Q1 2020 Earnings Call

May 5, 2020

[music].

Good afternoon, we will be getting the macrogenics 2021st quarter corporate progress and financial results Conference call and just a moment all participants are in a listen only mode at the moment and we will conduct a question and that answer session at the conclusion of the call at this point I will turn the call over two and Uh huh.

Operator: BF-WATCH TV 2021 Good afternoon. We will begin the MacroGenics 2020 First Quarter Corporate Progress and Financial Results conference call in just a moment. All participants are in a listen-only mode at this time, and we will conduct a question and answer session at the conclusion of the call. At this point, I will turn the call over to Anna.

Anna Krasavskaya: Krasavskaya, Vice President, Investor Relations and Corporate Communications of MacroGenics. Good afternoon, and welcome to the MacroGenics conference call to discuss our first quarter 2020 financial and operational results. For anyone who has not had a chance to review our results, we issued a press release this afternoon outlining today's announcement, which is available under the Investors tab on our website at macrogenics.com. You may also listen to this conference call via our 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 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. However, actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our annual, quarterly, and current reports filed with the SEC

Chris Chris So Scott, Vice President Investor Relations, and corporate Communications and Michael Jordan.

Thank you good morning, good afternoon, and welcome to the Macrogenics conference call to discuss our first quarter Twentytwenty financial and operational results for anyone who has not had a chance to review our results. We issued a press released this afternoon outlining today's announcement, which is available under the investors tab on our web site at Macrogenics thought.

Anna Krasavskaya: 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. Thank you, Anna.

Oh, you May also listen to this conference call via our webcast on our website, where it will be archived for 30 days beginning approximately two hours. After the call was completed 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 for.

Segment purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995 actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factor section of our annual quarterly and current reports.

Because the FCC. 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 chain.

Change except to the extent to required by applicable.

And now I'd like to turn the call over to Dr. SKO, obtaining president and Chief Executive Officer of Macrogenics up.

Thank you.

Scott Koenig: I'd like to welcome everyone participating via conference call and webcast today. Given the ongoing COVID-19 pandemic, it goes without saying that I hope all of you, as well as your family members, are safe. Thank you for joining us. This afternoon, I will provide an update on our clinical programs and the data expected during the year. But before I do so, I will first turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer, who will review our financial results for the quarter.

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

James Karrels: Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended March 31, 2020, which highlight our financial position as well as our recent progress. As described in our release, MacroGenics had research and development expenses of $48.9 million for the quarter ended March 31, 2020, compared to $47.1 million for the quarter ended March 31, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs. We had general and administrative expenses of $10.2 million for the quarter ended March 31, 2020, compared to the same amount for the quarter ended March 31, 2019.

Given the ongoing covered my team.

It goes without saying that I hope all of you as well as your family members of say.

Thank you for joining us this afternoon I will provide an update on our clinical program and the data expected during the year.

Before I do so let me first turn the call over to Jim Terrell Senior Vice President and Chief Financial Officer on view, our financial results for the quarter.

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

James Karrels: We have recorded total revenue consisting primarily of revenue from collaborative agreements of $13.7 million for the quarter ended March 31, 2020, compared to $9.7 million for the quarter ending March 31, 2019. This increase was primarily due to revenue recognized for manufacturing services under the Clinical Supply Agreements with Insight and Xilab, as well as milestone payments under the Xilab Agreement for clinical trial initiations in Greater China. We recorded a net loss of $44.7 million for the quarter ended March 31, 2020, compared to a net loss of $45 million for the quarter ended March 31, 2019. And finally, our cash, cash equivalents, and marketable securities as of March 31, 2020 were $170.8 million, compared to $215.8 million. $2.8 million as of December 31, 2019.

As described in our release Macrogenics had research and development expenses of $48.9 million for the quarter ended March 31, 2020 compared to $47.1 million for the quarter ended March 31 29 team.

This increase was primarily due to an increase in development and clinical trial costs for multiple programs, we had general and administrative expenses of $10.2 million for the quarter ended March 31, 2020 compared to the same amount for the quarter ended March 31 2019.

We have recorded total revenue consisting primarily of revenue from collaborative agreements of $13.7 million for the quarter ended March 31 2020.

Compared to $9.7 million for the quarter ending March 31 2019.

This increase was primarily due to revenue recognized for manufacturing services under the clinical supply agreements with insight and xylem as well as milestone payments under the xylem agreement for clinical trial initiation in greater China.

We recorded net loss of $44.7 million for the quarter ended March 31, 2020, compared to a net loss of $45 million for the quarter ended March 31 29 team.

And finally, our cash cash equivalents in marketable securities as of March 31, 2020 were $170.8 million compared to 215.

$8 million as of December 31, 2019.

We anticipate that our cash cash equivalents in marketable securities as of March 31, 2020, combined with anticipated and potential collaboration payments should now enable us to fund our operation into 2022, assuming our programs and collaborations advances currently contemplated we had previously guided intent.

James Karrels: We anticipate that our cash, cash equivalents, and marketable securities as of March 31, 2020, combined with anticipated and potential collaboration payments, should now enable us to fund our operations into 2022, assuming our programs and collaborations advance as currently contemplated. Previously Guided into 2021. Extension was made possible through several factors, including our program prioritization. Now I'll turn the call back to Scott.

2021. This extension was made possible through several factors, including our program prioritization efforts and now I'll turn the call back to Scott.

Thank you Jim we're encouraged by the progress in clinical activity that we continued to observe across our broad portfolio of seven antibodies based product candidate and anticipate presented clinical data from all these molecules this year.

While we expect some near term impact on clinical trial site initiation and patient enrollment due to the unprecedented challenges posed by the comment I'd Ben.

We have not changed our guidance for the timing of key anticipated 2020 clinical data read outs or regulatory events.

I will start reported Susan that our investigational by specific CD 123 by Cdthree Dart molecule.

During our plenary session at the virtual HCR annual meeting held last week Dr., Sergio Intel will present, the translational data, suggesting that TV 53, mutated acute myeloid leukemia or AML as correlated with an immune to infiltrate the tumor micro environment in the bone marrow, which.

Scott Koenig: During a plenary session at the virtual AACR annual meeting held last week, Dr. Sergio Rutella presented translational data suggesting that TP53-mutated acute myeloid leukemia, or AML, is correlated with an immune-infiltrated tumor microenvironment in the bone marrow, which, as previously reported, predicts and was, in fact, associated with response to plosivitazumab. This new analysis, built on prior data by Dr. Rutella presented at ASH last year, shows that the same immune signature was associated with a lack of response to chemotherapy or with a response to clausotuzumab immunotherapy in the ongoing phase one, two dose expansion study. In addition, we are scheduled to meet with the FDA in the coming weeks to gain feedback on our planned registration path in the U.S. for Clotetuzumab for the treatment of patients with AML who are refractory to induction treatment, defined as primary induction failure, or PIF, patients, and patients who relapse within six months of initial response. We intend to share these plans with you before the end of the second quarter. Of the approximately 20,000 patients diagnosed with AML in the U.S. annually, at least 30% fail to achieve a complete response with intensive induction therapy. These AML patients have a poor prognosis and limited options to treat this particularly challenging disease.

As previously reported predicts and was in fact associated with response to close as soon as Matt.

This new one ounces build our prior data by Dr. retail.

Resented at Ash last year, showing the same immune signature was associated with a lack of response to chemotherapy over the response uploaded to the math immunotherapy and the ongoing phase one two dose expansion study.

Separately, we are scheduled to meet with the FDA in the coming weeks became feedback on our plan registration path. The U.S. uploaded season that for the treatment of patients with and now we're refractory to induction treatment defined as primary induction failure or Pi ADHD patients and patients who relapsed within.

Six months of initial response.

We intend to shed these plans with you before the end of the second quarter.

I will be approximately 20000 patients diagnosed with animals in the U.S. annually at least 30% sale to achieve a complete response with intensive induction therapy.

These AML patients are the poor prognosis with limited options to treat this particularly challenging disease.

Scott Koenig: We expect to present updated data from the ongoing expansion study of flood attitudes and maps in this AML population in the second half of 2020. Meanwhile, separately, we stopped enrollment in an ex-US Phase I-II study combining flautituzumab with retifanilamab, an anti-PD-1 molecule also known as MgAO-12, in patients with relapsed or refractory AML. This decision followed the successful completion of the first planned dose escalation cohort of 300 nanograms per kg per day of flautituzumab plus 3 mg per kg of retifanilamab and was not due to any safety finding or lack of activity. We plan to resume the study at UF sites in the future.

We expect to present updated data from the ongoing extension study of other Susan that in the same male population in the second half of 2020.

Separately, we stopped enrollment in an ex U.S phase one two study combining while this season.

Rather sad OLED, let Matt and anti PD, one molecule also known as Mgo 12.

In patients with relapsed or refractory even though this decision follows the successful completion of the first slant dose escalation cohort of 390 plans for King per day inflow. This season.

Three legs for Kid of Renaissance on that and was not to the any safety finding or lack of activity. We plan to resume the study as you websites in the future.

I would like to turn to the clinical abstracts that have been selected for presentation at the upcoming ASCO annual meeting that will be held virtually at the end of May.

Scott Koenig: I would like to turn to the clinical abstracts that have been selected for presentation at the upcoming AFSCO annual meeting that will be held virtually at the end of May. The first is an oral presentation covering dose escalation and select expansion cohorts from the ongoing Phase I study of MgDL-13, our investigational bispecific PD-1 bilact-3 DART molecule. The overall safety profile of MgTO13 as it relates to immune-mediated toxicity is generally consistent with anti-PD-1 molecules with respect to event type and frequency. However, we have not identified a maximum tolerated dose. Tumor-specific expansion cohorts are being treated at a flat dose of 600 milligrams once every two weeks. Among these valuable patients, we are observing activity of MGD-013 across expansion cohorts in several tumor types, including after anti-PD-1 therapy, which warrants further investigation. While expression of LAG-3 or PD-L1 was not criteria for study entry, high LAG-3 expression on archival biopsy tissue seems to associate with response to MgTl13 monotherapy.

The first is an oral presentation covering dose escalation and select expansion cohorts from the ongoing phase one study of MTO 13.

Investigational by specific PD, one by lack three dart molecule.

The overall safety profile, then GTL 13, as it relates to immune mediated toxicity is generally consistent with anti PD, one molecule with respect to move them tight and frequency.

We have not identified a maximum tolerated dose.

Tumor specific expansion cohorts of being treated at a flat those of 600 milligrams. Once every two weeks.

Among the valuable patients we are observing activity of NGL 13 across expansion cohorts in several tumor types, including after anti PD, one therapy, which was further investigation.

While expression of lag three or PDL, one we're not criteria for study entry hi lag three expression on archival biopsy tissue seems to associated with response NGL 13 monotherapy.

Scott Koenig: We are also conducting further translational work into other potential correlative biomarkers. Because we noted that margituximab, our investigational ST-engineered monoclonal antibody targeting HER2, enhances lag-free expression on effector cells, we initiated an expansion cohort for a combination with MgD013. Most notably, and as you will hear more about at ASCO, in a cohort of over a dozen valuable patients with advanced HER2-positive tumors treated with a combination of MgDL13 and margituximab, we observed confirmed and unconfirmed objective responses in excess of 40%. All responders remain on therapy.

We're also conducting further translational work into other potential Carlo Biomarkers.

Because we noted that margin tux in that our investigational FC engineered monoclonal antibodies targeting her to enhances lastly expression on effector cells, we initiated an expansion cohort Rick combination with NGL 13.

Most notably and as you will hear more about at ASCO in a cohort of over a dozen valuable patients with advanced her two positive tumors treated with a combination of MTO 13, and margin tuck them that we observe confirmed and not confirmed objective responses in excess of 40%.

All responds remain on therapy, we're very encouraged by this observation that we believe represents synergistic activity of the two molecules based on our results in monotherapy study.

Scott Koenig: We are very encouraged by this observation, which we believe represents synergistic activity of the two molecules based on our results in monotherapy studies. For additional context, published data indicate that responses among HER2-positive breast cancer patients treated with trastuzumab plus anti-PD-1 or anti-PD-L1 antibodies are 0% among PD-L1-negative patients and 15% among PD-L1-positive patients. Given this strong early efficacy signal and favorable safety profile, we expect to prioritize the combination of MgDL13 and margituximab for further development. We believe that the combination of FDA engineering and dual checkpoint blockade engages both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments.

For additional context published data indicate that responses among her two positive breast cancer patients treated with Trastuzumab plus anti PD, one or anti PD. One antibodies are zero percent among PDL, one negative patients and 15% among PDL one positive patients.

Given the strong early efficacy signal and favorable safety profile, we expect to prioritize the combination of NGL 13, and margins types of math for further development.

We believe that the combination of FC engineering, a dual checkpoint blockade engages both innate and adaptive immune responses against a broad range of tumors with very tumor microenvironments.

Separately xylem fab, our regional partner in greater China is continuing to explore NGL 13 in combination with their pipeline assets, including the rapid rip a PARP inhibitor in patients with advanced gastric cancer and derivatives.

Scott Koenig: Additionally, Xi Lab, our regional partner in Greater China, is continuing to explore MgdO13 in combination with their pipeline assets, including norepirib, a PARP inhibitor in patients with advanced gastric cancer, and rivivib, a dual-target tyrosine kinase inhibitor of the VEGF-FGF receptors in patients with hepatocellular carcinoma. The second presentation of clinical results at ASCO will be a poster covering initial dose escalation data from the ongoing Phase I study of MGC018, our investigational antibody drug conjugate targeting B7H3. A dose escalation study is ongoing. Among enrolled patients, the safety profile, which includes hematologic and skin toxicities, as expected, has been manageable. In dose escalation, we have also observed early evidence of clinical activity, especially in patients with metastatic castration-resistant prostate cancer, or MCRPC, with reductions in PSA levels of 50% or more in five of seven patients treated, including one with substantial regression of bone disease.

A dual target tyrosine kinase inhibitor of the digest FGF receptors in patients with have had a cellular carcinoma.

The second presentation of clinical results at ASCO will be a poster covering initial dose escalation data from the ongoing phase one study of energy C. O 18, our investigational antibody drug conjugates targeting disseminates three.

Scott Koenig: Based on these encouraging observations, we are planning a dose expansion in patients with metastatic CRPC once the dose escalation is completed. The third and final of our clinical presentations at ASCO will be a poster of results stratified by chemotherapy from the Phase 3 SOFIA study of marginal toxomab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. A note regarding the timing of the final analysis of overall survival in SOFIA.

Dose escalation study is ongoing.

Among enrolled patients the safety profile, which includes hematologic and in toxicities as expected as been manageable in dose escalation. We have also observed early evidence of clinical activity, especially in patients with metastatic castration resistant prostate cancer or NCR PC.

With reductions in PSC levels of 50% or more in five of seven patients treated including one with substantial regression of bone disease based on these encouraging observation, we're planning a dose expansion in patients with metastatic see RPC once the dose escalations completed.

The third and final of our clinical presentations at ASCO will be a poster results stratified by chemotherapy and the phase three Sophia study a margin talking about plus chemotherapy compared to trust isn't that plus chemotherapy in patients with her two positive metastatic breast cancer.

No regarding the timing of the final analysis of overall survival in Sofia.

We continue to anticipate reporting finalized what she's though in the second half of 2020 pending the accrual of death events needed part of the protocol to conduct the analysis.

Scott Koenig: We continue to anticipate reporting final OS results in the second half of 2020, pending the accrual of death events needed per the protocol to conduct the analysis. As a reminder, the FDA has indicated its plan to schedule an Oncologic Drugs Advisory Committee, or ROADAC, meeting in the second half of 2020 and has a Prescription Drug User Fee Act, or PDUFA, target action date for marzituximab for the treatment of HER2-positive metastatic breast cancer in December 2020. While we are discussing margituximab, beyond breast cancer, we are opening clinical sites globally to enroll patients in the Phase II-III Mahogany Study, evaluating the combination of margituximab and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer. Initially, Mahogany is evaluating marzituximab plus redofanlamab, our investigational anti-PD-1 antibody, licensed insight in patients with HER2, IHC3+, and PD-L1-positive disease. This single-arm part of the mahogany study, which we refer to as Module A, is designed to support a potential accelerated approval of margituximab plus retifalumab in the U.S. based on a primary efficacy endpoint of objective response. I can comment on our initial observations.

Separately as a reminder, the FDA has indicated is planned to schedule and the ontological drugs Advisory Committee or ODAC meeting in the second half of 2020 and has a prescription drug user fee ACO for do put target action date for margin tucked in that for the treatment of her two positive metastatic breast cancer in December two.

20.

While we are discussing margin tucked in that beyond breast cancer, we are opening clinical sites globally to enroll patients in the phase two three mahogany study evaluating the combination of margin touched on that and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer.

Scott Koenig: We have observed objective responses in the first three or four valuable patients treated in the study with this chemo-free regimen. These are very early observations, but they support our optimism around possibilities for market toughness in this indication. As you will recall, we observed responses in approximately 50% of second-line patients with HER2 IHC 3 plus and PD-L1 positive disease in the study of margituximab and pembrolizumab. We expect to report initial data from mahogany module A in the second half of 2020. The second component of the mahogany study, which we refer to as Module B, is designed as a randomized controlled trial to evaluate the combination of margituximab with chemotherapy plus either retophanolamide or MgDL-13 compared to trastuzumab and chemotherapy in a broader population of patients with advanced HER2-positive gastric cancer.

Initially mahogany is evaluating largest toughmet plus rather than let Matt our investigational anti PD one antibody license inside.

In patients with her to I see three plus and PDL one positive disease.

This single arm part of the mahogany study, which we referred to as module away is designed to support a potential accelerated approval of margins have some them bus retrofit allomap in the U.S. stays on a primary efficacy endpoint of objective response rate.

I can comment on our initial observations we have observed objective responses in the first three or four a valuable patients treated on the study with this chemo free regimen.

These are very early observations that support our optimism around possibilities for margins tucked in that in this indication.

As you'll recall, we observe responses and approximately 50% of second line patients with her two I had C plus and PDL one positive disease in the study of margins have some have been pembrolizumab. We expect to report initial data from mahogany modulating the second half of 2020.

The second component of mahogany study, which we referred to as modules me is designed as a randomized controlled trial to evaluate the combination margin tuck them that with chemotherapy plus either retrofit allomap or NGL 13, compared to try to Susan that and chemotherapy.

In a broader population of patients with advanced Hertwo positive gastric cancer.

We expect the first initiate module will be in greater China in collaboration with our regional partner I left in the second half of 2020.

Scott Koenig: We expect the first INITIATE module to be in Greater China in collaboration with our regional partner, BiLab, in the second half of 2020. To briefly discuss Ritophalimab, Insight plans to present data in the second half of 2020 from their potentially registration-enabling monotherapy study in patients with anal cancer, which is now fully enrolled. Two other monotherapy studies of retophalomab are also ongoing in MSI-high endometrial cancer and Merkel cell carcinoma and could potentially support registration.

