Q4 2023 MacroGenics Inc Earnings Call

Okay.

Operator: Good afternoon. We will begin the MacroGenics 2023 fourth quarter corporate progress and financial results conference call in just a moment. All participants are in listen-only mode at this moment.

Good afternoon.

Speaker Change: We will begin to Macrogenics 2023 fourth quarter corporate progress and financial results conference call in just a moment.

Speaker Change: All participants are in listen only mode at the moment.

Operator: 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 Jim Karrels, Senior Vice President and Chief Financial Officer of MacroGenics. Thank you, operator.

Speaker Change: We will conduct a question and answer session at the conclusion of the call.

Speaker Change: At this point I will turn the call over to Jim Charles Senior Vice President Chief Financial Officer of Macrogenics.

Thank you operator.

James Karrels: Good afternoon, and welcome to the MacroGenics conference call to discuss our fourth quarter 2023 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcement. This release is available under the Investors tab on our website at MacroGenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed. 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 Li Actual results may differ materially from those indicated by these four linking statements as a result of various important factors, including those discussed in the risk factors section of our annual, quarterly, and current reports filed with the SBA.

James Karrels: Good afternoon, and welcome to Macrogenics conference call to discuss our fourth quarter 2023 financial and operational results.

James Karrels: For anyone who has not had a chance to review. These results we issued a press release. This afternoon outlining today's announcements. This release is available under the investors tab on our website at Macrogenics Dot com.

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

James Karrels: I would like to alert listeners that todays discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 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 factors section of our annual quarterly and current reports filed with the SEC.

James Karrels: In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representative 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, Jim.

James Karrels: In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law.

James Karrels: And now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of Macrogenics.

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

Scott Koenig: Jim I'd like to welcome everyone participating via conference call and webcast today I will provide key updates on our clinical programs. This afternoon.

Scott Koenig: Before I do so let me first turn the call back to Jim.

Scott Koenig: View, our financial results.

James Karrels: Thank you, Scott. This afternoon, MacroGenics reported financial results for the year ended December 31, 2023, which highlight our financial position. As described in a release this afternoon, MacroGenics total revenue was $58.7 million for the year ended December 31, 2023, compared to total revenue of $151.9 million for the year ended December 31, 2022. Revenue for the year ended December 31, 2023 included $29 million in revenue from collaborative and other agreements. Margenza had net sales of $17.9 million and $9.8 million in contract manufacturing revenue.

Scott This afternoon Macrogenics reported financial results for the year ended December 31, 2023, which highlight our financial position as described in our release. This afternoon Macrogenics total revenue was $58 $7 million for the year ended December 31, 2023, compared to total revenue of $151 9 million for the year ended December.

Scott Koenig: 31 2022.

Revenue for the year ended December 31, 2023 included $29 million in revenue from collaborative and other agreements margins and net sales of $17 9 million and $9 8 million in contract manufacturing revenue.

Our research and development expenses were $166 $6 million for the year ended December 31, 2023 compared to $207 million for the year ended December 31 2022.

Scott Koenig: This decrease was primarily due to decreased manufacturing related costs for Barbara duo decreased development and clinical trial costs related to <unk> and decreased costs related to discontinued studies, partially offset by increased expenses related to <unk>, six and Mtc <unk> development Scott will tell you about these two.

James Karrels: Our research and development expenses were $166.6 million for the year ended December 31, 2023, compared to $207 million for the year ended December 31, 2022. This decrease was primarily due to decreased manufacturing-related costs for Vograduo, decreased development and clinical trial costs related to margituximab, and decreased costs related to discontinued studies, partially offset by increased expenses related to MGC 026 and MGC 028 development. Scott will tell you about these two ADC product candidates in a few minutes. Our selling general and administrative expenses were $52.2 million for the year ended December 31, 2020, compared to 58.9 million for the year ended December 31, 2022. The decrease was primarily related to decreased selling costs for Margenza.

Scott Koenig: Product candidates in a few minutes, our selling general and administrative expenses were $52 2 million for the year ended December 31, 2023, compared to $58 9 million for the year ended December 31 2022.

Scott Koenig: The decrease was primarily related to decreased selling costs former genzyme.

Scott Koenig: During the year ended December 31, 2023, Macrogenics received $100 million proceeds from the sale of our single digit royalty interest on global net sales of Ts yield too Dear eye health care acquisitions L. P. In March. In addition, we received a $50 million milestone payment from Santa fee related to the achievement of the primary end.

Scott Koenig: And a T cell clinical study.

Scott Koenig: Under GAAP guidelines and pursuant to the financial accounting standards Board accounting standards codification or ASC 470. This combined $150 million was included in other income as a quote gain on royalty monetization arrangement on quota in 2023.

Scott Koenig: Our net loss was $9 $1 million for the year ended December 31, 2023, compared to a net loss of $119 8 million for the year ended December 31 2022.

Scott Koenig: Our cash cash equivalents and marketable securities balance as of December 31, 2023 was $229 8 million compared to $154 3 million as of December 31, 2022.

Scott Koenig: Finally in terms of our cash runway consistent with our prior guidance, we anticipate that our cash cash equivalents and marketable securities balance of $229 $8 million as of December 31, 2023.

James Karrels: During the year ended December 31, 2023, MacroGenics received $100 million in proceeds from the sale of our single-digit royalty interest on global net sales of TZLD to DRI Healthcare Acquisitions LP in March. In addition, we received a $50 million milestone payment from Sanofi related to the achievement of a primary endpoint in a TZLD clinical study. Under GAAP guidelines and pursuant to Financial Accounting Standards Board Accounting Standards Qualification or ASC 470, this combined $150 million was included in other income as a quote, gain on royalty monetization arrangement, unquote, in 2023. As a result, our net loss was $9.1 million for the year end of December 31, 2023, compared to a net loss of $119.8 million for the year end of December 31, 2022.

Scott Koenig: In addition to projected and anticipated future payments from partners and product revenues should extend our cash runway into 2026 are anticipated funding requirements reflect expected expenditures related to the phase II Tamarac clinical trial. The phase two lorikeet study of <unk> in <unk>.

Scott Koenig: As well as our other ongoing clinical and preclinical studies and now I will turn the call back to Scott.

Scott Koenig: Thank you Jim we continue to believe our proprietary pipeline of product candidates has great promise I will walk you through each of our key programs, including newly disclosed molecules momentarily.

Scott Koenig: As well as tell you about our plans for upcoming clinical programs.

Scott Koenig: Sure I do that and building on what Jim said I'll quickly remind you that since mid 2022 through our business development efforts as well as milestone achievement, we have received $335 million of non dilutive capital.

Scott Koenig: This includes $215 million from prevention <unk> Saturday in connection with Tcl $75 million from Gilead and $45 million from insight in connection with sinus.

Scott Koenig: Okay onto our pipeline.

Scott Koenig: Well, we're a minimum abdul compazine of overdue.

James Karrels: Our cash equivalents and marketable securities balance as of December 31, 2023 was $229.8 million, compared to $154.3 million as of December 31, 2022. Finally, in terms of our cash runway, consistent with our prior guidance, we anticipate that our cash, cash equivalents, and marketable securities balance of $229.8 million as of December 31, 2023, in addition to projected and anticipated future payments from partners and product revenues, should extend our cash runway into 2026 Our anticipated funding requirements reflect expected expenditures related to the Phase 2 Tamarack clinical trial, the Phase 2 Lorikeet study of lorotiromab in MCRPC, as well as our other ongoing clinical and preclinical studies. Now, I'll turn the call back to Scott.

Scott Koenig: As our ADC designed to deliver DNA alkylating <unk> cytotoxic payload to tumors expressing <unk> <unk> three.

Scott Koenig: <unk> III is a member of the <unk> family of molecules involved in immune regulation overdue was designed to take advantage of this antigens broad expression across multiple solid tumor types.

Scott Koenig: As you know we believe that this has the attributes of an ideal cancer target.

We began enrolling the tamarac phase II study of overdue.

Scott Koenig: Under a modified study protocol during the second quarter of 2023 and completed enrollment of this study in November months ahead of the schedule.

Scott Koenig: In fact 177 patients receive overdue in this study exceeding this study design goal of 100 participants.

Scott Koenig: As a reminder, tamarac is being conducted in patients with metastatic castration resistant prostate cancer or <unk>.

Who were previously treated with one prior androgen receptor axis targeted therapy.

Scott Koenig: Participants may have received up to one prior taxane containing regimen.

Scott Koenig: No other chemotherapy agents.

Scott Koenig: This study is being conducted to evaluate overdue on patients across two experimental arms of either two mix per gig are $2 seven mix per kg every four weeks.

Scott Koenig: Thank you, Jim. We continue to believe our proprietary pipeline of product candidates has great promise. I will walk you through each of our key programs, including newly disclosed molecules, momentarily, as well as tell you about our plans for upcoming clinical programs. But before I do that, and building on what Jim said, I'll quickly remind you that since mid 2022, through our business development efforts, as well as milestone achievement, we have received $335 million of non-dilutive capital. This includes $215 million from Prevention DRI Sanofi in connection with TZL, $75 million from Gilead, and $45 million from Insight in connection with Zinus. Okay, on to our pipeline. Boverimidumab duocarbazine, or BoverDuo, is our ADC designed to deliver a DNA alkylating duochromycin cytotoxic payload to tumors expressed by B7H3.

Scott Koenig: In January the Tamarac independent data safety monitoring Committee recommended continuing the study based on a protocol specified interim analysis.

Scott Koenig: Also in early February we submitted an abstract to ash go that included safety data from the January data cutoff.

