Company Overview - MacroGenics has been focused on next-generation antibody therapeutics for cancer treatment for over 20 years [2] - The company leverages three core modalities to drive its proprietary pipeline, including an ADC portfolio that utilizes third-party drug linker chemistries from Synaffix, now part of Lonza [3] Product Pipeline - MacroGenics has three disclosed ADC programs in its current portfolio [3] - The company has a broad partnership with Gilead that includes three T cell-related constructs, with one clinical program targeting CD123 and CD3, and two undisclosed preclinical programs [4]

MacroGenics FY Conference Summary Company Overview - **Company**: MacroGenics (NasdaqGS: MGNX) - **Focus**: Development of next-generation antibody therapeutics for cancer treatment, with over 20 years of experience [2][3] Core Modalities - **Antibody-Drug Conjugates (ADCs)**: Three ADC programs in the portfolio, leveraging third-party drug linker chemistries from Synaffix and proprietary antibody engineering [2][3] - **T-cell Engagers**: Partnership with Gilead on three T-cell related constructs, including a clinical program targeting CD123 and CD3 [3] - **Dual Checkpoint Approach**: Led by the lorigerlimab program, a bispecific antibody targeting PD-1 and CTLA-4 [3] ADC Pipeline Highlights - **MGC026 (Anti-B7H3 ADC)**: - Features a novel payload (exatecan) that is 2-5 times more potent than deruxtecan, with better bystander killing effects and reduced susceptibility to multidrug resistance [8] - No evidence of interstitial lung disease (ILD) observed in clinical trials, a potential differentiator from competitors [9][10] - Targeting multiple solid tumors, including small cell lung cancer and castrate-resistant prostate cancer [12] - **MGC028 (ADAM9 ADC)**: - A second-generation ADC targeting ADAM9, with a focus on safety and efficacy based on previous learnings from a first-generation molecule [21][22] - Phase 1 data expected in the second half of 2026, targeting various solid tumors [25][26] - **MGC030**: - A first-in-class Topo 1 ADC with strong preclinical data, IND expected in Q3 2026 [30] Lorigerlimab Program - **Dual Checkpoint Inhibitor**: Blocking both PD-1 and CTLA-4, with over 300 patients dosed [35] - **Safety Profile**: Early data shows fewer adverse events compared to traditional combinations like ipilimumab and nivolumab [35] - **Current Status**: Enrollment paused due to grade 4 adverse events, including one fatality; working with the FDA to resume [37][38] Financial Position - **Cash Position**: Approximately $190 million at the end of the year, with a history of raising over $600 million in non-dilutive capital over the last 3.5 years [28] - **Partnerships**: Significant future milestone payments from partnerships, including $1.6 billion from Gilead and $540 million from Incyte [43][45] Strategic Focus - **Prioritization of Programs**: Focus on advancing ADC programs to proof-of-concept inflection points while managing cash runway effectively [28][29] - **Potential for New Partnerships**: Open to future collaborations, especially for broad utility targets [17][19] Conclusion - **Outlook for 2026**: Anticipated to be a pivotal year for MacroGenics with multiple data readouts and strategic advancements in their pipeline [49]

