Q4 2020 MacroGenics Inc Earnings Call

Good afternoon, we will begin the macrogenics 2024th quarter and full year corporate progress on our financial results conference call in just a moment.

Operator: We will begin the MacroGenics 2020 4th Quarter and Full Year Corporate Progress and Financial Results Conference Call in just a moment. All participants are in listening mode at this time, and we will conduct the question and answer session at the conclusion of the call. At this point, I will turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer of MacroGenics. Thank you.

All participants are in listen only mode at the moment and we will conduct a question and answer session at the conclusion of the call at.

At this point I will turn the call over to Jim <unk>, Senior Vice President and Chief Financial Officer of Macrogenics.

Thank you good afternoon, and welcome to Macrogenics conference call to discuss our fourth quarter and full year 2020 financial and operational results.

James Karrels: Good afternoon, and welcome to MacroGenics' Conference Call to discuss our fourth quarter and full year 2020 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at www.macrogenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.

For anyone who has not had a chance to review. These results we issued a press release. This afternoon outlining todays announcement, which is available under the investors tab on our website at www from Macrogenics Dot com.

You May also have us on this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.

I would like to alert listeners that todays discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 995.

James Karrels: I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these four forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our annual, quarterly, and current reports filed with the FC State.

Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed on the risk factors section of our annual quarterly and current reports filed with the SEC.

In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

James Karrels: In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except to the extent required by applicable law. And now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics.

We may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law and now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of Macrogenics.

Thank you Jim I'd like to welcome everyone participating via conference call and webcast today.

Scott Koenig: Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key highlights from our clinical programs, but before I do so, let me first turn the call back to Jim, who will review our financial results for the year.

Good afternoon, I will provide key highlights from our clinical programs, but before I do so on the first turn the call back to Jim who will review our financial results for the year.

Thank you Scott This afternoon Macrogenics reported financial results for the year ended December 31, 2020, which highlight our financial position as well as our recent progress as.

James Karrels: Thank you, Scott. This afternoon, MacroGenics reported financial results for the year ended December 31, 2020, which highlight our financial position as well as our recent progress. As described in a release this afternoon, MacroGenics' total revenue, consisting primarily of revenue from collaborative agreements, was $104.9 million for the year ended December 31, 2020, compared to $64.2 million for the year ended December 31, 2019. Revenue recognized during the fourth quarter ended December 31, 2020, included $40 million, the latter of which was not reflected in our cash on our December 31, 2020 balance sheet as it was received in early 2021.

As described in our release this afternoon Macrogenics total revenue consisting primarily of revenue from collaborative agreements was $104 $9 million for the year ended December 31, 2020, compared to $64 2 million for the year ended December 31, 2019 revenue recognized during the fourth quarter ended December 31 2020.

Included $40 million of milestones from insight and a $20 million upfront payment from Janssen.

The latter of which was not reflected in our cash on our December 31, 2020 balance sheet as it was received in early 2021.

Our research and development expenses were $193 2 million for the year ended December 31, 2020, compared to $195 3 million for the year ended December 31, 2019 general and administrative expenses were $42 7 million for the year ended December 31, 2020 compared to $46 one.

James Karrels: Our research and development expenses were $193.2 million for the year ended December 31, 2020, compared to $195.3 million for the year ended December 31, 2019. General administrative expenses were $42.7 million for the year ended December 31, 2020, compared to $46.1 million for the year ended December 31, 2019. This decrease was primarily due to a decrease in external costs, including consulting.

For the year ended December 31 2019.

Decrease was primarily due to a decrease in external costs, including consulting fees.

Macrogenics net loss was $129 $7 million for the year ended December 31, 2020, compared to a net loss of $151 8 million for the year ended December 31 2019.

James Karrels: MacroGenics' net loss will be $129.7 million for the year ended December 31, 2020, compared to a net loss of $151.8 million for the year ended December 31, 2019. Our cash, cash equivalents, and marketable security balance as of December 31, 2020 will be $272.5 million, compared to $215.8 million as of December 31, 2019. Again, the $20 million upfront from Janssen as well as the recently disclosed $10 million milestone from Insight were not reflected in our cash balance at year end.

Our cash cash equivalents in marketable securities balance as of December 31, 2020 was $272 5 million compared to $215 8 million as of December 31, 2019, again, the $20 million upfront from Jensen as well as the recently disclosed $10 million milestone.

Right.

Was not reflected in our cash balance at yearend.

Let me mention a few things about our cash runway earlier this year prevention bio announced the fda's acceptance of their BLA for <unk> for the delay or prevention of clinical type one diabetes in at risk individuals.

Target action date is July two with an advisory Committee meeting tentative tentatively set in May.

James Karrels: Finally, let me mention a few things about our cash runway. Earlier this year, Prevention Bio announced the FDA's acceptance of their BLA for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals. The produced target action date is July 2, with an advisory committee meeting tentatively set in May. You'll recall that we had earlier developed and sold teplizumab to them in 2018. And if approved, MacroGenics is entitled to receive a $60 million milestone as well as royalties on sales.

Call that we had earlier developed and sold to pose map for them in 2018, and if approved macrogenics is entitled to receive a $60 million milestone as well as royalties on sales for cash budgeting purposes, we typically discount such milestones as we have no control over that.

That background, there was no adjustment necessary to our previously disclosed cash guidance and to remind listeners we anticipate that our cash cash equivalents and marketable securities as of December 31, 2020.

Combined with anticipated and potential collaboration payments should enable us to fund our operations into 2023, assuming the company's programs and collaborations advance as currently contemplated and now I will turn the call back to Scott.

James Karrels: For cash budgeting purposes, we typically discount such milestones as we have no control over them. With that background, there is no adjustment necessary to our previously disclosed cash guidance. And to remind listeners, we anticipate that our cash, cash equivalents, and marketable securities as of December 31, 2020, combined with anticipated and potential collaboration payments, should enable us to fund our operations into 2023, assuming the company's programs and collaborations advance as currently contemplated. And now, I'll turn the call back to Scott.

Thank you Jim 2020 was a big year for Macrogenics would the presentation are various datasets across our portfolio and most of the major oncology conferences, including ACR ESCO ESMO.

<unk>, San Antonio and Nash as well as the approval of more gender as an end of year holiday gift.

Still we are equally if not more excited about our prospects in 2021.

We are particularly excited about the multiple ongoing registrational for potentially registration, enabling studies, including flow to Tuesday Mab in AML in March it talks about in gastric cancer and this is in addition to two per <unk> target action date in July related to <unk> and <unk>.

Scott Koenig: Thank you, Jim. 2020 was a big year for macrogenics with the presentation of various data sets across our portfolio and most of the major oncology conferences, including AACR, ASCO, ESMO, SITC, San Antonio, and ASH, as well as the approval of Margenza as an end-year holiday gift. Still, we are equally, if not more, excited about our prospects in 2021. We are particularly excited about the multiple ongoing registrational or potentially registration-enabling studies, including flotatizumab and AML and margitoximab in gastric cancer.

It sounds on that.