Scott Koenig: We anticipate providing an expanded more mature clinical update including initial efficacy data in the second quarter of 2024 at this meeting.

Scott Koenig: In addition, we anticipate providing updated clinical data, including radiographic progression free survival or PFS. The study's primary endpoint at a conference during the second half of 2024, we plan to expand the tumor types being evaluated in a tamarac trial and we will enroll additional.

Scott Koenig: Patients with non small cell lung cancer small cell lung cancer melanoma squamous cell carcinoma of the head and neck and anal cancer.

Scott Koenig: We expect to initiate dosing in these additional cohorts in mid 2024.

Scott Koenig: Next I'll update you on Lora Gerald <unk>, our Bispecific tetravalent PD, one by <unk> Dart molecule.

Scott Koenig: B7H3 is a member of the B7 family of molecules involved in immune regulation. VOBERDUO was designed to take advantage of this antigen's broad expression across multiple solid tumor types. As you know, we believe that this has the attributes of an ideal cancer target. We began enrolling the Tamarack Phase II study of Obraduo under a modified study protocol during the second quarter of 2023 and completed enrollment of the study in November, months ahead of schedule. In fact, 177 patients received VOBRA Duo in this study, exceeding the study design goal of 100 participants. As a reminder, TAMARAC is being conducted in patients with metastatic castration-resistant prostate cancer, or MCRPC, who have been previously treated with one prior androgen receptor axis targeted therapy. Participants may have received up to one prior taxing containing regimen but no other chemotherapy agent. This study is being conducted to evaluate Voverduo in patients across two experimental arms of either 2 mg per kg or 2.7 mg per kg every four weeks.

Scott Koenig: We designed large ela, Matt to have preferential blockade on dual PD, one <unk> four expressing cells, such as tumor infiltrating lymphocytes or til, which are most abundant in the tumor microenvironment.

Scott Koenig: We are enrolling the Lora heat study a randomized phase II clinical trial of Lora Journal and that in combination with Docetaxel versus Docetaxel alone in second line chemotherapy naive and CRP C patients.

Scott Koenig: A total of 150 patients are planned to be treated in the two to one randomized study.

Scott Koenig: The current study design includes the primary study endpoint of our PFS.

Scott Koenig: We anticipate providing a trial update in the second half of this year.

Scott Koenig: In addition, we continue to enroll patients in the phase <unk> dose escalation study of overdue in combination with large allomap in patients with advanced solid tumors.

Scott Koenig: We anticipate commencing a dose expansion study of this combination in MCR PC and another indication in 2024.

Scott Koenig: Next up <unk> 24 is our next generation bi specific CD 123 by CD three dart molecule that incorporates a CD three component designed to minimize cytokine release syndrome, while maintaining an antitumor side Olympic activity and permitting intermittent dosing.

Scott Koenig: In January, the Tamarack Independent Data Safety Monitoring Committee recommended continuing the study based on a protocol-specified interim analysis. Also, in early February, we submitted an abstract to ASCO that included safety data from the January data cutoff. We anticipate providing an expanded, more mature clinical update, including initial efficacy data, in the second quarter of 2024 at this meeting. In addition, we anticipate providing updated clinical data, including Radiographic Progression-Free Survival, or RPFS, the study's primary endpoint, at a conference during the second half of 2024. We plan to expand the tumor types being evaluated in the TAMARAC trial, and we'll enroll additional patients with non-small cell lung cancer, small cell lung cancer, melanoma, squamous cell carcinoma of the head and neck, and anal cancer. We expect to initiate dosing in these additional cohorts in mid-2024. Next, I'll update you on laurogelamab, a bispecific tetravalent PD-1 by CTLA-4 dart molecule. We designed lorigelimab to have preferential blockade on dual PD-1 and CTLA-4 expressing cells, such as tumor infiltrating lymphocytes or TILs, which are most abundant in the tumor microenvironment.

Scott Koenig: Through a longer half life.

Scott Koenig: Our phase one dose escalation study of Mgd <unk> 24 is ongoing in patients with CD 123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia, and Myelodysplastic syndromes recall that gilead has the option to license Mgd.

Scott Koenig: 24 at predefined decision points during the phase one study.

Scott Koenig: Next I'm very excited to tell you about our growing ADC portfolio, which now includes an additional product candidate in the clinic.

Scott Koenig: As I've mentioned on prior calls we have been developing preclinical ADC molecules utilizing linker payload technologies, we licensed from sent FX the <unk>.

Scott Koenig: First of these is <unk> 26, a clinical ADC, incorporating a <unk> targeting antibody and a novel Topoisomerase, one inhibitor based linker payload.

Scott Koenig: <unk> E is cleavable linker payload is based on exit T can a clinically validated and potent cancer thicken that readily combines with Sinn effects hydro space technology.

Scott Koenig: We believe Senate, Texas approach potentially provides advantages vis vis other topoisomerase one inhibitor based adcs in fact exit T can appears to be more potent and less susceptible to multi drug resistance mechanisms than other top one inhibitors such as SME.

Scott Koenig: <unk> 38, and <unk> can additionally site specific conjugation of certainty Ken to the normally guide cost related amino acid in the FC domain abolishes, the FC gamma receptor and mannose receptor binding.

Scott Koenig: Which contribute to non targeted uptake of adcs and alveolar macrophages and reported to be associated with lung toxicity.

Scott Koenig: We are enrolling the Laura Keats study, a randomized phase 2 clinical trial of loriduralimab in combination with docetaxel versus docetaxel alone in second-line chemotherapy-naive MCRPC patients. A total of 150 patients are planned to be treated in the two-to-one randomized study. The current study design includes a primary study endpoint of RPFS.

Scott Koenig: And therefore, it may provide a safety benefit for patients the variable domain of the molecule targeting <unk> 783 is the same sequence contained in broker duo we recently initiated a phase one dose escalation study of MDC Oh 26.

Scott Koenig: We view <unk> as a complementary approach developer duo for targeting <unk> three.

Scott Koenig: More specifically, we believe that having distinct mechanisms of action Volcker duo and Mtc, Oh, 26 may address different cancers tumors stages or be used in combination with alternate agents or potentially with one another to enhance their clinical utility.

Scott Koenig: We anticipate providing a trial update in the second half of this year. In addition, we continue to enroll patients in the Phase I-II Dose Escalation Study of Voverduo in combination with laurogerolimab in patients with advanced solid tumors. We anticipate commencing a dose expansion study of this combination in MCRPC and another indication in 2024. Next up, MgD024 is our next-generation bi-specific CD123 by CD3 DART molecule that incorporates a CD3 component designed to minimize cytokine release syndrome while maintaining an antitumor cytolytic activity and permitting intermittent dosing through a longer half-life. Our Phase 1 Dose Escalation Study of MgD O24 is ongoing in patients with CD123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndrome.

Scott Koenig: We remain confident in the potential of targeting the <unk> pathway.

Scott Koenig: Our total one inhibitor strategy as an additional valuable tool in our therapeutic repertoire, we plan to present preclinical data for <unk> at the upcoming American Association for cancer research or ACR annual meeting next month.

Scott Koenig: Preview of what Youll see.

Scott Koenig: In preclinical studies <unk> six exhibited a favorable profile with potent in vivo activity towards <unk> expressing tumor xenograft, representing a range of cancer indications <unk> 26 was tolerated in cinema <unk> monkeys are relevant toxicology.

Scott Koenig: Model at exposure levels exceeding those required for anti tumor activity. We look forward to showing you the data set next month.

Scott Koenig: In addition, we are readying a second topoisomerase, one inhibitor based ADC <unk> 28 for which we currently expect to submit an IND later this year.

Scott Koenig: MDC out 28 is a preclinical ADC, incorporating and Adam nine targeting antibody and the second of our ADC molecules, incorporating <unk> novel Linker payload.

Scott Koenig: Recall that Gilead has the option to license MGD-024 at predefined decision points during the Phase 1 study. Next, I'm very excited to tell you about our growing ADC portfolio, which now includes an additional product candidate in the clinic. As I mentioned on prior calls, we have been developing preclinical ADC molecules utilizing linker payload technologies we licensed from Synefix. The first of these is MGC026, a clinical ADC incorporating a B7H3 targeting antibody and a novel topoisomerase I inhibitor-based linker payload. SYNTECAN-E.

Scott Koenig: Adam nine or integrin and metallic proteinase domain nine is a member of the atom family of multi functional type one transmembrane proteins that play a role in tumor Genesis and cancer progression and is over expressed in multiple cancers, making it.

Scott Koenig: <unk> target for cancer treatment.

Scott Koenig: <unk> 28 is a second Adam nine targeted ADC that we have pursued the first was <unk> 936, a molecule with a <unk> payload that was advanced under co development arrangement with Immunogen, Inc. Now part of Abbvie under the 50 50 collaboration Immunogen led Clint.

Scott Koenig: This cleavable linker payload is based on ExaTECAN, a clinically validated and potent cancer thecan that readily combines with Cinefix HydraSpace technology. We believe Sinofix's approach potentially provides advantages vis-a-vis other topoisomerase 1 inhibitor-based ADCs. In fact, exotecan appears to be more potent and less susceptible to multidrug resistance mechanisms than other TOP1 inhibitors, such as SN38 and durexetecan. Additionally, site-specific conjugation of sintecan to the normally glycosylated amino acid in the FC domain abolishes FC gamma receptor and Mannhouse receptor binding, which contribute to non-targeted uptake of ADCs in alveolar macro The variable domain of the molecule targeting B7H3 is the same sequence contained in Vobriduo.