Summary of MacroGenics Conference Call Company Overview - **Company**: MacroGenics (NasdaqGS: MGNX) - **CEO**: Eric Risser - **CFO**: James Karrels - **Industry**: Biotechnology, focusing on oncology and antibody-drug conjugates (ADCs) [3][2] Core Product Development Pillars - **ADC Programs**: Three ADC programs in the portfolio, aiming for best-in-class or first-in-class molecules [3][4] - **Bispecific Platform**: Focus on dual blockade of immune checkpoints, with a notable program, lorigerlimab, currently on partial clinical hold [3][4] - **Next-Generation T-Cell Engagers**: Lead asset partnered with Gilead, with ongoing development of additional molecules [4][3] Recent Developments and Strategic Focus - **Leadership Changes**: New CEO emphasizes a heightened sense of urgency and focus on foundational value drivers [5][6] - **Operational Efficiency**: Aiming for a leaner operational footprint and judicious capital deployment [6][7] - **Program Adjustments**: Early termination of the lorigerlimab prostate cancer study due to non-competitive profile [6][7] Lorigerlimab Update - **Clinical Hold**: The program is on partial clinical hold due to serious adverse events, including Grade 4 thrombocytopenia and myocarditis [9][10] - **Enrollment Status**: 41 patients enrolled before the hold; ongoing discussions with the FDA to resume enrollment [10][12] - **Next Steps**: Comprehensive clinical update expected by mid-2026, assessing safety and efficacy [12][15] ADC Technology Positioning - **Platform Advantages**: Utilizes a site-specific conjugation approach, leading to uniform drug-to-antibody ratios (DAR) and potentially improved safety profiles [17][18] - **Comparison with Competitors**: MacroGenics believes its ADCs are more efficient in internalization and have better potency compared to competitors [19][20] - **Market Dynamics**: The ADC market is expected to be competitive but not winner-takes-all, with multiple development opportunities across various cancers [22][23] MGC026 and MGC028 Updates - **MGC026 (B7-H3 ADC)**: Completed dose escalation; expansion cohorts initiated with a clinical update expected mid-2026 [26][27] - **MGC028 (ADAM9 ADC)**: Rapid progression through dose escalation; clinical update anticipated in the second half of 2026 [32][35] Business Development and Financial Position - **Partnerships**: Historically active in business development, with over $600 million in non-dilutive funding in the last three and a half years [46][47] - **Cash Position**: Current cash balance of approximately $190 million, with potential milestone payments from partnerships totaling up to $1.6 billion [52][53] - **Upcoming Milestones**: Key updates expected in 2026, including IND submissions and clinical updates for various programs [55][56] Conclusion - **Future Outlook**: MacroGenics is focused on executing its strategic plan, with significant updates and potential catalysts expected in the near future, particularly in the ADC space and ongoing clinical trials [55][56]

MacroGenics (MGNX) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to a loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +47.31%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.48 per share when it actually produced earnings of $0.27, delivering a surprise of +156.25%.Over the last four quarters, the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36112 MACROGENICS, INC. (Exact name of registrant) Delaware 06-1591613 (State of organization) (I.R.S. Employer Identification Number ...

Initial MGC026 (B7-H3 ADC) Phase 1 results in mid-2026Initial MGC028 (ADAM9 ADC) Phase 1 results in second half of 2026Lorigerlimab Phase 2 LINNET study update in mid-2026IND submission for MGC030, a first-in-class TOP1i-based ADC, on track for 3Q 2026Cash, cash equivalents and marketable securities of $189.9 million as of December 31, 2025; cash runway guidance remains into late 2027 ROCKVILLE, Md., March 09, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical comp ...

March 9, 2026 Legal Notices The information in this slide deck is current as of March 9, 2026, unless otherwise noted, and is qualified in its entirety by reference to MacroGenics' Annual, Quarterly and Current Reports filed with the SEC. MacroGenics undertakes no obligation to update any of the information herein. Cautionary Note on Forward-Looking Statements Any statements in this presentation about future expectations, plans and prospects for MacroGenics ("Company"), including statements about the Compan ...

Summary of MacroGenics FY Conference Call Company Overview - **Company**: MacroGenics (NasdaqGS: MGNX) - **Focus**: Next-generation antibody therapeutics for cancer treatment, utilizing proprietary platforms such as DART and Trident for bispecific and trivalent targeting [2][3] Financial Position - **Cash Runway**: Extended to late 2027, with over $600 million in non-dilutive capital raised in the last three years [4] - **Current Cash Position**: Approximately $221 million as of Q3 [11] Product Pipeline - **Fully Owned Products**: Four product candidates, with three assets from early development now marketed [3][4] - **ADC Pipeline**: - O26 and O28 in clinical trials, with O28 targeting ADAM9 and O26 targeting B7H3 [6][9] - O30 expected to move towards IND filing later this year [6] - **Lorigerlimab**: Undergoing a partial clinical hold in the LINNET study, focusing on gynecologic cancers [5][6] Strategic Focus - **Key Strategic Imperatives**: Six strategic imperatives to be extended through the end of 2026, emphasizing disciplined capital allocation [5] - **Clinical Development**: Focus on driving assets to important clinical inflection points, with a rigorous approach to risk management across the portfolio [20] Clinical Data and Efficacy - **Lorigerlimab Efficacy**: - 26% confirmed overall response rate (ORR) in prostate cancer, with some patients treated for over two years [17][18] - Emphasis on durability of responses and disease control rates as critical success metrics [15] - **ADCs**: - MGC026 shows promise with a robust linker and payload, potentially offering better safety and efficacy compared to competitors [25] - MGC028 targeting ADAM9 has broad expression in various cancers, with ongoing assessments for proof of concept [27] Partnerships and Collaborations - **Gilead Partnership**: Expanded to include three molecules, with ongoing phase 1 studies [35] - **Strategic Partnerships**: Focus on timing and asset suitability for partnerships, with a strong interface with top pharmaceutical companies [37][38] Market Position and Future Outlook - **Competitive Landscape**: MacroGenics is well-positioned with a balanced portfolio of wholly owned and partnered assets, targeting both validated and first-in-class opportunities [10][11] - **Underappreciated Value**: Current share price below cash value, with significant option value across the portfolio and a strong track record of high-value transactions [39][41] Conclusion - **Overall Assessment**: MacroGenics is strategically focused on advancing its innovative cancer therapies while maintaining a strong financial position and exploring valuable partnerships, despite current market undervaluation [39][41]