And finally, we know many of you eagerly await clinical data for multiple dose expansion a proof of concept studies, including the next waves of data from <unk>.

Tebo telematics and Mgd <unk> 19.

With that backdrop, let me use this time to walk you through updates on our portfolio of eight clinical molecule.

First let me provide an update on margin from that.

In December the U S. FDA approved margins in combination with chemotherapy for the treatment of adult patients with metastatic <unk> positive breast cancer, who have received two or more prior anti <unk> two regimen at least one of which was for metastatic disease.

Scott Koenig: And this is in addition to two PDUFA target action dates in July related to teplizumab and retifanilamab. And finally, we know many of you eagerly await clinical data for multiple dose expansion or proof-of-concept studies, including the next waves of data from MGC 018. With that backdrop, let me use this time to walk you through updates on our portfolio of eight clinical models. First, let me provide an update on margituximab.

The anticipated March launch is being coordinated with our commercial partner episodic.

They are a pioneer of next generation commercial services to the global life Sciences industry, and we intend to leverage their integrated commercial services to efficiently launch more gender.

We have been working closely with ever signed on to fully align our commercialization strategy to distribute product educate healthcare providers and ensure patient access to <unk>.

Scott Koenig: In December, the U.S. FDA approved Margenza in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The anticipated March launch is being coordinated with our commercial partner, Eversonics.

While maintaining macrogenics cash runway to fund out broader portfolio.

As disclosed on November under the terms of our agreement with ever Center, we maintain full ownership of margin talks a mab, including all manufacturing regulatory and development responsibilities for the product.

<unk> has a co exclusive right to conduct a pre commercialization activities and will utilize their internal capabilities to support sales and marketing market access channel management services data analytics Medical affairs, and other patient access related services.

Scott Koenig: They are a pioneer of next-generation commercial services to the global life sciences industry, and we intend to leverage their integrated commercial services to efficiently launch Margenta. We have been working closely with Eversana to fully align our commercialization strategies to distribute products, educate healthcare providers, and ensure patient access to margitoximab, while maintaining MacroGenics Cash Runway to fund our broader portfolio. As disclosed in November, under the terms of our agreement with Eversana, we maintain full ownership of Margin Tuxomab, including all manufacturing, regulatory, and development responsibilities for the product. Eversana has a co-exclusive right to conduct approved commercialization activities and will utilize its internal capabilities to support sales and marketing, market access, channel management services, data analytics, medical affairs, and other patient access-related services.

Ever solder in Macrogenics will equally share in funding ever sonat commercialization expenses.

Macrogenics will book margin Tux Mat sales.

In exchange for co funding these expenses at the Santa will learn future revenue share payments, which they will be capped at 125 percentage.

Cumulative service fees.

The term of the agreement is five years following the date of FDA approval subject to pre defined termination provisions affording us the ability to potentially partner margin talks a map in the future.

Therefore, we will hold on providing sales guidance until margins is on the market and we have a better sense of uptake by oncologists.

Finally, with regard to margin toxin madmen breast cancer based on the current accrual rate of overall survival events in the ongoing phase III Sophia metastatic breast cancer study that supported the FDA approval. We now anticipate that the final OS analysis will take place in the second half of 2021.

Scott Koenig: Eversona and MacroGenics will equally share in funding Eversona's commercialization expenses. MacroGenics will book March of Tuxomab sales. In exchange for co-funding these expenses, FSANA will earn future revenue share payments, which shall be capped at 125% of... cumulative service fee.

As a reminder, the final OS analysis occurs upon the accrual of the 385th OS events.

Scott Koenig: The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions, affording us the ability to potentially partner-margin Tuximab in the future. I'll briefly mention that we have modest expectations for Margenza sales given the competitive realities that have taken place in the HER2-positive breast cancer market, including multiple new approvals, which is great for patients. Therefore, we will hold off providing sales guidance until Margenza is on the market and we have a better sense of uptake by oncologists.

Beyond breast cancer, we are evaluating margin tax a map in the phase II three mahogany study in patients with advanced gastric and gastroesophageal junction cancer.

This trial consists of two modules designed to evaluate margin tax on that as an investigational agents in combination with a checkpoint inhibitor with or without chemotherapy as a potential first line treatment for patients with advanced or metastatic her two positive gastric <unk> gastric esophageal junction.

Cancer.

We anticipate sharing initial safety and efficacy data in the first half of 2021 of the Evaluable patients in module, a who were treated with a combination of red of fans on that and investigational anti PD, one antibody and margin tucks in Nab.

Scott Koenig: Finally, with regard to margitoximab in breast cancer, based on the current accrual rate of overall survival events in the ongoing phase three SOFIA metastatic breast cancer study that supported FDA approval, we now anticipate that the final OS analysis will take place in the second half of 2021. As a reminder, the final OS analysis occurs upon accrual of the 385th OS event.

We've submitted early data on a subset of the module a cohort patients for presentation at a scientific conference in the first half of 2021.

Enrolment in bi module, B, which is evaluating <unk> plus either up to a macrogenics checkpoint inhibitor molecules in combination with chemotherapy compared to standard of care therapy.

Scott Koenig: Beyond breast cancer, we are evaluating margituximab in the Phase II-III mahogany study in patients with advanced gastric and gastroesophageal junction cancer. This trial consists of two modules designed to evaluate margitoximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for a patient with an advanced or metastatic HER2-positive gastric or We anticipate sharing initial safety and efficacy data in the first half of 2021 from the available patients in Module A who were treated with retifanilamab, an investigational anti-PD-1 antibody, and margituximab.

Trastuzumab and chemotherapy in patients with her two positive tumors irrespective of PDL. One expression is currently ongoing in coordination with our regional partner in Greater China XI lab.

Module B is expected to continue enrollment through throughout 2021.

Next let me discuss voted to the map our investigational Bispecific CD 123 by C D. Three dart molecule.

At the annual Ash conference in December we had several flow to them that data presentation.

Highlights of these presentations included achieving a complete remission rate, including CRC or age of 25 per cent and the primary induction failure or early relapse population based on a total of 40 for AML patients in the ongoing study.

Eight of the 14 respond as received allogeneic.

Hematopoietic.

Stem cell transplantation as a consolidation therapy with durable remission with immediate not reached as of November 10, 2020 data cutoff.

Scott Koenig: We've submitted early data on a subset of the Module 8 cohort patients for presentation at a scientific conference in the first half of 2021. Enrollment in Module B, which is evaluating Margituximab plus either of two macrogenic checkpoint inhibitor molecules in combination with chemotherapy, compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2 positive tumors, irrespective of PD-L1 expression, is currently ongoing in coordination with our regional partner in Greater China, Xi Lab. Module B is expected to continue enrollment throughout 2021.

The most common treatment related adverse event was mild to moderate grade one or two crs events with only a single grade three events reported.

We are very encouraged by the initial activity and safety data and continue to enroll the single arm Registrational clinical study to evaluate flow the teaser map in up to 200 AML patients with refractory AML.