Scott Koenig: Development of <unk> 936, neither macrogenics, nor abbvie intends to further pursue development of <unk> 936, as the molecule did not receive our pre established clinical safety and efficacy benchmarks, we plan to present preclinical mtc.

Scott Koenig: Oh 28 data at the upcoming ACR annual meeting in April.

Scott Koenig: As a preview MDC out 28 exhibited specific dose dependent in vivo anti tumor activity towards Adam nine positive CTX in pdx models, including in gastric lung pancreatic colorectal and head and neck cancers.

Scott Koenig: <unk> 28 was well tolerated in a repeat dose nonhuman primate toxicology study up to 55 milligrams per kg the highest dose level tested.

Scott Koenig: Note.

Scott Koenig: <unk> toxicities that are typically seen when the tanzanite payloads and which we observed in our <unk> 936, <unk> toxicology study were not observed in the <unk> 28 pilot toxicology study, we plan to present more preclinical data on this asset.

Scott Koenig: The ACR.

Scott Koenig: We recently initiated a phase one dose escalation study of MGC026. We view MGC 026 as a complementary approach to Vobra Duo for targeting B7H3. More specifically, we believe that having distinct mechanisms of action, VOBRA Duo and MGC 026, may address different cancers, tumor stages, or be used in combination with alternate agents or potentially with one another to enhance their clinical utility. We remain confident in the potential of targeting the B7H3 pathway, viewing our TOPO1 inhibitor strategy as an additional valuable tool in our therapeutic repertoire. We plan to present preclinical data for MGC 026 at the upcoming American Association for Cancer Research (AACR) annual meeting next month. Here's a preview of what you'll see. In preclinical studies, MGC026 exhibited a favorable profile with potent in vivo activity toward B7H3 expressing tumor xenografts representing a range of cancer indications. MGC026 was tolerated in cynomolgus monkeys, a relevant toxicology model, at exposure levels exceeding those required for anti-tumor activity.

Scott Koenig: We currently anticipate submitting an investigational new drug or IND application for <unk> 28 by the end of 2024.

Scott Koenig: In addition, beyond <unk> six and <unk> 28, we're exploring additional molecules for potential future R&D submission stay tuned.

Scott Koenig: Finally, <unk> is an FC optimized monoclonal antibody that targets <unk> 783.

Scott Koenig: Our academic collaborators have initiated an investigator sponsored randomized translational intense phase two investigator sponsored study of <unk> and up to 219 men with prostate cancer. The heat study will evaluate the activity of Neo adjuvant <unk>.

Given prior to radical prostatectomy in men with high risk localized prostate cancer eligible patients will undergo a pretreatment prostate biopsy.

Scott Koenig: And conventional imaging, both <unk> and bone scan as well as PSM eight pad and optional prostate MRI as per institutional preferences.

Scott Koenig: To conclude we believe we have the technical development and clinical expertise as well as financial resources to support our vision of developing and delivering life changing medicines to cancer patients.

Speaker Change: We will now be happy to open the call for questions.

Scott Koenig: Operator.

Speaker Change: To ask a question. Please press star one on your telephone and wait for your name to be announced.

Scott Koenig: We look forward to showing you the data set next month. In addition, we are readying a second tuboisomerase I inhibitor-based ADC, MgCO28, for which we currently expect to submit an IND later this year. MGC028 is a preclinical ADC incorporating an ADAM9 targeting antibody and the second of our ADC molecules incorporating Sinofix's novel linker payload. Adam-9, or Disintegrin and Metalloproteinase Domain 9, is a member of the Adam family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment.

To withdraw your question. Please press star one again.

Speaker Change: Please standby, while we compile the Q&A roster.

Speaker Change: Our first question comes from Jonathan Chang with Leerink Partners. Your line is now open.

Speaker Change: Yeah.

Jonathan Chang: Hi, guys. Thanks for taking my questions. First question can you help set expectations for the preliminary tamarac data coming up at <unk> and then second question can you discuss the rationale behind expanding the tamarac study to include patients with non small cell lung cancer small cell.

Jonathan Chang: No my head and neck and anal cancer.

Speaker Change: In forming this decision thank you.

Thank you so much Jonathan.

Speaker Change: <unk> heard me previously.

Speaker Change: We had taken an evaluation of our own data.

Speaker Change: Published recently by <unk>.

Speaker Change:

Scott Koenig: MGC028 is the second ADAM9 target ADC that we have pursued. The first was IMGC936, a molecule with a metansinoid payload that was advanced under a co-development arrangement with Immunogen, Inc., now part of AbbVie. Under the 50-50 collaboration, Immunogen led clinical development of IMGC936.

Speaker Change: On the 7300 molecule at ESMO.

Speaker Change: This past fall and other data that was out there with regard to activity against the prostate cancer.

Speaker Change: And with that as I have noted.

Speaker Change: And which we have not changed the.

Our ranges that we would see.

Just to recall, we saw about half the patients in our three Meg per kg Q3 weekly dosing.

Speaker Change: <unk> duo in our expanded approximately 40 patient cohort.

Scott Koenig: Neither MacroGenics nor AbbVie intends to further pursue the development of IMGC936 as the molecule did not achieve our pre-established clinical safety and efficacy benchmark. We plan to present preclinical MGC 028 data at the upcoming AACR annual meeting in April. As a preview, MGC 028 exhibited specific dose-dependent anti-tumor activity toward ADAM9-positive CDX and PDX models, including in gastric, lung, pancreatic, colorectal, and head and neck cancer. MgCl-28 was well-tolerated in a repeat-dose non-human primate toxicology study up to 55 mg per kg, the highest-dose level test.

Speaker Change: About half those patients, reducing PSA 50 from baseline a.

Speaker Change: Given the dosing right now a $2 seven in Q4 and to Q4 and with expectations. If the safety is improved as we expect we should be actually delivering as much or more of the $2 seven mix Q4 as compared to historical.

Treatment with the three mix Q3 as a result, we expect the PSA 50 to be in a similar range somewhere between 40% and 60%.

Speaker Change: PSA 50 reduction with regard to overall response rate again as we have previously presented approximately a quarter of the patients achieved.

Scott Koenig: Of note, ocular toxicities that are typically seen when the tantinoid payloads are used, and which we observed in our IMGC 936 Cinnamologous Toxicology Study, were not observed in the MGC 028 Pilot Toxicology Study. We plan to present more preclinical data on this asset at AACR. We currently anticipate submitting an investigational new drug or IND application for MGCO-28 by the end of 2024. In addition, beyond MGC-026 and MGC-028, we're exploring additional molecules for potential future IND submissions. Stay tuned. Finally, inoblituzumab is an FC-optimized monoclonal antibody that targets B7H3. Our academic collaborators have initiated an investigator-sponsored, randomized, translationally intense, phase two investigator-sponsored study of inoblituzumab in up to 219 men with prostate cancer. The HEAT study will evaluate the activity of neoadjuvant inoblituzumab given prior to radical prostatectomy in men with high-risk localized prostate cancer.

Speaker Change: Both confirmed it confirms.

Speaker Change: Responses and this similar to that which was reported by Daiichi a 25%.

Speaker Change: Expectations is we should be 25% or greater with.

Speaker Change: With regard to our PFS, which is the primary endpoint of this study.

Speaker Change: Very important one in terms of obviously a prolonged <unk> both.

Speaker Change: The life and the quality of life of these patients.

Speaker Change: Daiichi reported five three months of our PFS and what we have said is that we expect to have at least six or greater.

In terms of our PFS going forward.

Speaker Change: Now with regard to the specific tumor types.

Speaker Change: We have selected the first study.

Speaker Change: In these expansions again, taking advantage of our own experiences.

Speaker Change: <unk>.

Treatment of patients with a subset.

Speaker Change: Of these tumors as well as the histology.

Speaker Change: And expression of <unk> three on these tumor types. We think these are very promising tumors to pursue I should also point out while we are expanding into five different tumors. Now. We are also considering additional tumors in the future to conduct studies.

Speaker Change: Understood maybe just a clarifying question on that.

Operator: Eligible patients will undergo a pretreatment prostate biopsy and conventional imaging, both CT and bone scan, as well as PSMA PET and optional prostate MRI as per institutional preference. To conclude, we believe we have the technical development and clinical expertise, as well as financial resources to support our vision of developing and delivering life-changing medicines to cancer patients. We would now be happy to open the call for questions. Operator.

Speaker Change: So the decision kind expanding the study to include these other tumor types.

Speaker Change: Yes.

Speaker Change: Based on your own internal <unk>.

Speaker Change: Data or data you are seeing in the competitive landscape for both.

I would say both obviously.

Speaker Change: Given the experience in small cell for instance, where.

Speaker Change: Bulk Daiichi enhancer I've seen.

Speaker Change: Very nice activity in small cell cancer, we have not had that.

Speaker Change: Opportunity to test it in patients with small cell cancer. So this became a very obvious one to include among among the five I would say the others.

Jonathan Chang: To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A ROST. Our first question comes from Jonathan Chang with Levering Partners. Your line is now open. Hi guys, thanks for taking my question. First question, can you help set expectations for the preliminary TAMRAC data coming up at ASCO? And then, second question, can you discuss the rationale behind expanding the TAMRAC study to include patients with non-small cell lung cancer, small cell melanoma, head and neck, and anal cancer? What is informing this decision? Thank you. Thank you so much, Jonathan.

Speaker Change: Based on our own experiences.

Speaker Change: As well as street.

Speaker Change: Preclinical work that we are done.

Speaker Change: Against these targets, but again I am not.

Speaker Change: We're not even limiting it to these five we are also considering others, which would be.