FDA Approvals & Rejections - Armata Pharmaceuticals received FDA QIDP designation for AP-SA02, a bacteriophage-based candidate for complicated Staphylococcus aureus bacteremia, providing five years of market exclusivity and eligibility for Fast Track status [2][3] - Allurion Technologies gained FDA PMA approval for the Gastric Balloon System, a swallowable Smart Capsule that promotes fullness for about four months, targeting patients with a BMI of 30-40 [4][5] - Eton Pharmaceuticals' DESMODA oral solution was approved for managing central diabetes insipidus, with an expected peak annual sales of $30 million - $50 million [9][11] Deals - Gilead Sciences announced the acquisition of Arcellx for $115 per share, totaling an implied equity value of $7.8 billion, enhancing its position in cell therapy [12][13] - Vir Biotechnology entered a global collaboration with Astellas for VIR-5500, receiving $335 million in upfront payments and potential additional milestones of up to $1.37 billion [14][15][16] - Kairos Pharma signed a term sheet to acquire two oncology assets from Celyn Therapeutics, focusing on cancer therapeutics [17][18][20] Clinical Trials - Breakthroughs - MoonLake Immunotherapeutics reported positive Phase 2 trial results for Sonelokimab in axial spondyloarthritis, with 81% of patients achieving an ASAS40 response at Week 12 [21][22] - Novo Nordisk's CagriSema missed its primary endpoint in a Phase 3 trial against Zepbound, showing 23% weight loss compared to 25.5% with Tirzepatide [25][26][27] - Gossamer Bio's seralutinib missed the primary endpoint in the PROSERA Phase 3 study for pulmonary arterial hypertension, showing a placebo-adjusted improvement in Six-Minute Walk Distance [28][30][31] - Argenx's VYVGART met primary goals in the Phase 3 ADAPT OCULUS trial for ocular myasthenia gravis, demonstrating significant improvement in ocular scores [37][38][39]

Core Viewpoint - The FDA has placed a partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab, affecting new patient enrollment due to recent safety events [1][2]. Group 1: FDA Clinical Hold - The partial clinical hold was initiated after MacroGenics notified the FDA of a temporary pause in enrollment due to safety events involving four patients, including Grade 4 thrombocytopenia (2 patients), Grade 4 myocarditis (1 patient), and Grade 4 neutropenia with concurrent septic shock leading to a Grade 5 event (1 patient) [2]. - No new patients will be enrolled in the LINNET study until the hold is lifted, but current participants can continue receiving the study drug [1][2]. Group 2: LINNET Study Details - The LINNET study evaluates lorigerlimab, a bispecific DART® molecule targeting PD-1 and CTLA-4, as monotherapy in patients with platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) [3]. - The study is designed as a Simon two-stage trial, initially enrolling approximately 20 patients, with the potential to expand to an additional 20 patients if a predefined activity threshold is met [3]. - The primary endpoint of the study is the objective response rate (ORR), with multiple secondary endpoints [3]. Group 3: Company Overview - MacroGenics is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for cancer treatment [4]. - The company generates its pipeline from proprietary next-generation antibody-based technology platforms, enabling strategic collaborations with global pharmaceutical and biotechnology companies [4].