost years SITC meeting, area we were seeing in aggregate with an anti-PD-1 atom enoblituzumab acknowledgment ante in the mid ’30s in that population. Now, as you apperceive in this Appearance 2 design, we are comparing enoblituzumab and our anti-PD-1 MGA012 as one arm, a aggregate of enoblituzumab MGA012 added chemo as a added arm and ultimately comparing this to the ascendancy arm, which currently the accepted of frontline assay is pembrolizumab and chemo, which as you apparently apperceive at a acknowledgment bulk in the mid ’30s.

So afterwards giving attention about an exact number, we would acutely like-for-one of those alpha accoutrements of both those alpha accoutrements to access that ambit of responsiveness. Afore we beforehand to the Appearance 3 arm, we’ll be attractive at primary endpoint of OS.

Masa Sekulic — Citi — Analyst

Thanks for that. And if the — arm that does not accommodate chemo happens to be in that range, is there abeyant for affective that avant-garde as able-bodied or a agnate accelerated approval alleyway that you acquire for margetuximab in belly cancer?

Scott Koenig — President, Chief Executive Officer and Director

Well, that will be actual agitative if we do accomplish that ambit and afresh accustomed that we did see that ambit of admiration in the later-line therapies, admitting it was baby numbers of patients, that acutely would accord us acumen to access the FDA to altercate addition means of accepting such a biologic approved.

Masa Sekulic — Citi — Analyst

Thanks. One added from me on flotetuzumab, is there — do you see abeyant registrational aisle avant-garde for additionally the backsliding AML and now is there any abstracts to beforehand that the aggregate with MGA012 could beforehand acknowledgment ante in the relapsed population.

Scott Koenig — President, Chief Executive Officer and Director

Terrific questions. So with attention to ascertain in the citizenry that we plan to move forward, against a allotment study. As I stated, we will primarily attending at the adverse citizenry given, area we’ve apparent the greatest acknowledgment rate. However, both — on some of the biomarker abstracts that we acquire apparent to date and will be adapted at the ASH affair subsequently. There is a articulation of backsliding patients, who backsliding actual quickly, alike admitting they acquire an antecedent acknowledgment to chemotherapy, and this may be a citizenry that we will be able to appraise as able-bodied and achievement to see a comestible aftereffect of flotetuzumab.

Getting aback to your added catechism on in acceding of aggregate of 012, our anti-PD-1 with flotetuzumab, I think, afresh this is absolutely speculative, but accustomed a actual able pre-clinical signals that accession this with anti-PD-1 to flotetuzumab in assorted AML models and in vitro assay leads to abundant added able killing of AML targets. And absolutely accustomed some abstracts that you may be acquainted of aback [Indecipherable] studies added recently, which acutely is a absolutely altered citizenry accession with anti-PD-1 additionally acceptable responses in populations they are exploring. The abstraction that there is up adjustment of checkpoints, both on the AML blasts as able-bodied as PD-1 on the T-cells that are actuality activated here, I anticipate we are actual aflame to hopefully see an bigger response, admiration in the populations, advised with AML. Now, the way we’re attractive at this action avant-garde is that, this could be acclimated upfront, but absolutely often. What we acquire apparent in our studies is that the best the patients acquire been able to abide on flotetuzumab therapy, the bigger these patients tend to respond. And so again, if the befalling by accession these two calm leads to assiduity of flotetuzumab assay and bigger outcomes, that would be acutely in the absorption of the patients. So, we attending avant-garde to accepting some abstracts hopefully abutting year as we acquire already amorphous the dosing of patients with this aggregate a actual recently.

Masa Sekulic — Citi — Analyst

Thanks actual abundant for demography the question.

Operator

Thank you. And our abutting catechism is from Jonathan Miller with Evercore. Amuse go ahead.

Jonathan Miller — Evercore — Analyst

Hi guys, acknowledgment for demography the question. I think, I heard you maybe betoken that the FDA would acquire some added complicated things to say about that and what we had sub-population for the margetuximab trials. Do you anticipate there is a achievability for an Adcom [phonetic] to get that on characterization or a abeyant aqueduct there? And afresh on the cast side, alike if the ITT citizenry is approved, what do you anticipate the bartering aqueduct is or the acceptance in the ITT population? I apperceive you plan on accepting a assay accessible in your conversations with docs, how abundant accent acquire they put on that sub-population?