Speaker Change: Very good opportunities for looking at the value of overdue.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Chelsea <unk> with Guggenheim. Your line is now open.

Chelsea: Oh, Hey, guys. Thanks for taking my question.

Chelsea: First regarding that Asheville abstract.

Chelsea: What should we expect to be included in that will it just be safety or well preliminary efficacy data also be in the abstract.

Chelsea: And then secondly could you just remind us how patient enrollment tracked throughout 2023, and how we should think about follow up on the 177 patients in the fall <unk> presentation. Thank you.

Speaker Change: Thank you so much kelsey.

Scott Koenig: As you've heard me previously, we did an evaluation of our own data that was published recently by Daiichi on the 7300 molecule at ESMO this past fall and other data that was out there with regard to activity against prostate cancer. And with that, as I have noted, and which has not changed the ranges that we were seeing, just to recall, we saw about half the patients in our 3 MIG per KG three-weekly dosing of OBRADUO in our expanded approximately 40-patient cohort of about half those patients reducing PSA50 from baseline. Given the doses right now of 2.7q4 and 2q4, and with expectations, if the safety is improved as we expect, we should be delivering as much or more of the 2.7-mix q4 as compared to historical treatment with the 3-mix q3. As a result, we expect the PSA-50 to be in a similar range, somewhere between 40 and 60%. With regard to the overall response rate, again, as we have previously presented, approximately a quarter of the patients achieved both confirmed and unconfirmed responses. And this is similar to that which was reported by Daiichi at 25%.

Speaker Change: Because of the timing and I'll discuss enrolment in a second so it became quite obvious as I pointed out we had to do a cutoff date in January for the data submission in early February at ESCO.

Speaker Change: And as a result, we primarily relied on safety data.

To be included in the abstract but also noting that our plan was to present, obviously the clinical efficacy efficacy data as we were able to.

Speaker Change: Cumulated additional data closer to the time of ESCO.

Speaker Change: Again to give you a sense of why these decisions were made in terms of the presentations.

Speaker Change: We with the amendment of the original Tamarac study, we began to enroll a few patients in the end of the second quarter, but as it turns out two thirds of the patients of the 177 patients were enrolled.

Speaker Change: Between the second half of the third quarter and the first half of the fourth quarter. So not sufficient time was allowed to accumulate.

Speaker Change: Data regarding efficacy and so that's why the decision was made.

Speaker Change: Two are primarily inclusive the safety data in the abstract.

Speaker Change: Perfect. Thank you so much.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from Stephen Willey with Stifel. Your line is now open.

Stephen Douglas Willey: Yes. Good afternoon, thanks for taking the question.

Stephen Douglas Willey: Maybe just a follow up on the enrollment kinetics you just referenced Scott can you just I guess speak or characterize as to whether or not.

Scott Koenig: So our expectation is that we should be 25% or greater. With regard to RPFS, which is the primary endpoint of this study and a very important one in terms of obviously prolonging both the life and the quality of life of these patients, Daiichi reported 5.3 months of RPFS. And what we have said is that we expect to have at least six or greater in terms of RPFS going forward. Now, with regard to the specific tumor types we have selected for study in these expansions, again, taking advantage of our own experiences in treating patients with a subset of these tumors, as well as the histology and expression of B7H3 on these tumor types.

Those.

Stephen Douglas Willey: That bolus of patients that came in.

Stephen Douglas Willey: Second half <unk> first half <unk> was that primarily across newly opened sites or were.

Stephen Douglas Willey: Were those across sites, where the treating investigator.

Stephen Douglas Willey: Sufficient experience with the drug.

Speaker Change: Thanks for the question Steve So.

As we have.

Speaker Change: Talking about it before.

Speaker Change: The initial sites with a new amendment that were opened or were in the U S. But the number of sites in the U S.

Speaker Change: We're small.

The greatest number of sites, we're in Europe, and so with the.

Speaker Change: Approval of the amendments in the European sites later in the year. This great created an opportunity for initiating enrollment in a large number of sites and as we've discussed before.

Speaker Change: The rapidity of enrollment was far beyond what we expected and in fact.

Scott Koenig: We think these are very promising tumors to pursue. I should also point out, while we are expanding into five different tumors now, we are also considering additional tumors in the future to conduct studies on. Understandable, maybe just a clarifying question on that. So the decision kind is expanding the study to include these other tumor types. This is based on your own internal data or data you're seeing in the competitive landscape or both. I would say both.

Speaker Change: We ended up probably.

Speaker Change: Hold me to the exact number.

Speaker Change: Approximately a third the size that we intended to enroll.

Speaker Change: Open we're never open because of the SaaS enrollment.

Speaker Change: Later in the year on these newly opened sites so.

U S sites continue to enroll but just because of the proportion that were in Europe.

Scott Koenig: Obviously, given the experience in small cell, for instance, where both Daiichi and Hanso have seen very nice activity in small cell cancer, we have not had that opportunity to test it in patients with small cell cancer. So this became a very obvious one to include among the five. I would say the others were based on our own experiences as well as preclinical work that we had done against these targets. But again, I am not, nor are we even limiting it to these five.

Compared to Asia, and the U S.

Speaker Change: The majority of got enrolled in Europe, and that and that bolus in the second half of the year.

Speaker Change: Okay. So just to clarify these word new sites that came online in Europe or were these sites that had already enrolled.

Speaker Change: Well again remember the regulatory timing for getting the amendment through was after that of the U S. So it occurred after the U S started to enroll these patients the majority came in.

Scott Koenig: We are also considering others, which would be very good opportunities for looking at the value of OBRADUO. One moment for our next question. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is now open. Oh, hey, guys.

Speaker Change: In Europe. It was just just the sheer numbers of sites there.

Speaker Change: Understood.

Speaker Change:

Speaker Change: And then I guess in in kind of baking off the $2 7 million 2.0, Q4 W. Doses I mean, I know you just referenced 2.7 is.

Kelsey Goodwin: Thanks for taking my question. First, regarding the ASCO abstract, what should we expect to be included in there? Will it just be safety, or will preliminary efficacy data also be included in the abstract? And then, secondly, could you just remind us how patient enrollment will track throughout 2023 and how we should think about follow-up on the 177 patients in the full ASCO presentation? Thank you. Thank you so much, Kelsey.

Speaker Change: Is it safe to say that you guys have settled on a on a go forward dose at this point and would there be any need to evaluate.

Speaker Change: Both dosing regimens as you expand into some of these additional tumor types.

Speaker Change: I think it's too early to have a final answer on that.

Ed.

Speaker Change: Clearly.

Speaker Change: We want to continue to follow the safety.

Speaker Change: As well as the ultimate activity and as I alluded to in my earlier remarks.

Speaker Change: Expectations for instance, rps or PFS among occur to the.

Scott Koenig: Because of the timing, and I'll discuss enrollment in a second, this became quite obvious. As I pointed out, we had to do a cutoff date in January for the data submission in early February at ASCO. And as a result, we primarily relied on safety data to be included in the abstract, but also noting that our plan was to present, obviously, the clinical efficacy data as we were able to accumulate additional data closer to the time of ASCO. Again, to give you a sense of why these decisions were made in terms of the presentation.

Speaker Change: After the mid year.

Speaker Change: So I think we'll have to see the totality of data to be definitive about which one.

Speaker Change: One goes forward, but as pointed out in the comments earlier.

Speaker Change: The daily data safety monitoring.

Speaker Change: Committee in January looking at the safety.

Speaker Change: At this time and the activity at the time that was available in January.

Speaker Change: <unk> concluded that the boats doses should should continue.

Speaker Change: So I think it will be a decision that we will arrive at by mid year.

Speaker Change: Okay.

Speaker Change: And last question is is the maturity of that our PFS statistic rate limiting to your ability then to.

Scott Koenig: With the amendment to the original TAMARAC study, we began to enroll a few patients at the end of the second quarter. But as it turns out, two-thirds of the patients, of the 177 patients, were enrolled between the second half of the third quarter and the first half of the fourth quarter. So not sufficient time was allowed to accumulate data regarding efficacy. And so that's why the decision was made to primarily include the safety data in the abstract. Perfect. Thank you so much.

Speaker Change: Initiate these additional dose expansion cohorts no no.

Speaker Change: That will not.

Speaker Change: Slow that down at all.

Speaker Change: Working both from a regulatory regulatory advantage and operationalize ing. This.

Speaker Change: So that we can get going by midyear.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from <unk> with BMO capital markets. Your line is now open.

Speaker Change: Great. Thanks for taking our question just a couple for me here too just thinking about.

The mono therapy study.

Speaker Change: Study just you can maybe start.

Speaker Change: Describing what youre thoughts around sort of the pivotal path for development for that in terms of mono therapy or in combination based on what you are observing from tamarac, so far and whether or not any of sort of the recent data sets that have come out and prostate.

Scott Koenig: Thank you. One moment for our next question. Our next question comes from Stephen Willey with Stiefel. Your line is now open. Yeah, good afternoon.

Stephen Douglas Willey: Thanks for... Maybe just to follow up on the enrollment. Can you just do it, I guess.

Speaker Change: Sort of maybe changes the dynamic of how youre thinking about.

Pivotal development.

Scott Koenig: Characterized, Is that primarily across Newly Opened Sites, or... Transcribed by https://otter.ai, Thanks for the question, Steve. So, as we have spoken about it before, the initial sites with a new amendment that were opened were in the U.S., but the number of sites in the U.S. were small.

Speaker Change: What we're doing.

Thanks, Ed.

I won't comment on the activity.

Speaker Change: From the Tamarac study that will come out as go but obviously I'm looking at.