To briefly discuss run afoul of Mab insight plan to present data in the second half of 2020 from there potentially registration, enabling monotherapy study in patients with an l. cancer, which is now fully enrolled.

Two other monotherapy study the Red asylum.

Our also ongoing and then ESI high endometrial cancer, and Merkel cell carcinoma, and could potentially support registration.

In addition, we expect inside to initiate a phase three study known as podium three or four in patients with metastatic non small cell lung cancer in 2020.

Scott Koenig: In addition, we expect Insight to initiate a phase 3 study known as Podium 304 in patients with metastatic non-small cell lung cancer in 2020. In all, there are currently five registration-directed clinical studies ongoing or planned in 2020 by either company across a broad range of tumor types. Let me next turn to NGD 019, an investigation of bi-specific PD-1 by the CTLA-4-DARG molecule.

And all that are currently five registration directed clinical studies ongoing or planned in 2020 by either company across a broad range of tumor types.

Let me next turn to NGL 19, and an investigational by specific PD, one by sequelae for Dart molecule. The dose escalation is ongoing in all comer population with advanced cancer, we have not restricted the studies the tumor types that are known to respond to checkpoint inhibitors.

Scott Koenig: The dose escalation is ongoing in an all-comer population with advanced cancer. We have not restricted the study to tumor types that are known to respond to checkpoint inhibitors. We are currently enrolling patients in additional dose-escalation cohorts with no dose-limiting toxicities observed. Of the 13 evaluable patients treated at doses of 3 mg per kg or greater, we have observed 4 patients across different tumor types, with 3 confirmed and 1 unconfirmed objective responses. We are encouraged by these admittedly very early data and plan to submit results from those escalations of presentations at scientific conferences later this year. Finally, let me discuss Enobla-tuzumab, our investigational STN-engineered anti-B7H3 monoclonal antibody.

We are currently enrolling patients in additional dose escalation cohort with no dose limiting toxicities observed.

The 13, a valuable patients treated at doses of three milligrams per kilogram upgrader, we have observed for patients across different tumor types with reconfirmed and one on confirmed objective response.

We are encouraged by these admittedly very early data and plan to submit results from dose escalation for presentation at scientific conferences later this year.

Finally, let me discuss ennobled season.

Our investigational Essien engineered antibody seven athree monoclonal antibody.

Scott Koenig: In consideration of the current global and domestic COVID-19 pandemic, the planned Phase 2 study initiation of nobletuzumab in combination with checkpoint blockade as chemotherapy-free treatment of patients with advanced head and neck cancer will be delayed. We expect to provide an update on the timing for initiating the study in the second half of 2020. The delay in the study does not reflect a lack of enthusiasm for this model. As you can see, despite the current global crisis, we continue to expect 2020 to be a data- and catalyst-rich year for macrogenics. We would now be happy to address any questions that callers may have. Operator. To ask a question, please press star then 1.

In consideration of the current global and domestic Cobot 19 pandemic. The planned phase two study initiation of the noble Susan that in combination with checkpoint blockade as chemotherapy free treatment to patients with advanced head neck cancer will be delayed we expect to provide an update on the timing for initiating the studies.

The second half of 2020.

The delay to the study does not reflect a lack of enthusiasm for this molecule.

As you can see despite the current global crisis, we continue to expect 2020 to be a data and catalyst rich year for Macrogenics.

We would now be happy to address any questions at call. It may have operator.

To ask a question. Please touch Star then one once again that started one to ask a question.

Operator: Once again, that's Star 1 to ask a question. And our first question comes from the line of Christopher Marri with Nomura. Your line is open. Hey, good afternoon, everybody.

First question comes from the line of Christopher Marinac with Nomura. Your line is open.

Hey, good afternoon, everybody. Thank you for the the update Scott.

Unknown Speaker: Thank you for the update, Scott. It was quite extensive. I guess, maybe just to begin with MGC 08. You had highlighted that the heme and the skin tox were as expected and manageable. Could you just elaborate, is that a tox caused by the B7H3 engagement, or is that separate from your..., your payload on the PDF?

Quite quite extensive I guess, maybe maybe just to begin with Mtc zero 18 on you'd highlight that that highlighted that they seem I guess can tell its was as expected and manageable party celebrate that talks caused by 67 age three engagement or is that separate from the or.

You know payload on the HCV.

Thank you very much a jackson's the though for the question.

Scott Koenig: Thank you very much, Jackson, for the question. Obviously, details will be presented at the poster session at ASCO. The expectations with regard to the hematological were related to the toxin, and the skin observations were either due to the toxin or due to the targeting of B7H3.

Obviously, the details will be presented at the poster session at ASCO.

The expectations with regard to the Haematological was related to the taxes and the of the.

The skin.

Observations.

Work.

Either due to the toxin or.

Due to the targeting disseminates three.

Scott Koenig: Right now, it's unclear, but as I noted, they are manageable toxins. Okay, great. And then, with respect to Sophia's final book, you know, it sounds like that's going to hit before, you know, a PDUFA decision. How do we think about the sort of thing FDA has expressed to you, or our understanding is that they've expressed to you that an OS result is not necessary in your view, you know, how should we think about the potential outcome? [inaudible] final result with respect to any Hi, Jackson, thanks for the question. Right now, we're continuing to monitor the number of events of death. As I've indicated, this is still anticipated in the second half of this year. But it's very hard to predict with precision when this will occur.

And now it's.

Unclear, but as I noted they are manageable toxicities.

Okay, Great and then with respect to Sofia spinal book, you know it sounds like that's going to hit before.

Ill up to two fold.

Decision.

How should we think about sort of that.

FDA has expressed to you or our understanding is that they've expressed to you that on I know last result is it's not necessary in your view you know how how should we think about.

The potential for outcomes on the Sofia.

[music].

Final result, with respect to.

Any.

Approval decision.

Jackson, Thanks to the question right now we're continuing to monitor the number of.

In terms of debt.

As I've indicated this is still anticipated in the second half of this year.

It's very hard to predict with precision of when this will occur my expectation. It will be later in this year and obviously there has to be some data cleaning. So it may be very close eat into the up the do per day, when that data will be ready to to present so.

At this point our plan is to take the second interim analysis for ROE as and use that as the basis, which is obviously didnt ready provided to the seem to be alike filing for evaluation. If any changes occur we will obviously update everyone.

At that appropriate time.

Great and then just sticking with much touching that the mahogany progress looks really exciting.

Scott Koenig: And then just sticking with Margituximab, the mahogany progress looks really exciting with your observed responses in three of four valuable patients. I was just wondering if you could comment on what level of number one durability we expect to see in terms of these responses. How durable are they?

With your absurd responses in three of four evaluable patients.

I was just wondering if you could comment what what level.

That number winter ability, we expect to see in terms of these responses Hunter bar. They how much time have you have you observe and for and how much will be available at ASCO and then two I can previously you had discussed that this could be.

Scott Koenig: How much time have you observed them for? And how much will be available at ASCO? And then two, I think previously you discussed that this could potentially be potentially registrational worthy, the module A with a response rate as an endpoint in this patient population. So just maybe, if you could, remind us of your plans with respect to that and maybe what the hurdle might be. In terms of, I suppose, adding more patients to the expansion part of that Module A. So that's a couple of questions.

Potentially registrational.

Worthy the module eight within it with that.

A response rate as an endpoint in this patient population. So just maybe if you could.

Remind us of peer plans with respect to that and maybe what the hurdle might be.

In terms of I, suppose adding more patients to the expansion part of that actually thank you.

So that's a couple of questions. So with regard to the length of duration of response with its still these patients are still on on treatments. So it's still too early to predict even in these fewer few patients what the targeted the PFS or.

Scott Koenig: So with regard to the length of duration of responsiveness, it's still early to predict, even in these few patients, what the target of PFS or OS would be. Just to give you a little context, the median PFS for first-line therapy for the TOGA regimen was 6.7 months, and the OS was 13.1 months. So our hope is that this will far exceed that with regard to PFS and OS.

So with would be just to give you a little contacts.

The median PFS.

Sure front first line therapy.

For the telco regimen to 6.7 month and the unless it was 13.1 months. So our hope is that this will have far exceed that with regard to PFS and Oh, yes with regard to overall response rate, which is the target is is endpoint of for the existing alarms.

Unknown Speaker: With regard to overall response rate, which is the target endpoint for the single-arm study, just again, to recall, TOGA was 47%. Our hope is that this will be north of 50%, and we will use that as a basis for decision. As we pointed out previously, we said that we should have a sufficient number of data from the initial patients to make a decision whether we are achieving the targeted range that would then encourage us to finish our completion of enrollment. And we will plan to update everyone later this year, assuming we continue to enroll at the rate we have been doing at this point. Okay, great. Thank you very much. Congratulations. Yeah, thank you very much. And sorry, I thought the volume was very low. Is it you, Chris?

Study.

But again to recall Togo was 47%.

Our hope is that this will be a north of 50%.

As the use of the basis for decision as we pointed out previously.

We have said that we should have a sufficient number of data from the initial patients to make a decision whether 'em we are.

Achieving the targeted range that would then.

Our adjusted finish out deepen over enrollment and we will plan to update.

Everyone. Later this year, assuming if we continue to enroll at the rate, though we're busy doing at this point.

Okay, great, but there wasn't much regulations.

Thank you very much I am sorry, I suppose.

The board the volume is very low it's you as the you Chris.

Unknown Speaker: It's me. Yeah, sorry. You should have known the questions were easier. I'm sorry; thank you so much. Thank you. And our next question comes from Deb Geatchuck of Bidet with H.G. Wainwright.

It may get sorry, you said no other questions for easier.

Sorry to make it so much [laughter].

Thank you and our next question comes from the GE capital along with his formulary your line open.

Hey, good afternoon.

Unknown Speaker: Your line is open. Hey, good afternoon. A lot of data dropped here, so I probably have missed a few. So, based on the activity with MGD013, do you expect to develop a companion diagnostic, or is the trend that you alluded to regarding correlation of responses with LAG-3 expression mostly a trend, and you don't have anything concrete yet? And, you know, because of PD-1 and LAG-3, you're getting a pretty holistic kind of response. Rather than me commenting on that, why don't you stay and wait for the ASCO presentation? There may be merit in developing a diagnostic associated with this to select patients that would most benefit from this, but again, wait for the ASCO presentation to hear the details. Okay, then just a clarification here for the upcoming data with the MGD013.

Lot of data drop here, so I probably have missed a few.

So based on the activity with MDD Zito 13, do you expect to develop a companion diagnostic pour the trend that you alluded to regarding correlation of responses, but like three expression is mostly a trend and you don't have anything concrete yet and you know because to be one like three you're getting a pretty holistic kind of response.

Rather than the commenting on that.

Why don't you say and wait for the ASCO presentation.

There may be marriage of the developing a diagnostic associated with this.

To select patients that would most benefit from that but again well wait for the ASCO presentations to hear the details.

Okay.

Then just a clarification here and for the upcoming data with the M. good easy it'll 13.

To.

Unknown Speaker: So you mentioned responses in multiple different tumor types in the post-PD-1 setting. So are these patients primary refractory patients, or patients who progressed after an initial response? You know, we have cohorts of approximately 16 in some of these expansion groups, and so there are mixed histories in these patients. And I can't specify, off the top of my head, for the particular populations we will show at the meeting where they fall, but we can follow up with you afterwards.

You mentioned responses and multiple different tumor types in the fourth speedy one setting. So are these patients primary refractory patients outpatient suit progressed after an initial response.

You know the we had cohorts of approximately 16 in some of these expansion groups and so there is a mix histories on these patients and I can specify off the top of my head for the particular populations, we will show at the meeting.

Where they fall, but we can follow up with you on afterwards.

Great and just one quick follow up on a zero 18 did you reach the recommended phase two dose and the the 50% be it said reductions in five out of seven but bonder aggression.

Scott Koenig: Great, and just one quick follow-up on R018. Did you reach the recommended phase two dose and the 50% PHA reduction in five out of seven with bone regression? Is this at the RP2D, or is the dose escalation still ongoing? This was the dose escalation is still ongoing. These were actually at lower doses, and on previous calls, I had indicated we were very encouraged by the data we were seeing even in this lower dose range. So we have actually moved the dose up, and we're right now enrolling patients in what we believe would be the top dose to establish a maximum tolerated dose. Whether we achieve that with this highest dose is unknown, but we do not intend to go higher.

Is this adds to the IP to de or is the dose escalation still ongoing.

This was the other dose escalation is still ongoing these were actually at lower doses and then on previous calls I has indicated we were very encouraged by the data we're seeing even in this lower doses range. So we're actually moved the dose up.

We are right now enrolling patients than what we believe would be the top dose to establish a maximum tolerated dose whether we achieved that was its highest dose we do not intend to go higher.

Scott Koenig: And we will select based on the response rate and pharmacokinetics and, obviously, the safety profile of the preferred dose going forward. But the fact that we're seeing such a high response rate across multiple doses is obviously very exciting for us. Congratulations. I'll hop back in the queue. I have a few more.

And we will select based on the response rate and pharmacokinetics and obviously the safety profile.

The preferred dose going forward, but the fact that we're seeing a such a high response rate across multiple doses is obviously very exciting for us.

Scott Koenig: I'll come back in later. Thank you. Thank you. And our next question comes from David Lebowitz with Morgan Stanley. Your line is open. Thank you very much for taking my question. David, David, we can't hear you, can you talk closer to the phone? When you meet later with the FDA on the 4th of Tuesday, what are the, what are the ranges?

Threats I'll hop back in the Q will have a few more I'll come back later. Thank you. Thank you.

Thank you enter next question comes from David Lebowitz with Morgan Stanley Your not line is open.

Thank you very much for taking my question.

When you meet with David David I, We can't hear you can you talk closer to the phone.

When you meet later.

The FDA put it to the man.

What are what are the range of possible outcome you think.

The Registrational path forward.

If I heard your question, where you were very soft Ya.

Scott Koenig: If I heard your question, you were very soft here on our end, is what is the outcome of our expected outcome of the meeting with the FDA later this month? As I had previously indicated, we met with the FDA last September to discuss the design of a registration study in the refractory population. They agreed that this was a population that was very suitable and addressable and necessary given the current state of affairs for this population.

Our end is what is the outcome of black our expected outcome was a meeting with the FDA later this month.

As I have previously indicated we had met with the FDA last September on to discuss the design of a registration study in the refractory population. They agree that this was a population of that.

Was a very suitable and addressable and necessary given the current state of affairs for this population, obviously, we can't predict what an outcome of any meeting with the F.D. is but we're very highly encouraged based on the last meeting we have with them with some of the open questions. We.

Scott Koenig: Obviously, we can't predict what the outcome of any meeting with the FDA will be, but we're very highly encouraged based on the last meeting we had with them on some of the open questions. We were going to provide them, which we have already done, some additional data on new patients that have been enrolled at the targeted doses, both with regard to safety and response rate. And, as I had previously indicated, they were very interested in the historical data of patients with so-called refractory disease and their response rates as reported in the published literature over the last 30 years, and we provided them with all that data. Our goal right now is mainly to come up with some final designs for this trial and some certain understandings of what a targeted successful outcome would be for this study. Right now, we're very optimistic, but until we have that meeting, we can't give you any more clarity about the outcome. That makes sense.

Well go to provide them, which we've already done some additional data on new patients that have been enrolled as a target is doses both with regard to safety and response rate and as I have previously indicated they were very interested in the historical data a patients would so call refractory disease and their risk.

Science rate as reported in the published literature over the last three years, we've provided them with all that data. So our goal right now is mainly to to come up with some a final designed on this trial and some certain understanding the what a targeted successful outcome.

Before the studies so right now we're very optimistic but until we have the meeting we can't give you anymore clarity about though the outcome.

Scott Koenig: And I might have missed this when you mentioned it on the call, but on the Phase 1-2 combination with formerly named MGA-012 that was halted, what was the primary reason it was halted? Is this COVID-19 related? So what happened is that enrollment slowed down because this was an ex-U.S. study in three countries, including Spain, where basically all the sites shut down; Australia sites were shutting down, and Israel sites were shutting down. And basically, with very poor enrollment and incurring very significant costs, just maintaining a CRO, we said it didn't make sense to continue paying these huge fees, and so we said, "Let the COVID-19 Thanks for taking my question. Thank you, David. Thank you. And our next question comes from the line of Yigal Nochomovitz with City. Your line is now open. Hi, this is Samantha Andreagal.

Didn't make sense.

And I might've missed this when you mentioned on the call, but on the phase one two accommodation with some formerly named M.D.A.

As there are one two or that was halted what was the primary reason was halted there's this cobot 19 related or or so what happens is is that enrollment slowed down because it was the next U.S. study in three countries, including staying which are basically all aside shut down or.

Failure sites were shutting down and Israel sites were shutting down and basically was very poor enrollment and incurring very significant costs just the maintaining a CR always said it doesn't make sense to continue paying.

These huge season. So we said, let the cobot 19 pandemic, a slowdown and we will resume the study in the U.S.

Makes sense, thanks for taking my question.

Thank you David.

Okay.

Thank you enter next question comes along the lines the ball no big.

Citi. Your line is now open.

Hi, this is demands on shake off pretty much you're taking your questions [noise].

Scott Koenig: Thank you very much for taking our question. On SOFIA and for the potential ODAC meeting for Margituximab, what questions do you believe you need to be prepared to answer clearly in order to generate a successful outcome? I'm sure that as you expect the ODAC meeting, you are actively preparing for that ahead of time. Just curious, like, what are your thoughts there?

And to see and there's a potential ODAC meeting to make a tech snap.

Question seasonally the need to teach appeared to and clearly and I got to generate successful outcome and ensure that you're expecting attack meeting you are absolutely. The tanks that ahead of time, just curious like they act.

[music].

Yeah, I think the probably the biggest questions on that a looming in which is then publicly aired in many different settings is oh, the valued clinically all of the molecule in the intensity population that with regard to the PFS.

Scott Koenig: I think probably the biggest questions that are looming and which have been publicly discussed in many different settings are the value clinically of the molecule in the intensively treated population with regard to the PFS data that we presented. As you know, we saw a hazard ratio in the intensively treated population of a reduction of 24% compared to the control population, but a very short actual value in terms of months with regard to the improvement in that marginal toxin metatreated population. I think the second question is related to the epithelial population, which, as you know, was a targeted exploratory population that was predefined but did not allocate any alpha in the analysis. And given that, as we have shown quite clearly, most of the therapeutic benefit is related to that epithelial population, which represents 85% of the overall population, how the FDA views that population, and further inquiries there. I think those are probably the two major questions looming. Great, thank you; that's very helpful.

Oh stated that we presented as you know when we saw a hazard ratio and intend to treat population of a reduction of 24%.

Compared to the control population, but a very short of actual value in terms of months.

With regard to the.

The improvement in that market touching their treated population.

I think there. The second question is related to the Apple wheel population, which as you know was a targeted exploratory population that was predefine, but did not.