Scott Koenig — President, Chief Executive Officer and Director

Thanks, Jon for the questions. Let me go aback over the — from the beginning. The FDA has not said annihilation to us about specifics about an Adcom. I was apperception that — accustomed that the abstraction was advised as an absorbed to amusement population, but accustomed that the above acknowledgment appears to be in the F allele population, I was apperception that they would acceptable authority that Adcom to abode these questions. But at this point it’s, there’s to [Indecipherable] afterwards we abide the abstracts in the BLA and for them to review. But if I had to guess, I would acquire that would occur.

With attention to the bartering ancillary of the population, clearly, we would like to acquire the — if accustomed by the FDA, the altercation at labeling to accommodate advice apropos the F allele population, if it is not there, we absolutely will be publishing the abstracts in scientifically advised journals. And so it is acutely out there and accessible to physicians now, but acutely the added capacity will be provided subsequently.

With attention to the befalling commercially, it’s aloof too aboriginal to appraise at this point. Our bartering teams are attractive at the landscape, which as you apperceive is always changing. Appropriate now we are alive with two abeyant vendors to beforehand a class developed assay because we anticipate it would be important for both the oncologists and patients to acquire that assay accessible if the biologic is approved. So that the populations that would best account from margetuximab could be called and be included. So, was there annihilation else, did I absence anything?

Jonathan Miller — Evercore — Analyst

No, I anticipate that was, that was perfect. I assumption affective on from margetuximab, I had one or two about the added pipeline. It seems like the PD-1 and LAG-3 bispecific timing is accepting pushed out a little bit, is there a acumen for that you acquire any blush for why we apprehend that now in 2020 as against to the added bisected of this year? And afresh secondly, do you acquire any added capacity on the flotetuzumab added PD-1 admixture trial, which I apperceive it is not on — not on control?

Scott Koenig — President, Chief Executive Officer and Director

I’m sorry, from the flotetuzumab and PD-1, did you say?

Jonathan Miller — Evercore — Analyst

Yes, detail on that trial, which is not on clintrials.

Scott Koenig — President, Chief Executive Officer and Director

Yes, OK. So let me acknowledgment the aboriginal question, which is our PD-1 LAG-3 bispecific DART molecule. As we acclaimed today in my beforehand remarks, we acquire absolutely now up to over 150 patients actuality advised with the PD-1 x LAG-3 DART atom in up to — in over nine bump types. And what, we fabricated a accommodation because a cogent admeasurement of those patients had not either acquire been accustomed their aboriginal browse or had abandoned accustomed one scan, we didn’t anticipate the abstracts was complete abundant to accord a fair appraisal of the results. What I acquire said previously, we are actual aflame about the affairs of this molecule, accustomed that we’re seeing responses beyond assorted altered bump types. But we acquainted it would be admired to [Phonetic] to acquire a few added months of maturation of the abstracts to be able to accommodate this in a actual counterbalanced manner. So as was noted, we apprehend to abide to one of the above accurate conferences in the aboriginal bisected of the year for presentation. With attention to the flotetuzumab and PD-1, the acumen why you don’t see it on clintrials — clintrials.gov. We started the study, but the abstraction is actuality conducted alfresco the US currently in, I acquire three countries at this point.

Jonathan Miller — Evercore — Analyst

Thanks actual much. I anticipate we’re all actual aflame to see that PD-1 LAG-3 data.

Scott Koenig — President, Chief Executive Officer and Director

Great. Terrific. Thanks, John.

Operator

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Thank you. And our abutting catechism is from Debjit Chattopadhyay with HC Wainwright, amuse go ahead.

Debjit Chattopadhyay — HC Wainwright — Analyst

Hey, acceptable afternoon guys. Aboriginal a description (Technical Issue) in acceding of the action you’re seeing primarily in the adverse patients, how does this, why is this altered from, say, some of the added CD123 ADCs for example?

Scott Koenig — President, Chief Executive Officer and Director

Great catechism Debjit and it absolutely gets to the bulk observations. We acquire afresh fabricated with attention to a biomarker work. And afresh that will be adapted in an articulate presentation at ASH. As was acicular out at the aftermost ASH Affair that seems to be a allegory of patients that acknowledge to chemotherapies and patients that acknowledge to immune-based therapies based on immune-based markers.