Speaker Change: The landscape.

Speaker Change: What is necessary to.

Scott Koenig: The greatest number of sites were in Europe, and so with the approval of the amendments in the European sites later in the year, this created an opportunity for initiating enrollment in a large number of sites. And as we've discussed before, the rapidity of enrollment was far beyond what we expected. And in fact, we ended up probably, and don't hold me to the exact number, approximately a third of the sites that we intended to open were never opened because of the fast enrollment later in the year on these new sites. So U.S. sites continued to enroll, but just because of the proportion that were in Europe compared to Asia and the U.S., the majority got enrolled in Europe in that bolus in the second half of the year. So just to clarify, these were new sites that came online in Europe, or were these sites... Well, again, remember, the regulatory timing for getting the amendment through was after that of the U.S., so it occurred after the U.S. started to enroll these patients. The majority came in from Europe; it was just the sheer numbers of sites.

Speaker Change: Get a high confidence for.

Speaker Change: A regulatory approval.

Speaker Change: I think we're in a fortunate position now that with a 177 patients dose.

Speaker Change: The Bill and what I commented on earlier that we had a sizable number of patients that were both.

Speaker Change: Chemotherapy experienced as well as chemotherapy naive in this study so while we entered into the study with the idea that.

Speaker Change: Any phase III study would likely to be.

Speaker Change: Done in a post chemo experienced population.

Speaker Change: We have now changed that view that clearly is in a chemo naive population.

Speaker Change: Both the efficacy and safety.

Speaker Change: Warranted that seems to be a very suitable population in earlier line population to pursue.

Speaker Change: And we can also pursue the late line as well so we still have everything open at this point, but until we have more mature data, we won't make make that decision.

Scott Koenig: Unknown Speaker. .. .. .. And then, I guess in in in kind of baking off the, https://www.youtube.com.ac,.

Speaker Change: Great. Thank you.

Speaker Change: Thank you Paul.

Speaker Change: For our next question.

Speaker Change: Yeah.

Speaker Change: Our next question comes from <unk> <unk> with Citigroup. Your line is now open.

Citigroup: Yeah, Hi, Scott and team. Thank you.

Scott Koenig: .. Is it safe to say that you guys have settled? Will there be any? You know, I think it's too early to have a final answer on that. Clearly, we want to continue to monitor safety, as well as ultimate activity. And as I alluded to in my earlier remarks, the expectation, for instance, RPFS won't occur after the mid-year. So I think we'll have to see the totality of data to be definitive about which one goes forward. But as pointed out in the comments earlier, the Data Safety Monitoring Committee in January, looking at the safety at the time and the activity at the time that was available in January, concluded that both doses should continue. So I think it'll be a decision that we will arrive at by mid-year. And the last question is, what is the maturity of that RPFS? No, no, I think that that will not slow that down at all.

Citigroup: Just to clarify so for the Astro abstract it seems like you're just going to it's going to be focused on the safety.

Scott Koenig: But in the presentation at the conference itself or should we expect to see any initial radiographic PFS data or not.

Speaker Change: So thank.

Speaker Change: Thank you very much he golf, so clearly we will show as much efficacy data as possible at the cutoff time.

Likely.

Speaker Change: This is going to be a month.

Speaker Change: A month and a half before the.

Speaker Change: <unk>.

Speaker Change: Our submission is ready for presentation. So as you know the meeting itself is at the end of May I would presume that they will.

Speaker Change: Require us to have the material prepared by mid May.

Speaker Change: So my expectation would be that there would be a cutoff date sort of late March early April.

Speaker Change: With that we will clearly have a lot of data available on patients that have been dose for many months.

Speaker Change: So that would include.

Speaker Change: Obviously, PSA 50 reductions.

Speaker Change: We've looked at overall response rate.

Scott Koenig: We are working both from a regulatory regulatory advantage and operationalizing this so that we can get going by mid year. Thank you. One moment for our next question. Our next question comes from Etzer Darout with BMO Capital Markets. Your line is now open.

Speaker Change:

Speaker Change: For a full day to state obviously, a full dataset with safety with regard to our PFS will have to see how many patients have been dosed for how long to see if we can do some at least preliminary cuts on our PFS. It may require us to wait until the next meeting.

Speaker Change: In the early fall.

Speaker Change: To update that but.

Etzer Darout: Great. Thanks for taking the question. Just a couple for me here, too.

Speaker Change: We certainly will provide as much data as we can.

Speaker Change: Okay. Thanks, and then a moment ago you referenced the PFS.

Scott Koenig: Just thinking about the model therapy, what we're doing, the study, you could maybe start just describing what your thoughts are around sort of the pivotal path or development for that in terms of model therapy or in combination based on what you're observing from Tamarack so far and whether or not any of the recent data sets that have come out about prostate cancer, you know, sort of maybe changes the dynamic of how you're thinking about, you know, the Thanks. Thanks, Etzer. Again, I won't comment on the activity from the Tamarack study that will come out at ASCO. But obviously, looking at the landscape, what is necessary to get high confidence for regulatory approval?

Speaker Change: At least six months it would be the expectation.

Speaker Change: Just wondering for some of these other.

Speaker Change: Comps out there, which we're all familiar with the card trial on the vision trial for <unk> for their respectively.

Speaker Change: Yeah.

Speaker Change: We're slightly higher around eight an eight and a half months those are reasonable expectations or not for what one should expect for <unk> for for Tamarac, Yeah. No I mean again it will depend on whether we go into the chemo naive population or or or chemo experienced and how late line. We would do those studies.

Speaker Change: So that's why it's a little broad if you look at the controls for the studies that you described.

Speaker Change: <unk>.

Speaker Change: Obviously, it will depend on what the.

Speaker Change: <unk> controlled drug is it.

Scott Koenig: I think we are in a fortunate position now that with the 177 patients' dose and what I have commented on earlier, that we had a sizable number of patients that were both chemotherapy experienced as well as chemotherapy naive in this study. So while we entered into the study with the idea that any phase three study would likely be done in a post-chemo experience population, we have now changed that view that clearly, if in a chemo naive population, if both the efficacy and the safety warranted, that seems to be a very suitable population. An early aligned population to pursue. And we can also pursue the late line as well.

Speaker Change: Typical ones for instance for <unk>.

Speaker Change: Chemo naive population was docetaxel for around eight months.

Speaker Change: And similarly in.

Speaker Change: The activity.

Speaker Change: For the card study was about eight months, so, yes, I think that.

Speaker Change: Again, which population you ultimately look at.

Speaker Change: Would require more than just six it would be eight or higher and certainly I just don't want to limit.

Speaker Change: What what.

This drug could potentially treat we just don't know the answer yet I would just pointing out the base minimum.

Particularly on them or later line population would be at least six months.

Speaker Change: Okay.

Speaker Change: Thank you one moment for our next question.

Okay.

Speaker Change: Our next question comes from Jon Miller with Evercore. Your line is now open.

Scott Koenig: So we still have everything open at this point, but until we have the more mature data, we won't make that decision. Great, thank you. Thank you. One moment for our next question. Our next question comes from Yigal Nochomovitz. Citigroup, your lines are now open.

Jonathan Miller: Hi, guys. Thanks for taking the question.

Jonathan Miller: I would love to ask.

Those additional indications that you are moving overdue into in the Tamarac study.

Jonathan Miller: Do you have any additional data from any of those indications in the phase one expansion that we haven't seen at this point.

Yigal Dov Nochomovitz: Yeah, hi, Scott and team. Thank you. Just to clarify, so for the ASCO abstract, it seems like you're just going to be focused on safety. But in the presentation at the conference itself, should we expect to see any initial radiographic PFS data or not? So, thank you very much, Yigal.

Jonathan Miller: Obviously, we've seen a lot of interest in these indications with PCB industry more broadly but preview.

Previously you had said you were prioritizing prostate for bandwidth reasons and to sort of competitively b and white space. There. So can you talk us through a little bit about what changed and why your decision to chase after those indications coming now.

Scott Koenig: So clearly, we will show as much efficacy data as possible at the cutoff time. Likely, this is going to be a month, a month and a half before the submission is ready for presentation. So, as you know, the meeting itself is at the end of May; I would presume that they will require us to have the material prepared by mid May. So my expectation would be that there would be a cutoff date, sort of late March or early April.

Jonathan Miller: And then secondly, I'd love if you could go in a little bit deeper into your differentiation of the new <unk> to six <unk> ADC.

The other.

Jonathan Miller: Total one payload ADC is against the same target that are that are in development.

Speaker Change: Thanks, So much John yes, so as you well know.

Scott Koenig: With that, we will clearly have a lot of data available on patients that have been dosed for many months. So that would include, obviously, PSA 50 reductions, would look at overall response rates, you know, a full data set, obviously a full data set with safety. With regard to RPFS, we'll have to see how many patients have been dosed for how long to see if we can make some at least preliminary cuts on RPFS. It may require us to wait until the next meeting in the early fall to update that. But we certainly will provide as much data as we can. Okay, thanks. And then a moment ago, you referenced the PFS of at least six months. This would be the expectation.

While we have been focusing on prostate cancer because of bandwidth which is correct.

John: As you May recall about two years ago, we were intending to do an expansion is a further expansion in melanoma, but had to cut back because of cash at that time. So that was that was clearly.

John: A population that we had a strong interest and we also had seen in the expansion studies.

John: Very good activity.

John: In other indications so.

John: Things like non small cell lung cancer.

Became a great opportunity to us activity in head and neck cancer as well we have not had any.

John: Experience.

John: With anal cancer.