Allocate any alpha in the analysis and given that which we have shown quite clearly most of the therapeutic benefit is related to that FCO population, which represents 85% of the overall population.

How the FDA views on that population.

And further inquiries there I think those are probably the two major up questions a looming.

Great. Thank you that's kinda helpful. And then you mentioned in your prepared remarks, Hey, you were going to open an expansion cohort for MGT Olin screen magic text to nine.

Scott Koenig: And then you mentioned in your prepared remarks that you were going to open an expansion cohort for MGD-013 and margituximab. I wonder if you could give a bit more context to the study you quoted as a comparator for Herceptin combined with PD-1 therapy. You said a 0% response rate for PD-01 negative. What line of therapy was that study conducted in? And in the data that you're gonna be presenting for MGD-013 and Margituximab, I think you said 40% responders. How many of those are PD-01 negative?

[laughter] Wonder if you could take more contracts at a steady quoted as that comps for herceptin minus PD one therapy. If it is there a precipitous entre PDL one negative what line of therapy was that steady connected and and the data that you're going to be presenting frenzy deal entrainment detection that he said 40% responders.

How many of those are PDL, one negative and just trying to get a clear picture of how that kids state can pack.

Scott Koenig: Just trying to get a clearer picture of how those two studies compare. I think it would be premature for me to state this on this call, so please attend or listen to the meeting at ASCO. We will have clarity about all those aspects with regard to line of therapy, specific tumors, and the PDL1 expression pattern, but it would be inappropriate for me to comment on this now before the ASCO presentation. Okay, got it. And we'll certainly be tuning in to that.

I think you a pre may be premature for me to state. This at this call.

So please attended or listened to.

The meeting at ASCO, we will have.

Clarity about.

All those aspects with regard to liner therapy specific tumors.

The PDL, one expression patterns, but it would be an appropriately for me to comment on this now before the ASCO presentation.

Okay got it I understand there will certainly be carrying into that I guess, if one more question for me maybe they have a bigger picture question, yes, we're going to see it you know obviously that.

Scott Koenig: I have one more question for you, maybe a bit of a bigger picture question. We're going to see, you know, obviously a meaningful data set for MGD-013 at ASCO, and you're still in dose escalation for MGD-019, but we should get initial data for them in the second half. Given that these are both assets that are bi-specific with a PD-1 arm, I guess, I'm just wondering how you think that both of these assets are going to fit into the treatment landscape together. Are there certain tumor types or even potentially drug combinations where you think each of these assets may be better suited? I think what you will see, which relates to both molecules, is the value of this bispecific in enhancing responses in populations with regard to both PD-L1 expression and prior treatment with anti-PD-1 and PD-L1 therapy. What we anticipate for both these molecules is that they will be easily combinable with other assets. We showed you the illustration today of MARGE plus 13.

Meaningful dataset from PDL entry at ASCO, and you're still in dose escalation for and Jiechi 019, but what we should get initial data from the second half.

I just given that these are both assets that are by specific for the PD. One arm I guess Im just wondering how you're thinking that both of these assets are going to finish the treatment landscape together are there certain tumor types or even potentially drug combinations, where you think each of these assets maybe better it.

I think once you will see.

Which relates to both molecule.

Is the value of this by specific in enhancing responses.

In populations with regard.

It's both a PD one PDL, one expression and prior treatment with anti PD, one PDL one therapies.

What we envisioned for both these molecule is is that they will be easily combinable.

With other assets.

Scott Koenig: As you know, we are in the ongoing gastric study as well as planned for MARGE plus 13. But one of the big goals for the 19th study was to achieve the synergy that one sees for combining an anti-PD-1 with an anti-CTLA-4 without getting the toxicity that has been previously observed with ipinebo combinations. Just to correct a statement, we have completed the dose escalation part of 19. We will share that with you later this year, as I said, at a follow-up conference. But as I have indicated previously, we are far above the dose that the typical IPI needle combination is. You know, IPI has been used historically, mostly in the clinic, originally at 3 mg per kg, and currently, in current studies, at 1 mg per kg, and we're far above that dose, and, as indicated here, with a toxicity profile that is quite favorable with regard to observations with respect to typical anti-PD-1 treatment-associated effects. Just to give you a historical refreshment, when we did the monkey study with MGD-019, we went up to doses of 100 mg per kg without associated significant toxicities. And remember, at much lower doses, ipinebo caused those animals to die with very severe diarrhea and dehydration.

We showed you the illustration today of March plus plus 13.

As you know 'em, we are happy ongoing gastric study.

Well planned for March plus 13.

But what are the big.

Goals for the 19 study was to achieve the synergy that one seeds for combining and anti PD, one where they MPC telus for without getting the toxicity that has been previously observed with if you need a combination.

Just to kind of correct.

Statement.

We have completed the dose escalation part of 19, we will share that with you later this year.

As I said I don't have a follow up conference.

But what I had indicated previously.

We are far above the dose that the typical it'd be nivo combination as you know if he has been used historically, mostly in the clinic originally a three month for kids and currently in current studies that one they per case and were far above that dose and has indicated here with a toxicity.

Profile that is.

Quite favorable with regard to.

Observations with respect to a typical anti PD one.

A treatment associated effects.

Just to give you a historical refreshment when we do the Monkey study with Mgd, Oh, Oh 19, we went off the doses of 100 makes for keurig without a associated is significant toxicities and remember.

Our at much lower doses.

If the Nivo I'm cause those animals to die with very severe diarrhea dehydration. So the enhanced.

Scott Koenig: So the enhanced ability to activate T-cells without the associated toxicity is one of the things that will, I think, be important for the value of this asset. Okay, great. Thank you so much, and I appreciate all the color there.

Ability to activate T cells without the associated toxicity is one of the things that will I think.

Be important for the value of this asset.

Okay, great. Thank you so much and appreciate the color there.

Thank you enter next question comes from Peter Lawson Your line is helpful.

Scott Koenig: Thank you. And our next question comes from Peter Lawson. Your line is open. Hi there, this is Mitchell.

Hi, there. This is Mitchell one for peer then you could taking our question. The first one is Ah going into the December PDUFA can you give us an update on how you're preparing for the potential launch for Mirvetuximab.

Scott Koenig: And Peter, thank you for taking our questions. The first one is going into the December PDUFA, can you give us an update on how you're, and potential launch from our detox. So, as we have previously mentioned earlier in the year, we have done our marketing assessments.

So oh, we have a metro as we've previously mentioned earlier in the year.

We have done our marketing assessments one of the things. Obviously, we're monitoring is the launches of up other drugs that have been recently approved in the third and late line therapies.

Scott Koenig: One of the things we're obviously monitoring is the launches of other drugs that have recently been approved for third and late line therapy. So we are doing our homework both on the marketing side and other aspects of the drug. We have engagement obviously before COVID-19 with our MSLs in the community to educate them with regard to FC engineering and the value potentially of the immune-mediated effects that are associated with molecules like margituximab. Our plan, as I said previously, is to open up discussions again with additional partners who can be in a position to help commercialize this molecule. And then just one more, just wanted to get your thoughts on how you're thinking about the release of data in kind of a socially distancing world. Is this, you know, do you think about waiting for year-end conferences for better reception from the medical community? Or is that something you're getting thought to?

So we are doing our homeware, who both on the marketing side and other aspects of the drug.

We have engagement, obviously before cobas 19, with RMS cells in the community to educate them with regard to see engineering and the value potentially out of a immune mediated effect. Some that are associated with a molecule like margin touched some.

Our plan as I said previously is to open up discussions are again with additional partners, who can be in a position.

To help commercialize this molecule.

Thank you and then just one more just wanted to get your thoughts on how you're thinking about the release of data in kind of a social distancing world is there a you know do you think about a waiting for year end conferences for better reception from the medical community or is that something you're going to appeal.

So you know again, if you saw today, we were very transparent with trying to provide as much data recognizing that there's been much there are lot of challenges.

Scott Koenig: So, you know, again, if you saw today, we were very transparent in trying to provide as much data, recognizing that there's been a lot, there are a lot of challenges that are occurring currently, and we expect will continue throughout the year for access. So, our goal is to be as open with ongoing studies as we can. We're not planning to give patient-by-patient updates, but we will provide as much data as we can in sizable numbers so that you can be aware. One of the things that we're very excited about, as I have said previously, all seven of our clinical molecules are active, and right now, our goal for the course of this year and next year is to have multiple registration studies ongoing and to build on the prospects of these molecules to get them to patients as Thank you. And our next question comes from John Miller. Your line is open.

Our current currently and we expect will continue throughout the year where access so.

Our goal is to be has all been with ongoing studies ESM CAD, we're not planning to give patient by patient update, but we will provide as much data as we can and in sizable numbers.

So that you can be aware what are the things that we're very excited about as I have said previously all seven of our clinical molecules are active and right now our goal in the course of this year next year is to have multiple registration studies are ongoing.

And to build on the prospects of these molecules to get them to patients as quickly as possible.

Thank you and next question comes from Don Miller Your line is open.

Scott Koenig: Hi guys, thanks for taking my question and congrats on all of the progress. I guess after the AACR presentation on flotatuzumab and the T53 genotyping observations you made there, are you still focused on the refractory population, or is there a space for a genotype-defined population? Can you get a larger population by going for TP53 mutant patients as opposed to simply refractory populations? Great question,

Hi, guys. Thanks for taking my question and congrats on all of the progress.

I guess after the HCR presentation and put it to them in a in the typically three beautiful typing observations you made there or are you still focused on the refractory population or is there a states for a Geo said defined population. You know is it is it better I can you get a larger population but going.

Or TPP TB TPP mutant patients as opposed to simply refractory population.

Great question John has at this point it out P 53 is about 10% overall the population.

Scott Koenig: As has been pointed out, P53 is about 10% overall of the population. As I pointed out today, that's a subset of refractory patients. These are probably the most refractory.

As I pointed out today, that's a subset of refractory patients. These are probably the most refractory and given that we saw in house study so far as reported about a 40% response rate in this particular population, we're very excited that even in the most refractory population.

Scott Koenig: And given that we saw in our study so far, as reported, about a 40% response rate in this particular population, we're very excited that even in the most refractory population, we're seeing a good response. So our goal is to actually treat the entire refractory population, which we think at the minimum is at least 30% and could be as much as 50% of the overall AML population. So, in fact, we will not select based on genotype going into the study. Absolutely understandable. I guess another follow-up then for your cash runway, which now reaches into 22, could you provide a little more color on what had to get prioritized out in order to extend the runway that far?

We're seeing up a good response, so our goal is to actually treat the entire refractory population, which we think at the minimum it's at least 30% and could be as much as 50% or the overall and the population so that.

In fact, we will not selected based on genotype and going into the study.

Yes, absolutely a understood.

I guess another follow up then for your cash runway, which now reaches into 22 or could you put it anymore color on on what had to get prioritized out in order to extend the runway that book.

Sure. So I think so we tried to give you a lot of detail here about obviously, a specific programs here and I.

Scott Koenig: So, I think we tried to give you a lot of detail here about, obviously, specific programs here, and I think that, you know, the ability to decide at various trigger points when to advance a program. One of the points we have made previously and as part of our analysis, historically, we would typically look at four, five, or six different tumor types for a given indication. As I pointed out today, for instance, for MGCO-18, we've got to focus in initially on the prostate population with then the ability to expand further. So, again, by narrowing down many of these programs to one or two indications, we were able to actually project considerable savings going forward. That's in part because of the way we were getting to 2022, but there are other things that contributed to that analysis.

I think that.

You know the ability to decide at various trigger points went to advance the program one of the points. We have made previously and as part of our analysis.

Historically, we would typically look at four or five or six different tumor types for given indication as I pointed out today for instance, Brad you see awaiting we've got a focusing initially on the I'd say a population was then the ability to spend from us. So again bye now.

Moving down many that programs to one or two indication.

We were able to actually project of considerable savings going forward. That's in part on the way. We were again just 2022, but there are other things that.

Contributed to that analysis.

That makes perfect sense and I guess, one more a last one then I noticed that unlike many of your peers and perhaps admirably you have been pretty youve neglected to do any work on Kobin yourself.

Scott Koenig: And I guess one more last one then. I noticed that unlike many of your peers, and perhaps admirably, you have been pretty, you've neglected to do any work on COVID yourself. You left that to others.

You you, let's set to others, what's been driving your decision, making there and do you think that youre technology or could be useful in the ongoing been done.

You know what else is very difficult decision for us obviously, we have expertise. Some historically if you go back into the history of the company. We had worked on many different infectious diseases. You know we have an ongoing HIV trial without our outdoor quite specific so it would have been quite easy for us.

Scott Koenig: What's been driving your decision making there? And do you think that your technology could be useful in the ongoing pandemic? You know, that was a very difficult decision for us.

Scott Koenig: Obviously, we have expertise; historically, if you go back into the history of the company, we have worked on many different infectious diseases. You know, we have an ongoing HIV trial with our DARPA-specific, so it would have been quite easy for us to jump into the development side of things. But given such a broad cancer-focused program, we didn't want to remove all the infrastructure and, obviously, the costs that we've now allocated to the seven clinical and multiple preclinical programs to then move them into the COVID-19 initiative, particularly for the development of antibodies or biospecific molecules. Particularly given that we saw that there was an immediate response from very large pharmaceutical companies who had a lot more assets than we did.

The jump into the development side of things, but given with such a broad a cancer focused program. We didn't want to we will all the.

Infrastructure and obviously the cost that we know allocated to the seven clinical and multiple preclinical program to then I'm moving into the covered eight October 19 initiative, particularly for tree for development of antibodies or by specific molecule.

Typically given that we saw that there wasn't any response very large pharmaceutical companies, let a lot more assets than we did.

However, we have reached out to academic investigators who are we will work with in the past.

Scott Koenig: However, we have reached out to academic investigators who we've worked with in the past and have indicated to them that if they have very unusual molecules that could actually contribute, because of our infrastructure with regard to development and manufacturing, we could provide some help down the road. But right now, we're prioritizing moving forward with our cancer molecule.

As indicated to that if they have very unusual molecules that could actually contribute because of our infrastructure with regard to development and manufacturing we could provide some help down the road, but right now we're prioritizing moving forward with our can.

Answer a molecules.

Got it thank you very much.

Scott Koenig: Thank you very much. Thank you, and our next question comes from the line of Stephen Willey. We'll see if your line is open. Yeah, good afternoon. Thanks for taking the questions. I guess, Scott, maybe just kind of given some of the enthusiasm embedded within your commentary around Marge.

Thank you enter next question comes from the line, whom Willey with Stifel. Your line is broken.

Yeah. Good afternoon, thanks for taking the questions.

I guess, Scott, maybe just kind of given some of the enthusiasm.

Embedded within your commentary around margin.

And angio wants three.

I'm just curious if if if that at all makes you restate the with the design of module B.

Scott Koenig: [inaudible] I'm curious if that at all makes you rethink the design of Module B. I guess, specifically, just given that you're looking at, you know, the Insight PD-1 there and the Buy Specific, and obviously, you're, you know, I guess, favorably leveraged from an economic perspective to the Buy Specific here. So I'm just curious as to what your thoughts there are. Could you also maybe just talk a little bit about the lag three expression within gas? Yeah, so with regard to the design of Module B, remember the complexity of mahogany, the single-arm study was intended, a single-arm study intended for a subpopulation for accelerated approval. And with our agreement with the FDA, part of the design of Module B was going to be confirmatory to have the O-12, which is retafamilumab, which is called retafamilumab now, as a second study, even though it was designed with chemotherapy for confirmation. So right now, the plan is to continue with Module B enrollment; as we've said, ZAI is moving forward with enrollment in China later this year.

I guess, specifically just given that you're looking at you know the the insight PD, one there and the bi specific and obviously your.

I guess favorably levered from an economic perspective to to the bi specific here. So just curious as to what you're stops there are and and.

Can you also maybe just talk a little bit about lag three expression within gastric cancer.

Yeah, so with regard to what the design of module B.

Remember the complexity of Ah mahogany. The single arm studies was intended to a single arm study intended for sub population for accelerated approval and with our agreement with the FDA part of the design of the module will be.

What's gonna be confirmatory, Oh, so have a the oh the old 12, which is rather uptime about what's causing the problem that now and they a second study.

Even though with design a with chemotherapy for confirmation. So right now the plan is to continue with the module, we enroll into that as we've said Xively is moving forward for enrolling in China. Later this year, we will then follow up with that.

Scott Koenig: We will then follow up with that. As we get more experience with combinations of 13, remember, as I said, we just have a little over a dozen patients with a combination that caused multiple different tumor types. And again, wait for ASCO to see the specifics there. I think there is an opportunity both to execute on the mahogany study and to do a very focused, well-designed study of MgD O-13 with MARCH in a broader number of indications. So right now, we're still in the discussion phase on how we will move forward, and obviously, we'd like to see additional data. Obviously, we want to see how long these responses last, but the initial data is very encouraging to us. Is there anything you can say about Lag 3 expression on gas? Yeah, I mean, it's not the highest, but there's a significant difference. I don't recall the exact numbers.

As we get more experience with combinations of 13 remember.

As I've said, where we just have a little over a dozen patients with a combination which of course multiple different tumor types of again wait for ASCO to see.

The the specifics there I think there's an opportunity both to execute on the mahogany study and to do a very salty as well design study.

MTV old surging with March in Borden number of indication. So right now we're still in this discussion stays on how we will move forward. It obviously like to see additional data clearly we want to see how long these responses less but the initial data is very encouraging to us.

So just trying to beat and say about like three expression on gastric cancer.

Yeah, I mean, it is it's not the highest but there are significant I don't recall the exact numbers I think our data was higher in the subset of.

Scott Koenig: I think our data was higher in the subset of the specimens we've looked at compared to what's been out in the literature, but it was significantly over 50% of the population. That's helpful. You just talked a little bit about some of the, That's been... taken here in an effort to extend cash runaway. Can you maybe just speak a little bit to the assumptions regarding the underlying collaborative payments that are embedded within the runway guidance, I guess specifically as to whether or not that includes some kind of regulatory payment from Insight as a result of an MGA-12 approval. Thank you. So, we can't give you the granularity of the timing of payments and the type of payment.

[laughter] specimens, we've looked at compared to what's going out in the literature, whatever it was a significantly over 50% of the of the Oh the population.

Okay. That's helpful and then.

Just lastly, you just talk a little bit about some of those the privatization that's been.

That's been.

Ah taking your in an effort to extend cash runway Kim.

Can you, maybe just speak a little bit to the assumptions regarding the underlying collaborative payments that are.

Embedded within the runway guidance, I guess, specifically as to whether or not that includes some kind of regulatory payment from inside as result of although.

But on June 12 approval, it's like you yeah.

So we can't give me the granularity of funds the timing of payments and the type of payment and obviously we have imposed.