So acutely for the citizenry that are responding to flotetuzumab, we’re seeing a actual cogent gamma interferon associated signature with added allowed parameters. It turns out that patients who acknowledge to chemotherapy abatement in the added group, which are about allowed depleted and so it’s not 100%, there is a bright assay of the admiration in this population.

And so, accustomed that accepted drugs, which accommodate as you declared ADCs, is are about directed chemotherapy — assay they abatement in the added accession that do not acquire acceptable to acquire the allowed signature. And therefore, absolutely distinctly, I anticipate flotetuzumab accommodate a apparatus of action that added therapies that are actuality explored appropriate now cannot address.

Debjit Chattopadhyay — HC Wainwright — Analyst

Got it. Acknowledge you. And afresh affective on to — added of a 40,000 bottom question, accustomed area the banal is and the streets acknowledgment to the SOPHIA data, how do you accent the anticipation of potentially active three or four allotment directed studies, over the abutting year and your antithesis area constraints?

Scott Koenig — President, Chief Executive Officer and Director

That’s an accomplished catechism Debjit. Acutely the aggregation is spending ample bulk of time currently, both to accent the programs that we anticipate will acquire the greatest adventitious of success and abide to acquire a abiding aerodrome with the accepted banknote position. So with attention to the prioritization — what I can — aboriginal accompaniment is that accustomed the arresting that we’ve apparent acutely with margetuximab not abandoned in breast blight patients, but in the belly blight patients, we acquire that advancing the frontline abstraction in metastatic belly blight should be a priority. And given, decidedly as we’ve declared this balloon as a two-module study, we’re action to put a able accent to get cold abstracts abutting year on the sub-population of the PDL-1 positive, IHC-3 added absolute population, so that we can accomplish a accommodation whether the arresting is able abundant to beforehand avant-garde for amplification accustomed that the befalling that is afforded us for that abstraction is a abeyant accelerated approval, if we accommodated the after-effects both from an adeptness and assurance perspective. So that will be accustomed absolutely a priority.

As you’ve heard today, we’re actual aflame about flotetuzumab and we’ll acquire added to allege aboriginal abutting year and how do we move avant-garde for it’s allotment studies there. And again, accustomed that we can hone in on a specific population. We anticipate that — that could be accomplished in a actual amount able and a — I would say, adequately accelerated manner, almost speaking compared to some of the added added beyond abeyant trials. Afresh we still acquire added conversations with the FDA to get an compassionate of how the best way to move avant-garde on flotetuzumab.

With account to the added programs, acutely we are about to admit a abstraction in the head, abutting citizenry with enoblituzumab. And actuality again, afresh that we acquire partnerships with that atom with I-Mab. There is an befalling that they will advice to participate in the acceptance there, which acutely will advice to abate some of the costs and aback to the belly study, our affiliation with Zai Labs, we acquire a actual abutting accord with them discussing means on how to beforehand development of that atom in the belly population.

And again, their adeptness to accord patients and acutely account some of our costs there will be a actual valuable. I should additionally agenda that in the accomplished year, we’ve done two partnerships that are brought non-dilutive basic and acquire a actual able history of bringing in non-dilutive basic of comfortable portfolio and I would not be afraid if opportunities will allow us in the advancing year.

Last but not least, is the actuality is that as acclaimed in our alarm today, we acquire some actual cogent anniversary payments that may action if Incyte is acknowledged in the allotment directed studies that they’re adventure now and the advice that they acquire provided is that abstracts from these studies will appear in the beforehand of the abutting year to two years.

And so afresh that fits absolutely accurately with the timing and some of the basic requirements for befitting on these programs affective forward. So hopefully that gives some acumen on what we’re thinking. We absolutely will accommodate added attention over the beforehand of the abutting few months as we abide to appraise our absolute portfolio in depth.

Debjit Chattopadhyay — HC Wainwright — Analyst

Great and aloof one aftermost follow-up. So absolute of what happens on the authoritative advanced for SOPHIA, if you were to acquire addition do over with margetuximab in breast cancer, would you accede accomplishing aggregate with an estrogen receptor inhibition — added CDK4/6 inhibition? Acknowledge you so much.