We anticipate providing further updates on the clinical development of Florida twos on that in the second half of this year and completing full enrollment of this study in 2022.

I'll next discuss M. D. C O 18, our investigational antibody drug conjugate designed to deliver a DNA alkylating door commodity cytotoxic payload to cells that express B 783.

Scott Koenig: Next, let me discuss flotatuzumab, our investigational bispecific CD123-CD3-DART molecule. At the annual ASH conference in December, we had several flow-to-tuzumab data presentations. Highlights of these presentations included achieving a complete remission rate, including CR-CRH of 25% in the primary induction failure or early relapse population, based on a total of 44 AML patients in the ongoing study. Eight of the 14 responders received allogeneic hematopoietic stem cell transplantation as a consolidation therapy with durable remission, with a median not reached as of November 10, 2020 data cutoff The most common treatment-related adverse event was mild to moderate grade 1 or 2 CRS events, with only a single grade 3 event reported.

Post 2020, we selected three milligrams per kilogram as the recommended dose for expansion.

In November we initiated the enrollment of patients with metastatic castration resistant prostate cancer triple negative breast cancer, and non small cell lung cancer and dose expansion portion of the phase one clinical study.

We are highly focused on execution of the M. D. C O 18th study and expect to provide an update on at mid year, including results from patients who were dosed at the highest for Mig per kid dose escalation level.

We have submitted a placeholder abstract to a mid year conference based on available data.

Next I would like to turn to tableau tell them at our.

<unk> by specific PD, one by lag three dart molecule previously known as M. D. D O 13.

We are evaluating tebo tell them that in a phase one dose expansion study as both monotherapy in several tumor types as well as in a combination study with margin tucked at Nab.

Scott Koenig: We are very encouraged by the initial activity and safety data and continue to enroll the single-arm registrational clinical study to evaluate flotatizumab in up to 200 AML patients with refractory AML. We anticipate providing further updates on the clinical development of flotatuzumab in the second half of this year and completing full enrollment in this study in 2022. I'll next discuss MGC018, our investigational antibody drug conjugate designed to deliver a DNA-alkylating duochromatin cytotoxic payload to cells that express B7H3. Post-ASCO 2020, we selected 3 mg per kg as the recommended dose for expansion.

The S. I D. C meeting in November 2020 updated data was presented from our ongoing combination study of tableau tell them that that margin tux map in patients with advanced her two positive neoplasms.

At Ash in December 'twenty 'twenty data was presented from the ongoing tepid tell him that phase one dose expansion study in patients with relapsed refractory diffuse large b cell lymphoma.

In this study 20 D. L. B C. L patients were enrolled half of whom were car T cell therapy experience.

As of October 23rd 2020, the cutoff date, there were 13 response evaluable patients.

I'm an area or a 53, 8% seven of 13 patients was observed including responses in five of seven car T cell naive patients and then to have six car T cell experienced patients the latter of whom both had complete responses.

Scott Koenig: In November, we initiated the enrollment of patients with metastatic castration-resistant prostate cancer, triple negative breast cancer, and non-small cell lung cancer in the dose expansion portion of the Phase I clinical study. We are highly focused on execution of the MGCO-18 study and expect to provide an update on it midyear, including results from patients who were dosed at the highest 4 mg per kg dose escalation level. We have submitted a placeholder abstract to a mid-year conference based on available data.

So I would tell him that was generally well tolerated among heavily pretreated relapsed.

Reflect refractory C. L. B C L patients with manageable infusion related reactions and no evidence of tumor lysis syndrome.

We expect to provide updates on both our monotherapy Tebo Telematics study in combination study with margin tuck them up in 'twenty, 'twenty, one including future development plans.

I should note that in November 2018, we licensed design lab, the rights to develop and commercialize tebo tell on that in mainland, China, Hong Kong, Macau and Taiwan.

Scott Koenig: Next, I would like to turn to Tebotelumab, our investigational bispecific PD-1 bilact-3 DART molecule, previously known as MgDO13. We are evaluating tebotelomab in a phase one dose expansion study as monotherapy in several tumor types, as well as in a combination study with margitoximab. At the SITC meeting in November 2020, updated data will be presented from our ongoing combination study of pebotelumab and margitoximab in patients with advanced HER2-positive neoplasm. At ASH in December 2020, data will be presented from the ongoing Tebitelimab phase one dose expansion study in patients with relapsed refractory diffused large B-cell lymphoma.

So I currently has multiple ongoing monotherapy and combination studies or tebo tell them that.

Speaking of tablet tell them that I liked the next tell you about a study combining this molecule with another of our investigational FC engineered antibody.

In the coming weeks, we expect to initiate a combination study of a nobu tusa mab, which targets be 783 in a chemo free regimen in frontline squamous cell carcinoma of the head and neck with either turbot tell them that for patients who are PD lone negative or would rather stand on that in patients who are PDL one positive.

Let me next discuss M. G. D O 19, our investigational bispecific checkpoint dart molecule that targets PD, one and C. T L. A for <unk>.

Scott Koenig: In this study, 20 DLBCL patients were enrolled, half of whom were CAR T-cell therapy experienced. As of October 23, 2020, the cutoff date, there were 13 response-evaluable patients. Preliminary ORR of 53.8%, 7 of 13 patients, was observed, including responses in 5 of 7 CAR T cell nave patients and in 2 of 6 CAR T cell experienced patients, the latter of whom both had complete

Recall that at the ESMO virtual Congress in September data from our phase one dose escalation study of M. G. D. O 19 was reported via oral presentation.

We have expanded the study initially in patients with microsatellite stable colorectal cancer and checkpoint naive non small cell lung cancer at the recommended phase two dose of six mix per gig.

We expect to provide a clinical update on this study in mid 2021.

Scott Koenig: Kevotelumab was generally well-tolerated among heavily pre-treated relapsed refractory DLBCL patients, with manageable Infusion-Related Reactions, and No Evidence of Tumor License Injury. We expect to provide updates on both our monotherapy tebatellumab study and combination study with margituximab in 2021, including future development plans. I should note that in November 2018, we licensed the right to develop and commercialize Tebotelumab in Mainland China, Hong Kong, Macau, and Taiwan to Xilab.

Let me next turn to read a fan labatt the investigational anti PD, one antibody that we license to insight as I N C. M. G. A 0012 as.

As announced last month, the FDA has accepted for priority review insights BLA for Red fans on that as the potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal were progressed on or who are intolerant of platinum based chemotherapy.

According to inside statements that they do for target action date for Red are found on that is July 25th 'twenty 'twenty, one with a likely FDA Advisory Committee meeting as part of the review process.

Scott Koenig: Zi currently has multiple ongoing monotherapy and combination studies of Tebotelumab. Speaking of Tebotelumab, I'd like to next tell you about a study combining this molecule with another of our investigational FC-engineered antibodies. In the coming weeks, we expect to initiate a combination study of inoblituzumab, which targets B7H3, in a chemo-free regimen for front-line squamous cell carcinoma of the head and neck with either tebutelumab for patients who are PD-L1 negative or with retifanilumab for patients who are PD-L1 positive.