Scott Koenig: And obviously, we've imposed what I think is a very conservative evaluation of expectations with regard to that, just to give you, again, context to refresh your memory, just the regulatory and approval milestones, amounts of $405 million, that's obviously across several indications in different territories. But given where I know the programs are, as I pointed out today, that the anal study is fully enrolled, there are, as I said, five registration-enabling studies We think that we expect some significant milestones coming from that. That's part of our calculation. But that's not by itself the decider on how we got to 2022. Steve, this is Jim.

Hey, what I think is a very conservative.

About valuation of the of expectations with regard to that just to give you again context to refresh your memory, just the regulatory and approval milestones amounts of $405 million, that's obviously across.

Several indications in different territories, but and given.

Where I know the programs are as I pointed out today that the a animal study is fully enrolled there as I said five registration enabling studies ongoing.

We think that.

We expect a significant milestones coming from that that part of our calculation.

But that's not by itself the desire on how we got to 2022.

Got it thanks for taking my questions. Dave. This is Jim keep in mind also that our agreement with prevention bio enables us to achieve a $60 million milestone upon the potential PLM approval of to place a map now in our mom and by the way that molecule has breakthrough designation status.

James Karrels: Keep in mind also that our agreement with Prevention Bio enables us to achieve a $60 million milestone upon the potential BLA approval of Tiplizumab. Now, in our model, and by the way, that molecule has breakthrough designation status, and they expect to complete the submission of the BLA sometime this year, I think in the fourth quarter of this year. Now, we take that $60 million and we haircut that, and I think you will find that we haircut that fairly significantly just to reflect some risk.

They expect to complete the submission of a B.L.A. sometime this year I think in the fourth quarter. This year now we take that $60 million and we have cut that I think you find that we have got that fairly significantly just reflect some risk. So we try to do this very conservatively and we were constantly updating the probability to sign.

James Karrels: So we try to do this very conservatively, and we're constantly updating possibilities assigned to the various milestones across the portfolio to get a real-time sense of where we are. Appreciate the thanks to CollegeHip. Thank you. And our next question comes from Esther Darout of Guggenheim. Your line is open.

And to the various milestones across the portfolio just to get a real time sense of where the numbers might be.

Understood appreciate the.

Extra culture. Thanks.

Thank you and our next question comes online and they're they're all Guggenheim. Your line is open.

Great. Thanks for taking a question. This the proposal I guess my first question is they didn't so any question corridor of before or Oh on nine.

Scott Koenig: Great. Thanks for taking the question. There are a couple.

Scott Koenig: I guess my first question is, so in the extension cohort for 019, patients on prior therapy, you know, with combinations of PD-1 and CTLA-4 look like they're being excluded. I guess based on the data that you're seeing, do you see this as more positioned for PD-1 naive or some sort of refractory population? And I guess the second question, you know, if any read on whether or not you started to see some additivity for flutatuzumab and PD-1 at the 300 nanograms per kg dose in the study. So with regard to whether we're targeting the nave or refractory population, the patients that were included in the study included both. So I think that, in fact, MgD019 could be address Obviously, we need a lot more experience with larger numbers because all we have right now is a limited data set without any significant—without expansion in particular tumor types.

Patients on therapy, you know with combinations of PD, one city early for it looks like they're being excluded I guess based on the data that you're seeing do you think this is more position for PD, one naive or PD on sort of refractory population and I guess.

Second question.

Any read on whether or not you started to see some additivity corporatism Babin PD one at the 200 net of grams per keurig bills on the study that was sort of stopped.

Yeah, so with regard to whether we're targeting the naive or refractory population.

The.

Patients that were included in this study included both so I think that in fact.

Mgo 19 of could be.

Addressable for both population, obviously, we need a lot more experience in large numbers because all we have right now is up a limited dataset without a significant live without expansion in particular tumor types.

Scott Koenig: But again, we'll provide more data later this year on this molecule. But at this point, we think both populations could be served by this as a monotherapy by itself or in combination with other drugs to enhance immune reactivity. With regard to the combination of flotatuzumab plus retrofinalmab, we just had too few patients that were enrolled in the study to come to any conclusion. You know, when you see enhanced responses in a single or two patients, it's hard to interpret. So it is just too early to say.

Again who'll provide.

More data later this year on this molecule, but at this point, we think both populations or could be serviced by of this as a monotherapy by specific or in combination with other drugs to enhance.

Immune reactivity with regard to the.

Combination of flows in season that plus.

Revert back on a we're just not too few patients that were enrolled in this study the come to any conclusion.

You know when do you see enhanced hey responses in a single or or two patients. It's hard to interpret so just too early to is just say I would say, though that.

Scott Koenig: I would say, though, that our analysis historically with regard to the upregulation of PD-L1 in patients treated with a single cycle of flotatuzumab has been quite consistent. I also should note that the study by Sergio Rotella, given that the immune environment favors that of treatment with flotatuzumab, which includes activation of checkpoint molecules, it seems quite natural that some combination of this would benefit a subset of So we will continue to explore that combination in the future, as I noted. Thanks, Scott.

Our analysis.

Historically with regard to the Upregulation of PDL one.

In patients treated with a single cycle uploaded to the that it's been quite consistent I also have should note that the study by searching rotella given that the immune.

Environment Savers that Oh treatment with plugged in to that which includes activation of checkpoint molecule.

It seems quite natural that some combination of this would benefit certainly a subset of patients. So we will continue to explore that combination in the future as I noted.

Thanks Scott.

Thank you enter next question comes on the line at Tommy truly California now.

Scott Koenig: Thank you. And our next question comes from the line of Jonathan Chang. Your line is now open. Hello, team. This is John Baradon on behalf of Jonathan Chang.

Hello team this is John paradigm for Jonathan.

Scott Koenig: My first question is, you mentioned that you have not reached a maximum tolerated dose for MGD-013 yet. How did you choose the dose that you're treating with, and what confidence do you have that it is the correct dose, given the high levels of dose that you're able to achieve? Thanks for that question. Obviously, as for many checkpoint molecules, you often don't reach a maximum tolerated dose. So what we look for is pharmacokinetics, occupancy of various receptors, and we pick the dose based on that and, obviously, have integrated the safety profile as well. So, what I can say is, as pointed out earlier, this is a well-behaving molecule. It has very nice pharmacokinetics and, again, a good safety profile comparable to that of anti-PD-1 treatments. So that's how we're picking the dose. Got it?

My first question is are you mentioned that you have not reached a maximum tolerated dose for every deal one through yet.

How did you choose the joke that does that you're treating with and all companies to do you have that it is the correct those.

Given the the high dosing the high levels of does that you're able to achieve.

So thanks, Pat answer that question, we obviously have so many checkpoint molecules off and you don't reach a maximum tolerated dose.

So while we look for his pharmacokinetics.

Occupancy of various resets, there's and we picked the dose based on that and obviously that's integrated.

The safety profile as well.

So what I, what I can say is as pointed out earlier. This is a well behaving molecule. It has a very nice pharmacokinetics and they again, a good safety profile comparable to that of anti PD one treatments, so and that's how we're picking the.

Yes.

Got it for MGC zero, one it's a you mentioned the interest in moving forward and prostate cancer could you just remind us the expression levels of piece of an age three.

Scott Koenig: And for MGC018, you mentioned the interest in moving forward in prostate cancer. Could you just remind us the expression levels of B7H3 in prostate cancer and any potential strategy to select for biomarker expression in that patient population? As you know, as we pointed out previously, B7H3 is highly expressed in most solid tumors, and in particular, prostate. Almost all prostate specimens, both primary tumors as well as metastatic tumors, have very high levels of B7H3.

In prostate cancer, and any potential strategy to select for biomarker expression.

In a patient population.

As you know as we pointed out previously B seven Athree, it's highly expressed on most solid tumors and in particular prostate almost all of prostate specimens both a primary tumors as well as metastatic tumor has very high levels of each other names.

Ah ha three so we do not expect the need of particularly for prostate cancer.

Scott Koenig: So we do not expect the need, particularly for prostate cancer, to actually require any diagnostic. Obviously, we will analyze that mostly retrospectively once patients are in the study to see if there is any gradation based on relative levels of expression, but we don't expect that to be an impediment. As you know, we have collaborated on another B7H3 molecule called linovituzumab as a neoadjuvant treatment in an IST study with Johns Hopkins, who have previously shown that giving inovituzumab in patients with primary prostate cancer before they had resection of their prostate had a very nice localization of inovituzumab in the tumor, and this was also associated Great. Thank you. And one more, if you don't mind.

To actually require any diagnostic obviously, we will analyze that mostly retrospectively.

First patient during this in the study to see if there is any gradation based on a relative levels of expression, but.

We don't expect that to be an impediment as you know we have had a collaboration on another be something they see molecule flipping over to them that as the neoadjuvant treatment in a highest t. study with Johns Hopkins.

Who have previously shown that giving them a number to use a mass in patients with primary prostate cancer before they have you section of their Pos they.

Had a very nice localization of another to them out in the tumor and this was also associated with an increase of inflammatory cells in a tumor which is typically very cold.

So we believe that both molecules may have.

Opportunities to be use in various settings for prostate and other tumor types.

Great. Thank you and one more if you don't mind.

Scott Koenig: Of course, the data for the overall survival of margituximab is still coming in, but do you have an expectation of what setting you might like to present the final overall survival data, be it a conference or a press release? Well, obviously, this is an important event for the company, so we will certainly make a press release when the data is available, but certainly, we will present the final data at a conference. It all depends on when the data comes in, but it probably would be too early for San Antonio Breast.

Of course, the data for the overall survival of merger talks have is still coming in.

But do you have.

An expectation of what setting you might like to present the final overall survival data.

The at a conference or press release.

Well, we obviously this is an important event for the company. So we will certainly press release when the data is available, but certainly we will present the final data I'm at a conference. It all depends on when the data come then.

It probably is would be too early for San Antonio breast, it's possible, but more likely some us.

Scott Koenig: It's possible, but more likely at some scientific conference next year. Got it. Thank you. Thank you. And our next question comes from Tom Schrader. Your line is open. Good afternoon.

Scientific conference next year.

Got it thank you.

Thank you and our next question comes coupon Screener. Your line is helpful.

Good afternoon. Thanks for all the details of a back to the ODAC panel.

Scott Koenig: Thanks for all the details. Back to the ODAC panel. So do you expect the driving force there is the small subset of patients that seem to have done worse? And also, and I apologize; this was asked, if you in fact get the hints that you're going to get approved for a subset, does that change your launch timing? With regard to the second, no, that doesn't change anything in that regard. As we have indicated before, we think that having at least a research-based diagnostic for selecting patients based on their CD16 allele would be valuable for selecting patients that may be best helped by the drug. I wouldn't actually characterize this as a driving subset being worse, which is the 15% of the VB population. As we've pointed out numerous times, we think that the worst response in that population may be a combination of differences. One problem is that it was a very small subset.

So do you expect the driving force there is the small subset of patients that have seemed to have done worse and also what and I apologize this was that.

If you in fact get the hints that you're going to get approved for a subset does that change your launch timing.

With regard to live with regard to the second know that doesn't change anything in that regard as though we have indicated before.

We think that I'm, having a lease they research base.

Diagnostics for.

Selecting patients back based on there's T 16, a wheel would be valuable for selecting patients than maybe best helped by far the drug.

I wouldn't actually characterized this is a thriving subset being worse, which is the 15% of the bebe population as we pointed out this numerous times.

Well, we think that the the worst response in that population, maybe a combination of a severances. One is is that it was a very small subset I'm. So just from the randomization patients were not select is based on the CD Sixteena legal.

Scott Koenig: So just from the randomization, patients were not selected based on a CD16 allele. And so, as we have pointed out and was pointed out by Hope Rugo at the San Antonio breast meeting, many of the characteristics of the randomizations seem to favor the trastuzumab VB population compared to the margitoximab population, and that's just the randomization that goes with a very small population. So at this point, given that there's no statistical significance to that, while there was clearly a numerical trend that TRAS was working better in the VB population, we hope that the study gets approved on intent to treat, but if the FDA does agree and ODAC agrees to limit us to the F allele, we would not be unhappy, and we will be prepared to provide the support via a research diagnostic at the time of that launch, which would not Thanks.

And so as we have pointed out and was pointed out by hope Rugo Atas, San Antonio breast, meaning.

Many of the characteristics for randomization.

[noise] seem to favor the trust Susan that TV population compared to the margin Tonight population and that's just the the randomization that goes with a very small population. So at this point given that there's no statistical significance of that.

While there was clearly a numerical trends that traffic was working better in as easy population. We hope that the study gets approved on intend to treat but if the FDA does agreeing ODAC agreed the limit us to the at folio.

We would not be unhappy and we will be prepared us to provide the support via a research diagnostic at time of that launch which would not be delayed.

Okay, great. Thanks, and then quickly on the ahwahnee prostate cohort.

Scott Koenig: And then quickly on the 018 prostate cohort. Are you going to try to get patients before chemo? Because I assume that's kind of where you would like an ADC to be slotted?

Are you going to try to get patients before chemo because I assume that's kinda would where you would like an 80 seem to be slaughtered or will you have to treat later line patients in this next cohort.

Well you know as you know time the beauty.

Scott Koenig: Or will you have to treat later-line patients in this next cohort? Well, you know, as you know, Tom, the beauty of such a molecule as we're describing, you know, post-taxing and post-androgen blockers, there's very little after those. And as a result, we actually think to start with a very late-line population, which is, these patients were, in fact, that population; most of these patients had extensive bony disease. I mean, in fact, all the patients had bony disease, so this might be a very good first indication. But clearly, there could be opportunities to go earlier in line, and as I pointed out in an earlier question, there also is an opportunity, as we pointed out, to treat in neoadjuvant settings various B7H3 targeted agents, which could be inoblatuzumab, it could be ATEEN, and it could be other things that we'll talk about in the future. Yeah, got it.

Such a molecule as we're describing.

You know post taxing and post the androgen blockers.

There's very little up after those and as a result, we actually think I'm just start with a very late line population.

Which.

These patients were in fact that population most of these patients had extensive bone disease.

I mean fact rotation that Bali disease that this might be a very good first indication, but clearly them there could be opportunities to go earlier, why and then as I pointed out on an earlier question you're also as an opportunity as we pointed out is.

Treating in Neoadjuvant settings.

Various be 73 targeted the agents, which could be an overseas than that it could be.

18, and it could be other things that will talk about in the future.

Yeah got it okay. Thank you.

Thank you enter next question comes from the line.

Scott Koenig: Okay, thank you. Thank you. And our next question comes from the line of Evan Zagerman. Your line is open. Hi, Scott.

And then he really your line is still thing.

Hi, Scott. Thanks for taking my question Hope you all are well so just on M. Judy's your own I know you kinda provided through really preliminary data.

Scott Koenig: Thanks for taking the question. I hope you all are well. So just on MGD-019, I know you kind of provided some really preliminary data on some responses. Can you give us any color as to any thoughts on the duration of those responses and also what type of tumors are in the mix and how advanced are these patients? I know you don't want to provide all the data, but any more color on that data would be super helpful. So rather than characterize the detail here, let me say that the four responders we alluded to were four different tumor types. These were all very late-stage patients and very interesting responses, including tumor types you would not expect, not your traditional populations of renal cancer or patients with melanoma. These were distinct populations.

On some responses can you give us any color as to any thoughts on duration of those responses and also what type of tumors are in the mix and how advanced are these patients I know you don't want to provide all the data, but any more color on that data would be super helpful.

So rather than I'd characterize detailed here, let me say that on the four responds in food we alluded to were four different tumor types. He's we're all very late stage patients.

Very interesting responses in including a tumor types you would not expect up your traditional.

Populations of renal cancer or patients with melanoma these where.

Assisting population again numbers a small but this affairs truth. This is a very exciting opportunity for this drug.

Scott Koenig: Again, the numbers are small, but if this bears fruit, this is a very exciting opportunity for this drug. Okay, and then do you plan to dose beyond the three milligrams per kilogram? I know you said or greater, but are we going to get, how high do you think you'll go with that?

Okay, and then do it do you plan to dose beyond the three milligrams per kilogram.

I know you said or greater but are we gonna get how high do you think you'll go with that.

Again not to 'em, we pointed out that we gave the result of three milligrams or higher we got to our top dose of ready, which is quite considerably higher right now based on the pharmacokinetics.

Scott Koenig: Again, we pointed out that we gave results of three milligrams or higher. We got to our top dose already, which is quite considerably higher. Right now, based on the pharmacokinetics and, again, occupancy and things that we're discussing and obviously looking at the safety profile in a larger data set, clearly, the dose will be higher than three mgs per kit, but we haven't made a decision yet about what the final dose

And again occupancy and things that were discussing and obviously I'm looking at the same safety profile in the large dataset then the clearly the.

So this will be higher degree days per kit, but we haven't made a decision yet what the final dose is well we should have that by the time, we have a public presentation later this year.

Scott Koenig: Well, we should have that by the time we have a public presentation later this afternoon. Okay, and then just can you remind us, aside from head and neck, any other tumor types that can be targeted with, you know, an anti-B7H3 like enlatuzumab? And I'll put two things in there. I'm sorry.

Okay, and then just can you remind us you know aside from head and neck any other Tom tumor types that can be targeted with you know and anti b seven athree like I know well to them out.

I know, but plasma learning.

So again as I pointed out be Sevenx three is highly expressed the most solid tumors. If you remember the data we presented at CITC.

Scott Koenig: So again, as I pointed out, B7H3 is how to express the most solid tumors. If you remember the data we presented at SITC, we highlighted not only the head and neck of patients; we were very excited about the prospects of combining an AMP PD-1 with Oblituzumab in patients with lung cancer who are PD-L1 negative. So again, the prospects of such a molecule here could be pursued in other tumor types like lung cancer and others, which we will point to going forward. All right. Thank you so much for the call. I appreciate it. Thank you. And our next question comes from the line of four speakers. Your line is now open.

We highlight not only that net of patients. We were very excited about the prospects of combining and anti PD, one with inovas use of that in patients with lung cancer, who are PDL one negative. So again the prospects ahead of us such.

Thank you here I couldn't be pursued in other tumor types like lung cancer, and others again, which we will point to going forward.

Alright. Thank you so much for the color I appreciate it.

Thank you enter next question comes on the line of Sports Peter Your line is helpful.

Hi, this isn't the on for Brian. Thank you for taking my questions and just a quick one penny regarding market like regarding my technology.

Scott Koenig: Hi, this is Cynthia on behalf of Boris. Thank you for taking our questions. Just a quick one for me.

Scott Koenig: Regarding Mark Hucknab, are there any updates around Xylabs' registrational study in greater China, especially in light of COVID-19 enrollment? And then can you remind us whether the study is also looking at the 158 S allele subset population? So the answer is that they've gotten a regulatory review, and they are initiating studies in the various countries that they have rights to. At this point, given what we understand the circumstances are in China, things are open, and there should not be any deterrence to enrolling in the study. So, as we pointed out, this will occur during the course of this year, but we don't have any details with regard to the specificity of specific patients. All right, thank you. Thank you, and we have a follow-up question from the line of Debjit Chatterpade. Your line is open.

