Summary of MacroGenics Conference Call Company Overview - **Company**: MacroGenics (NasdaqGS: MGNX) - **New CEO**: Eric Risser, appointed in August 2025, has been with the company for over 16 years, previously serving as Chief Operating Officer and leading business development [2][4] Strategic Imperatives - **Key Focus Areas**: 1. Clarifying the lower durable development strategy 2. Advancing two ADC (Antibody-Drug Conjugate) programs in the clinic targeting B7H3 and ADAM9 3. Advancing another IND (Investigational New Drug) for an undisclosed target (MGC030) 4. Advancing two additional product candidates from early-stage discovery 5. Strengthening corporate partnerships 6. Solidifying the financial position of the company [2][3] Product Development Updates - **Lorigerlimab**: - A CTLA-4 PD-1 bispecific antibody being studied in prostate cancer and gynecological malignancies - The LOWERKEY trial for prostate cancer was discontinued due to efficacy issues, but the Linet trial for gynecological malignancies remains active [5][6][10] - Early Phase I data showed a 26% response rate in prostate cancer, indicating potential despite challenges [9] - **ADC Programs**: - **B7H3 ADC**: Competitive landscape is intensifying, with multiple agents in development. MacroGenics believes in the strong expression profile of B7H3 across various solid tumors [18][19] - **ADAM9 ADC**: The program is in dose escalation, with a focus on GI-related cancers. MacroGenics aims to leverage learnings from previous partnerships to enhance this program [28][29][31] - **MGC030**: Expected to submit an IND next year, utilizing the Synaffix platform with an exatecan-based payload [32][36] Financial Position - **Cash Position**: As of September, cash and cash equivalents stood at $146 million, with an additional $75 million expected from partnerships in Q4 2025. This extends the cash runway into late 2027 [50][48] Collaborations and Partnerships - **Gilead Collaboration**: Expanded to include three programs, focusing on T-cell engagers and leveraging MacroGenics' proprietary platforms [44][46] - **Sanofi Collaboration**: Recent milestones triggered $50 million, adding to the $25 million from Gilead, contributing to a total of over $600 million in non-dilutive capital over the last three years [48][49] Market Dynamics - **Competitive Landscape**: The oncology sector is seeing increased competition, particularly in ADCs and checkpoint inhibitors. MacroGenics is positioning itself to explore combination therapies and capitalize on its diverse portfolio [41][40] Future Outlook - **Clinical Updates**: Expect updates on the Linet trial in mid-2026, with ongoing evaluations of ADC programs and potential for accelerated development paths in certain indications [15][12] This summary encapsulates the key points discussed during the MacroGenics conference call, highlighting the company's strategic direction, product development, financial health, and market positioning.

Core Insights - MacroGenics, Inc. reported financial results for Q3 2025, highlighting strategic advancements and financial performance [1][2][11] Financial Performance - Total revenue for Q3 2025 was $72.8 million, down from $110.7 million in Q3 2024, with collaboration revenue at $53.0 million compared to $101.4 million in the previous year [11][15] - Contract manufacturing revenue increased to $19.8 million in Q3 2025 from $4.6 million in Q3 2024, reflecting increased third-party production [11][15] - Research and development expenses decreased to $32.7 million in Q3 2025 from $40.5 million in Q3 2024, primarily due to discontinued internal development of certain programs [11][13] - Net income for Q3 2025 was $16.8 million, a decrease from $56.3 million in Q3 2024 [11][16] Strategic Developments - The company secured $75 million in additional non-dilutive partnership payments expected in Q4 2025, extending its relationship with Gilead to include a preclinical program [2][5] - MacroGenics decided to halt the development of lorigerlimab in prostate cancer but will continue its exploration in ovarian and other gynecologic cancers through the ongoing LINNET Phase 2 study [4][7] - The company is advancing three antibody-drug conjugate (ADC) programs, including MGC026, MGC028, and MGC030, with MGC026 recently entering Phase 1 expansion cohorts [9][12] Cash Position and Guidance - As of September 30, 2025, the cash, cash equivalents, and marketable securities balance was $146.4 million, down from $201.7 million at the end of 2024 [14][16] - The company anticipates that its cash runway will extend into late 2027, supported by expected partnership payments and ongoing cost-reduction initiatives [16][17]