Scott Koenig: I'm just wondering about some of these other comps out there, which we're all familiar with the CARD trial and the VISION trial, or Cabeza-Taxel and Covicta, respectively. As we know, those were slightly higher around eight and eight and a half months. Are those reasonable expectations or not for what one should expect for Tamarax? Yeah, no, and again, it'll depend on whether we go into the chemo-naive population or chemo experience population and how late we do those studies. So that's why it's a little broad.

John: With the Volcker duo and small cell.

John: As obvious as I alluded to before based on.

John: Others experienced there. So those are the initial reasoning behind going after this and we believe that with the improved.

John: Potential safety profile of the new dosing regimen.

John: These patients with these other cancers, we will be able to stay on drug longer.

John: Potentially.

Scott Koenig: If you look at the controls for the studies that you described, it obviously will depend on what the control drug is. The typical ones, for instance, in the chemo-naive population, were docetaxel for around eight months. And similarly, the activity for the CARD study was about eight months. So yeah, I think that, again, which population you ultimately look at would require more than just six; it would be eight or higher. And certainly, I just don't want to limit what this drug could potentially achieve. We just don't know the answer yet.

John: Good outcomes and that's why we're looking to expand into those indications now with regard to 026.

John: As I pointed out this.

John: This is a great opportunity for us.

John: So really.

John: Take in an important answer important questions and have a great opportunity.

John: For treating a wide range of cancers as you are well aware.

John: Different chemotherapies work in different tumors and combination chemotherapy as well as combinations with other modalities.

The typical standard of treatment.

Scott Koenig: I was just pointing out the base minimum, particularly on a later line population, would be at least six. Thank you. One moment for our next question. Our next question comes from John Miller with Evercore. Your line is now open. Hi guys, thanks for taking the question.

John: For cancer, and so given that we've had wonderful.

John: Experience with the variable domain of overdue.

John: Its activity and what we believe to potentially be a superior turbo.

Jonathan Miller: I would love to ask about those additional indications that you're moving Voverduo into in the Tamarack study. Do you have any additional data from any of those indications in Phase 1 expansion that we haven't seen at this point? And obviously, we've seen a lot of interest in these indications with B7H3 more broadly, but previously, you had said you were prioritizing prostate cancer for bandwidth reasons and to sort of competitively be in white space there. So can you talk us through a little bit about what changed and why your decision to chase after those indications is coming now? And then secondly, I'd love if you could go a little bit deeper into the differentiation of the new 026 B7H3 ADC from the other TOPA1 payload ADCs against the same target that are in development. Thanks so much, John.

John: Topo one inhibitor.

John: Payload are based on the <unk> profile and as I pointed out from various vantage points, including.

John: Increased activity potency.

John: A less susceptibility to <unk>, some multi drug resistance.

John: Better cell permeability bystander effect.

John: The fact as Daiichi has pointed out many of the.

John: Uh huh.

John: Interstitial lung disease complications they are ascribing to.

John: Binding to alveolar macrophages and by the fact that this.

John: This <unk> platform.

John: Eliminates the binding.

John: <unk>.

John: Through.

John: FC receptors as well as mass receptors, one shouldn't potentially has the ability to reduce.

John: ILD effect with a topo one inhibitor. So from all of these vantage point and from all the things that I described earlier looking at the ability to treat with Purdue owl looking at potential combinations without 26 down the line looking at treatment of different tumor.

Scott Koenig: Yes. So, as you well know, while we've been focusing on prostate cancer because of bandwidth, which is correct, as you may recall, about two years ago, we were intending to do an expansion as further expansion for melanoma, but had to cut back because of cash at that time. So that was clearly a population that we had a strong interest in.

John: I think this.

John: <unk> with a great opportunity.

Speaker Change: Thanks, Scott have we seen all of the data from the various other indications that you were looking at in phase one before you put those on hold.

Speaker Change: Okay.

Scott Koenig: We have not attacked announcement.

Scott Koenig: Yes, we have not and.

Scott Koenig: To date, we will.

Scott Koenig: We also saw very good activity in other indications, so things like non-small cell lung cancer became a great opportunity for us, activity in head and neck cancer as well. We have not had any experience with anal cancer with the VOBRA duo.

Scott Koenig: Put all that data together for publication so yes.

Scott Koenig: Future time, but there is data yet to be presented.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Our next question comes from Caveri Pullman with <unk>. Your line is now open.

Kaveri Pohlman: Yeah, good evening and thanks for taking my questions.

Scott Koenig: And small cell was as obvious as I alluded to before, based on others' experience there. So that was the initial reasoning behind going after this. And we believe that with the improved potential safety profile of the new dosing regimen, these patients with these other cancers will be able to stay on the drug longer to have potentially good outcomes. And that's why we're looking to expand into those indications. Now, with regard to O2-6, as I pointed out, this is a great opportunity for us to really take an important step, answer important questions, and a great opportunity for treating a wide range of cancers. As you are well aware, different chemotherapies work in different tumors, and combination chemotherapy, as well as combinations with other modalities, is the typical standard of treatment for cancer.

Kaveri Pohlman: For the upcoming readout.

Kaveri Pohlman: We'll have <unk> data out for both Docetaxel naive and experienced patients, but since you are not going to have mature our PFS data till second half how are you thinking about making a decision on where you go in terms of a phase three trial.

Speaker Change: Well a good question because clearly there will be other metrics that we will be looking at beyond just the our PFS, but there will be a certain number of those patients that will have advanced.

Speaker Change: Certainly we'd like to have the full.

Speaker Change: Data set to make a final decision, but I think by mid year, we will know I'm quite well if we're on track.

Speaker Change: For our moving forward to a phase III point, and obviously, we don't want to wait till the last minute because operationally I'm, there's a lot to do.

Speaker Change: Not the least of which is.

Speaker Change: Engagement with our regulatory agencies to describe.

Plans and get feedback there. So we were just.

Scott Koenig: And so, given that we've had wonderful experience with the variable domain of VOBERDUO in its activity, and what we believe to potentially be a superior TOPO1 inhibitor payload, based on the SINIFIX profile, and as I pointed out, from various vantage points, including increased activity, potency, less susceptibility to efflux, multi-drug resistance, better cell permeability, and bystander effect. And the fact, as Daichi has pointed out, many of the interstitial lung disease complications are attributed to binding to alveolar macrophages, and by the fact that this SINIFIX platform eliminates the binding through FC receptors, as well as mass receptors, one should potentially have the ability to reduce the ILD effect with a TOPO1 inhibitor. So, from all these vantage points, and from all the things that I described earlier, looking at the ability to treat with VOBERDUO, looking at potential combinations with O26 down the line, looking at treatment for different tumors, I think this provides us with a great opportunity. Thanks, Scott. Have we seen all of the data from the various other indications that you were looking at in phase one before you put those on hold? We have not done so. We have not done so. We have not done so.

Speaker Change: Wanna be as aggressive as possible once we have at least a large body of data.

Speaker Change: Available to us by mid year.

Speaker Change: Alright, that's helpful. And then my second question is regarding M. G. D. O Q4, any color on when you expect to complete the phase one trial and how much time Gilead will have to make a decision to opt in once you provide the data.

Speaker Change: So with regard to 024 as I was commenting on we are in the middle of dose escalation as you know for.

Speaker Change: T cell redirected, killing mechanism for bi specifics the regulatory agencies have been very.

Speaker Change: Tripped.

Speaker Change: On the rate in which one can do the dose escalation and so that's really been what the most the limiting factor here. So I can't tell you what the end will be we are through many cohorts of groups and continuing.

Speaker Change: As quickly as possible.

Speaker Change: That Julie.

Speaker Change: Gilead hasn't.

Speaker Change: Until a short period of time after we present the full phase one data to them to opt in on the program. So they are clearly theres still time and clearly if they if.

Speaker Change: During the dose escalation if they decide they want to opt in they have the right to do so.

Speaker Change: Thank you for a moment for our next question.

Speaker Change: Yes.

Speaker Change: Yeah.

Speaker Change: Our next question comes from Tara Bancroft with TD Cowen. Your line is now open.

Scott Koenig: Yeah, we have not. And at a future date, we will put all that data together for publication. So yes, at a future time, but there is data yet to be presented. Thank you. One moment for our next question. Our next question comes from Kaveri Pohlman with BTIG. Your line is now open. Yeah, good evening.

Hi, good afternoon.

Speaker Change: No.

Tara Bancroft: I understand the rationale for potentially enabling broad development of OCA develop with the with the inclusion of pre taxane patients.

Tara Bancroft: But.

Tara Bancroft: I'm curious what details you will give us in the presentation about baseline characteristics and in particular will you include time to progression on initial therapy and I have depending on your answer a follow up on that.

Kaveri Pohlman: Thanks for taking my question. For the upcoming readout, you will have OBRADUO data for both DOSA-Texel naive and experienced patients, but since you are not going to have mature RPFS data till the second half, how are you thinking about making a decision on where to go in terms of a phase three trial? Well, a good question, Kaveri.

Tara Bancroft: So.

Tara Bancroft: Clearly tried to provide a detailed possible on that population I don't know.

Tara Bancroft: How many of the patients we have that data in the database.

Tara Bancroft: In terms of their time to progression.

Speaker Change: I will have to go back and look at that.

Speaker Change: And update you.

Speaker Change: At a future date I, just don't know that off the top of my head of how many of those patients we have.

Speaker Change: That data.

Speaker Change: Okay, yeah. Thanks.