Are there any I think trends I last educational study in greater China, especially in light and cover 19 liquor enrollment and then can you remind us when it does take also looking at the one to date actually all subset population.

So the answer is is that they've done a regulatory review and they are initiating studies in the various.

Countries that they have rights too.

At this point given what we understand the circumstances on China things are all of it and this should not be any deterrent to enrolling that study so.

As we pointed out of this will occur.

During the course of this year, but we don't have any details with regard to a specificity of specific patient yeah.

Hi, Thank you.

Thank you only have a fall.

Question from one of the G. China today your line is open.

[noise] the thanks for squeezing me back in.

Scott Koenig: Hey, thanks for screening me back in. So with regard to the lag 3 expression, um, I don't know if you have the answer to this or not. But have you noticed any difference between patients who are primary refractory versus patients who initially responded? Does lag 3 expression increase over time, obviously, if it's a, you know, escape pathway for PD-1? And it's too early to say that, again, rather than me giving any more details, listen to the ASCO presentation. I think you'll get a lot of new information on that call, but certainly we will have to follow up on dissecting this based on the historical treatment profiles of these patients. But you'll see, certainly, as I pointed out, the relative expression levels of LAG-3 being associated, I can't say it's predictive, but associated with higher expression.

So, let's take us to like three expression I don't know if you have the answer to this or not but have you noticed any difference between patients who are parameter factory versus patients who have initially responded does lag three especially an increase over time, obviously if it if it's you know escape topic for PD one.

And then it's it's too early to say that I again, rather than me, giving annual detailed listen to the ASCO presentation, I think you'll get a lot of new information at that call, but certainly we will have to follow up on sexiness based on the historical.

Well a treatment.

Profiles of these patients but.

You'll see you'll see certainly as I pointed out.

The oh, rather than expression levels of last three being associated I can't say is predicted but associated with higher expression.

Got it thanks, so much.

Scott Koenig: Thank you so much. Thank you, and I'm not answering any further questions at this time. I'd just like to thank everyone again for joining us this afternoon and to let you all know that we look forward to continuing to advance our program in the coming year and providing updates on our progress. Have a nice evening.

Thank you and I'm not showing any further questions at this time.

I just like to thank everyone again for joining us this afternoon and to let you all know that we look forward to continuing to advance our program in the coming here in providing updates on our progress has a nice evening.

Ladies and gentlemen, this concludes todays conference call I will now disconnect everyone have a good thing.

[music].

Good afternoon, we will begin the macrogenics 2021st quarter corporate progress and financial results Conference call and just a moment all participants are in a listen only mode. At the moment, we will conduct a question answer session.

Operator: Ladies and gentlemen, this concludes today's conference call. You may now disconnect. Everyone have a good day. The Ultimate Parody Site!

Anna Krasavskaya: .., www.mercierfilms.ca www.mercierfilms.ca www.mercierfilms.ca [inaudible] Good afternoon, we will begin the MacroGenics 2020 first quarter corporate progress and financial results conference call in just a moment. All participants are in a listen only mode at the moment, and we will conduct a question and answer session at the conclusion of the call. At this point, I will turn the call over to Anna.

Version of the call at this point I will turn the call over two and like I said.

Anna Krasavskaya: Krasovka, Vice President, Investor Relations, and Corporate Communications of MacroGenics. Good afternoon, and welcome to the MacroGenics conference call to discuss our first quarter 2020 financial and operational results. For anyone who has not had a chance to review our results, we issued a press release this afternoon outlining today's announcement, which is available under the Investors tab on our website at macrogenics.com. You may also listen to this conference call via our 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 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. However, actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factor section of our annual, quarterly, and current reports filed with the SEC

So Scott Vice President Investor Relations, and corporate Communications and Michael Jackson.

Thank you good morning, good afternoon, and welcome to the Macrogenics conference call to discuss our first quarter Twentytwenty financial and operational results for anyone who has not had a chance to review our results. We issued a press release. This afternoon outlining today's announcement, which is available under the investor tab on our website macrogenics.

Scott Koenig: 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. Thank you, Anna.

Oh, you might also listen to this conference call via our webcast on our website.

Where it will be archived for 30 days beginning approximately two hours after the call. It completed 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 purposes of the safe Harbor provisions under the private Securities Litigation Reform Act Mike.

He 95 actual results may differ materially from those indicated by these forward looking statements as a result of various important Boston, including those discussed in the risk factor section of our annual or quarterly and current reports filed with the FCC. In addition, any forward looking statements represent our views only as of <unk>.

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 changed except to the extent to required by applicable.

Now I'd like to turn the call over to Dr., Scott <unk>, President and Chief Executive Officer, Oh Macrogenics.

Thank you.

Scott Koenig: I'd like to welcome everyone participating via conference call and webcast today. Given the ongoing COVID-19 pandemic, it goes without saying that I hope all of you, as well as your family members, will stay. Thank you for joining us. This afternoon, I will provide an update on our clinical programs and the data expected during the year. But before I do so, let me first turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer, who will review our financial results for the quarter.

I'd like to welcome everyone participating via conference call a webcast today.

Given the ongoing overnight.

It goes without saying that I hope all of you what was your family members will say.

<unk>.

This afternoon, I will provide an update on our clinical program and the data expected during the year.

Before I do so let me first turn the call I'm going to jump Carol Senior Vice President and Chief Financial Officer, or you are financial results for the quarter.

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

James Karrels: We have recorded total revenue consisting primarily of revenue from collaborative agreements of $13.7 million for the quarter ended March 31, 2020, compared to $9.7 million for the quarter ended March 31, 2019. This increase was primarily due to revenue recognized for manufacturing services under the Clinical Supply Agreements with Insight and Xilab, as well as milestone payments under the Xilab Agreement for clinical trial initiations in Greater China. We recorded a net loss of $44.7 million for the quarter ended March 31, 2020, compared to a net loss of $45 million for the quarter ended March 31, 2019. And finally, our cash, cash equivalents, and marketable securities as of March 31, 2020 were $170.8 million, compared to $215.8 million. $1.8 million as of December 31, 2019.

Described in our release Macrogenics had research and development expenses, a $48.9 million for the quarter ended March 31, 2020 compared to $47.1 million for the quarter ended March 31 2019.

We have recorded total revenue consisting primarily of revenue from collaborative agreements of $13.7 million for the quarter ended March 31 2020.

Compared to $9.7 million for the quarter in March 31, 2019.

This increase was primarily due to revenue recognized for manufacturing services under the clinical supply agreements with insight and silo out as well as milestone payments under the design lab agreement for clinical trial initiation in greater China.

We recorded net loss of $44.7 million for the quarter ended March 31, 2020, compared to a net loss of $45 million for the quarter ended March 31 2019.

Finally, our cash cash equivalents and marketable securities as of March 31, 2020 were $170.8 million compared to 215.

Point $8 million as of December 31, 20 Nike.

We anticipate that our cash cash equivalents in marketable securities as of March 31, 2020, combined with anticipated potential collaboration payments should now enable us to fund our operation into 2022, assuming our programs and collaborations advances currently contemplated we previously guided.

James Karrels: We anticipate that our cash, cash equivalents, and marketable securities as of March 31, 2020, combined with anticipated and potential collaboration payments, should now enable us to fund our operations into 2022, assuming our programs and collaborations advance as currently contemplated. Previously Guided into 2021, extension was made possible through several factors, including our program prioritization. Now I'll turn the call back to Scott.

It did 2021. This extension was made possible through several factors, including our program prioritization efforts and now I'll turn the call back to Scott.

Thank you Jim we're encouraged by the progress in clinical activity that we continue to observe across our broad portfolio, a seven antibodies based product candidate.

Scott Koenig: Thank you, Jim. We are encouraged by the progress in clinical activity that we continue to observe across our broad portfolio of seven antibody-based product candidates and anticipate presenting clinical data from all these molecules this year. While we expect some near-term impact on clinical trial site initiation and patient enrollment due to the unprecedented challenges posed by the COVID-19 pandemic, we have not changed our guidance for the timing of key anticipated 2020 clinical data readouts or regulatory events. I will now report it to the man, our investigational bi-specific CD123 by CD3 dark molecule. During a plenary session at the virtual AACR annual meeting held last week, Dr. Sergio Rutella presented translational data suggesting that TP53-mutated acute myeloid leukemia, or AML, was correlated with an immune-infiltrated tumor microenvironment in the bone marrow, which, as previously reported, predicts and was, in fact, associated with response to, This new analysis, built on prior data by Dr. Ritella, presented at ASH last year, showing the same immune signature was associated with a lack of response to chemotherapy, or with a response to pleurotuzumab immunotherapy, in the ongoing phase one, two dose expansion study.

Anticipate presented clinical data from all these molecules this year.

Well, we expect some near term impact on clinical trial site initiation and patient enrollment due to the unprecedented challenges posed by the comment I'd band.

We have not changed our guidance so the timing of key anticipated 2020 clinical data read outs or regulatory that.

I will start reported to them that our investigational Biospecifics GT 1003 by Tdthree Dart molecule.

During a plenary session at the virtual HCR annual meeting last week after surgery I can tell accept the translational data, suggesting that TV 73, mutated acute myeloid leukemia or AML, though that's correlated with an immune infiltrate the tumor micro environment and the bone marrow, which.

As previously reported predict and was in fact associated with response the quota student.

There's no one else is built on prior data by Dr. Thomas presented at Ash last year, showing the same immune signature was associated with a lack of response to chemotherapy or whether responsible for the to the map immunotherapy and the ongoing phase one or two dose expansion study.

Separately, we are scheduled to meet with the FDA in the coming we became feedback on our plan registration Pat do you asked for holiday season that for the treatment of patients with and now we're refractory to induction treatment defined as primary induction failure or P. I asked patients and patients who relapsed within.

Scott Koenig: In addition, we are scheduled to meet with the FDA in the coming weeks to gain feedback on our planned registration path in the U.S. for Clotetuzumab for the treatment of patients with AML who are refractory to induction treatment, defined as primary induction failure, or PIF, patients, and patients who relapse within six months of initial response. We intend to share these plans with you before the end of the second quarter. Of the approximately 20,000 patients diagnosed with AML in the U.S. annually, at least 30% fail to achieve a complete response with intensive induction therapy. These AML patients have a poor prognosis and limited options to treat this particularly challenging disease. We expect to present updated data from the ongoing expansion study of flood issues in this AML population in the second half of 2020. Meanwhile, separately, we stopped enrollment in an ex-U.S.

Six months of initial response.

We intend to share these plans with you before the end of the second quarter.

Approximately 20000 patients diagnosed with and on the U.S. annually.

30% failed to achieve a complete response with intensive induction therapy.

No patients are the poor prognosis with limited options to treat this particularly challenging disease.

We expect to present updated data from the ongoing expansion study apologies.

In the same male population in the second half of 2020.

Separately, we stopped enrollment and then ex US assays. Once you study combining quite as do the math.

Scott Koenig: Phase I-II study combining Clotetuzumab with retophanolamide, an anti-PD-1 molecule also known as MgAO-12, in patients with relapsed or refractory AML. This decision followed the successful completion of the first planned dose escalation cohort of 300 mg per kg per day of Clotetuzumab plus 3 mg per kg of retophanolamide We plan to resume the study at U.S. sites in the future. Now, I would like to turn to the clinical abstracts that have been selected for presentation at the upcoming ASCO annual meeting that will be held virtually at the end of May. The first is an oral presentation covering dose escalation and select expansion cohorts from the ongoing Phase I study of MgDL-13, our investigational bispecific PD-1-bilact-3 dark molecule. The overall safety profile of MgTL13, as it relates to immune-mediated toxicity, is generally consistent with anti-PD-1 molecules with respect to event type and frequency. We have not yet identified a maximum tolerated dose.

So, let Matt and anti PD, one molecule also known as as well.

Patients with relapsed or refractory M., though this decision follow the successful completion of the first class dose escalation cohort of 309 grams for kids today for the season.

Well its remix procure a renaissance.

I was not today safety farming or lack of activity we plan to resume the study a U.S. sites in the future.

I would like to turn to the clinical abstracts that have been selected for presentation at the upcoming ASCO annual meeting that will be held virtually at the end of May.

The first is an oral presentation covering dose escalation and select expansion cohort on the ongoing phase one study of MTO 13, our investigational by specific PD, one by lack breed dart molecule.

The overall safety profile of NGL 13, as it relates to immune mediated toxicity is generally consistent with anti PD, one molecule with respect to events high frequency.

We have not identify the maximum tolerated so.

Tumor specific expansion cohorts of being treated that apply those of 600 milligram. Once every two weeks.

Scott Koenig: Tumor-specific expansion cohorts are being treated at a flat dose of 600 milligrams once every two weeks. Among these valuable patients, we are observing activity of MGD-013 across expansion cohorts in several tumor types, including after anti-PD-1 therapy, which warrants further investigation. While expression of LAG-3 or PD-L1 was not criteria for study entry, high LAG-3 expression on archival biopsy tissue seems to associate with response to MgDL3 demyelotherapy.

Among evaluable patients we are observing activity of NGL 13 across expansion cohorts in several tumor types, including after anti PD, one therapy, which was further investigation.

While expression of like three or PDL, one we're not criteria for study entry how are you likely expression on archival biopsy tissue seems to associated with response to MGT out there do you monotherapy.

Scott Koenig: We are also conducting further translational work into other potential correlative biomarkers. Because we noted that Marga Tuxomab, our investigational ST-engineered monoclonal antibody targeting HER2, enhances lag-free expression on effector cells, we initiated an expansion cohort for a combination with MgdO13. Most notably, and as you will hear more about at ASCO, in a cohort of over a dozen valuable patients with advanced HER2-positive tumors treated with a combination of MgDL13 and margituximab, we observed confirmed and unconfirmed objective responses in excess of 40%. All responders remain on therapy.

We're also conducting further translational work into other potential Carlo Biomarkers.

The courts, we noted that margins talks about our investigational SPX yet on what anybody it's hardly heard to enhance his lastly expression on a factor. So we initiated an expansion cohort Rick combination with NGL 13.

Most notably and as you will hear more about I'd ask though in a cohort of over a dozen valuable patients with advanced her two positive tumors treated with a combination of NGL third margetuximab, we observe confirmed and I confirmed objective responses in excess of 40%.

All responds remain on therapy, we're very encouraged by this observation that we believe represents synergistic activity in the two molecule based on our results in monotherapy study.

Scott Koenig: We are very encouraged by this observation, which we believe represents synergistic activity of the two molecules based on our results in monotherapy studies. For additional context, published data indicate that responses among HER2-positive breast cancer patients treated with trastuzumab plus anti-PD-1 or anti-PD-L1 antibodies are 0% among PD-L1-negative patients and 15% among PD-L1-positive patients. Given this strong early efficacy signal and favorable safety profile, we expect to prioritize the combination of MgpO13 and margituximab for further development. We believe that the combination of FDA engineering and dual checkpoint blockade engages both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments.

For additional context.

Data indicate that responses among her two positive breast cancer patients treated with tries to the map, but anti PD, one or anti PD. One antibodies are zero percent among PDL, one negative patients and 15% among PDL one positive patients.

Given the strong early efficacy signal and favorable safety profile, we expect to prioritize accommodation to that 13 and margins talk to that so far this development.

We believe that the combination of FCX, the earning a dual checkpoint blockade gauges, both innate and adaptive immune responses against a broad range of tumors with very tumor microenvironments.

Separately XY lab, our regional partners greater China, essentially to explore NGL 13 in combination with their pipeline assets, including Neuroprotective PARP inhibitor in patients with advanced gastric cancer and derivatives.

Scott Koenig: Separately, Xi Lab, our regional partner in Greater China, is continuing to explore MgTO13 in combination with their pipeline assets, including norepirib, a PARP inhibitor in patients with advanced gastric cancer, and rivivib, a dual-target tyrosine kinase inhibitor of the VEGF-FGF receptors in patients with hepatocellular carcinoma. The second presentation of clinical results at ASCO will be a poster covering initial dose escalation data from the ongoing Phase I study of MGC018, our investigational antibody drug conjugate targeting B7H3. Those escalations, the study is ongoing. Among enrolled patients, the safety profile, which includes hematologic and skin toxicities, as expected, has been manageable. In dose escalation, we have also observed early evidence of clinical activity, especially in patients with metastatic castration-resistant prostate cancer, or MCRPC, with reductions in PSA levels of 50% or more in five of seven patients treated, including one with substantial regression of bone disease.

A dual target tyrosine kinase inhibitor that Jeff FGF receptors in patients with the patent cellular carcinoma.

The second presentation of clinical result that up though will be a poster covering initial dose escalation data from the ongoing phase one study of LNG C. O 18, our investigational antibody drug conjugate targeting disseminates three.

Dose escalation study is ongoing.

Among enrolled patients the safety profile, which includes logic and skin toxicity as expected as been manageable in dose escalation. We have also observed early evidence of clinical activity, especially in patients with metastatic castration resistant prostate cancer or MCR PC.

<unk> reductions of USA levels of 50% or more in five or seven patients treated including one with substantial regression of bone disease.

Scott Koenig: Based on these encouraging observations, we are planning a dose expansion in patients with metastatic CRPC once the dose escalation is completed. The third and final of our clinical presentations at ASCO will be a poster of results stratified by chemotherapy from the Phase 3 SOFIA study of marginal toxomath plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer. A note regarding the timing of the final analysis of overall survival in SOFIA.

Based on these encouraging observation, we're planning a dose expansion in patients with metastatic see RPC once the dose escalation is completed.

No regarding the timing of the final analysis of overall survival in Sofia.

We continue to anticipate reporting quite a lot when she's though and the second half of 2020 pending the accrual of death events needed part of the protocol to conduct the analysis.

Scott Koenig: We continue to anticipate reporting final OS results in the second half of 2020, pending the accrual of death events needed per the protocol to conduct the analysis. As a reminder, the FDA has indicated its plan to schedule an Oncologic Drugs Advisory Committee or RODAC meeting in the second half of 2020 and has a Prescription Drug User Fee Act or PDUFA target action date for margituximab for the treatment of HER2-positive metastatic breast cancer in December 2020. While we are discussing margituximab, beyond breast cancer, we are opening clinical sites globally to enroll patients in the Phase II-III Mahogany Study, evaluating the combination of margituximab and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer. Initially, Mahogany is evaluating marzituximab plus redofanlamab, our investigational anti-PD-1 antibody, licensed insight in patients with HER2, IHC3+, and PD-L1 positive disease.

Separately as a reminder, the FDA has indicated its plan to schedule, a ecologic drugs Advisory committee or ODAC meeting and the second half of 2020 and has a prescription drug user fee. After the Dupont target action date for margin talks about the treatment of her two positive metastatic breast cancer in December 22.

Morning.

While we are discussing margin talk to them.

Breast cancer, we are opening clinical sites globally to enroll patients in the phase two three mahogany study evaluating the combination of margin talk to that and checkpoint blockade as a frontline treatment very fast gastric and gastroesophageal Johnson cancer.