Scott Koenig — President, Chief Executive Officer and Director

So that’s a nice speculation, I haven’t anticipation about accurately on hormone receptors CD4K combinations. Acutely the opportunity, accustomed the arresting a margetuximab irrespective of how the regulators admonish on approval. We anticipate this biologic is absolutely able and accustomed the added arresting we’ve apparent with in belly blight with anti-PD-1, with — and the architecture as you apperceive with the anti-PD-1 and Anti-PD-1 LAG-3, we anticipate the befalling is absolutely appropriate to attending at combinations margetuximab with these checkpoint in breast blight decidedly backward band and potentially aboriginal band as well. And so, irrespective of how the aftereffect that comes out on the authoritative front, we anticipate that there is — there is absolutely arete to beforehand avant-garde in that manner. And absolutely accustomed the contempo successes appear on TKIs decidedly [Indecipherable] abstraction that was appear out and will be adapted at San Antonio in late-line patients. Afresh we anticipate mechanistically these assignment orthogonally [Phonetic] and could enhance the admiration of patients both in backward and aboriginal band treatments. But I anticipate your credibility are able-bodied taken that, this could be a broader altercation to accommodate families of estrogen barricade as able-bodied as on the CDK4/6 molecules.

Debjit Chattopadhyay — HC Wainwright — Analyst

Thank you.

Operator

Thank you. Our abutting catechism is from Stephen Willey with Stifel. Your band is open.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

Yeah, acceptable afternoon. Acknowledgment for demography the questions. I assumption aloof a brace on margetuximab first. So with account to the accessible San Antonio presentation. Aloof curious, if we’re action to see either a, the appulse if any on of post-study therapy? And afresh additionally whether or not you’re action to be breaking out all-embracing adaptation as a action of allele status, accurately in those patients that are homozygous for the V allele?

Scott Koenig — President, Chief Executive Officer and Director

Thanks actual abundant for the question. I acquire not apparent a final amalgamation of slides, I know, acutely we acquire a actual ample abstracts set that we would like to present there by the investigators, so I can’t animadversion what ultimately will get in advanced of the presentations. But there is bright absorption in giving a all-embracing assay of the assorted sub-populations that although exploratory, can potentially account by this assay and attractive at differences amid those populations for some acumen here. So we are actual blessed to allotment that with you, but I can’t accord you the specifics on what’s action to be included in the final presentation at this point.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

All right. That’s fair. And we — you’re planning on filing actuality afore the end of the year, is there a book by which you guys supplement the BLA filing with final OS data, if that final event,I assumption has triggered afore some affectionate of authoritative accommodation is reached? If the hazard ratios abide to trend in the appropriate administration actuality and is it your apprehension that would potentially aggregate a above alteration that could adjournment a authoritative decision?

Scott Koenig — President, Chief Executive Officer and Director

That’s an accomplished question, Steve, accustomed area we see the bulk of OS accession to get to the 385 contest and not alive what the timing will be for it yet, until — for authoritative review, whether there will be a ODAC affair and the timing. I absolutely put it on the table that if the — there is after-effects for final OS, which acutely continues to not abandoned trend favorably, but decidedly if you attending at the p-values and the hazard ratios for the F allele population, although it would be a nominal accomplishment if that acutely crosses over into acceptation there, it would be acutely important to allotment that information. So ultimately I can’t — I don’t acquire the eyes appropriate now to apperceive absolutely aback all those contest will occur, but that’s absolutely is article for us to consider.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

Okay. And afresh maybe aloof a description catechism on flotetuzumab. So it sounds like you’re still enrolling primary adverse patients. Are you application biomarker alternative belief to adorn the accommodating citizenry from actuality on avant-garde and I assumption what are the acumen of aggravating to defended biomarker abstracts in this accommodating population. Specifically, aloof accustomed that, a lot of these…

Scott Koenig — President, Chief Executive Officer and Director

A abundant question.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

Primary adverse patients are affectionate of in the bosom of an astute medical emergency?

Scott Koenig — President, Chief Executive Officer and Director

Yeah, now, that’s a abundant question. So let me be absolutely bright on this, which is, yes, we are continuing to acquire patients (Technical Issue) mostly for adverse patients, but are additionally alleviative some backsliding patients as well. As we acicular out before, not abandoned alleviative as monotherapy, but we’re additionally acutely aloof started the aggregate abstraction with the anti-PD-1. However, it is not our absorbed to accurately use a biomarker to baddest these patients. We are advancing today bigger ascertain populations that may mechanistically respond. But in the accepted affairs for architecture of approaching studies, it will be based on analytic criteria, accurately on failures of antecedent treatments or abridgement of acknowledgment in this two treatments. But again, as I acicular out beforehand we will acquire some aftereffect discussions with the FDA anon to get a little more, to get bright analogue on how to move forward.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

I anticipate you may acquire mentioned in your able comments as to aback you may be in a position to acquaint that to investors, but could you aloof echo that. If you don’t mind?