Core Viewpoint - MacroGenics, Inc. has appointed Eric Risser as President and CEO, succeeding Scott Koenig, who served for 24 years, effective August 13, 2025 [1][2] Group 1: Leadership Transition - Eric Risser has been with MacroGenics since 2009 and has held various roles, most recently as Chief Operating Officer, where he oversaw key functions and corporate development efforts that generated over $1.6 billion in non-dilutive capital [1][3] - Scott Koenig, the outgoing CEO, is recognized for his leadership in developing three FDA-approved products and will continue to serve as a Director and advisor [2] Group 2: Strategic Vision - Eric Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value therapies for cancer patients [3] - The company plans to invest resources strategically to generate significant value for both patients and shareholders [3] Group 3: Company Overview - MacroGenics is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for cancer treatment [4] - The company utilizes proprietary next-generation antibody-based technology platforms to generate its pipeline and has established strategic collaborations with global pharmaceutical and biotechnology firms [4]

Core Viewpoint - MacroGenics, Inc. is advancing its clinical pipeline, particularly with the initiation of the Phase 2 LINNET study for lorigerlimab, targeting unmet needs in ovarian and gynecologic cancers, while also reporting financial results for Q1 2025 [1][2]. Clinical Development Updates - The first patient has been dosed in the LINNET Phase 2 study of lorigerlimab for platinum-resistant ovarian cancer and clear cell gynecologic cancer, with a focus on addressing significant unmet needs [2][7]. - The LORIKEET Phase 2 trial, involving 150 patients, is ongoing to evaluate lorigerlimab in combination with docetaxel for metastatic castration-resistant prostate cancer (mCRPC), with results expected in the second half of 2025 [6][7]. - MacroGenics is developing three antibody-drug conjugates (ADCs) in collaboration with Synaffix, including MGC026, MGC028, and MGC030, targeting various solid tumors [4][6]. Financial Performance - Total revenue for Q1 2025 was $13.2 million, an increase from $9.1 million in Q1 2024, primarily due to collaborative agreements and contract manufacturing [8][13]. - Research and development expenses decreased to $39.7 million in Q1 2025 from $46.0 million in Q1 2024, while selling, general and administrative expenses also fell to $10.7 million from $14.7 million [8][13]. - The net loss for Q1 2025 was $41.0 million, compared to a net loss of $52.2 million in Q1 2024, indicating improved financial performance [8][13]. Cash Position and Guidance - As of March 31, 2025, MacroGenics had cash, cash equivalents, and marketable securities totaling $154.1 million, down from $201.7 million at the end of 2024, which supports operations into the second half of 2026 [8][11]. - The company plans to implement cost-saving measures to extend its financial runway while continuing to progress its clinical pipeline [8][11].

Financial Data and Key Metrics Changes - MacroGenics reported total revenue of $150 million for the year ended December 31, 2024, compared to $58.7 million for the year ended December 31, 2023, representing a significant increase primarily due to a net increase of $85 million in revenue from milestones under the Incyte License Agreement [24][25] - Research and development expenses rose to $177.2 million in 2024 from $166.6 million in 2023, driven by increased costs related to MGC028 and lorigerlimab, offset by decreased costs from discontinued projects [25][26] - Selling, general, and administrative expenses increased to $71 million in 2024 from $52.2 million in 2023, influenced by an $8 million amendment fee related to the asset sale of MARGENZA [26] - The net loss for 2024 was $67 million, compared to a net loss of $9.1 million in 2023 [27] - Cash, cash equivalents, and marketable securities stood at $201.7 million as of December 31, 2024, down from $229.8 million in 2023, with an anticipated cash runway extending into the second half of 2026 [27][28] Business Line Data and Key Metrics Changes - The company achieved $118.9 million in revenue from collaborative and other agreements, $16.4 million from net sales, and $13.1 million from contract manufacturing in 2024 [25] - The ongoing LORIKEET Phase 2 trial for lorigerlimab has completed enrollment, with a primary endpoint of radiographic progression-free survival [10][11] Company Strategy and Development Direction - MacroGenics aims to advance its diverse clinical portfolio, focusing on antibody-based cancer treatments, with significant milestones achieved in 2024 [7][9] - The company plans to initiate the LINNET Phase 2 study for lorigerlimab in mid-2025, targeting unmet needs in ovarian cancer and clear cell gynecologic cancer [12] - The company is exploring potential partnerships for the vobra duo program while continuing to develop alternative anti-B7-H3 ADC MGC026 [22][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2024 and the potential for continued advancements in 2025, highlighting the importance of their innovative pipeline [29][31] - The board is actively searching for a successor to the CEO, with a commitment to support the company during the transition [31] Other Important Information - The company reported a $36.3 million gain from the sale of MARGENZA to TerSera Therapeutics [27] - Management emphasized the importance of ongoing clinical trials and the potential for new partnerships to enhance the company's growth trajectory [31] Q&A Session Summary Question: What are the gating factors to starting the LINNET study? - Management indicated that the standard-of-care for later-line ovarian cancer is low, with overall response rates of 10% to 15% for anti-PD-1 therapies, making the selected patient population critical for the study [35] Question: Can you discuss the rationale behind developing lorigerlimab in ovarian and clear cell gynecologic cancers? - Management noted that these cancers represent untreated areas for checkpoint inhibitors, and lorigerlimab targets T-cells in the tumor microenvironment, potentially offering better tolerability and efficacy [42][44] Question: How does the rPFS data for vobra duo clarify the path forward for MGC026? - Management stated that MGC026 is different from vobra duo, with a different linker and payload, and they believe it has the potential for activity beyond what was observed with vobra duo [50][51] Question: What are the expectations for the discontinuation rate in the LORIKEET study? - Management expects a better discontinuation rate than previous checkpoint inhibitors due to the well-tolerated nature of lorigerlimab [82] Question: How far along is the Phase 1 study for MGC028? - Management confirmed that the study just commenced a few weeks ago and is expected to progress quickly, with no pre-selection of patients based on ADAM9 expression at this stage [87][88]