Initially mahogany is evaluating Mark just talk that was ratified.

Our investigational anti PD, one antibody license inside in patients with her two I see.

Yes, and PDL one positive disease.

This single part of the mahogany study, which we referred to as module away is designed to support a potential accelerated approval the margins talks and that was ratified.

Scott Koenig: This single-arm part of the mahogany study, which we refer to as Module A, is designed to support a potential accelerated approval of margituximab plus retifalumab in the U.S. based on a primary efficacy endpoint of objective response rates. I can comment on our initial observations. We have observed objective responses in the first three or four valuable patients treated in the study with this chemo-free regimen. These are very early observations, but they support our optimism around possibilities for margin taxamath in this indication.

In the U.S. based on a primary efficacy endpoint objective response rate.

I can comment on our initial observations we have observed objective responses in the first three or four valuable patients treated on study with this chemo free regimen.

These are very early observations much simpler optimism around possibilities from margetuximab in this indication.

Scott Koenig: As you will recall, we observed responses in approximately 50% of second-line patients with HER2IHC3+ and PD-L1-positive disease in the study of margituximab and pembrolizumab. We expect to report initial data from mahogany module A in the second half of 2020. The second component of the mahogany study, which we refer to as Module B, is designed as a randomized controlled trial to evaluate the combination of margituximab with chemotherapy plus either retifanilamab or MgdO13 compared to trastuzumab and chemotherapy in a broader population of patients with advanced HER2-positive gastric cancer. We expect to first initiate Module B in Greater China in collaboration with our regional partner Briefly discuss where Phalimab Insight plans to present data in the second half of 2020 from their potentially registration-enabling monotherapy study in patients with anal cancer, which is now fully enrolled. Two other monotherapy studies of retophalomab are also ongoing in MSI-high endometrial cancer and Merkel cell carcinoma and could potentially support registration.

You'll recall, we observe responses and approximately 50% of second line patients.

Her two I had C plus and PDL, one positive disease and the study of margin talks and that doesn't have a lesson that we expect to report initial data from mahogany modulating the second half of 2020.

The second component mahogany study, which we referred to as module today, it's designed as a randomized controlled trial to evaluate the combination margin talk from that with chemotherapy, Oh, Tivo retrofit I'm on that or actually know 13 compared to trust isn't that chemotherapy.

A broader population of patients with advanced Hertwo positive gastric cancer.

We expect the first initiate module will be in greater China in collaboration with our regional partner. So I left in the second half of 2020.

To briefly discuss later found that insight plans to present data in the second half of 2020 from there potentially registration, enabling monotherapy study in patients without L. cancer, which is now fully enrolled.

Two other monotherapy study direct effect on.

Our also ongoing and then ESI high endometrial cancer, and Merkel cell carcinoma, I could potentially support registration.

In addition, we expect insight to initiate a phase three study known as podium three or four in patients with metastatic non small cell lung cancer in 22 wanting.

Scott Koenig: In addition, we expect Insight to initiate a phase 3 study known as Podium 304 in patients with metastatic non-small cell lung cancer in 2020. In all, there are currently five registration-directed clinical studies ongoing or planned in 2020 by either company across a broad range of tumor types. Let me next turn to MGD-019, an investigational biospecific PD-1 by CTLA-4 DARD molecule.

And all that are currently five registration directed clinical studies ongoing or planned in 2020 by either company across a broad range of tumor types.

Let me next turn to NGL 19, and investigational by specific PD, one ICICI life for Dart molecule. The dose escalation is ongoing and all comer population with advanced cancer, we have not restricted the studies the tumor types that are known to respond to checkpoint inhibitors.

Scott Koenig: The dose escalation is ongoing in an all-comer population with advanced cancer. We have not restricted the study to tumor types that are known to respond to checkpoint inhibitors. We are currently enrolling patients in additional dose-escalation cohorts with no dose-limiting toxicities observed. Of the 13 evaluable patients treated at doses of 3 mg per kg or greater, we have observed 4 patients across different tumor types, with 3 confirmed and 1 unconfirmed objective responses. We are encouraged by these admittedly very early data and plan to submit results from those escalations of presentations at scientific conferences later this year. Finally, let me discuss Enobla-Tuzumab, our investigational STN-engineered anti-B7H3 monoclonal antibody.

We are currently enrolling patients in additional dose escalation cohort with no dose limiting toxicities observed.

The 13 evaluable patients treated at doses of three milligrams per kilogram upgrader, we have observed for patients across different tumor types with reconfirmed and one on confirmed objective response.

We are encouraged by these admittedly very early data and plan to submit results from dose Escalations presentation at scientific conferences later this year.

Finally, let me discuss ennobled season that our investigational asked me in engineered and maybe seven nicely monoclonal antibody.

Consideration of the current global and domestic Coke is 19 pandemic. The planned phase two study initiation of another season that in combination with checkpoint blockade as chemotherapy free treatment of patients with advanced tighten that cancer will be the way, we expect to provide an update on the timing for initiating this study.

The second half of 2020.

The way to the study does not reflect a lack of enthusiasm for this molecule.

As you can see despite the current global crisis, we continue to expect 2020 to be a data catalyst riskier from Macrogenics.

We would now be happy to address any questions I call. It may have operator.

To ask a question. Please touch Star then one once again at Star one to ask a question.

Operator: To ask a question, please touch star, then 1. Once again, that's star 1 to ask a question. And our first question comes from the line of Christopher Mari with Nomura. Your line is open. Hey, good afternoon, everybody. Thank you for the update. Scott.

And our first question comes from the line of Christopher Omari with Nomura. Your line is open.

Hey, good afternoon, everybody. Thank you for the the update Scott.

Unknown Speaker: Quite, quite extensive. I guess, maybe maybe just to begin with MGC 08. You had highlighted that the heme and the skin tox were as expected and manageable. Could you just elaborate, is that a tox caused by B7H3 engagement, or is that separate from your..., your payload on the PD?

Quite quite extensive.

Yes, maybe maybe just to begin with having GC zero 18, you'd highlight that that highlighted that they seem almost can tell its was as expected and manageable party celebrate that talks caused by.

Seven age three engagement or is that separate from the or.

You know payload on the PTC.

Thanks, Thanks, very much a jackson for the other question obviously, you've got details will be presented at the poster session at ASCO.

The expectations with regard to the Haematological was related to the toxic and the.

The skin observations.

Sure.

Either due to the toxin or.

Due to the targeting a b 783 right now it's.

Scott Koenig: Right now, it's unclear, but as I noted, they are manageable toxins. Okay, great. And then, with respect to Sophia's final book, you know, it sounds like that's going to hit before, you know, a PDUFA decision. How should we think about, sort of, what FDA has expressed to you, or our understanding is that they've expressed to you that an OS result is not necessary in your view, you know, how should we think about, The potential for outcome, on the SOFIA final result with respect to any, Right now, we're continuing to monitor the number of events of death. As I've indicated, this is still expected in the second half of this year. It's very hard to predict with precision when this will occur.

Oh unclear, but as I noted they are manageable toxicities.

Okay, Great and then with respect to Sofias final book It sounds like that's kind of hit before.

Ill up that do file.

Decision.

How should we think about sort of that.

After he has expressed to you or our understanding is that they've expressed to you that.

I know last result is it's not necessary and your view you know how how should we think about.

The potential for outcomes on the Sofia.

Yeah.

Final result, with respect to.

Any.

Approval decision.

[laughter] Jackson, Thanks to the question right now we're continuing to monitor the number of.

Events of debt as I've indicated this is still anticipated.

The second half of this year, it's very hard to predict with precision. When this will occur my expectation. It will be later this year and obviously there has to be some data cleaning. So it may be very close even to the Paducah day when that they would be ready.

Scott Koenig: My expectation is that it will be later in this year, and obviously, there has to be some data cleaning. So, it may be very close to the DUFA date when that data would be ready to present. So, at this point, our plan is to take the second interim analysis for OS and use that as the basis, which has obviously been already provided to the FDA in the BLA filing for evaluation. If any changes occur, we will obviously update everyone at that appropriate time. Great. And then just sticking with margituximab, the mahogany progress looks really exciting with your observed responses in three of four valuable patients. I was just wondering if you could comment on what level of number one durability we expect to see in terms of these responses. How durable are they?

To to present so at this point of our plan is just take the second interim analysis for O S and use that as the basis, which is obviously just ready provided to the FDA seem to be like filing.

For evaluation, if any changes occur we will obviously update everyone.

At that appropriate time.

Great and then just sticking with much touching that the mahogany progress looks really exciting.

With your absurd responses in three or four evaluable patients.

Just wondering if you could comment what what level.

That number winter ability, we expect to see and in terms of these responses a terrible are they how much time have you have you observe import.

And how much will be available at ASCO and then and then two I can previously you had discussed that this could be.

Potentially registrational.

Worthy the module eight what that with a threat response rate as an endpoint in this patient population. So just maybe if you could.

Remind us of your plans with respect to that and maybe what the hurdle might be.

In terms of I, suppose adding more patients to the expansion part of that actually thank you.

So that's a couple of questions. So with regard to the length of duration of response with its still these patients are still on on treatment. So it's still too early to predict or even though these few were few patients what the targeted PFS or.

Scott Koenig: So with regard to the length of duration of responsiveness, it's still, these patients are still on treatment. So it's still too early to predict even in these few patients what the target PFS or OS would be. Just to give you a little context, the median PFS for first-line therapy for the TOGA regimen was 6.7 months, and the OS was 13.1 months.

So it would be just to give you a little context.

The median PFS.

For first line therapy.

For the Telco regiment of 6.7 month, and the or was it was 13.1 month. So our hope is that this will far exceed that with regard to PFS and Oh west with regard to overall response rate, which is the targeted is endpoint.

Scott Koenig: So our hope is that this will far exceed that with regard to PFS and OS. With regard to overall response rate, which is the target endpoint for the single-arm study, just again to recall, TOGA was 47%. Our hope is that this will be north of 50% and use that as a basis for decision. As we pointed out previously, we have said that we should have a sufficient number of data from the initial patients to make a decision whether we are achieving the targeted range that would then encourage us to finish completion of enrollment. And we will plan to update everyone later this year, assuming we continue to enroll at the rate we have been doing at this point. Okay, great. Thank you very much. Congratulations. Yeah, thank you very much. And sorry, I thought the volume was very low. Is that you, Chris?

For the single arm study.

Just to get to recall Togo was 47% of our hope is that this will be north of 50%.

As the use of the basis for decision as we pointed out previously.

We have said that we should have a sufficient number of data from the initial patients to make a decision whether we are.

Achieving the targeted range that would then I'm.

Encourage us to finish out so you can never enrollment and we will plan to update.

Everyone. Later this year, assuming if we continue to enroll at the rate, though we have been doing at this point.

Okay, great, but there wasn't much.

Thank you very much I am sorry, I thought.

The board volume is very low you as the you Chris.

Unknown Speaker: It's me. Yeah, sorry. You should have known the questions were easier. I'm sorry; thank you so much. Thank you. And our next question comes from Sajit Chakraborty with H.G. Wainwright.

It may get sorry, you said no other questions for easier.

Sorry, Thank you so much [laughter].

Thank you and then next question comes from that GE capital today, It's for already your line open.

Hey, good afternoon.

Unknown Executive: Your line is open. Hey, good afternoon. A lot of data dropped here, so I probably have missed a few. So, based on the activity with MGD013, do you expect to develop a companion diagnostic, or is the trend that you alluded to regarding correlation of responses with LAG-3 expression mostly a trend, and you don't have anything concrete yet? And, you know, because of the PD-1 LAG-3, you're getting a pretty holistic kind of response. Rather than me commenting on that, why don't you stay and wait for the ASCO presentation?

Lot of data drop here, so I am probably have missed a few.

So based on the activity with MDD Zito 13, do you expect to develop a companion diagnostic or the trend that you alluded to regarding quarterly responses, but like three expression is mostly a trend and you don't have anything concrete yet and you know because to be one like three you're getting a pretty holistic kind of response.

Rather than the commenting on that one and you say and wait for the ASCO presentation.

Scott Koenig: There may be merit in developing a diagnostic associated with this to select patients that would most benefit from this, but again, wait for the ASCO presentation to hear the details. Okay, then just a clarification here about the upcoming data with MGD-013. So you mentioned responses in multiple different tumor types in the post-PD-1 setting. So are these patients primary refractory patients, or patients who progressed after an initial response? You know, we have cohorts of approximately 16 in some of these expansion groups, and so there are mixed histories in these patients. And I can't specify, off the top of my head, for the particular populations we will show at the meeting where they fall, but we can follow up with you afterwards.

There may be marriage of the developing a diagnostic associated with this.

To select patients that would most benefit from it but again Oh wait for the ASCO presentations the here the details.

Okay.

Then just a clarification here and for the upcoming data with the MDD zero 13. So.

Mentioned responses and multiple different tumor types and the pause PD one setting. So are these patients primary refractory patients outpatient suit progressed after an initial response.

You know the we have cohorts of approximately 16 and some of these expansion groups.

So there is a mix histories on these patients and I can specify off the top of my head for the.

Particular population, we will show at the meeting where they fall, but we can follow up with you and afterwards.

Great and just one quick follow up on Zito 18 did you reach the recommended phase two dose and the the 50% vs introductions in five out of seven but bones aggression.

Scott Koenig: Great, and just one quick follow-up on R018. Did you reach the recommended phase 2 dose and the 50% PSA reductions in five out of seven with bone regression? Is this at the RP2D, or is the dose escalation still ongoing?

Is this adds to the RP duty or is the dose escalation study ongoing.

Scott Koenig: This was the, the dose escalation is still ongoing. These were actually at lower doses, and on previous calls, I had indicated we were very encouraged by the data we were seeing even in this lower dose range. So, we have actually moved the dose up; we're right now enrolling patients at what we believe would be the top dose to establish a maximum tolerated dose. Whether we achieve that with this highest dose, we do not intend to go higher, and we will select based on the response rate and pharmacokinetics and, obviously, the safety profile of the preferred dose going forward. But the fact that we're seeing such a high response rate across multiple doses is obviously very exciting for us. Congratulations. I'll hop back in the queue. I have a few more.

This was the other dose escalation is still ongoing these were actually at lower doses and out on previous calls I has indicated we were very encouraged by the data we're seeing even in this lower doses range. So we've actually moved the dose.

Well I would where right now enrolling patients than what we believe would be the top dose to establish a maximum tolerated dose whether we achieved that with its highest dose we do not intend to go higher and we will select based on the response rate and pharmacokinetics and obviously the safety.

While.

The preferred dose going forward, but the fact that were seeing such during high response rate across multiple doses is obviously very exciting for us.

Congrats I'll hop back in the Q will have a few more I'll come back later. Thank you. Thank you.

Thank you enter next question comes from David Lebowitz with Morgan Stanley Your not line is open.

Unknown Executive: I'll come back in later. Thank you. Thank you. And our next question comes from David Lebowitz with Morgan Stanley. Your line is open. Thank you very much for taking my question. David, David, we can't hear you. Can you talk closer to the phone?

Thank you very much for taking my question.

When you meet with David David I, We can't hear you can you talk closer to the phone.

When you meet later.

David Lebowitz: When you meet later with the FDA on 4-2, what is, what is the range? If I heard your question, you were very soft here on our end, is what is the outcome of our expected outcome of the meeting with the FDA later this month? As I previously indicated, we met with the FDA last September to discuss the design of a registration study in the refractory population. They agreed that this was a population that was very suitable and addressable and necessary given the current state of affairs for this population.

Yeah, Yeah for the two of them and what are one of the range of possible outcome you think.

Anticipation of path forward.

If I heard your question what are your very soft tiara and on our end is what is the outcome of black our expected outcome to the meeting with the FDA. Later this month as I have previously indicated we had met with the FDA last September.

Stocks the design of a registration study in the refractory population. They agreed that this was a population.

That.

Was a very suitable and addressable and necessary given the current state of affairs.

It's a population obviously, we can't predict what an outcome of any meeting with the update is but we're very highly encouraged based on the last meeting we have with them with some of the open questions. We were going to provide them, which we've already done some additional data on new patients that have been enrolled.

Scott Koenig: Obviously, we can't predict what the outcome of any meeting with the FDA is, but we're very highly encouraged based on the last meeting we had with them about some of their open questions. We were going to provide them, which we have already done, some additional data on new patients that have been enrolled at the targeted doses, both with regard to safety and response rate. And, as I have previously indicated, they were very interested in the historical data of patients with the so-called refractory disease and their response rates as reported in the published literature over the last 30 years. And we provided them with all that data.

There's a targeted doses both with regard to safety and response rate and as I have previously indicated they were very interested in the historical data a patients with so call refractory disease and their response rate as reported in the published literature over the last 30 year and we provided them with all that data.

So our goal right now is mainly to.

David Lebowitz: So our goal right now is mainly to come up with some final designs for this trial and some certain understandings of what a targeted successful outcome would be for this study. So right now, we're very optimistic, but until we have that meeting, we can't give you any more clarity about the outcome. Mm-hmm. That makes sense. And I might have missed this when you mentioned it on the call, but on the Phase 1-2 combination with the formerly named MGA-012 that was halted, what was the primary reason it was halted? Is this COVID-19 related, or was it just- So what happened is that enrollment slowed down because this was an ex-U.S. study in three countries, including Spain, where basically all the sites shut down; Australia sites were shutting down, and Israel sites were shutting down.

To come up with some final designed on this trial and some certain understanding the what a targeted successful outcome would be for this study. So right now we're very optimistic but until we have the meeting we can't give you anymore clarity about though the outcome.

It makes sense.

And I might have missed this when you mentioned on the call, but on the phase one two a combination.

With so formerly need M.D.A. 0012, or that was halted what was the primary reason was halted business cobot 19 related or or so what happens is is that enrollment slowed down because it was the next U.S. study in three countries.

Including Spain, which basically all sides shut down Australia sites were shutting down and Israel sites were shutting down and basically I would very poor enrollment and incurring very significant costs just the maintaining a CR always said it doesn't make sense to continue.

Scott Koenig: And basically, with very poor enrollment and incurring very significant costs, just maintaining a CRO, we said it didn't make sense to continue paying these huge fees. And so we said, let the COVID-19 pandemic slow down, and we will resume the study in the U.S. Thanks for taking my question. Thank you, David. Thank you, and our next question comes from the line of Yigal Nochomovitz with City. Your line is now open. Hi, this is Samantha on Freegal.

Pain or these huge season, so we said Oh lets the Calvin 19, a pandemic a slow down and we will resume the study in the U.S.

Makes sense, thanks for taking my question.

Thank you David.

Thank you enter next question comes along the lines evolve.

But then the Citi. Your line is now open.

Hi. This is you mentioned shake out thanks, very much for taking my questions [noise].

