ROCKVILLE, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress. "Over the past several years, MacroGenics has established itself as a pioneer in the field of antibody-based therapeutics for patients battling cancer. Today, we have a promis ...

Pipeline and Programs - MacroGenics' cash runway is extended through the first half of 2027[9, 10] - Lorigerlimab shows a confirmed Objective Response Rate (ORR) of 25.7% and a PSA50 response rate of 28.6% in mCRPC patients[23] - MGC026, a B7-H3 directed program, is in Phase 1 dose escalation, with dose expansion anticipated in selected indications in 2025[43] - MGC028, an ADAM9 ADC, shows potent anti-tumor activity in preclinical models, with a Phase 1 dose escalation study ongoing[50] - MGD024, a CD123 × CD3 DART molecule, is in Phase 1 dose escalation in hematological malignancies, with a Gilead collaboration commenced in October 2022[60] Financials and Partnerships - MacroGenics received $365 million in upfront and milestone payments[12] - MacroGenics is eligible to receive up to $210 million in potential regulatory milestones and up to $330 million in potential commercial milestones[12] - MacroGenics could receive 15-24% tiered royalty (after 20x cap reached)[12] - As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents, and marketable securities[9, 11, 72] - A $70 million upfront payment was received in June 2025[9, 12]

Summary of MacroGenics Conference Call Company Overview - **Company**: MacroGenics - **Industry**: Precision Medicines, specifically in oncology and immunotherapy Key Points and Arguments 1. **R&D Focus**: MacroGenics has a strong history of drug discovery and development, currently having four assets in the clinic, all homegrown, leveraging both internal platform technology and licensed drug linker chemistry for their ADC portfolio [3][49] 2. **Lead Asset**: The lead asset is Lorigirilimab, a bispecific molecule targeting PD-1 and CTLA-4, with a randomized phase two study fully enrolled, expecting data later this year [4][50] 3. **ADC Programs**: Two ADC programs utilizing a Topo-1 based drug linker are in phase one dose escalation, with promising prospects anticipated [5][50] 4. **T Cell Engager**: A bispecific molecule targeting CD3 and CD123 is part of an option-based deal with Gilead, also in phase one dose escalation [5][51] 5. **Future Innovations**: Additional molecules are being advanced in research labs, with one ADC program, MGC030, expected to enter the clinic next year [6][52] Bispecific Molecule Insights 1. **Lorigirilimab's Efficacy**: Initial monotherapy data showed a 26% confirmed overall response rate (ORR) in a late-line castrate-resistant prostate cancer population, with significant PSA reductions [11][12] 2. **Durability of Response**: Patients exhibited long durable responses, with some remaining on study for over two years, which is notable compared to previous treatments [12] 3. **Lorikeet Study**: A randomized phase two study combining Lorigirilimab with docetaxel is ongoing, aiming to demonstrate improved progression-free survival (PFS) compared to docetaxel monotherapy [13][18] Ovarian Cancer Study 1. **Lynette Study**: Focuses on ovarian and gynecological cancers, aiming to show meaningful activity and durability in a historically less responsive indication [19][20] 2. **Response Rates**: Traditional PD-1 monotherapy has shown single-digit response rates, while combinations with CTLA-4 have improved this to 25-30% [19][20] B7-H3 Targeting 1. **MGC026 Development**: A next-generation ADC targeting B7-H3 is being developed, leveraging a proprietary platform that enhances potency and reduces toxicity [25][26] 2. **Broad Application**: B7-H3 has a wide expression across various solid tumors, with ongoing studies in small cell lung cancer and other indications [29][30] Financial and Operational Insights 1. **Cash Position**: As of year-end 2024, MacroGenics had $200 million in cash, with a runway extending into the second half of 2026 [34] 2. **Non-Dilutive Capital**: The company has successfully raised approximately $475 million in non-dilutive capital over the past three years, avoiding formal market offerings since February 2019 [35][37] 3. **Gilead Collaboration**: The partnership with Gilead includes an exclusive option for the CD123 CD3 DART molecule, with ongoing phase one trials focusing on hematologic malignancies [38][39] Leadership Transition 1. **CEO Search**: A nationwide search for a new CEO is underway, with Scott Koenig continuing to support the company during the transition [45]

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]