In addition to anal cancer insider status is pursuing development of red with Allomap as monotherapy and potentially registration, enabling studies in patients with MSI high endometrial cancer Merkel cell carcinoma and lung cancer.

In addition, they are evaluating the molecule in combination with other other assets in their immune oncology portfolio.

I will remind listeners debt under our collaboration agreement with insight, we have achieved $65 million in milestones to date, including $40 million in the fourth quarter of 2020 and are eligible to receive up to a total of $355 million and.

Remaining development and regulatory milestones and up to $330 million in potential commercial milestones if.

Scott Koenig: Let me next discuss MgD019, our investigational bispecific checkpoint DART molecule that targets PD-1 and CTLA-4. Recall that at the ESMO Virtual Congress in September, data from our Phase I Dose Escalation Study of MGD-019 were reported via oral presentation. We have expanded the study initially in patients with microsatellite-stable colorectal cancer and checkpoint-naive non-small cell lung cancer at the recommended phase 2 dose of 6 mg per kg.

Read up on the map is approved and commercialized macrogenics would be eligible to receive royalties tiered from 15% to 24% on future worldwide net sales of the molecule.

And finally, our second investigational ADC I M. G C 936, which targets Adam nine is being advanced under co development agreement with Immunogen.

Under a 50 50 collaboration Immunogen is leading clinical development and they have indicated they expect to complete dose escalation and move to expansion cohorts in the phase one study with initial data anticipated by the end of 'twenty 'twenty, one or early 'twenty 'twenty two.

Scott Koenig: Let me next turn to retifanilamab, the investigational anti-PD-1 antibody that we licensed to Insight as INCMGA0012. As announced last month, the FDA has accepted for priority review the Insights BLA for retifanilamab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy.

As I mentioned earlier 'twenty 'twenty was a productive year and in 'twenty and 'twenty. One we expect to continue to build momentum and advance our pipeline of innovative product candidate.

We would now be happy to open the call for questions operator.

Thank you, ladies and gentlemen to ask a question you will need to press star one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.

Scott Koenig: According to Insider statements, the BDUFA target action date for retifanlamab is July 25, 2021, with a likely FDA Advisory Committee meeting as part of the review process. In addition to anal cancer, Insider stated it is pursuing the development of retifalumab as monotherapy and potentially registration-enabling studies in patients with MSI-high endometrial cancer, Merkel cell carcinoma, and lung cancer. In addition, they are evaluating the molecule in combination with other assets in their immune oncology portfolio.

Our first question comes from having synchrony with credit Suisse. Your line is open.

Guys. Thank you so much for taking the question congrats on all the progress last year and I'm looking forward to this year, so on margins, our and gastric from a module a.

What what did you see in those patients have prompted you just submit on the data to a meeting in this half of the year and can you just remind us what you want to see from this trial overall and if the data from module a would be potentially sufficient for some sort of accelerated approval.

Thank you very much other than okay. Your nice comments.

Scott Koenig: I will remind listeners that under our collaboration agreement with Insight, we have achieved $65 million in milestones to date, including $40 million in the fourth quarter of 2020, and are eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones, and up to $330 million in potential commercial milestones. If Retofanlamab is approved and commercialized, MacroGenics would be eligible to receive royalties tiered from 15% to 24% on future worldwide net sales of the molecule.

So we have achieved enrollment of the first part of module, a which was 40 patients.

Some of these patients.

That's been enrolled quite recently.

We have been able to follow up on at least two scans on a significant number of those patients and so we felt that it would be valuable to begin to report on the results and so we put a placeholder abstract into our ESCO and if its accepted we will likely.

Well I did update at a later.

Cut of the data in the spring.

And be able to provide you the insights on the results of this study as you recall.

The basis for our interest in the frontline setting was set by the study we conducted and second lines debt.

Scott Koenig: And finally, our second investigational ADC, IMGC 936, which targets ADAM9, is being advanced under a co-development agreement with immunization. Under our 50-50 collaboration, Immunogen is leading clinical development, and they have indicated they expect to complete dose escalation and move to expansion cohorts in the Phase I study, with initial data anticipated by the end of 2021 or early 2022. As I mentioned earlier, 2020 was a productive year, and in 2021, we expect to continue to build momentum and advance our pipeline of innovative product candidates. We would now be happy to open the call to questions. Operator.

Selling of gastric cancer. These are patients post herceptin and chemotherapy, where they were treated with Martha talks on that and an anti PD, one where we saw.

Very nice objective responses in this population.

And particularly with notable.

Is the overall survival benefit which was superior to patients both on the second and first line setting.

Also the safety data was dramatically better of both in cases of patients treated.

With therapies in first line and second line setting by historical data with.

Operator: Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.

Hum.

To give you a perspective the frontline on the.

Treatment of patients standard of care is herceptin and chemotherapy based on on a study called Toga, Inc.

That study the overall response rate was 47% there was a 68% grade three adverse event.

Operator: Please stand by while we compile the Q&A roster. Our first question comes from Evan Segerman with Credit Suisse. Your line is open. Hey guys, thank you so much for taking the question. Congratulations on all the progress last year, and I'm looking forward to this year. So, on Margenza and Gashrek from Module A. What did you see in those patients that prompted you to submit the data to a meeting in this half of the year, and can you just remind us what you want to see from this trial overall and whether the data from Module A would be potentially sufficient for some sort of accelerated approval?

Observation in that study.

So with that we obviously at a baseline we'd like to see overall response.

Rates greater than 47%, we have internal goals of obviously.

Set which we have not disclosed.

Luckily.

So far we've been book quite encouraged by the data that we've seen to date.

Great. Thank you.

Thank you. Our next question comes from Jonathan Chang with S. T. V's Leerink your line is open.

Hi, guys. This is David Russo on for Jonathan Thanks for taking our questions and congrats on all the progress last year.

Scott Koenig: Thank you very much, Evan, for your nice comments. So we have achieved enrollment in the first part of Module A, which was 40 patients. Some of these patients have been enrolled quite recently, and we have been able to follow up on at least two scans on a significant number of those patients. And so we felt that it would be valuable to begin to report on the results. And so we put a placeholder abstract into ASCO.

First question is just could you help set expectations for the updated <unk> data in mid 2021 in terms of how many evaluable patients from the different expansion cohorts.

And then with regard to the prostate cancer cohort, how many patients do you expect computer assisted valuable.

Scott Koenig: And if it's accepted, we will likely provide an update at a later cut of the data in the spring and be able to provide you with insights on the results of the study. As you recall, the basis for our interest in the frontline setting was set by the study we conducted in the second-line setting of gastric cancer. These are patients who have been post-herceptin in chemotherapy, where they were treated with margituximab and an anti-PD-1 antibody, where we saw very nice objective responses in this population.

David Thanks, very much growth question.

As you know.

We have advanced forward in expansion studies is M. D C O N E.

We decided at after the Astro conference in based on additional analysis of pharmacokinetics of the drug in.