Samantha Andreagal: Thanks very much for taking our questions. On SOFIA and for the potential ODAC meeting for Margituximab, what questions do you believe you need to be prepared to answer clearly in order to generate a successful outcome? I'm sure that as you're expecting the ODAC meeting, you are actively preparing for that ahead of time. Just curious, like, what are your thoughts there?

Onset C N for the potential ODAC meeting to merger Tech slab.

Questions do you believe you need to teach appeared to and clearly and I got to generate a successful outcome I'm sure that you're expecting ODAC meeting you are actively preparing for that ahead of time, just curious like I'm sorry.

Oh.

Yeah, I think the probably the biggest questions I'm not a looming, which is then publicly aired in many different setting is oh the value clinically a of the molecule in the intensity population that with regard to the PFS.

Oh stated that we presented as you know and we saw a hazard ratio any attempt to treat population of a reduction of 24%.

Compared to the control population, but a very short actual value in though in terms of months.

With regard to the Oh, the improvement in that market touching their treated population.

The second question is related to the Apple wheel population, which as you know was a targeted exploratory population that was predefine, but did not allocate any alpha in the analysis and given that which we have shown quite clearly most of the therapy.

Really benefit is related to that FCO population, which represent 85% of the overall population.

How the FDA views on that population and further inquiries. There I think those are probably the two major up questions a looming.

Great. Thank you that's very helpful. And then you mentioned in your prepared remarks, you were going to open an expansion cohort for MGT Olin re imagined Texan that [laughter] I Wonder if you could get to pick more contracts for the study you quoted as that comps for Herceptin minus PD one therapy, you said it.

Samantha Andreagal: And then you mentioned in your prepared remarks that you were going to open an expansion cohort for MGD-013 and margituximab. I wonder if you could give a bit more context to the study you quoted as a comparator for Herceptin combined with PD-1 therapy. You said a 0% response rate for PD-01 negative. What line of therapy was that study conducted in? And in the data that you're gonna be presenting for MGD-013 and Margituximab, I think you said 40% responders. How many of those are PD-01 negative?

There are pieces entre PDL, one negative what minus therapy was that steady connected and and you know in the data that you're gonna be presenting frenzy deal in three of my protection that he said, 40% responders. How many of those are PDL, one negatives and just trying to get a clear picture of how that she has stayed compare.

Scott Koenig: Just trying to get a clearer picture of how those two studies compare. I think it would be premature for me to state this on this call, so please attend or listen to the meeting at ASCO. We will have clarity about all those aspects with regard to line of therapy, specific tumors, and the PD-L1 expression pattern, but it would be inappropriate for me to comment on this now before the ASCO presentation. Okay. Understandable. And we'll certainly be tuning into that.

I think you a pretty may be premature for me to state. This at this call.

So please attended or listened to.

The meeting at ASCO, we will have.

Clarity about.

All those aspects with regard to liner therapy specific tumors.

The PDL, one expression pattern, but it would be inappropriate for me to comment on this now before the ASCO presentation.

Okay got it I understand and we'll certainly be tuning into that I guess, if one more question for maybe a bit of a bigger picture question, Yes, we're going to see it you know obviously that.

Samantha Andreagal: One more question for me, maybe a bit of a bigger picture question, we're going to see, you know, obviously a meaningful data set for MGD-013 at ASCO, and you're still in dose escalation for MGD-019, but we should get initial data for them in the second half. Given that these are both assets that are bi-specific with a PD-1 arm, I guess, I'm just wondering how you think that both of these assets are going to finish the treatment landscape together. Are there certain tumor types or even potentially drug combinations where you think each of these assets may be better suited? I think what you will see, which relates to both molecules, is the value of this bispecific in enhancing responses in populations with regard to both PD-L1 expression and prior treatment with anti-PD-1 and anti-PD-L1 therapy. What we envision for both these molecules is that they will be easily combinable with other assets. We showed you the illustration today of MARGE plus 13.

Meaningful dataset from PDL, one three at ASCO, and you're showing dose escalation for Jiechi 019, but what we should get initial data for the second half.

Given that these are both assets that are by specific for the PD one arm I guess I'm just wondering how you're thinking that both of these assets are going to finish the treatment landscape as together are there certain tumor types or even potentially drug combinations, where you think each of these assets maybe better it.

I think what you will see.

Which relates to both molecule is the value of this by specific and enhancing responses.

And populations with regard.

It's both a PD one PDL, one expression and prior treatment with anti PD, one PDL one therapies.

What we envisioned for both these molecule is is that they will be easily combinable.

With other assets.

We showed you the illustration today.

March plus plus 13.

Scott Koenig: As you know, we are in the ongoing gastric study as well as planned for MARGE plus 13. But one of the big goals for the 19th study was to achieve the synergy that one sees for combining an anti-PD-1 with an anti-CTLA-4 without getting the toxicity that has been previously observed with ipinebo combinations. Just to correct a statement, we have completed the dose escalation part of 19. We will share that with you later this year, as I said, at a follow-up conference. But as I have indicated previously, we are far above the dose that the typical IPI-Nevo combination is. You know, IPI has been used historically, mostly in the clinic, originally at three mgs per kg, and currently, in current studies, at one mgs per kg, and we're far above that dose, and, as indicated here, with a toxicity profile that is quite favorable with regard to observations with respect to typical anti-PD-1 treatment Just to give you a historical refreshment, when we did the monkey study with MGD-019, we went up to doses of 100 mg per kg without associated significant toxicities. And remember, at much lower doses, ipinebo caused those animals to die with very severe diarrhea and dehydration.

As you know 'em, we are happy ongoing gastric study.

As well planned for March plus 13.

But what are the big.

Goals for the 19 study was to achieve the synergies out of one seeds for combining anti PD, one where they MPC telus for without getting the toxicity that has been previously observed with if you need a combination.

Just to.

Correct.

Statement.

We have completed the dose escalation part of 19, we will share that with you later this year as I said I know a follow up conference.

But what I had indicated previously.

We are far above the dose that the typical it'd be nivo combination as you know if he has been used historically, mostly in the clinic originally a three month for kids and currently in current studies at one they per case and were far above that dose and has indicated here with a toxicity.

Profile that is.

Quite favorable with regard to.

Observations with respect to a typical anti PD one of a treatment associated effects.

Just to give you a historical refreshment when we do the Monkey study with Mgd own Oh 19, we went off the doses of 100 makes for keurig without a associated is significant toxicities and remember.

At much lower doses.

It'd be nivo of course, though the animals to die with very severe diarrhea dehydration. So the enhanced ability to activate T cells without the associated toxicity is one of the things that will I think.

The important for the value of this asset.

Okay, great. Thank you so much and I appreciate all the color there.

Thank you enter next question comes from Peter Lawson Your line is open.

Mitchell Swaroop Kapoor: Thank you. And our next question comes from Peter Lawson. Your line is open. Hi there, this is Mitchell. I'm on behalf of Peter.

Hi, there. This is Mitchell one for Peter then you could taking our question. The first one is Ah going into the December PDUFA can you give us an update on how you're preparing for the potential launch margetuximab.

Scott Koenig: Thank you for taking our questions. The first one is going into the December CDUFA; can you give us an update on how you're doing, and potential launch? So, as we have previously mentioned earlier in the year, we have done our marketing assessments.

So as though we have a metro as we've previously mentioned earlier in the year.

We have done our marketing assessments one of the things. Obviously, we're monitoring is the watches of up other drugs that have been recently approved in.

Scott Koenig: One of the things we're obviously monitoring is the launches of other drugs that have recently been approved in third and late-line therapy. So we are doing our homework; we're both on the marketing side and other aspects of the drug. We have engagement obviously before COVID-19 with our MSLs in the community to educate them with regard to FC engineering and the value potentially of immune-mediated effects that are associated with molecules like margituximab. Our plan, as I said previously, is to open up discussions again with additional partners who can be in a position to help commercialize this molecule. Thank you. And then, just one more.

Third and late life therapies.

So we are doing our homework for both.

Marketing side and other aspects of the drugs.

We have engagement, obviously before Coas 19, when I ran that sells in the community.

Educate them with regard to FC engineering, and the value potentially up of up immune mediated effect. So that are associated with a molecule like margin talks about our plan as I said previously is to open up discussions are again with additional.

Partners, who can be in a position.

To help commercialize this molecule.

Thank you and then just one more.

Scott Koenig: I just wanted to get your thoughts on how you're thinking about the release of data in kind of a socially distancing world. Is this, you know, do you think about waiting for year-end conferences for better reception from the medical community? Or is that something you're getting back to?

Just wanted to get your thoughts on how you're thinking about but really to data in kind of a social did something called the thought you know do you think about.

Waiting for your own conferences for better reception from the medical community or a is that something you're going to appeal.

So you know again, if you saw US today, we were very transparent with trying to provide as much data recognizing that there's been much. There are lot of challenges that are occurring currently and we expect will continue throughout the year, where access so our goal.

Scott Koenig: So, you know, again, if you saw today, we were very transparent in trying to provide as much data, recognizing that there's been a lot, there are a lot of challenges that are occurring currently, and we expect will continue throughout the year for access. So our goal is to be as open with ongoing studies as we can. We're not planning to give patient-by-patient updates, but we will provide as much data as we can in sizable numbers so that you can be aware. One of the things that we're very excited about, as I have said previously, all seven of our clinical molecules are active. And right now, our goal for the course of this year and next year is to have multiple registration studies ongoing and to build on the prospects of these molecules to get them to patients as quickly as possible. Thank you. And our next question comes from John Miller. Your line is open.

To be has all been with ongoing studies as we can we're not planning to give patient by patient update, but we will provide as much data as we can and in sizeable numbers. So that you can be aware one of the things that we're very excited about.

I have said previously all seven of our clinical molecules are active.

As of right now our goal in the course of this year next year is to have multiple registration studies are ongoing and to build on the prospects of these molecules to get them patients as quickly as possible.

Thank you enter next question comes from Don Miller Your line is open.

Hi, guys. Thanks for taking my question is congrats on all of the progress.

Jonathan Miller: Hi guys, thanks for taking my question and congrats on all of the progress. I guess after the AACR presentation on flotatuzumab and the T53 genotyping observations you made there, are you still focused on the refractory population, or is there a space for a genotype-defined population? Can you get a larger population by going for TP53 mutant patients as opposed to simply refractory populations? Great question,

I guess after the HCR presentation and put it to them in a in the TPP three beautifully being observations you made there or are you still focused on the refractory population or is there a states for Oh Gee. That's a defined population you know as it is it better I can you get a larger population but going.

Or keep it degree TB TPP mutant patients as opposed to simply refractory population.

Great question John has at this point it out.

Scott Koenig: As has been pointed out, P53 is about 10% overall of the population. As I pointed out today, that the subset of refractory patients is probably the most refractory. And given that we saw, in our study so far, as reported, about a 40% response rate in this particular population, we're very excited that even in the most refractory population, we're seeing a good response. So our goal is to actually treat the entire refractory population, which we think at the minimum is at least 30% and could be as much as 50% of the overall AML population. So, in fact, we will not select based on genotype going into the study. Absolutely understandable. I guess another follow-up then, for your cash runway, which now reaches into 22, could you provide any more color on what had to get prioritized out in order to extend the runway that far?

He said the three is about 10% over all the population as I pointed out today that the subset of refractory patients. These are probably the most refractory and given that we saw in a study so far as reported about a 40% response rate in this particular population.

We're very excited that even in the most refractory population, we're seeing up a good response, so our goal is to.

Actually treat the entire refractory population, which we think at the minimum it's at least 30% and could be as much as 50% or the overall I am not population so that.

In fact, we will not select is based on genotype and going into the study.

Absolutely a understood.

I guess another follow up then.

For your cash runway, which now reaches into 22 or could you put out of anymore color on on what had to get prioritized out in order to extend the runway that book.

Sure. So I think so we tried to give you a lot of detail here about obviously specific programs here and I.

Scott Koenig: So, I think we tried to give you a lot of detail here about, obviously, specific programs here, and I think that, you know, the ability to decide at various trigger points when to advance a program. One of the points we have made previously and as part of our analysis, historically, we would typically look at four or five or six different tumor types for a given indication. As I pointed out today, for instance, for MGCO-18, we are going to focus initially on the prostate population with then the ability to expand further. So, again, by narrowing down many of these programs to one or two indications, we were able to actually project considerable savings going forward. So, that's in part due to the way we were getting to 2022, but there are other things that contributed to that analysis.

I think that.

You know the ability to decide at various trigger points went to advance the program. One of the point is we have made previously and as part of their analysis. Historically, we would typically look at four or five or six different tumor types forgive me.

Indication as I pointed out today for instance, Brad you see awaiting we've got to focusing initially on the I see a population with that and the ability you know said from a so again by narrowing down maybe that programs to one or two indication.

We were able to actually project of considerable savings going forward. That's in part on the way. We were again just 2022, but there are other things that.

Contributed to that analysis.

That makes perfect sense and I guess, one more last one then I noticed that unlike many of your peers and perhaps admirably you have been pretty youve neglected to do any work on Kobin yourself.

You you, let's say two others, what's been driving your decision, making there and do you think the youre technology or could be useful in the ongoing been done.

You know that was a very difficult decision for us obviously, we have expertise. Some historically if you go back into the history of the company. We had worked on many different infectious diseases. You know, we have an ongoing HIV trial or with our outdoor quite specific so it would have been quite easy for us.

Scott Koenig: And do you think that your technology could be useful in the ongoing pandemic? You know, that was a very difficult decision for us. Obviously, we have expertise; historically, if you go back into the history of the company, we have worked on many different infectious diseases. You know, we have an ongoing HIV trial with our DARPA-specific, so it would have been quite easy for us to jump into the development side of things. But given such a broad cancer-focused program, we didn't want to remove all the infrastructure and, obviously, the costs that we've now allocated to the seven clinical and multiple preclinical programs to then move them into the COVID-19 initiative, particularly for the development of antibodies or biospecific molecules. Particularly given that we saw that there was an immediate response from very large pharmaceutical companies who had a lot more assets than we did.

Jump into the development side of thing, but given with such a broad a cancer focused program. We didn't want to we will all the.

Infrastructure and obviously the costs that we know allocated to the seven clinical and multiple preclinical program. So then I'm moving into the covered eight over 19 initiative, particularly for tree for development of anybody or by specific molecule.

Typically given that we saw that there wasn't a median respond very large pharmaceutical companies, let a lot more assets than we did.

However, we have reached out to academic investigators, who we will work within the past.

Stephen Douglas Willey: However, we have reached out to academic investigators who we've worked with in the past and have indicated to them that if they have very unusual molecules that could actually contribute, because of our infrastructure with regard to development and manufacturing, we could provide some help down the road. But right now, we're prioritizing moving forward with our cancer molecule. Got it. Thank you very much. Thank you, and our next question comes from the line of Stephen Willey. Let's see, your line is open.

And I think you gave it to that if they have very unusual molecules.

Actually contribute because of our infrastructure with regard to development and manufacturing we could provide some help slow down the road, but right now were prioritizing moving forward with our cancer molecules.

Got it thank you very much.

Thank you and our next question comes on the line in Willey with Stifel. Your line is broken.

Yeah. Good afternoon, thanks for taking the questions.

Scott Koenig: Yeah, good afternoon. Thanks for taking the question. I guess, Scott, maybe just kind of given some of the enthusiasm embedded within your commentary around Marge.

I guess, Scott, maybe just kind of given some of the enthusiasm.

Embedded within your commentary around margin.

And mgo once three.

I'm just curious if if if that it all makes you rethink the with the design of module B.

Scott Koenig: [inaudible] Curious if that at all makes you rethink the design of Module B. I guess specifically given that you're looking at, you know, the Insight PD-1 there and the Buy Specific, and obviously you're, you know, favorably leveraged from an economic perspective to the Buy Specific here. So just curious as to what your thoughts there are. Could you also maybe just talk a little bit about lag three expression within gas? Yeah, so with regard to the design of Module B, remember the complexity of mahogany. The single-arm study was intended, a single-arm study intended for subpopulations for accelerated approval. And with our agreement with the FDA, part of the design of Module B was going to be confirmatory to have the O12, which is retrofamilamab, which is called retrofamilamab now, as a second study, even though it was designed with chemotherapy for confirmation. So right now, the plan is to continue with Module B enrollment; as we've said, ZAI is moving forward with enrollment in China later this year.

I guess, specifically just given that you're looking at you know the the insight PD, one there and the bi specific and obviously your.

I guess favorably leveraged from an economic perspective to to the bi specific here. So just curious as to what your thoughts there are and and.

You also maybe just talk a little bit about lag three expression within gastric cancer.

Yep, so with regard to what the design of module B.

Remember the complexity of Ah mahogany I'm just single arm studies was intended as a single arm study intended for sub population for accelerated approval and with our agreement with the FDA part of the design of the module b or what.

What's gonna be confirmatory, Oh, I have a the oh, the all 12, which is rather uptime about overtime when I'm now as they a second study or even though with design a with chemotherapy for copper.

Nation. So right now the plan is to continue with the module we enroll in effect as you said site is moving forward for enrolling in China. Later this year, we will then follow up with that.

As we get more experience with combinations of 13 remember.

As I said, where we just have a little over a dozen patients with a combination which of course multiple different tumor types of again wait for ASCO to see.

The the specifics there I think there's an opportunity both to execute on the mahogany study and do a very focused well design study of MTV O 13, with March and bought a number of indication. So right now we're still in this discussion stays on how we would move forward and obviously.

Scott Koenig: I think there is an opportunity both to execute on the mahogany study and to do a very focused, well-designed study of MgDO13 with MARCH in a broader number of indications. So right now, we're still in the discussion phase on how we would move forward, and obviously, we'd like to see additional data. Clearly, we want to see how long these responses last, but the initial data is very encouraging to us. Is there anything you can say about lag 3 expression on gas?

Like to see additional data.

Clearly, we want to see how long these responses less but the initial data is very encouraging to us.

It is ready to say about like three expression on gastric cancer.

Yes. It is it's not the highest but there are significant I don't recall the exact numbers.

Scott Koenig: Yeah, I mean, it's not the highest, but there's a significant difference. I don't recall the exact numbers, but I think our data was higher in the subset of specimens we looked at compared to what's been out in the literature, but it was significantly over 50% of the population. That's helpful. And then...

I think our data was higher in the subset of.

Specimens, we've looked at compared to what's going out in the literature, whatever it was significantly over 50%.

The Oh the population.

Okay. That's helpful and then.

Just lastly, you just talk a little bit about some of those the privatization that's been.

Scott Koenig: Unknown Speaker 0, You just talked a little bit about some of that's been... taken here in an effort to extend cash runaway. Can you maybe just speak a little bit to the assumptions regarding the underlying collaborative payments that are embedded within the runway guidance, I guess, specifically as to whether or not that includes some kind of regulatory payment from inside as a result of an MGA-12 approval. Thank you. We can give you the granularity of the timing of payments and the type of payments. And obviously, we've imposed what I think is a very conservative evaluation of expectations with regard to that.

That's been.