Financial Data and Key Metrics Changes - MacroGenics reported total revenue of $150 million for the year ended December 31, 2024, compared to $58.7 million for the year ended December 31, 2023, representing a significant increase primarily due to a net increase of $85 million in revenue recognized from milestones achieved under the Incyte License Agreement [24][25] - Research and development expenses were $177.2 million for the year ending December 31, 2024, compared to $166.6 million for the year ending December 31, 2023, reflecting increased costs related to MGC028 and lorigerlimab [25][26] - The net loss was $67 million for the year ended December 31, 2024, compared to a net loss of $9.1 million for the year ended December 31, 2023 [27] - Cash, cash equivalents, and marketable securities balance as of December 31, 2024, was $201.7 million, down from $229.8 million as of December 31, 2023, with an anticipated cash runway extending into the second half of 2026 [27][28] Business Line Data and Key Metrics Changes - Revenue from collaborative and other agreements was $118.9 million, with net sales contributing $16.4 million and contract manufacturing revenue at $13.1 million for the year ended December 31, 2024 [25] - The company plans to initiate the LINNET Phase 2 study for lorigerlimab, targeting unmet needs in platinum-resistant ovarian cancer and clear cell gynecologic cancer, with enrollment expected to commence by mid-2025 [11][12] Market Data and Key Metrics Changes - The ongoing LORIKEET Phase 2 trial for lorigerlimab has completed enrollment, with a primary endpoint of radiographic progression-free survival (rPFS) [10] - The TAMARACK Phase 2 study results for vobramitamab duocarmazine (vobra duo) showed a median rPFS of 9.5 months for the 2.0 mg/kg cohort and 10.0 months for the 2.7 mg/kg cohort in patients with metastatic castration-resistant prostate cancer (mCRPC) [21][22] Company Strategy and Development Direction - MacroGenics aims to advance its diverse clinical portfolio, focusing on antibody-based cancer treatments, with significant milestones achieved in 2024 and plans for continued progress in 2025 [7][29] - The company is exploring potential alternatives for partnering the vobra duo program while continuing to develop the anti-B7-H3 ADC MGC026 [22][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's innovative pipeline and the potential for lorigerlimab in previously untreated areas of ovarian cancer and clear cell gynecologic cancers [42][44] - The board is actively searching for a successor to the CEO, with a commitment to support the company during the transition [31] Other Important Information - The company completed the sale of MARGENZA to TerSera Therapeutics in the fourth quarter, providing non-dilutive capital to support clinical pipeline investments [31] - The anticipated funding requirements reflect expected expenditures related to ongoing clinical studies, including the LORIKEET study [28] Q&A Session Summary Question: What are the gating factors to starting the LINNET study? - Management indicated that the standard-of-care for later-line ovarian cancer is low, with overall response rates of 10% to 15% for anti-PD-1 therapies, and they are optimistic about the potential of lorigerlimab in this setting [35] Question: Can you discuss the rationale behind developing lorigerlimab in ovarian and clear cell gynecologic cancers? - The management highlighted that lorigerlimab targets T-cells in the tumor microenvironment, which may lead to better outcomes compared to existing checkpoint inhibitors [42][44] Question: How does the rPFS data for vobra duo clarify the path forward for MGC026? - Management noted that MGC026 is different from vobra duo, with a different linker and payload, and they believe it has the potential for activity beyond what was observed with vobra duo [49][50] Question: What are the expectations for the discontinuation rate in the LORIKEET study? - Management expects better tolerability with lorigerlimab compared to prior checkpoint inhibitors, anticipating a lower discontinuation rate [82] Question: How far along is the Phase 1 study for MGC028? - The Phase 1 study for MGC028 has just begun, and while they are not pre-selecting patients based on ADAM9 expression, they are focusing on tumor types known for upregulation [87][88]