On the valuation of safety that a three Meg per kg dosing was the go forward dose that we want to taken these expansion cohorts. We set a goal for enrolling 40 patients in per se in castration resistant prostate cancer 20 patients with non small cell lung cancer and 20 patients with triple negative breast.

Scott Koenig: And particularly notable is the overall survival benefit, which was superior to patients both in the second- and first-line setting. Also, the safety data was dramatically better, both in cases of patients treated with therapies in the first-line and second-line setting compared with historical data. With that, to give you a perspective, the frontline treatment of patient standard of care is receptive to chemotherapy based on a study called TOGA. In that study, the overall response rate was 47%.

We obviously had to submit amendments for the various protocols and it took several months to achieve that that was.

<unk> reached in October and we enrolled the first patients in November in the prostate study.

During Christmas things slowed down and now in the beginning of the year. We are now on a nice ramp of the enrolment of patients. So given that there's very short follow up period. Even in these additional initial patients are we don't expect large numbers of patients to be able to be updated midyear, but.

Obviously, we would like to provide as much data as possible based on the enrollment that we're seeing at the current time, we do expect to meet our objectives by midyear of enrolling for the 40 patients in prostate cancer 20 in non small cell lung and maybe in the triple negative.

Scott Koenig: There was a 68% grade three adverse event observation in that study. So with that, we obviously, at a baseline, would like to see overall response rates greater than 47%. We have internal goals of, obviously, a set which we have not disclosed publicly. But so far, we've been quite encouraged by the data that we've seen to date.

As well, but more likely late later this year.

With regard to.

The data that we will provide as noted in my previous remarks. We will include patients that were in the dose escalation on the study at for Migs per Kid.

Operator: Great. Thank you. Thank you. Our next question comes from Jonathan Chang with SCV Link. Your line is open. Hi guys, this is David Ruchon on behalf of Jonathan.

And several of those patients are still on treatment even at this time.

So again, we will provide his update as much.

What we can in terms of data available at some cut day in the spring and obviously, even later in the year, we will provide additional on data as more scans come in and analysis of PSA, particularly in prostate patients with regard to the resist.

Operator: Thanks for taking our questions and congratulations on all the progress last year. First question is just could you help set expectations for the updated MGC018 data in mid-2021 in terms of how many valuable patients from the different expansion cohorts will be? And then, with regard to the prostate cancer cohort, how many patients do you expect could be resistant to valuable?

Valuation of the prostate patients. This protocol will allow patients that have both pony only disease as well as measurable disease and in various organs.

There is no set number and at this point from the patients who have been enrolled we clearly have ah patients that are coming in with measurable disease, but I won't be able to give you the specifics until other time occurs at the meeting.

Scott Koenig: David, thanks very much for those questions. As you know, we have advanced forward and expansion studies of MGC018. We decided after the ASCO conference and based on additional analysis of pharmacokinetics of the drug and evaluation of safety that a 3 mg per kick dose was the go-forward dose that we wanted to take in these expansion cohorts. We set a goal of enrolling 40 patients with castration-resistant prostate cancer, 20 patients with non-small cell lung cancer, and 20 patients with triple negative breast cancer. We obviously had to submit amendments for the various protocols, and it took several months to achieve that.

Got it. Thanks, that's helpful. And then just for the prostate cancer patients given that youll have some patients from dose escalation and expansion what kind of duration of PSA response, do you think would be encouraging in this late line patient population and are there any other durability metrics that you might be looking to assess.

Yes.

Thank you Linda and obviously, if you look at the historical data from other standard of care on the.

The length of time, which one sees a 50% reduction of PSA level is relatively quite short.

Maybe in the order of two to three months, maybe slightly longer in certain cases, so clearly we want to clear that bar and Anna.

We look for the length of duration of response in this to be six months or hopefully even even longer one thing we have observed from the patients treated so far to give you a little perspective is is that.

Scott Koenig: That was reached in October, and we enrolled the first patients in November for the prostate study. During Christmas, things slowed down, and now at the beginning of the year, we are now on a nice ramp of enrollment. So given that there is a very short follow-up period, even in these initial patients, we don't expect large numbers of patients to be able to be updated mid-year. But obviously, we would like to provide as much data as possible.

For the patients are able to continue on the drug that the effects seem to seem to less obviously, we can't predict what's going to happen in the future. So the goal here is to identify the ideal not only dose of the drug but the dosing interval of the drug and obviously select the population.

That can have on.

The most ex.

<unk> two on treatment with <unk> and in those cases, we hope that that will then lead to prolonged responses with regard to the other objective responses is obviously, we are monitoring for other metastatic lesions. So we will look at radiographic evidence of PFS and then ultimately.

Scott Koenig: Based on the enrollment that we're seeing at the current time, we do expect to meet our objectives by mid-year of enrolling 40 patients in prostate cancer, 20 in non-small cell lung cancer, and maybe triple negative breast as well, but more likely later this year. With regard to the data that we will provide, as noted in previous remarks, we will include the patients that were in the dose escalation arm of the study at 4 mg per kit, and several of those patients are still on treatment even at this time.

Our goal is obviously overall survival given in these late line pay.

Patients survival.

<unk> is quite modest.

On the order of a little more than a year.

Thank you. Our next question comes from Anna <unk> with Evercore. Your line is open.

Thank you. This is it both for AMR and John Hi, Scott.

Could you remind us.

What is the biomarker panel debt youre using for the lag three PD one by specific.

Scott Koenig: So again, we will provide and update as much as we can in terms of data available at some cut date in the spring. And obviously, even later in the year, we will provide additional data as more scans come in and analysis of PSA, particularly in prostate patients. With regard to the resistance evaluation of prostate patients, this protocol will allow patients that have both boney-only disease as well as measurable disease in various organs.

That includes.

And clothes and battery and some other markets.

You have talked about before.

Could you give us some specific and how are you measuring that panel and how do you see that getting our commercial adoption. Thanks.

Thank you Bo and a great question.

And the data that we presented last year was based on our own internal.

Scott Koenig: There is no set number, and at this point, from the patients who have been enrolled, we clearly have patients that are coming in with measurable disease, but I won't be able to give you the specifics until the time for the meeting arrives.

E C.

Data that we have developed.

With the antibodies to lag three we also analyze that data with respect.

Two transcript levels in collaboration with not a strength.

Scott Koenig: Got it. Thanks. That's helpful. And then just for the prostate cancer patients, given that you have some patients from dose escalation and expansion, what kind of duration of PSA response do you think would be encouraging in this late-line patient population? And are there any other durability metrics that you might be looking to assess? Thank you.

And with not a string we looked at a.

Fairly large group of immune associated markers.

And as we noted previously.

Previously we had seen some very nice correlation with responsiveness and the monotherapy treated patients.

Scott Koenig: Yes, thank you. And obviously, if you look at the historical data from other standards of care, the length of time for which one sees a 50% reduction in PSA levels is relatively quite short, and maybe in the order of two to three months, maybe slightly longer in certain cases. So clearly, we want to clear that bar, and we look for the length of this duration of responsiveness to be six months or, hopefully, even longer.

With some of the gamma interferon associated genes and.

