Business Description

Except as otherwise indicated herein or as the context otherwise requires, references in this annual report on Form 10-K to "MacroGenics," the "company," "we," "us" and "our" refer to MacroGenics, Inc. and its consolidated subsidiaries. “MacroGenics ® , the MacroGenics logo, DART ® , TRIDENT ® and the phrases Breakthrough Biologics, Life-Changing Medicines ® and Developing Breakthrough Biologics, Life-Changing Medicines ® are our trademarks. The other trademarks, trade names and service marks appearing in this report are the property of their respective owners. Overview We are a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer. We generate our pipeline of product candidates from our proprietary suite of antibody technology platforms. We are currently developing therapeutics utilizing multiple modalities, including antibody-drug conjugates (ADCs) and multi-specific antibodies (which we refer to as DART and TRIDENT molecules). The combination of our technology platforms and antibody engineering expertise has allowed us to generate promising product candidates – three of which have received marketing approval by the U.S. Food and Drug Administration (FDA) – and to enter into several strategic collaborations with global biopharmaceutical companies. These collaborations have provided us with over $1.6 billion of non-dilutive funding since our inception in 2000, and have enabled us to leverage the additional expertise of our collaborators to advance the development of multiple partnered product candidates. In addition, we operate a commercial-scale cGMP antibody manufacturing facility in our Maryland headquarters. We have utilized the facility to support our clinical programs and we also provide outsourced contract development and manufacturing services to our collaborators and other third parties for commercial and clinical products to offset a significant portion of the operating costs of this facility. We currently have three proprietary product candidates in clinical development: lorigerlimab, a bispecific DART molecule that targets checkpoint inhibitors PD-1 and CTLA-4; MGC026, an ADC that targets B7-H3 and delivers a novel topoisomerase I inhibitor (TOP1i)-based linker-payload, and MGC028, an ADC that targets ADAM9 and delivers a novel TOP1i-based linker-payload. We are also actively developing preclinical-stage ADC and next generation T-cell engager programs. We and our partners are developing or commercializing product candidates for which we retain certain economic rights. These include three products approved by the FDA: ZYNYZ ® (retifanlimab-dlwr), an anti-PD-1 monoclonal antibody (mAb) that we out-licensed; MARGENZA ® (margetuximab-cmkb), an anti-HER2 mAb that we sold to a partner; and TZIELD ® (teplizumab-mzwv), an anti-CD3 mAb that we sold to a partner. We are also collaborating with Gilead Sciences, Inc. (Gilead) on the development of MGD024, a bispecific DART molecule targeting CD123 and CD3 that utilizes our next-generation T-cell engager technology, as well as two additional undisclosed pre-clinical DART and TRIDENT molecule development programs. Our Portfolio of Product Candidates The table below depicts the status of our diverse pipeline of investigational oncology product candidates for which we retain commercialization or other important rights in the U.S. or more broadly: (a) No new patients will be enrolled in LINNET study until partial clinical hold is lifted by FDA. Current study participants may continue to receive study drug. 1 Our Wholly-Owned Product Candidates MGC026 MGC026 is an investigational ADC incorporating a B7-H3-targeting antibody and a novel TOP1i-based linker-payload, SYNtecan E™. This cleavable linker-payload is based on exatecan, a clinically validated and potent camptothecin, and is site-specifically conjugated using the GlycoConnect® technology developed by our collaboration partner, Synaffix B.V., a Lonza company (Synaffix). An ongoing Phase 1 dose escalation study of MGC026 was initiated in 2024. Study enrollment was completed in 2025 and we anticipate sharing the initial results of this trial in mid-2026. Based on the selection of a dosing regimen in dose escalation, a Phase 1 dose expansion study of MGC026 in selected indications was initiated in 2025 and is ongoing.…