ADAM9

Upcoming poster presentation of protocol-defined TAMARACK Phase 2 mCRPC study data at ESMO in SeptemberReceived $100.0 million in milestones related to Incyte’s advancement of ZYNYZ® (retifanlimab-dlwr) subsequent to quarter-endConfirming cash runway guidance into 2026 ROCKVILLE, Md., Aug. 06, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2024. “We are pleased to have the opportunity to present updated safety and efficacy data from our Phase 2 TAMARACK trial of vobra duo at the upcoming European Society for Medical Oncology (ESMO) Congress in September," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “In addition, we recently solidified our cash position with the receipt of $100.0 million in milestones, following the positive Phase 3 top-line results from Incyte’s registrational studies of retifanlimab in both anal and lung cancer.” Updates on Proprietary Investigational Programs Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below. B7-H3-Directed Therapies Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The TAMARACK Phase 2 study of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). MacroGenics completed enrollment of the TAMARACK study in the fourth quarter of 2023, and the study has reached its landmark primary endpoint of 6-month radiographic progression-free survival (rPFS) rate. While mCRPC study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression and survival.Updated TAMARACK safety and efficacy data, including the study’s primary endpoint, will be presented in a poster session at the ESMO Congress in September 2024. This data will be based on a data cut-off date of July 9, 2024. The abstract submitted to ESMO in May was based on an April 12 data cut off. MacroGenics expects to have the mature efficacy findings, including median rPFS, in the second half of 2024 and plans to present the data at a subsequent medical conference.Following the ESMO poster presentation, the Company plans to host a conference call with investors to discuss the TAMARACK data and potential next steps for vobra duo.MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination later this year. MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing. Lorigerlimab Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. In addition to the ongoing study of lorigerlimab in combination with vobra duo mentioned above, MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of rPFS. The Company anticipates completing enrollment of the study in 2024 or early 2025 and providing a clinical update in the first half of 2025. Emerging ADC Pipeline MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease 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. The Company continues to anticipate submitting an investigational new drug (IND) application for MGC028 by the end of 2024 and initiating a Phase 1 clinical study in 2025. Partnered Programs MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. (Gilead) has the option to license MGD024 at predefined decision points during the Phase 1 study.ZYNYZ® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. Incyte recently announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal and non-small cell lung cancer and continues to conduct global studies of retifanlimab across multiple indications.Subsequent to June 30, 2024, MacroGenics announced the achievement of $100.0 million in milestones from Incyte related to development progress of retifanlimab, following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met. MacroGenics is further eligible to receive up to a total of $210.0 million in remaining development and regulatory milestones and up to $330.0 million in potential commercial milestones from Incyte. MacroGenics receives tiered royalties of 15% to 24% from Incyte on any global net sales of the product and manufactures a portion of Incyte’s global commercial supply of retifanlimab. Second Quarter 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities balance as of June 30, 2024, was $140.4 million, compared to $229.8 million as of December 31, 2023. The June 30, 2024 balance did not include the $100.0 million in milestones subsequently received from Incyte.Revenue: Total revenue was $10.8 million for the quarter ended June 30, 2024, compared to total revenue of $13.1 million for the quarter ended June 30, 2023. The decrease was primarily due to less revenue recognized under the Provention Asset Purchase Agreement and was partially offset by increased revenue from the Company’s collaboration with Gilead and increased contract manufacturing revenue.R&D Expenses: Research and development expenses were $51.7 million for the quarter ended June 30, 2024, compared to $43.2 million for the quarter ended June 30, 2023. The increase was primarily due to manufacturing and IND-enabling costs related to MGC028.SG&A Expenses: Selling, general and administrative expenses were $14.4 million for the quarter ended June 30, 2024, compared to $13.7 million for the quarter ended June 30, 2023.Net Income (Loss): Net loss was $55.7 million for the quarter ended June 30, 2024, compared to net income of $57.5 million for the quarter ended June 30, 2023. Net income for the quarter ended June 30, 2023 included approximately $100.0 million as a component of Other Income related to the sale of the Company’s single-digit royalty interest on global net sales of TZIELD® (teplizumab-mzwv) to DRI Healthcare Acquisitions LP in March 2023.Shares Outstanding: Shares of common stock outstanding as of June 30, 2024 were 62,720,969.Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $140.4 million as of June 30, 2024, plus the $100.0 million in milestones subsequently received from Incyte, in addition to projected and anticipated future payments from partners and product revenues should support its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies. No Conference Call Given the embargoed TAMARACK data being presented at the upcoming ESMO presentation, the Company’s management has entered a quiet period and will not be hosting a conference call to discuss its financial results or corporate progress for the quarter ended June 30, 2024. The Company intends to resume its quarterly results conference calls in the future. MACROGENICS, INC.SELECTED CONSOLIDATED BALANCE SHEET DATA(Amounts in thousands) June 30, 2024 December 31, 2023 (unaudited) Cash, cash equivalents and marketable securities$140,372 $229,805 Total assets 201,137 298,418 Deferred revenue 79,321 80,894 Total stockholders' equity 57,819 152,613 MACROGENICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(Unaudited)(Amounts in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Revenues: Collaborative and other agreements$2,065 $6,021 $3,514 $22,708 Product sales, net 5,248 5,062 10,109 8,552 Contract manufacturing 2,893 1,587 5,169 5,202 Royalty revenue 98 — 258 421 Government agreements 493 466 851 749 Total revenues 10,797 13,136 19,901 37,632 Costs and expenses: Cost of product sales 176 258 446 371 Cost of manufacturing services 2,647 919 4,493 4,329 Research and development 51,732 43,229 97,760 89,101 Selling, general and administrative 14,423 13,692 29,133 27,219 Total costs and expenses 68,978 58,098 131,832 121,020 Loss from operations (58,181) (44,962) (111,931) (83,388)Gain on royalty monetization arrangement — 100,930 — 100,930 Interest and other income 2,523 2,275 5,216 3,348 Interest and other expense (6) (774) (1,139) (1,430)Net income (loss) (55,664) 57,469 (107,854) 19,460 Other comprehensive income (loss): Unrealized gain (loss) on investments 11 (80) (18) (67)Comprehensive income (loss)$(55,653) $57,389 $(107,872) $19,393 Net income (loss) per common share: Basic$(0.89) $0.93 $(1.73) $0.31 Diluted$(0.89) $0.92 $(1.73) $0.31 Weighted average common shares outstanding: Basic 62,663,677 61,880,096 62,477,108 61,845,151 Diluted 62,663,677 62,261,646 62,477,108 62,030,710 About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, including trial design, initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from the Company’s products and product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), the Company’s current cash resources supporting our planned operating expenses and capital requirements into 2026 and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com

ROCKVILLE, Md., Feb. 24, 2022 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2021. “We are excited about our 2022 plans for our B7-H3-directed programs for the potential treatment of multiple solid tumors. We believe we are well-positioned to be a leader in this promising field and are prioritizing our efforts around B7-H3. First, I am pleased to share that later this quarter, we plan to meet with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential registration-directed study of MGC018 in patients with metastatic castration-resistant prostate cancer (mCRPC). Second, we expect to initiate a study of MGC018 in combination with lorigerlimab, our bispecific DART molecule targeting PD-1 and CTLA-4, in the coming weeks. And third, during the second half of this year, we intend to provide an update from a study of our second B7-H3 targeted molecule, enoblituzumab, being evaluated in combination with two of our checkpoint molecules in front-line squamous cell carcinoma of the head and neck (SCCHN). Beyond these B7-H3 programs, we are advancing several of our other clinical-stage molecules and have a variety of ongoing preclinical activities intended to expand our pipeline of differentiated investigational product candidates for the potential treatment of cancer,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. Updates on Proprietary Programs B7-H3 Programs: MacroGenics is developing two investigational, clinical product candidates that target B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation. Recent highlights for these two molecules include: MGC018is an antibody-drug conjugate (ADC) that targets B7-H3. MacroGenics presented encouraging preliminary clinical results from an ongoing Phase 1/2 study of MGC018 in patients with solid tumors at the American Society of Clinical Oncology (ASCO) and European Society for Medical Oncology (ESMO) meetings in 2021. The Phase 1/2 study expansion cohorts are fully enrolled for patients with mCRPC (n=40) and smaller cohorts of patients (n=approximately 20 each) with non-small cell lung cancer (NSCLC), melanoma and triple negative breast cancer (TNBC), while the Company continues to recruit patients for the SCCHN cohort. MacroGenics plans to meet with FDA later this quarter to discuss its development strategy in mCRPC. In addition, the Company intends to provide an update on clinical data from the dose expansion cohorts in the second half of 2022 as the data further mature. Finally, beyond monotherapy, the Company expects to initiate a combination study of MGC018 with lorigerlimab across multiple indications in the coming weeks. Enoblituzumab is an Fc‐engineered, monoclonal antibody (mAb) that targets B7‐H3. MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in combination with retifanlimab, the Company's investigational, anti-PD-1 antibody that was licensed to Incyte, in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company expects to complete enrollment of the PD-L1 positive patient cohort during the first half of this year and provide an update on this cohort during the second half of the year. I-Mab, MacroGenics’ partner in Greater China, announced in December that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved its Investigational New Drug (IND) submission for the initiation of a Phase 2 trial in China for enoblituzumab in combination with pembrolizumab in patients with solid tumors, including NSCLC, urothelial carcinoma and other selected cancers. DART Molecules for Immune Checkpoint Blockade: MacroGenics is studying multiple investigational, PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable combination opportunities across the Company’s portfolio. Recent highlights include: Lorigerlimab (formerly MGD019)is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. MacroGenics is conducting a Phase 1/2 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), mCRPC, melanoma and checkpoint-naïve NSCLC. The Company anticipates sharing data from this ongoing study in the second half of 2022. As described above, MacroGenics expects to initiate a dose escalation study of MGC018 in combination with lorigerlimab in the coming weeks. Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab was evaluated in a Phase 1/2 dose expansion study in several tumor types and is currently being studied in combination with enoblituzumab in SCCHN. The Company expects to provide an update on potential future development plans for tebotelimab in the second half of 2022. MacroGenics' partner in Greater China, Zai Lab, recently informed the Company that it has decided to discontinue development of tebotelimab for indications it was enrolling in its territory and is evaluating future development plans in other indications. Bispecific CD123 × CD3 DART molecule: MacroGenics has prioritized the development of MGD024, its investigational, next-generation CD123 × CD3 DART molecule, and will discontinue the development of flotetuzumab. Recent updates of these DART molecules include: MGD024is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. In November, MacroGenics announced submission of an IND application for MGD024 to FDA. At the American Society of Hematology (ASH) Annual Meeting in December, MacroGenics presented preclinical data from the combination of MGD024 with standard-of-care agents used to treat CD123-positive hematological malignancies. The Company expects to initiate a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia (AML), pending IND clearance by FDA. Flotetuzumab is the Company’s first-generation, investigational, bispecific CD123 × CD3 DART molecule. An interim efficacy threshold from the single-arm study evaluating flotetuzumab in patients who were refractory to induction therapy was met with manageable safety. However, the Company has recently decided to prioritize the development of MGD024 and discontinue development of flotetuzumab, in view of the Company’s belief that MGD024 may offer certain advantages over flotetuzumab, including easier dose administration and a more facile means to combine with other agents. Margetuximab is an Fc-engineered mAb that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells. MARGENZA® (margetuximab-cmkb) was launched in March 2021 by MacroGenics and its commercial partner, Eversana Life Science Services, LLC, for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. In January 2022, Zai Lab announced that the China NMPA accepted the New Drug Application (NDA) for margetuximab for the treatment of the same HER2-positive breast cancer indication. Zai Lab recently informed MacroGenics that they have decided to discontinue enrollment of Module B of the MAHOGANY study in gastric cancer based on their review of both the clinical data and the changing treatment landscape. MacroGenics previously announced in November 2021 that the Company had decided to discontinue enrollment of Module A of the MAHOGANY study. Selected Partnered Program Updates: IMGC936is an investigational ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in multiple solid tumors and has indicated they anticipate disclosing initial data in 2022. Teplizumab is an investigational, anti-CD3 monoclonal antibody acquired from MacroGenics by Provention Bio, Inc. under an asset purchase agreement in 2018 for which MacroGenics is entitled to receive future milestone payments and royalties on net sales. Provention is developing teplizumab for the treatment of type 1 diabetes (T1D). On February 22, 2022, Provention announced that it had resubmitted the Biologics License Application (BLA) for teplizumab for the delay of clinical T1D in at-risk individuals. The BLA resubmission followed Provention’s Type B meeting with FDA earlier in the year. 2021 Financial Results Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021, were $243.6 million, compared to $272.5 million as of December 31, 2020. Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $77.4 million for the year ended December 31, 2021, compared to total revenue of $104.9 million for the year ended December 31, 2020. Revenue for the year ended December 31, 2021 included $12.3 million net sales of MARGENZA. R&D Expenses: Research and development expenses were $214.6 million for the year ended December 31, 2021, compared to $193.2 million for the year ended December 31, 2020. The increase was primarily related to development, manufacturing and clinical trial costs related to MGC018, as well as other preclinical molecules and increased clinical expenses related to enoblituzumab and lorigerlimab. These increases were partially offset by decreased development and manufacturing costs related to retifanlimab for Incyte and decreased clinical costs and BLA support for margetuximab. SG&A Expenses: Selling, general and administrative expenses were $63.0 million for the year ended December 31, 2021, compared to $42.7 million for the year ended December 31, 2020. The increase was primarily related to the MARGENZA launch, as well as labor-related costs and legal expenses. Net Loss: Net loss was $202.1 million for the year ended December 31, 2021, compared to net loss of $129.7 million for the year ended December 31, 2020. Shares Outstanding: Shares outstanding as of December 31, 2021 were 61,307,428.Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2021, plus anticipated and potential collaboration payments, and product revenues should enable it to fund its operations through 2023. Such guidance does not reflect anticipated expenditures related to the potential late-stage development of MGC018 in mCRPC or further expansion of studies currently ongoing. Conference Call Information MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the year ended December 31, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 1067087. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call. MACROGENICS, INC.SELECTED CONSOLIDATED BALANCE SHEET DATA(Amounts in thousands) December 31, 2021 December 31, 2020 Cash, cash equivalents and marketable securities $ 243,616 $ 272,531 Total assets 335,245 378,743 Deferred revenue 20,646 11,382 Total stockholders' equity 239,618 295,884 MACROGENICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) (Amounts in thousands, except share and per share data) Year Ended December 31, 2021 2020 2019 Revenues: Revenue from collaborative and other agreements $ 63,294 $ 97,764 $ 62,024 Product revenue, net 12,349 — — Revenue from government agreements 1,804 7,119 2,164 Total revenues 77,447 104,883 64,188 Costs and expenses: Cost of product sales 2,651 — — Research and development 214,577 193,201 195,309 Selling, general and administrative 63,014 42,742 46,064 Total costs and expenses 280,242 235,943 241,373 Loss from operations (202,795 ) (131,060 ) (177,185 ) Other income 680 1,321 25,374 Net loss (202,115 ) (129,739 ) (151,811 ) Other comprehensive income: Unrealized gain (loss) on investments (54 ) (23 ) 19 Comprehensive loss $ (202,169 ) $ (129,762 ) $ (151,792 ) Basic and diluted net loss per common share $ (3.37 ) $ (2.47 ) $ (3.16 ) Basic and diluted weighted average common shares outstanding 59,944,717 52,442,389 48,082,728 About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc.

Presentation of interim TAMARACK Phase 2 study data: updated safety and preliminary efficacy of vobra duo in mCRPC patientsConference call scheduled for today at 4:30 p.m. ET ROCKVILLE, Md., May 09, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2024. “We are very encouraged by the interim updated safety and preliminary efficacy data from the TAMARACK study of vobra duo in metastatic castration-resistant prostate cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We believe this interim data set helps validate our previously stated hypothesis that improved tolerability coupled with compelling biological activity could be achieved through dose reductions and a longer dosing interval. We believe vobra duo’s biological activity shown to date aligns well with the parameters we outlined at the outset of the study. Based on our evaluation of the interim data to date, we have initiated planning activities for a potential Phase 3 study that could commence next year. We anticipate sharing final safety, efficacy and durability data, including radiographic progression-free survival data, which is the primary endpoint of the study, in the second half of 2024. Furthermore, having preliminarily identified suitable vobra duo doses in mCRPC in the TAMARACK study, we have