And other immune activation genes.

Forward.

We have not announced specifically.

Which one on ones of these biomarkers will be employed for future study I would say at the minimum.

There the data to date on an expanded analysis of additional patients in our study.

Suggest on a measurement of lag three will be a value, particularly in solid tumor patients.

Scott Koenig: One thing we have observed from the patients treated so far, to give you a little perspective, is that if the patients are able to continue on the drug, the effects seem to last. Obviously, we can't predict what's going to happen in the future.

We will provide some update.

Probably around mid year on next steps going forward with regard to either monotherapy treatment in solid tumors.

Scott Koenig: So the goal here is to identify the ideal, not only dose of the drug but the dosing interval of the drug, and obviously select the populations that can have the most exposure to treatment with MGCO-18. And in those cases, we hope that that will then lead to prolonged responses. With regard to the other objective responses, obviously, we are monitoring for other metastatic lesions. So we will look at radiographic evidence of PFS, and then ultimately, our goal is obviously overall survival. Given in these late-life patients, survival is quite modest, on the order of a little more than a year.

C L or combination studies that are ongoing with the margin tucks on them in late line her two patients.

Thank you very much thank you.

Our next question comes from as you call them knock on love It slipped Citi. Your line is open.

Hi, This is Charlie on for Yigal. Thanks, So much for taking my question.

Yeah.

I'm sorry, just to follow up on a prior question on the mahogany module on a.

Initial data on that.

I'm, assuming you'll meet sort of that internal threshold.

Scott Koenig: Thank you. Our next question comes from Uma Rafet with Evercore. Your line is open. Thank you. This is both Omer and John. Hi Scott. Could you remind us what the biomarker panel that you're using for the LAG-3 PD-1 bispecific that Unknown Executive, Scott Koenig, Wei Chang, James Karrels, Etzer Darout, Paul Moore, Faisal

Thank you on.

What would the next steps when do you plan to enroll additional patients and if so how many patients are when do you need to go back to that to the FDA to discuss potential for accelerated approval.

Scott Koenig: Thank you, Bo, and a great question. The data that we presented last year was based on our own internal IHC data that we developed with antibodies to LAG3. We also analyzed that data with respect to transcript levels in collaboration with Nanostring. And with Nanostring, we looked at a fairly large group of immune-associated markers. And as we noted previously, we had seen some very nice correlation with responsiveness in the monotherapy-treated patients with some of the gamma interferon-associated genes and other immune activation genes.

Oh. Thank you currently for the question.

So we have that already had the discussion with the FDA with regard to the analysis of the data and what we would do next if we meet the.

Our criteria for a module a.

This would be a continuation of the study as is.

Continuing enrollment of patients patients.

I really modest number although we have not specifically defined what that is publicly.

We're also have initiated module will be.

With XI lab in Asia and have sites now in Europe, which we can.

Recruit patients ourselves, which is expected at the time, we will finish our analysis of this first part of module a.

It's important to note debt.

And within this module B there are on.

Scott Koenig: Going forward, we have not announced specifically which one or more of these biomarkers will be employed for future studies. However, I would say at the minimum, the data-to-data and expanded analysis of additional patients in our study suggest a measurement of LAC3 will be of value, particularly in solid tumor patients. But we will provide some updates probably around mid-year on next steps going forward with regard to either monotherapy treatment in solid tumors, DLBCL, or combination studies that are ongoing with margituximab late

Opportunities to look at the.

The contribution of components.

To support the study for.

The module a so all in total I think that if we are successful to meet the criteria said, Inc.

Lola can go fairly quickly and should have a.

Hopefully a good set of data that we could.

Support of submission to the FDA for accelerated approval.

Okay, Great. That's really helpful and I know you don't want to come.

On that on when we should expect initial data from multiple b.

Yeah, right now where we're still in the early throws of.

Scott Koenig: Thank you very much. Our next question comes from Yigal Nochomovitz with Citi. Your line is open. Hi, this is Carly on behalf of Yigal. Thanks so much for taking the questions.

Enrollment there as I said, so I lab as the main wooden roller right now we will turn that on a later this year again assuming.

We met a particular criteria, but I can't give you projections right now in terms of the timing on when that study will be complete.

Operator: First, just to follow up on a prior question on the Mahogany Module A initial data, this half. Assuming you meet sort of that internal threshold you were referring to on ORR, what would the next steps be? Would you plan to enroll additional patients, and if so, how many patients, or would you need to go back to the FDA to discuss the potential for accelerated approval?

Okay no problem understood. Thanks for taking the question.

Okay.

Thank you. Our next question comes from etc out with Guggenheim. Your line is open.

Hi, This is Paul on for Ed Thanks for taking our questions for.

For your Turbo tell him that study on D. L. V. C. L. You mentioned some clinical updates later this year could that sort of be around this year's ash meeting or are you aiming for something more near term and also wondering if you could speak on any plans to explore combinations with tebo and the setting for <unk>.

Scott Koenig: Thank you, Carly, for the question. So we have already had discussions with the FDA with regard to the analysis of the data and what we would do next if we meet the criteria for Module A. This would be a continuation of the study as is, continuing enrollment of patients. A really modest number, although we have not specifically defined what that is publicly. We have also initiated Module B with XyLab in Asia and have sites now in Europe where we can recruit patients ourselves, which is expected at the time we finish our analysis of this first part of Module A.

So with regard to the update we will provide an update.

Probably outside of decided to the confidence at least in terms of next next plan and potentially some of the data update on D. L. P. C L.

Probably be for ash, but.

Scott Koenig: It is important to note that within this Module B, there are opportunities to look at the contribution of components to support the study for Module A. So, all in all, I think that if we are successful in meeting the criteria set, enrollment can go fairly quickly, and we should hopefully have a good set of data that we can support.

It's not without a possibility that we would also include a submission.

Admissions to ash.

Sorry, I missed the second question was tebo and what combinations M&A, so let's explore combinations.

Oh, yeah. So as you may have heard earlier.

We're very excited about the start of a study right.

Literally in the next week or two from.

The other nodes are tusa mab.

Scott Koenig: Okay, great. That's really helpful.

Plus tebo telematics in PDL one negative.

Patients with head and neck cancer. This is a frontline study again, if you recall as we presented earlier this year in our combination of Teva with March the FC Engineering that we have incorporated in both of those molecules has the ability.

Scott Koenig: Yeah, right now, we're still in the early throes of enrollment there, as I said. Xylab is the main enroller right now. We will, you know, turn that on later this year, again, assuming we meet our particular criteria. But I can't give you projections right now in terms of the timing when that study would be completed.

Two up regulate various checkpoints, including PDL one.

Operator: Okay, no problem. Understandable. Thanks for taking the question. Thank you. Our next question comes from Etzer Darout with Guggenheim. Your line is open. This is Paul on behalf of Etzer.

Lag three and others and so again.

Our hope is is that when we.

Execute this in the head and neck study, we will take advantage of that activation property. So they can get a better therapeutic effect of combining tebo with another to the map.