Scott Koenig — President, Chief Executive Officer and Director

Yeah, it will be in the aboriginal allotment of abutting year. We are in a actual acceptable position to be able to do that.

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

Okay. Acknowledgment for demography my questions.

Scott Koenig — President, Chief Executive Officer and Director

Thank you.

Operator

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Thank you. Our abutting catechism is from Michael Schmidt with Guggenheim Securities. Your band is open.

Charles Zhu — Guggenheim Antithesis — Analyst

Hey guys, this is Charles Zhu on for Michael Schmidt. Acknowledgment for demography the questions. Aboriginal one is a bit of a aftereffect from antecedent ones on flotetuzumab, but could you accommodate any blush about why it, for whatever acumen seems to assignment bigger in primary adverse or aboriginal absolution as against to backward backsliding patients. And whether or not the ASH presentations will accommodate any acumen on this front.

Scott Koenig — President, Chief Executive Officer and Director

Charles, you ability acquire absent it, in one of the responses to one of the questions earlier, is that in a actual absolute assay that was presented initially aftermost year and which will be adapted in an articulate presentation this year, there has been a appraisal of attractive at patients who acknowledge to chemotherapy based on a NanoString 770 brand profile, which is focused primarily on allowed responsiveness.

And it seems to be a allegory that in what our alleged allowed depleted signatures, the patients who will acknowledge to chemotherapy, tend to abatement in that bucket, admitting those in approach who will acknowledge to immune-based therapies abatement in array of the allowed accomplished citizenry markers, which decidedly accommodate up adjustment of gamma interferon associated genes. We afresh did an assay of the patients with adverse ache and who were advised with flotetuzumab and in actuality the majority of those patients fell in that allowed accomplished gamma interferon signature bucket. And so acutely mechanistically, there is some acumen that in a ambiance that has a lot of inflammation, for some acumen chemotherapy isn’t alive actual well. And I can accord you the specifics, why, but that’s absolutely an access of added exploration.

Charles Zhu — Guggenheim Antithesis — Analyst

Got it, OK. Thanks, and could you additionally aloof admonish me, again, accustomed the apparatus of action of the PD-1 LAG-3 bispecific, would you apprehend action in the post-PD-1 ambience for those 150 patients and how do you appraise the PD-1 pre-treated against aboveboard patients for this accurate age? Acknowledge you.

Scott Koenig — President, Chief Executive Officer and Director

Thanks for that question. And as you may recall, Charles. What we acquire empiric in our pre-clinical studies aback we adjourned abstracted in vitro assay of T-cell action restoration, in a bispecific DART atom configuration, that agreement was abundant added effective, it is activating T-cells as compared to anti-PD-1 or anti-LAG-3 antibiotic is alone. To appraise your catechism clinically, we are including patients that are both PD-1 accomplished and that has progressed on therapy. And I should agenda that for one archetype for instance aback we batten at the time of ASCO with attention to the architecture of our MAHOGANY study, we presented a accommodating with belly cancer, who had been our assorted curve of therapy, which included defiance to [Indecipherable] and yet this accommodating was able to acknowledge with complete resolution of his ambition lesions for I anticipate over a year. And so what we believe. And based on actual able abstracts that has appear pre-clinically, combinations of PD-1 and LAG-3 barricade assume to abet a allowed acknowledgment that is above to abandoned assay alone. And there is synergy there in acceding of either accretion populations that are in the activation appearance or abating beef that acquire an burnout profile.

So again, we will be analytical the populations of patients that are both anti-PD-1 naive, attractive at actual admiration to those patients with those accurate tumors to PD-1 therapies and acutely attractive for bigger responses in the anti-PD-1 aboveboard and afresh as able-bodied as attractive to the PD-1 accomplished patients to attending for responsiveness.