Scott Koenig: You know, clearly, there will be other metrics that we will be looking at beyond just the RPFS. But there will be a certain number of those patients that will have advanced. We certainly would like to have the full data set to make a final decision, but I think by mid-year, we'll know quite well if we're on track for moving forward to a Phase 3 point. And obviously, we don't want to wait till the last minute, because operationally, there's a lot to do, not the least of which is engagement with regulatory agencies to describe plans and get feedback there. So we would just want to be as aggressive as possible once we have at least a large body of data available to us by mid-year. That's helpful.

Speaker Change: So.

Speaker Change: Alright, you're not excluding rapid progresses, right and if not how would you expect them to affect our PFS like is that where you were six months versus eight months expectations come from are those patients.

Speaker Change: I think you've hit the nail on the head and that's why I'm trying to give a little bit broad brush strokes on that and understanding of patients there or rapid progressions are allowed here as we opened up for instance, the study the original design of the study required a at least.

Speaker Change: <unk> months.

Speaker Change: Of.

Speaker Change: Treatment on in a rat.

Speaker Change: To be in.

Speaker Change: All a fight for enrollment in our study and when we.

Scott Koenig: And then my second question is regarding MGD-024. Any color on when you expect to complete the phase one trial and how much time Gilead will have to make a decision to opt in once you provide the data? So with regard to O24, as I was commenting, we are in the middle of dose escalation. As you know, for T cell redirected killing mechanisms for bi-specifics, the regulatory agencies have been very strict on the rate at which one can undo the dose escalation. And so that's really been what the most important, the limiting factor here.

Speaker Change: Remove that requirements clearly patients who had very short courses.

Speaker Change: And progressed quickly.

Speaker Change: Well it is very newly diagnosed.

Speaker Change: Patients.

Speaker Change: Hum before they got their initial treatment.

Speaker Change: Presented as metastatic disease. These are the type of patients that could have a much more.

<unk> of course, and a shorter course to any treatment. So that is why.

Speaker Change: We have gotten actually also feedback from kols that having a baseline of six months is not unreasonable for that type of patient.

Speaker Change: Okay. Thank you so much.

Scott Koenig: So I can't tell you what the end will be. We are through many cohorts of groups and continuing upward as quickly as possible. With that, Gilead hasn't until a short period of time after we present the full phase one data to them to opt in to the program. So clearly, there's still time.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Yeah.

Speaker Change: Our next question comes from according Kowalski with Barclays. Your line's now open.

Speaker Change: Okay.

Speaker Change: Hi, This is Peter Lawson.

From Barclays. So just couple of questions Firstly.

Peter Richard Lawson: In the abstract where we see safety data broken out by discontinuation rate.

Peter Richard Lawson: Or.

Peter Richard Lawson: Side effects such as comfort.

Peter Richard Lawson: Fusion.

Scott Koenig: And clearly, if during the dose escalation, if they decide they want to opt in, they have the right to do so. Thank you. One moment for our next question. Our next question comes from Tara Bancroft with TD Kallen. Your line is now open. Hi, good afternoon.

I got a follow up.

Peter you will have the discontinuation rates as of that cut.

Peter Richard Lawson: <unk> data.

Peter Richard Lawson: With regard.

Peter Richard Lawson: In the abstract itself I don't recall specifically.

Peter Richard Lawson: How deep in terms of the breakdown of the.

Tara Bancroft: So, I understand the rationale for potentially enabling broad development of overdraw with the inclusion of pre-taxing patients. But, I'm curious what details you will give us in the presentation about baseline characteristics and, in particular, will you include time to progression on initial therapy? And I have, depending on your answer, a follow-up on that. So, you know, we will clearly try to provide as much detail as possible on that population.

Speaker Change: As where I have to get back to you on that.

Speaker Change: Okay. Thank you and then in the Turmeric study.

Speaker Change: Patients been exposed to radiopharmaceuticals such as Victor.

Speaker Change: You have to break that out eventually.

Speaker Change: Yeah. Unfortunately, they are allowed in the study, but given the timing of the study and as I pointed out the majority of these patients.

Speaker Change: Came from Europe.

Speaker Change: The actual availability of predictable.

Speaker Change: And the timing didn't work out to get a.

Speaker Change: Predict though progressive is an experienced patients there we expect a few of them from.

From the U S, but very small numbers there.

Scott Koenig: I don't know how many of the patients we have that data in the database in terms of their time to progression. We'll have to go back and look at that and update you at a future date. I just don't know off the top of my head how many of those patients we have that data on. Okay. Yeah, thanks. So you're not excluding rapid progressors, right? And if not, how would you expect them to affect RPFS?

Speaker Change: Thank you for that.

Speaker Change: Quick question for Jim on the puts and takes around the.

James Karrels: Around the cash guidance, just with the expansion that would be seven phase III clinical trials.

Speaker Change: That's it.

James Karrels: Negative for cash, but what are the puts and takes we should kind of be thinking about for you to maintain that cash guidance. Yeah. Thanks, Peter Thanks for the question. So our guidance of cash runway into 2026 reflects the additional.

Speaker Change: Cohorts under the Tamarack umbrella that additional Barbara duo cohorts. So everything we're talking about all of these studies that were currently.

Speaker Change: Running.

Scott Koenig: Like, is that where your six-month versus eight-month expectations come from? Are those patients? I think you've hit the nail on the head, and that's why I'm trying to give a little bit of broad brushstrokes on that, on understanding the patients. Rapid progressors are allowed here.

Speaker Change: And.

Speaker Change: Talking about running are all included as part of our guidance.

Speaker Change: Gotcha.

Speaker Change: Any additional inflows of cash youre thinking through particular, counterbalanced that or was that always in the cash guidance Peter I'm, sorry could you repeat the question. Please.

Peter Richard Lawson: Any additional cash inflows.

Peter Richard Lawson: Thinking through or whether those cohort always in the cash guidance.

Peter Richard Lawson: Those cohorts are new to the guidance I'm there had been some savings.

Scott Koenig: As we opened up, for instance, the study, the original design of the study required at least 12 months of treatment on an ARAT to be qualified for enrollment in our study. And when we removed that requirement, clearly, patients who had very short courses and progressed quickly, as well as very newly diagnosed patients, before they got their initial treatment presented as metastatic disease, these are the type of patients that could have a much more aggressive course and a shorter course to any treatment. So that is why we have gotten feedback from KOLs that having a baseline of six months is not unreasonable for that type of patient. Okay, thank you so much.

Peter Richard Lawson:

Peter Richard Lawson: Well, there's always the possibility of additional business development activities and of course with $1 billion in milestones hanging out there related to both Tcl diners of which we've handicapped significantly.

Speaker Change: We'd anticipate.

Speaker Change: A recognition of some of those over the over the next couple of years.

Speaker Change: Okay.

Speaker Change: And there were some additional revenues coming in that Werent anticipated originally that.

Speaker Change: Part of this guidance so.

Speaker Change: Great. Okay. Thank you so much thanks for the clarity.

Thank you one moment for our next question.

Speaker Change: Our next question comes from Silvan <unk> with citizens JMP. Your line is now open.

Silvan: Yeah. Thank you. Thanks for taking my question and congrats on the progress.

Silvan: Maybe piggybacking a little bit on a previous question.

Courtney Kowalski: Thank you. One moment for our next question. Our next question comes from Courtney Kowalski with Barclays. Your line is now open.

Silvan: What what's the bar for safety profile it'd be abstract or also at the asphalt presentation versus the safety profile that we've seen on the older doses and I'm asking in particular, maybe.

Silvan: On the grade three or higher issues that we've seen with the hand foot mouth signal and perhaps some neutropenia idea can you just comment on what you're trying to improve and is there any bar that makes you.

Unknown Executive: Hi. A couple of questions, in the abstract, broken out by and The Bulletproof Executive 2013. Peter, you will have the discontinuation rates as of that cut of January data. With regard to the abstract itself, I don't recall specifically how deep in terms of the breakdown of the AEs were.

Speaker Change: Confident in the future here, Thank you and I have a follow up.

Speaker Change: Sure Silvan.

Just want to correct you our concern was not great three our Hanford, obviously, we want to avoid that at all though the incidence of that was quite low.

Unknown Executive: I'll have to get back to you on that. Thank you. And then in the Temerix,

The issue was that patients with either grade with grade two where they have experiencing pain.

Unknown Executive: The patient's been exposed to radiopharmaceuticals. Transcribed by https://otter.ai Yeah, unfortunately, they were allowed in the study. But given the timing of the study, and as I pointed out, the majority of these patients came from Europe, the actual availability of Plovicto and the timing didn't work out to get those Plovicto progressors and experienced patients there. We expect a few of them from the US, but in very small numbers. Quick question for Jim on the puts and take around the cash guidance just with the Expansion of the B7H3 Chloroquine Trial. I guess that's it. Negative for cash, but what are the puts and takes we should kind of be thinking about?

Speaker Change: B.

Speaker Change: Electing to come off treatment. Despite the fact that they were having antitumor effects and so number one is the most important is is that if we can decrease the incidence.

Speaker Change: Totally.

Speaker Change: And then for those.

Speaker Change: That has with a reduced incidence.

Speaker Change: Converting or preventing them from going from grade one to great too.

Speaker Change: It would be what our goal is there with regard to the neutropenia clearly that is something most likely due to free.

Speaker Change: Toxin getting to the bone marrow, but again. This is this is a situation where.

Speaker Change: It was largely a laboratory value.

Speaker Change: It did not.

Unknown Executive: maintain, Yeah, thanks, Peter. Thanks for the question. So our guidance of cash runway into 2026 reflects the additional cohorts under the Tamarack umbrella, the additional Bogerduo cohorts. So everything we're talking about, all of these studies that we're currently running and talking about running are all included as part of our guide. Are there any additional inflows of cash you're thinking through?