Got it. Thanks, that's helpful. And then just one more I was wondering if you could give a little bit more color on your <unk> for programmed and sort of how that differs from other excuse in that and sort of what kind of dosing regimen on you're aiming for with a longer half life there. Thanks.

Operator: Thanks for taking our questions. For your Tevo Telemath study in DLV-CL, you mentioned some clinical updates later this year. Could that sort of be around this year's ASH meeting, or are you aiming for something more near term? And also wondering if you could speak on any plans to explore combinations with Tevo during this session?

Scott Koenig: So with regard to the update, we will provide an update probably outside of the scientific conference, at least in terms of the next plan and potentially some of the data update on DLBCL, probably before ASH, but it's not without a possibility that we'd also include a submission to ASH. I missed the second question, which was...

Well thank you.

If you go back to some of our presentations at some of the scientific meetings, we're very excited about the prospects on the sort of next generation.

Redirected, killing mechanism in our Dart technology.

Exploiting the CV three based mechanisms we had.

Operator: www.microsoft.com

Scott Koenig: So, as you may have heard earlier, we're very excited about the start of a study right literally in the next week or two of Inoblituzumab plus Tevotelumab in PD-L1 negative patients with head and neck cancer. This is a front-line study. Again, if you recall, as we presented earlier this year in our combination of Tevo and Marge, the FC engineering that we have incorporated into both those molecules has the ability to up-regulate various checkpoints, including PD-L1, LAG-3, and others. And so, again, our hope is that when we execute this in the head and neck study, we will take advantage of that activation property to then get a better therapeutic effect when combining Tevo with Inoblituzumab.

Spent a lot of time screening various mutations that could alter slightly the properties of CD three so that the combined dart molecule targeted to a particular target on.

I would allow for maximum killing effect, but.

Mitigate the cytokine release associated with treatment, we have incorporated that paradigm in multiple molecules on the first one that will come and go into the clinic is M. D. D O two for which has the exact same CD 123 variable domain that's incorporated in flows.

Other than that but the slightly altered CD three that will allow for these hopefully improved properties of course, we've also added an FC domain.

And so the opportunity here is to extend the half life of this molecule. So the drug will be given intermittently we should be able to achieve C. Max with this with relative to safety.

Operator: Thanks, that's helpful. And then just one more.

Scott Koenig: I was wondering if you could give a little bit more color on your MGD-024 program and sort of how that differs from Flutter 2.0's MAD and sort of what kind of dosing regimen you're aiming for with the longer half-life there. Thanks.

If all goes well based on our preclinical data.

We'll start the study later this year right now it is viewed as not a replacement for Florida twos on them, but essentially an add on we see the prospects are most beneficial.

Scott Koenig: Thank you. If you go back to some of our presentations at some scientific meetings, we're very excited about the prospects of this sort of next-generation redirected killing mechanism in our dark technology, exploiting the CD3-based mechanisms. We spent a lot of time screening various mutations that could alter slightly the properties of CD3 so that the combined dark molecule targeted to a particular target would allow for maximum killing effects but mitigate the cytokine release associated with treatment.

This sense of using this once a patient is on for the Tuesday, Mab and goes into a remission to use it as maintenance and consolidation therapy as well as expanding this into other indications, including Myelodysplastic syndrome and the other malignancies. So we're very excited to be this we expect to be the first.

Several different CD three we've redirected next generation molecules.

Thank you. Our next question comes from David Lebowitz with Morgan Stanley. Your line is open.

Scott Koenig: We have incorporated that paradigm into multiple molecules, and the first one that will go into the clinic is MgDL24, which has the exact same CD123 variable domain that's incorporated in flotatuzumab, but a slightly altered CD3 that will allow for these hopefully improved properties. Of course, we've also added an FC domain, and so the opportunity here is to extend the half-life of this molecule, so the drug will be given We should be able to achieve C-max with this with relative safety if all goes well based on our preclinical data. We will start this study later this year.

Thank you very much for taking my question.

You characterize the opportunity for <unk>.

So thank you David.

As you know, we're very excited about the activity that insiders pursuing for red affirm a mab.

I would say I look at this from our perspective, both as a very good anti PD one molecule that is now being pursued as monotherapy in both niche and large.

On tumor indications and many many studies in combination I believe there are over now 30 clinical studies ongoing using red a family Matt with regard to the near term Paducah date. The first indication is a niche opportunity a small opportunity for which.

Scott Koenig: Right now, it is viewed as not a replacement for flotatuzumab but essentially an add-on. We see the prospects are most beneficial in the sense of using this once the patient is on flotatuzumab and goes into remission to use it as maintenance and consolidation therapy, as well as expanding this into other indications, including myelodysplastic syndrome and other malignancies. So we're very excited. We expect this to be the first of several different CD3 redirecting next-generation molecules.

There is a great needs of patients with anal cancer.

On progress.

Fairly rapidly and many of these patients.

Progress after platinum therapy or are intolerant of debt therapy. So we're hopeful that that will be the first molecule that will.

Operator: Thank you. Our next question comes from David Lovewitz with Morgan Stanley. Your line is open. Thank you very much.

The molecule the first indication will get in the market, but and so.

So I noted earlier there are multiple other registration directed studies being conducted by them. So there is opportunity to expand on the indications probably in a relatively short period of time for US. It's also a very important opportunity for revenue generation as we know.

Scott Koenig: So thank you, David. As you know, we're very excited about the activity that Insight is pursuing for retifalomab. I would say I look at this from a perspective both as a very good anti-PD-1 molecule that is now being pursued as monotherapy in both niche and large tumor indications and many, many studies in combination. I believe there are now over 30 clinical studies ongoing using retifalomab. With regard to the near-term PDUPA date, the first indication is a niche opportunity, a small opportunity for which there is a great need. Patients with anal cancer progress fairly rapidly, and many of these patients progress after platinum therapy or are intolerant of that therapy.

On the call today is literally in the last few months, we've got an additional $50 million of milestone payments from insight, we expect more to come and certainly.

If the drug is approved.

A significant milestone moodle comfort will be accompanying that as well.

So there will be an expected milestone.

With the first approval.

There would be expected milestone with approval the.

Not a net we cannot we're not enabled to be able to tell you the magnitude of that but given on approval of our first drug.

Debt that could be significant for us.

Scott Koenig: So we're hopeful that that will be the first molecule that will be the first indication we'll get in the market. But as I noted earlier, there are multiple other registration-directed studies being conducted by them. So there is an opportunity to expand the indications, probably in a relatively short period of time. For us, it's also a very important opportunity for revenue generation. As we've noted on the call today, literally in the last few months, we've gotten an additional $50 million in milestone payments from Insight. We expect more to come. And certainly, if the drug is approved, a significant milestone will be accompanying that as well.

Would it be reasonable to expect that there will be larger than the milestones you just received.

I'm not going to comment further on the specifics here, but it's considerable I would also make notes that.

There are future other milestones both for clinical and regulatory regulatory as well as commercial milestones that are quite sizable and then royalty rates that are 15% and our tiered up for that.

Or should I put it on the.

That's for sure.