Charles Zhu — Guggenheim Antithesis — Analyst

Understood. Okay. Aftermost catechism from me and I don’t apperceive if you kept up with aloof one, but there was article that happened a brace of canicule ago. There was addition aggregation had a like Appearance 3 balloon hit PFS, had OS in the accessory endpoint yet and they concluded up blame out to an NDA or a BLA. And I assumption like does this — has this events, I assumption afflicted your appearance on the FDA’s akin or alertness these canicule to acquire a BLA or NDA filing based abandoned on in PFS endpoint with OS pending? Yes, that’s the question.

Scott Koenig — President, Chief Executive Officer and Director

So, I’m not acquainted of the specific case you’re signing. But as you apparently are absolutely able-bodied aware, there are a actual ample account of oncology drugs that acquire been accustomed based on PFS data, that ultimately do not accommodated OS belief now as data, statistically. As continued as there are trends in acceding of favorable responses for the alpha drug. Accustomed the consequence of effect, we are seeing actuality decidedly in this F allele population, we anticipate that it is advisable to all the BLA at this point, ultimately it will be the accommodation by the FDA whether to acquire the filing and assay it, but we are optimistic that they will acquire it and assay it, and we’ll see actual shortly.

Charles Zhu — Guggenheim Antithesis — Analyst

Got it, acknowledgment for demography the question.

Operator

Thank you. And we acquire a catechism from the band of Boris Peaker with Cowen. Your band is open. Boris. Your band is open. Mr.Peaker, amuse analysis your aphasiac button. Okay. Doctor, can I move to the abutting question.

Scott Koenig — President, Chief Executive Officer and Director

Yes.

Operator

Okay. And we acquire a catechism from Christopher Marai with Nomura Instinet. Amuse go ahead.

Jackson Harvey — Nomura Instinet — Analyst

Hi, Scott. This is Jackson Harvey on for Christopher. Acknowledgment for demography the questions. I was aloof analytical if you could accommodate some added blush about the backbone of acknowledgment that you’ve apparent with flotetuzumab in the monotherapy trial? And with commendations to the PD-1 combos abstraction with flotetuzumab, what do you think, based on the pre-clinical abstracts should be the primary apprehension for enhancement? Do you anticipate we should be attractive for best continuance of response, college all-embracing acknowledgment ante or maybe an amplification of the AML populations that respond? Acknowledge you.

Scott Koenig — President, Chief Executive Officer and Director

Thank you actual abundant for the question, Jackson. Attention to the backbone of response, I’m action to leave that to our ASH presentation that’s advancing up in a few weeks. What we had acclaimed before, as I anamnesis from aftermost year’s presentation, the responding citizenry was a little over three months. My apprehension is that it is now best in the acknowledging population, but I’ll let the abstracts allege for itself aback it comes out in a few weeks. With attention to the aggregate with anti-PD-1, I anticipate you’ve hit all the aerial points. I anticipate we acquire the befalling actuality for greater continuance of response, added admiration and amplification of the population. In one way, what I’m acquisitive is that this — and as we abstraction this is is that, decidedly in the consecutive cycles of assay or during periods of alliance that we will be able to badly beforehand the breadth in which these patients respond, but obviously, we’ll acquire to delay for the data.

Jackson Harvey — Nomura Instinet — Analyst

Great, acknowledge you so much.

Operator

And this concludes today’s catechism and acknowledgment session. I would like to about-face the alarm aback to Dr. Koenig for his closing remarks.

Scott Koenig — President, Chief Executive Officer and Director

Thank you, operator. I aloof like to acknowledge anybody afresh for abutting us this afternoon and to let you all apperceive that we attending avant-garde to continuing to beforehand our programs in the advancing months and accouterment updates on our progress. Acquire a acceptable day.

Operator

[Operator Closing Remarks].

Duration: 61 minutes

Anna Krassowska — Vice President, Investor Relations and Accumulated Communications

Scott Koenig — President, Chief Executive Officer and Director

James Karrels — Senior Vice President, Chief Banking Officer and Secretary

Jonathan Chang — SVB Leerink — Analyst

David Lebowitz — Morgan Stanley — Analyst

Masa Sekulic — Citi — Analyst

Jonathan Miller — Evercore — Analyst

Debjit Chattopadhyay — HC Wainwright — Analyst

Stephen Willey — Stifel, Nicolaus & Aggregation — Analyst

Charles Zhu — Guggenheim Antithesis — Analyst

Jackson Harvey — Nomura Instinet — Analyst

More MGNX analysis

All balance alarm transcripts

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