Speaker Change: Our result in increased infections or febrile neutropenia.

Speaker Change: And so this is mostly handled by <unk>.

Speaker Change: Holding the whole thing the drug we're stopping the drug.

Speaker Change: And again, if we can reduce that.

Speaker Change: Both in terms of incidence and grade I think that would be better but that wasn't as as.

Speaker Change: Concerning to the treating physicians in managing these patients.

Unknown Executive: Unknown Executive, Kaveri Pohlman, MacroGenics Inc., Unknown Executive, Kaveri Pohlman, MacroGenics, Those cohorts are new to the guidance. There have been some savings. And there's always the possibility of additional business development activities.

Speaker Change: Great. Thank you and maybe about the lorikeet study well.

Speaker Change: We get data from that study this year and.

Speaker Change: Maybe how does that relates to your late stage a monotherapy plants. You know if you if you get data from the combo of what we're doing.

Unknown Executive: And of course, with a billion dollars in milestones hanging out there related to both TZL and Zinus, of which we've handicapped significantly, we would anticipate recognition of some of those over the next couple of years. And there were some additional revenues coming in that weren't anticipated originally that are part of this guidance. Okay, thank you. Thank you. One moment for our next question. Our next question comes from Silvan Tuerkcan with Citizens J&P. Your line is now open. Yeah, thank you. Thanks for taking my question on the progress. Maybe piggybacking a little bit. Questions?

Speaker Change: With regard to the timing of this will provide as I said earlier update on this study.

It ultimately it will depend on the speed in which we can enroll these patients.

Speaker Change: Clearly over the next two months will be OUI exceed the.

Speaker Change: The plan or will it take longer meaning later in the year to get full enrollment of this study if it's the latter it's more likely that we'll have a more fulsome update.

Speaker Change: In early 'twenty, five, but again, we will.

Speaker Change: Be able to give you a little bit more guidance later in the year based on enrollment.

Speaker Change: Enrollment rates.

Silvan Can Tuerkcan: ... What, what's the bar?

Unknown Executive: Safety Profile in the abstract or also at, versus the safety profile that, All that, on Grade 3 or higher. Transcription by Trans-Expert at Fiverr.com. What you're trying to improve and is there any bar, Silvan? I just want to correct you. Our concern was not Grade 3 hand-foot. Obviously, we want to avoid that at all, though the incidence of that was quite low.

Speaker Change: With regard to.

Speaker Change: Our success in this trial.

Speaker Change: Clearly we're testing this in a chemo naive population in combination with Docetaxel.

I think that if that trial is successful it's a great.

Speaker Change: Problem to have if the bulbar duo.

Speaker Change: Turns out also in that same line of therapy I should also say that we are not eliminating.

Speaker Change: Eliminating the possibility that we're going to look at.

Scott Koenig: The issue was that patients with grade 2 where they were experiencing pain would be electing to come off treatment despite the fact that they were having anti-tumor effects. And so number one is the most important, is that we can decrease the incidence totally. And then for those that have it with a reduced incidence, converting or preventing them from going from grade 1 to grade 2 would be our goal there. With regard to the neutropenia, clearly that is something most likely due to free toxin getting to the bone marrow. But again, this is a situation where it was largely a laboratory value. It did not result in increased infections or febrile neutropenia.

Speaker Change: Lorikeet, I'm, sorry, Laura Gerald I Mab in later line prostate cancer that is certainly a possibility to consider.

Speaker Change: But as I have said before.

We are also going to look to Laura Joe might have outside of prostate cancer going forward. So.

Speaker Change: It's just too early to make a decision on registration studies until we have the data.

Speaker Change: Great. Thank you.

Speaker Change: Thank you.

Speaker Change: Yes.

Speaker Change: As a reminder to ask a question. Please press star one one on your telephone.

Speaker Change: Wait for your name to be announced.

Speaker Change: To withdraw your question. Please press star one again.

Speaker Change: Yes.

Speaker Change: Next question.

Speaker Change: From Yigal <unk> with Citigroup. Your line is now open.

Yigal: Oh, hi, Thank you so much for taking the follow up Scott I just had a quick follow up on Tamarac. It's unusual that you see a trial that 77% over enrolled relative to the target and enrolled very quickly could.

Scott Koenig: And so this is mostly handled by holding the drug or stopping the drug. And again, if we can reduce that both in terms of incidence and grade, I think that will be better. But that wasn't as concerning to the treating physicians in managing these patients. Great, thank you. And maybe about the Laura Keats study. Will we get data from that study this year, and how does that relate to your late stage monotherapy plan? You know, if you get data from the combination of what we're doing.

Yigal: Could you just comment on some of the factors that resulted in the and the heavy open enrollment and as well as the.

Yigal: The speed to which it was over enrolled thanks.

Scott Koenig: Yeah. So you go with regard to our decision on letting so many more patients into the study.

Speaker Change: As we felt it.

Speaker Change: Was not ethical.

Speaker Change: For us to not allow these patients into the study if they had already been in screening in past.

Scott Koenig: With regard to the timing of this, we'll provide, as I said earlier, an update on the study. It will ultimately depend on the speed in which we can enroll these patients. Clearly, over the next two months, will we exceed the plan, or will it take longer, meaning later in the year, to get full enrollment in this study? If it's the latter, it's more likely we'll have a more fulsome update in early 25.

Speaker Change: Screening requirements and so we felt that we.

Speaker Change: We should do this because the patient's mayday and the investigators made great efforts.

Speaker Change: Find patients in the study.

Speaker Change: As I was commenting on earlier.

Speaker Change: A surge of enrollment.

Speaker Change: Once we had the go ahead.

Speaker Change: From the amended.

Speaker Change: Protocol in Europe.

Scott Koenig: But again, we'll be able to give you a little bit more guidance later in the year based on enrollment rates. With regard to the success of this trial, clearly, we're testing this in the chemo-nave population in combination with dosetaxel. I think that if that trial is successful, it's a great problem to have if the VOBER duo pans out in that same line of therapy. I should also say that we are not eliminating the possibility that we're going to look at laurogelamab in later-stage prostate cancer. That is certainly a possibility to consider.

Speaker Change: There was tremendous enthusiasm.

Speaker Change: To join this study and I'm sure there are a lot of different reasons as I was pointing out.

Speaker Change: Some of the amendments included the fact that we didn't require 12 months of of of treatments on in Iraq, and so patients who were progressing.

Speaker Change: Quickly.

Speaker Change: Were able to join the study and they probably did not have much in terms of other alternatives. There also it turns out to be a large number of patients for varying reasons, whether theyre not qualified.

Speaker Change: To go on Docetaxel or chemotherapeutic or they choose not to I think we attracted a large number of those patients into this study that allowed us to have a very sizable sub population of a chemo naive patients.

Scott Koenig: But, as I have said before, we are also going to look at laurogelamab outside of prostate cancer going forward. So it's just too early to make a decision on registration studies until we have the data. Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be called. To withdraw your question, please press star 11 again. Next question. This comes from Yigal Nochomovitz with Citigroup. Your line is now open.

Speaker Change: Got it thank you very much.

Speaker Change: Thank you.

I'm showing no further questions at this time I would.

Speaker Change: Now I'd like to turn it back to Scott <unk> for closing remarks.

Scott Koenig: Well. Thank you very much for participating in our call today, we look forward to obviously updating you at ash.

Scott Koenig: <unk> in the near term and talk to you at a future time that on earnings calls and in other venues. Thank you very much.

Yigal Dov Nochomovitz: Oh, hi, thank you so much for taking the follow-up. Scott, I just had a quick follow-up on Tamarack. You know, it's unusual that you see a trial that's 77% over enrolled relative to the target and enrolled very quickly. Could you just comment on some of the factors that resulted in the heavy over enrollment and as well as the speed to which it was over enrolled? Thanks.

Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.

Speaker Change: Okay.

Speaker Change: Okay.

Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Scott Koenig: Yeah, so Yigal, with regard to our decision to let so many more patients into the study, we felt it was not ethical for us not to allow these patients into the study if they had already been in screening and passed the screening requirements. And so we felt that we should do this because the patients made a commitment, and the investigators made great efforts to find patients in the study. As I was commenting earlier, you know, the surge of enrollment once we had the go-ahead from the amended protocol in Europe, there was tremendous enthusiasm to join the study. And I'm sure there are a lot of different reasons.

Speaker Change: Yeah.

Speaker Change: Okay.

Speaker Change: Hum.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Scott Koenig: As I was pointing out, some of the amendments included the fact that we didn't require 12 months of treatment on an ARAT. And so patients who were progressing quickly were able to join the study, and they probably did not have much in terms of other alternatives. There also, it turns out, are a large number of patients for varying reasons, whether they're not qualified to go on docetaxel or chemotherapeutics, or they choose not to. I think we attracted a large number of those patients into the study that allowed us to have a very sizable subpopulation of chemo-naive patients.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: So.

Speaker Change:

Speaker Change: [music].

Scott Koenig: Got it. Thank you very much. Thank you. I'm showing no further questions at this time. I would now like to turn it back to Scott Koenig.

Speaker Change: Okay.

Speaker Change: [music].

Scott Koenig: Closing remarks. Well, thank you very much for participating in the call today. We look forward to obviously updating you at ASCO in the near term and talking to you at future times on earnings calls and in other venues. Thank you very much. This concludes today's conference call. Thank you for participating. You may now disconnect, www.youtube.com, The Ultimate Parody Site! www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au www.youtube.com.au

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: Okay.

Speaker Change: [music].