Okay. Thank you for taking my question.

Okay.

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Yeah.

Hi, everyone. This is mitchell on for Peter on Thank you.

Scott Koenig: So there will be an expected milestone with the first approval.

Scott Koenig: There would be an expected milestone with approval. We are not, we're not enabled to be able to tell you the magnitude of that, but given the approval of the first drug, that could be significant for us.

For taking your questions.

For M D C zero on eight how do you think about the positioning in prostate cancer. Given you know, it's a broad landscape and what could pivotal designs look like down the line.

Scott Koenig: Would it be reasonable to expect that it would be larger than the one you just received?

Thanks for that Joe for that question as you know we started out analyzing patients who were very late stage patients.

Scott Koenig: I'm not going to comment further on the specifics here, but it's considerable. I would also make note that there are future other milestones both for clinical and regulatory as well as commercial milestones that are quite sizable. And then royalty rates that start at 15 percent and are tiered up to 24 percent.

As you noted in our dose escalation study many of these patients.

<unk> had been in as many as six lines of therapy previously.

Right now our.

Our current pursuit is in the castration resistant.

Prostate indication in patients who have progressed on a.

Scott Koenig: Thank you for taking the time. Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open. Hi everyone, this is Mitchell Lawson on behalf of Peter. Thanks for taking our questions. For MGC018, how do you think about the positioning in prostate cancer given it's a broad landscape and what could pivotal designs look like down the line?

A chemotherapeutic agents and the leased when they are agents.

So I think this is a is a nice.

First entry.

Into the treatment of prostate cancer, certainly we could be moving up early in line as well with regard.

To a registration study if the results they are out in the current study.

Operator: Thanks, Mitchell, for that question. As you know, we started out analyzing patients who are very late-stage patients. As you noted, in our dose escalation study, many of these patients had been on as many as six lines of therapy previously. Right now, our current focus is on the castration-resistant prostate indication in patients who have progressed on a chemotherapeutic agent and at least one anti-retroviral agent. So I think this is a nice first entry into the treatment of prostate cancer.

The current approved drug is a commodity taxable as the second chemotherapeutic agent and so I could envision.

A head to head study.

Of M. D C O 18 with cobalt in taxes as next steps for a registration study obviously, we would have to talk to the regulatory agencies with regard to that.

So let.

Let me leave it with debt.

That's great. That's very helpful and then on plug twos, Matt for you.

With the second half update what kind of updates can we expect and what could the size and scope on the next data set look like.

Operator: Certainly, we could be moving up early in line as well. With regard to a registration study, if the results bear out in the current study, the current approved drug is carbazitaxel as the second chemotherapeutic agent. So I could envision a head-to-head study of MGCO18 with carbazitaxel as the next steps for a registration study. Obviously, we would have to talk to the regulatory agencies with regard to that. Let me leave it at that.

Well. Thanks again for that question as you know we're in this.

A single arm registration study.

For Florida to the Nab and the primary induction failure early relapse population, we're enrolling that study currently we.

We have built in into the development of this.

Study, our various looks at the data.

Various.

In terms of patient enrollment.

Scott Koenig: That's great, that's very helpful. And then on Float2ZMab, with the second half update, what kind of updates can we expect, and what could the size and scope of the next dataset look like?

So right now on patients are enrolling, but I can give you right now the projections on that.

On the numbers that we will achieve by the end of the year. What we are targeting is some analysis of at least a first.

Scott Koenig: Thanks again for that question. As you know, we're in this single-arm registration study for flotatuzumab in the primary induction failure early relapse population. We're enrolling in that study currently. We have built into the development of this study various looks at the data at various times during patient enrollment. So right now, patients are enrolling, but I can't give you right now the projections of the numbers that we will achieve by the end of the year. What we are targeting is some analysis of at least a first or possibly second look at this data by the time of ASH, but right now, it's just too early to project that.

First or possibly second a look at this data by the time of Ash, but right now it's just too early to project that.

Thank you very much Scott.

Thank you once again later on if you wish to ask a question at this time. Please press Star then why don't you touched on telephone.

Our next question comes from Boris Becker with Cowen Your line is open.

Hi, This is Dan on for Boris Congrats on all the progress from 2020 and thanks for taking our questions. A quick one for me for N. G. D. O on nine should we expect data from both the colorectal and lung cancer cohorts in May 2021, and has enrollment been pretty similar between pellets court cohorts and what kind of data should we expect.

Operator: Thank you very much. Thank you. Once again, ladies and gentlemen, if you wish to ask a question at this time, please press star then 1 or your touchtone telephone. Our next question comes from Boris Peeker with Callen. Your line is open. Hi, this is Cynthia Onford-Borris.

Thanks, so much for those questions.

We are enrolling in the from PD, one T T like for 2019 molecule.

Operator: Congratulations on all the progress in 2020, and thanks for taking our questions. A quick one for me: for MGD-019, should we expect data from both the colorectal and lung cancer cohorts in mid-2021? And has enrollment been pretty similar between both cohorts, and what kind of data should we expect?

Colorectal is a pretty close to enrolment of that cohort. We're just starting from the enrolment on non small cell lung cancer cohort because we wanted to go into.

Checkpoint anti PD, one naive patients and as you know given that that's been approved and in the U S. We had to go ex U S to begin to recruit those patients those sites are up we're beginning to enroll for that arm of the study so I would.

Scott Koenig: Thanks so much for those questions. So we are enrolling in the PD-1 CTLA-4-019 molecule. The colorectal is pretty close to enrollment in that cohort, and we're just starting enrollment in the non-small cell lung cancer cohort because we wanted to go into checkpoint anti-PD-1 naive patients. And as you know, given that that's approved in the US, we had to go outside the US to begin to recruit those patients. Those sites are up.

Say that it's most likely we would this year be able to provide an update for the colorectal study.

Also.

We will be able to on the.

Talk about some additional cohorts that we will be adding to the study as well.

With regard to the specific scientific forum, we haven't chosen one yet, but we'll be providing updates during the course of the year.

Alright, Thank you for taking our questions.

Thank you Anna I'm currently showing no further questions at this time on like turn the call back over to Dr. Scott Koenig for closing remarks.

Scott Koenig: We're beginning to enroll for that arm of the study. So I would say that it's most likely we will be able to provide an update on the colorectal study this year. Also, it is likely we'll be able to talk about some additional cohorts that we will be adding to the study as well. With regard to the specific scientific forum, we haven't chosen one yet, but we'll be providing updates during the course of the year.

Thank you operator, and thank you all for participating in our call today, and we look forward to update you on our various programs and the beginning of our launch of a more gender have a great day.

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

Operator: Alright, thank you for taking our questions. Thank you. And I'm currently showing no further questions at this time. We'll turn the call back over to Dr. Scott Koenig for closing remarks.

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Scott Koenig: Thank you, operator, and thank you all for participating in our call today. We look forward to updating you on our various programs and the beginning of our launch of Margenza. Have a great day.

No.

Yes.

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Yes.

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Okay.

Yes.

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Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: The Ultimate Parody Site!