Ah taking your in an effort to extend cash runway Kim.

Can you, maybe just speak a little bit to the assumptions regarding the underlying collaborative payments that are.

Embedded within the runway guidance, I guess, specifically as to whether or not that includes.

I'm kind of regulatory payment from inside as result of although.

On June 12 approval. Thank you.

So we can't give me the granularity of the timing of payments and the type of payment and obviously we have imposed.

Hey, what I think is a very conservative.

About valuation of the of expectations with regard to that just to give you again contacts to refresh your memory, just the regulatory and approval milestones amounts of $405 million, that's obviously across.

Scott Koenig: Just to give you, again, context to refresh your memory, just the regulatory and approval milestones amounting to $405 million. That's obviously across several indications in different territories. But given where I know the programs are, as I pointed out today, that the anal study is fully enrolled, there are, as I said, five registration-enabling studies ongoing, and we think that we expect some significant milestones coming from that. That's part of our calculation, but that's not by itself the deciding factor on how we got to 2022. Steve, this is Jim.

Several indications in different territories, but and given.

Where I know the programs are as I pointed out today that the animal study is fully enrolled there are as I said five registration enabling studies ongoing.

We think that Oh, we expect significant milestones coming from that that's part of our calculation.

But that's not by itself the desire on how we got to 2022.

Got it got especially good questions Hey, this is Jim keep in mind also that our agreement with prevention bio enabled us to achieve a $60 million milestone upon the potential PLM approval of to put them out now in our mod and by the way that molecule has breakthrough designation status.

James Karrels: Keep in mind also that our agreement with Prevention Bio enables us to achieve a $60 million milestone upon the potential BLA approval of teplizumab. By the way, that molecule has breakthrough designation status, and they expect to complete the submission of the BLA sometime this year, I think in the fourth quarter of this year. Now, we take that $60 million and we haircut that, and I think you'll find that we cut that fairly significantly just to reflect some risk. So we try to do this very conservatively, and we're constantly updating. These probabilities are assigned to the various milestones across the portfolio.

We expect to complete the submission of a B.L.A. sometime this year I think in the fourth quarter. This year now we take that $60 million and we have cut that I think you find that we have got that fairly significantly just reflect some risk. So we try to do this very conservatively and we were constantly updating the probability to sign.

To the various milestones across the portfolio just to get a real time sense of where the numbers might be.

Understood appreciate the.

James Karrels: Understood. Appreciate the call. Thanks. Thank you. And our next question comes from the line of Esther Darout of Guggenheim. Your line is open.

Extra culture. Thanks.

Thank you and our next question comes online and I'm sure you're out Guggenheim. Your line is open.

Great. Thanks for taking a question list of Copel I guess my first question is they didn't so it makes sense and corridor of before or Oh, one night.

Etzer Darout: Great. Thanks for taking the question. There are a couple.

Scott Koenig: I guess my first question is, so in the extension cohort for 019, patients on prior therapy, you know, with combinations of PD-1 and CTLA-4 look like they're being excluded. I guess based on the data that you're seeing, do you see this as more positioned for PD-1 naive or some sort of refractory population? And I guess the second question is whether or not you started to see some additivity for flutatuzumab and PD-1 at the 300 nanograms per kg dose in the study that was sort of stopped. So with regard to whether we're targeting the naive or refractory population, the patients that were included in the study included both, so I think that in fact MgD019 could be addressable for both populations.

Patients on prior therapy, you know with combinations of PD, one city all the poor looks like they're being excluded I guess based on the data that you're seeing do you think this is more position to for PD, one naive or PD on sort of refractory population and I guess.

Second question.

Any read on whether or not you started to see some additivity quota to babin PD one at the 200 net of grams per keurig builds.

On the study that was sort of stopped.

Yeah, so with regard to whether we're targeting the naive or refractory population.

The patients that were included in the study included both so I think that in fact.

MTO 19 could be.

Addressable football population, obviously, we need a lot more experience in large numbers because all we have right now is up a limited dataset without a significant live without expansion in particular tumor types.

Scott Koenig: Obviously, we need a lot more experience in larger numbers because all we have right now is a limited data set without any significant, without expansion in particular tumor types, but again, we'll provide more data later this year on this molecule, but at this point, we think both populations could be served by this as a monotherapy by specific or in combination with other drugs to enhance immune reactivity. With regard to the combination of flotatuzumab plus retrofinalmab, we just had too few patients that were enrolled in the study to come to any conclusion. You know, when you see enhanced responses in a single or two patients, it's hard to interpret, so it's just too early to say. I would say, though, that our analysis historically with regard to the upregulation of PD-L1 in patients treated with a single cycle of flotatuzumab has been quite consistent.

But again, we'll provide.

More data later this year on this molecule, but at this point, we think both populations.

Be serviced by.

This as a monotherapy barge specific or in combination with other drugs to enhance a immune reactivity with regard to the.

Combination uploaded to the map plus.

I don't have we had just has to do patients that were enrolled in the study the content any conclusion.

You know when do you see enhanced hey responses in a single or two patients. It's hard to interpret so just to we're always is just say I would say, though that our analysis.

Historically with regard to the Upregulation of a PDL one in patients treated with a single cycle uploaded to the that it's been quite consistent I also have should note that the study by searching rotella given that.

Scott Koenig: I also should note that the study by Sergio Rotella, given that the immune environment favors that of treatment with flotatuzumab, which includes activation of checkpoint molecules, it seems quite natural that some combination of this would benefit a subset of patients, so we will continue to explore that combination in the future, as I noted. Thanks, Scott. Thank you, and our next question comes from the line of Jonathan Chang. Your line is now open. Hello, team. This is John Baradon speaking for Jonathan.

The immune environment savers that oh treatment with plugged in to that which includes activation of checkpoint molecule.

It seems quite actual that some combination of this would benefit certainly a subset of patients. So we will continue to explore that combination in the future as I noted.

Thanks Scott.

Thank you enter next question comes on the line and Don King. Your line is no one is now.

Well the team this is John bed on for Jonathan.

Scott Koenig: My first question is, you mentioned that you have not reached a maximum tolerated dose for MGD-013 yet. How did you choose the dose that you're treating with and what confidence do you have that it is the correct dose, given the high levels of dose that you're able to achieve? Thanks for that question.

My first question is are you mentioned that you have not reached a maximum tolerated dose for MGT, a one three yet.

How did you choose the joke that does that you're treating with and what companies to do you have that it is the correct those.

Given the the high dosing the high levels of does that you're able to achieve.

So thanks, Pat answer that question, we obviously have so many checkpoint molecules often you don't reach a maximum tolerated dose.

Scott Koenig: Obviously, as for many checkpoint molecules, often you don't reach a maximum tolerated dose. So what we look for is pharmacokinetics, occupancy of various receptors. And we pick the dose based on that and, obviously, have integrated the safety profile as well. So what I can say is, as pointed out earlier, this is a well-behaving molecule.

So what we look for his pharmacokinetics occupancy of various resets, there's and we picked this dose based on that and obviously, there's a great is.

The safety profile as well.

So what I, what I can say is as as pointed out earlier. This is a well behaving a molecule. It has a very nice pharmacokinetics and they are again, a good safety profile comparable to that of anti PD. One treatments. So that's how we're picking up.

Scott Koenig: It has very nice pharmacokinetics and, again, a good safety profile comparable to that of anti-PD-1 treatments. So that's how we're picking the dose. Got it. And for MGC018, you mentioned the interest in moving forward with prostate cancer. Could you just remind us the expression levels of B7H3 in prostate cancer and any potential strategy to select for biomarker expression in that patient population? As you know, as we pointed out previously, B7H3 is highly expressed in most solid tumors, and in particular, prostate cancer. Almost all prostate specimens, both primary tumors as well as metastatic tumors, have very high levels of B7H3.

Those.

Got it for MGC is 018, you mentioned the interest in moving forward and prostate cancer could you just remind us the expression levels of B seven H three in prostate cancer and any potential strategy to select for biomarker expression.

In that patient population.

As you know as we pointed out previously B seven Athree is highly expressed on most solid tumors and in particular prostate almost all of prostate specimens both primary tumors as well as metastatic tumor at very high levels of each other age.

Age three so we do not expect the need of particularly for prostate cancer to actually require any diagnostic obviously, we will analyze that mostly retrospectively and once patients. During this in the studies and see if there is any gradation base Roe.

Scott Koenig: So we do not expect the need, particularly for prostate cancer, to actually require any diagnostic testing. Obviously, we will analyze that mostly retrospectively once patients are in the study to see if there is any gradation based on relative levels of expression, but we don't expect that to be an impediment. As you know, we have collaborated on another B7H3 molecule called linovituzumab as a neoadjuvant treatment in an IST study with Johns Hopkins, who have previously shown that giving inovituzumab in patients with primary prostate cancer before they had resection of their prostate had a very nice localization of inovituzumab in the tumor, and this was also associated So we believe that both molecules may have opportunities to be used in various settings for prostate and other tumor types.

I'll just levels of expression, but you don't expect that to be an impediment. As you know we have kind of collaboration on another piece of they see molecule pulls and all the twos in that as the Neoadjuvant treatment in they I see study with Johns Hopkins.

Scott Koenig: Great. Thank you. And one more, if you don't mind.

Who have previously shown that giving them no let's use imagine patient with was primary prostate cancer before they have you section of there I'd say.

Had a very nice localization of another season that in the tumor and this was also associated with an increase in.

Inflammatory cells in a tumor which is typically very cold and so we believe that both molecules may have.

Opportunities to be use in various settings for prostate and other tumor types.

Great. Thank you and one more if you don't mind Oh.

Scott Koenig: Of course, the data for the overall survival of margituximab is still coming in, but do you have an expectation of what setting you might like to present the final overall survival data, be it a conference or a press release? Well, obviously, this is an important event for the company, so we will certainly make a press release when the data is available, but certainly, we will present the final data at a conference. It all depends on when the data comes in. It probably is, but it would be too early for San Antonio Breast.

Of course, the data for the overall survival of merger talks about is that still coming in.

But do you have.

An expectation of what setting you might like to present the final overall survival data.

Be at a conference or press release.

Well, we obviously this is an important.

Event for the company. So we will certainly press release when the data is available, but certainly we will present the final data I'm at a conference. It all depends on when the data come then.

It probably is would be up too early for San Antonio breast.

It's possible, but more likely some us.

Scientific conference next year.

Got it thank you.

Thank you and our next question comes from Tom Shrader. Your line is helpful.

Good afternoon. Thanks for all the details I've back to the ODAC panel.

Tom Schrader: Thanks for all the details. Back to the ODAC panel. So do you expect the driving force there will be the small subset of patients that seem to have done worse? And also, and I apologize; this was asked, if you in fact get the hints that you're going to get approved for a subset, does that change your launch timing?

So do you expect the driving force there is the small subset of patients that have seemed to have done worse and and also what and I apologize. This was a if you will in fact get the hints that you're going to get to accrue for a subset does that change your launch timing.

When we get away with regard to the second know that doesn't change anything in that regard as though we have indicated before.

Scott Koenig: With regard to the second, no, that doesn't change anything in that regard. As we have indicated before, we think that having at least a research-based diagnostic for selecting patients based on their CD16 allele would be valuable for selecting patients that may be best helped by the drug. I wouldn't actually characterize this as a driving subset being worse, which is the 15% of the VB population. As we've pointed out numerous times, we think that the worst response in that population may be a combination of differences. One problem is that it was a very small subset.

We think that I'm, having a lease a research based diagnostic for.

Selecting patients back based on.

There's T 16, a wheel wouldn't be valuable for selecting patients then maybe best.

Hello.

Part of the drug.

I wouldn't actually characterize this is a thriving subset being worse, which is the 15% of the BV population as we pointed out this numerous times well, we think that the the worst response in that population maybe a combination of.

Differences one is is that it was a very small subset.

Scott Koenig: So just from the randomization, patients were not selected based on a CD16 allele. And so, as we have pointed out and was pointed out by Hope Rugo at the San Antonio Press meeting, many of the characteristics of the randomizations seem to favor the trastuzumab VV population compared to the margitoximab population, and that's just the randomization that goes with a very small population. So at this point, given that there's no statistical significance to that, while there was clearly a numerical trend that TRAS was working better in the BB population, we hope that the study gets approved on intent-to-treat, but if the FDA does agree and ODAQ agrees to limit us to the F-folio, we would not be unhappy, and we will be prepared to provide the support via a research diagnostic at the time of that Thanks.

So just from the randomization patients were not select is based on the CD sixteena legal and so as we have pointed out.

And was pointed up I hope rugo at San Antonio breast meeting.

Many of the characteristics for randomization.

Seem to favor the trust tusa that TV population compared to the margin talks about population and that's just the randomization that goes with a very small population. So at this point given that there's no statistical significance of that while there was.

Clearly a numerical trends that traffic was working better in a de population. We hope that the study gets approved on attempt to tree, but if the FDA does agree and ODAC degrees, so limit us to the at folio 'em, we wouldn't have.

The unhappy and we will be prepared to provide the support via a research diagnostic at times that launch which would not be delayed.

Okay, great. Thanks, and then quickly on the one eight prostate cohort or are you going to try to get patients before chemo because I assume that's kind of where you would like an 80 seem to be slaughtered or will you have to treat later line patients in this next cohort.

Scott Koenig: And then quickly on the 018 prostate cohort. Are you going to try to get patients before chemo? Because I assume that's kind of where you would like an ADC to be slotted, or will you have to treat later-line patients in this next cohort? Well, you know, as you know, Tom, the beauty of such a molecule as we're describing, you know, post-taxing and post-androgen blockers, there's very little after those. And as a result, we actually think to start with a very late-line population, which, these patients were, in fact, that population; most of these patients had extensive bony disease. I mean, in fact, all the patients had bony disease. That might be a very good first indication.

Well you know as you know time, the beauty such a mountain glassware, describing you know post.

Taxing and post.

The androgen blockers, there's very little up after the those.

And as a result, we actually think just start with a very late line population.

Which.

These patients were in fact that population.

Most of these patients had extensive bone disease.

I mean in fact, all patients have only disease.

That this might be a very good first indication, but clearly them.

Scott Koenig: But clearly, there could be opportunities to go earlier in line, and as I pointed out in an earlier question, there also is an opportunity, as we pointed out, to treat in neoadjuvant settings various B7H3 targeted agents, which could be novotuzumab, it could be ATEEN, and it could be other things that we'll talk about in the future. Yeah, got it.

I couldn't be opportunities to go for all your line and as I pointed out earlier.

Earlier question.

We're also has an opportunity as we pointed out in treating neoadjuvant settings, various be 73 targeted the agents, which could be a noble season that it could be.

18, and it could be other things that will talk about in the future.

Yeah got it okay. Thank you.

Scott Koenig: Okay, thank you. Thank you. And our next question comes from the line of Evan Zagerman. Your line is open. Hi, Scott.

Thank you and our next question comes from the line.

As in filling your line is open.

Hi, Scott. Thanks for taking my question Hope you all are well so just on M. Judy's your own I know you kind of provided some really preliminary data.

Evan Zagerman: Thanks for taking the question. I hope you all are well. So just on MGD-019, I know you kind of provided some really preliminary data on some responses. Can you give us any color as to any thoughts on the duration of those responses and also what type of tumors are in the mix and how advanced are these patients? I know you don't want to provide all the data, but any more color on that data would be super helpful.

So rather than I'd characterize detail here, let me say that on the four responds and we alluded to were four different tumor types.

Scott Koenig: So rather than characterize detail here, let me say that the four responders we alluded to were four different tumor types. These were all very late stage patients. Very interesting responses, including tumor types you would not expect, not your traditional populations of renal cancer or patients with melanoma. These were distinct populations.

Well all very late stage patients.

Very interesting I'm responses in including a tumor types you would not expect up your traditional.

Populations of renal cancer or patients with melanoma these where.

The same populations again numbers a small but this up there is true. This is a very exciting opportunity for this drug.

Scott Koenig: Again, the numbers are small, but if this bears fruit, this is a very exciting opportunity for this drug. Okay, and then do you plan to dose it beyond three milligrams per kilogram? I know you said or greater, but are we going to get how high do you think you'll go with that? Again, we pointed out that we gave the results of three milligrams or higher. We've already got to our top dose, which is quite considerably higher. Right now, based on the pharmacokinetics and, again, occupancy and things that we're discussing and obviously looking at the safety profile in a larger data set, the dose will be higher than three mgs per kit, but we haven't made a decision yet about what the final dose is.

Okay, and then do it do you plan to dose beyond the three milligrams per kilogram.

I know you said or greater but are we gonna get how high do you think you'll go with that.

Again not to 'em, we pointed out that we gave the result of three milligrams or higher we got to our top those are ready, which is quite considerably higher right now based on the pharmacokinetics.

And again occupancy and things that were discussing and obviously.

Looking at the same safety profile in the largest datasets then they clearly the.

So this will be higher that remain for kids, but we havent made a decision yet what the final dose is well we should have that by the time, we have a public presentation later this year.

Scott Koenig: Well, we should have that by the time we have a public presentation later this afternoon. Okay. And then just can you remind us, aside from head and neck, any other tumor types that can be targeted with, you know, an anti-B7H3 like NL latuzumab? And I'll put two things in there. All right. So again, as I pointed out, B7H3 is hard to express in most solid tumors. If you remember the data we presented at SITC, we highlighted not only the head and neck of patients; we were very excited about the prospect of combining an anti-PD-1 antibody with enoblatuzumab in patients with lung cancer who are PD-L1 negative. So again, the prospects of such a molecule here could be pursued in other tumor types like lung cancer and others, again, which we will point to going forward.

Okay, and then just can you remind us you know aside from head and neck any other Tom tumor types that can be targeted with you know and anti b seven athree like I know what to them out.

No, but plasma learning.

So again as I pointed out these seven athree is highly expressed the most solid tumors. If you remember the data we presented at aside T.C.

Let me highlight is not only to and that a patient we were very excited about the prospects of combining and anti PD one when they know what Susan that in patients with lung cancer, who are PDL one negative so again the prospects of have such a molecule.

Here I couldn't be pursued in other tumor types like lung cancer, and others again, which we will point to going forward.

Alright. Thank you so much for the color I appreciate it.

Scott Koenig: All right. Thank you so much for the call. I appreciate it. Thank you. And our next question comes from the line of four speakers. Your line is now open. Hi, this is Cynthia on behalf of Boris. Thank you for taking our questions. Just a quick one for me. Regarding Mark Hucknab, are there any updates around Xylabs' registrational study in Greater China, especially in light of COVID-19 enrollment? And then, can you remind us whether the study is also looking at the 158 S allele subset population?

Thank you enter the next question comes on the line of Sports Peter Your line is now open.

Hi, This is simply on for Brian. Thank you for taking your questions and just a quick one for me regarding market like regarding my cuts Nab.

Are there any updates there on my last educational study in greater China, especially in light and cover 19 liquor enrollment and then can you remind us what other studies also looking at the one to date actually all subset population.

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