greater confidence in the molecule’s potential to help patients with a broad range of B7-H3-expressing cancers.” “The interim safety and anti-tumor activity observed to date in the TAMARACK study look very promising for patients with metastatic castration-resistant prostate cancer,” said Johann DeBono, Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust. “With the limited treatment options currently available to these patients, this novel ADC molecule could potentially become the first therapy targeting B7-H3 in patients with prostate cancer and would represent an important new treatment for this population.” Updates on Proprietary Investigational Programs Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below. B7-H3-Directed Therapies •Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. •MacroGenics completed enrollment of the TAMARACK Phase 2 study of vobra duo in November 2023. TAMARACK is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). •A new presentation of TAMARACK interim data, consisting of updated safety and preliminary efficacy data, all based on a data cut-off date of April 12, 2024, is available under "Events & Presentations" in the Investor Relations section of MacroGenics’ website or directly via this link. Below is a high-level summary of this interim data, which is subject to further updates: Vobra Duo2.0 mg/kg q4WVobra Duo2.7 mg/kg q4WPatients Enrolledn=91n=90PSA Reduction Summary: PSA Evaluable Patientsn=82n=71Any PSA Reduction ≥50%41 (50.0%)36 (50.7%)Confirmed PSA Reduction ≥50%36 (43.9%)26 (36.6%)Tumor Response Summary: RECIST Evaluable Patients with Measurable Disease at Baselinen=45n=32Disease Control Rate (CR+PR+SD)41 (91.1%)28 (87.5%)Overall Response Rate (CR+PR, confirmed only)8 (17.8%)8 (25.0%)Overall Response Rate (CR+PR, including unconfirmed)11 (24.4%)14 (43.8%)Safety Summary: Safety Populationn=90n=86Treatment-Emergent Adverse Events All Grade89 (98.9%)86 (100.0%)Treatment- Emergent Adverse Events Grade ≥349 (54.4%)44 (51.2%)TEAE Leading to Study Drug Discontinuation10 (11.1%)13 (15.1%)TEAE Leading to Study Drug Dose Reduction39 (43.3%)44 (51.2%)TEAE Leading to Study Drug Dose Interruption38 (42.2%)48 (55.8%)Five Most Common TEAE All GradeAsthenia (46.7%)Nausea (35.6%)Oedema peripheral (32.2%) Decreased appetite (28.9%) Fatigue (25.6%)Asthenia (58.1%)Decreased appetite (37.2%) Oedema peripheral (36.0%) Nausea (30.2%)Pleural effusion (29.1%)Pleural EffusionsGrade 1=8.9%Grade 2=8.9%No Grade ≥ 3 eventGrade 1=14.0%Grade 2=14.0%Grade 3=1.2%Palmar-plantar Erythrodysaesthesia SyndromeGrade 1=11.1%Grade 2=4.4%No Grade ≥ 3 eventGrade 1=12.8%Grade 2=9.3%Grade 3=1.2% • The median number of cycles of vobra duo administered was five (range of 1-10). • A total of five events with fatal outcome occurred as follows: one Grade 5 event in the 2.0 mg/kg dosing cohort: acute myocardial infarction (considered unrelated to study drug by the investigator); three Grade 5 events in the 2.7 mg/kg dosing cohort: one cardiac arrest (considered unrelated to study drug by the investigator) and two events of pneumonitis. In addition, a patient in the 2.7 mg/kg dosing cohort had a Grade 3 pleural effusion that is recorded as having a fatal outcome. The latter three deaths are being investigated, as follow-up is incomplete on this ongoing trial. • Additional data is provided in the presentation on the Company’s website and as filed with the Securities and Exchange Commission. • Based on a current evaluation of this interim data, the Company is undertaking the initial steps necessary to prepare for the potential initiation of a Phase 3 study in mCRPC in 2025. The final decision to pursue such a Phase 3 study will be based on an analysis of the final data set, including rPFS, when available. •The Company intends to share final safety, efficacy, and durability data, including the primary endpoint of radiographic progression-free survival, from the TAMARACK trial in the second half of 2024. •MacroGenics plans to expand the TAMARACK study of vobra duo by enrolling patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN) and anal cancer. The Company expects to initiate dosing in these additional cohorts in mid-2024. •MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination in mCRPC and at least one additional indication in 2024. •MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing.MGC026 preclinical data was presented recently at the American Association for Cancer Research (AACR) Annual Meeting. In preclinical studies, MGC026 was shown to have greater potency than B7-H3-directed antibodies conjugated to deruxtecan, or DXd, a topoisomerase-based payload utilized in other ADCs. In addition, the MGC026 payload has been shown to be less susceptible to multi-drug resistance (MDR) mechanisms than DXd and SN-38. •Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. The HEAT study, an investigator-sponsored, randomized Phase 2 clinical trial being conducted by MacroGenics’ academic collaborators, is ongoing. This study is being conducted to evaluate the activity of neoadjuvant enoblituzumab given prior to radical prostatectomy in up to 219 men with high-risk localized prostate cancer. Lorigerlimab •Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. In addition to the ongoing study of lorigerlimab in combination with vobra duo mentioned above, MacroGenics is enrolling LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of radiographic progression-free survival (rPFS). The Company anticipates completing enrollment of the study in 2024 and providing a clinical update in the first half of 2025. Emerging ADC Pipeline •MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease 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. The Company currently anticipates submitting an investigational new drug (IND) application for MGC028 by the end of 2024.MGC028 preclinical data was presented recently at the AACR Annual Meeting. In preclinical studies, MGC028 demonstrated specific antitumor activity in in vivo models representing gastric, lung, pancreatic, colorectal cancer, SCCHN and cholangiocarcinoma. In addition, in a non-human primate study, MGC028 was well tolerated at high dose levels, with mild, reversible side effects and no ocular toxicity, which is often a concern with tubulin-inhibitor-based ADCs. These promising preclinical results support the continued investigation of MGC028 as a therapeutic option for treating ADAM9-expressing solid cancers. Partnered Program •MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. has the option to license MGD024 at predefined decision points during the Phase 1 study. First Quarter 2024 Financial Results •Cash Position: Cash, cash equivalents and marketable securities balance as of March 31, 2024, was $184.2 million, compared to $229.8 million as of December 31, 2023. •Revenue: Total revenue was $9.1 million for the quarter ended March 31, 2024, compared to total revenue of $24.5 million for the quarter ended March 31, 2023. The decrease was primarily due to a decrease in revenue from collaborative and other agreements, including a $15.0 million milestone received from Incyte in the quarter ended March 31, 2023. •R&D Expenses: Research and development expenses were $46.0 million for the quarter ended March 31, 2024, compared to $45.9 million for the quarter ended March 31, 2023. •SG&A Expenses: Selling, general and administrative expenses were $14.7 million for the quarter ended March 31, 2024, compared to $13.5 million for the quarter ended March 31, 2023. The increase was primarily related to increased stock-based compensation expense and other professional fees. •Net Loss: Net loss was $52.2 million for the quarter ended March 31, 2024, compared to net loss of $38.0 million for the quarter ended March 31, 2023. •Shares Outstanding: Shares of common stock outstanding as of March 31, 2024 were 62,560,502. •Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $184.2 million as of March 31, 2024, in addition to projected and anticipated future payments from partners and product revenues should extend its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies. Conference Call Information To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call. MACROGENICS, INC.SELECTED CONSOLIDATED BALANCE SHEET DATA(Amounts in thousands) March 31, 2024 December 31, 2023 (unaudited) Cash, cash equivalents and marketable securities$184,237 $229,805Total assets 248,285 298,418Deferred revenue 79,019 80,894Total stockholders' equity 106,154 152,613 MACROGENICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(Amounts in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Revenues: Collaborative and other agreements$1,449 $16,686 Product sales, net 4,861 3,490 Contract manufacturing 2,276 3,615 Royalty revenue 160 422 Government agreements 358 283 Total revenues 9,104 24,496 Costs and expenses: Cost of product sales 270 113 Cost of manufacturing services 1,846 3,410 Research and development 46,029 45,872 Selling, general and administrative 14,709 13,527 Total costs and expenses 62,854 62,922 Loss from operations (53,750) (38,426)Interest and other income 2,693 1,073 Interest and other expense (1,133) (656)Net loss (52,190) (38,009)Other comprehensive income (loss): Unrealized gain (loss) on investments (29) 13 Comprehensive loss$(52,219) $(37,996) Basic and diluted net loss per common share$(0.84) $(0.61)Basic and diluted weighted average common shares outstanding 62,290,538 61,809,817 About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including initiation and enrollment in clinical trials, expected timing of results from clinical trials, discussions with regulatory agencies, commercial prospects of or product revenues from MARGENZA and the Company’s product candidates, if approved, manufacturing services revenue, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and future expectations and plans and prospects for the Company, as well as future global net sales of TZIELD and the Company’s ability to achieve the milestone payments set forth under the terms of the agreement with DRI (or its successors or assigns with respect to such agreement), and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises such as the novel coronavirus (referred to as COVID-19 pandemic); and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACTS: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com