MacroGenics Updates on Corporate Progress and Q2 2024 Financial Results

MacroGenics, Inc., a biopharmaceutical firm listed on NASDAQ as MGNX and located in Rockville, Maryland, has provided recent updates on its corporate progress and financial results for the quarter ending June 30, 2024. The company, dedicated to developing antibody-based cancer treatments, highlighted several key achievements and ongoing initiatives.

During the quarter, MacroGenics announced that updated safety and efficacy data from its Phase 2 TAMARACK trial involving vobramitamab duocarmazine (vobra duo) will be presented at the European Society for Medical Oncology (ESMO) Congress in September. The TAMARACK study, which focuses on patients with metastatic castration-resistant prostate cancer (mCRPC), has achieved its primary endpoint of a 6-month radiographic progression-free survival rate. Although patient dosing has concluded, participants are still being monitored for adverse events and disease progression.

The company recently bolstered its financial position by receiving $100 million in milestone payments following positive Phase 3 results from Incyte's registrational studies of ZYNYZ® (retifanlimab-dlwr) for anal and lung cancers. This further strengthens MacroGenics' cash runway, extending financial stability into 2026.

MacroGenics is advancing its proprietary investigational programs with a focus on B7-H3-directed therapies. Vobramitamab duocarmazine, an antibody-drug conjugate targeting B7-H3, is under investigation in combination with lorigerlimab in a Phase 1/2 study for various advanced solid tumors. Additionally, a Phase 1 dose escalation study for MGC026, another B7-H3-targeting ADC, is ongoing. MGC026 incorporates a topoisomerase I inhibitor payload developed by Synaffix, potentially addressing different cancers and stages and enhancing clinical utility when combined with other agents.

Lorigerlimab, a bispecific PD-1 × CTLA-4 DART® molecule, is being evaluated in combination with vobra duo and in the LORIKEET study. The LORIKEET study is a randomized Phase 2 trial comparing lorigerlimab and docetaxel to docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. Enrollment completion is anticipated by early 2025, with a clinical update expected in the first half of 2025.

In its emerging ADC pipeline, MacroGenics is preparing to submit an investigational new drug application for MGC028 by the end of 2024. This preclinical ADC targets ADAM9, a protein implicated in tumorigenesis and cancer progression, making it a promising candidate for cancer treatment.

MacroGenics' partnered programs include MGD024, a next-generation CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome while maintaining anti-tumor activity. A Phase 1 study of MGD024 in CD123-positive neoplasms is currently enrolling patients. Under an agreement with Gilead Sciences, Inc., Gilead has an option to license MGD024 during the Phase 1 study.

ZYNYZ® (retifanlimab-dlwr), a humanized monoclonal antibody targeting PD-1, continues to make strides in clinical development. Following positive Phase 3 results in squamous cell carcinoma of the anal canal and non-small cell lung cancer, MacroGenics announced the receipt of $100 million in milestones from Incyte related to retifanlimab's development progress. The company is eligible for additional milestone payments totaling up to $540 million and receives tiered royalties of 15% to 24% on global net sales of the product.

Financially, MacroGenics reported a cash, cash equivalents, and marketable securities balance of $140.4 million as of June 30, 2024. Total revenue for the quarter was $10.8 million, a slight decrease from the previous year's $13.1 million. Research and development expenses increased to $51.7 million, primarily due to manufacturing and IND-enabling costs related to MGC028. The company posted a net loss of $55.7 million for the quarter.

MacroGenics has opted not to host a conference call to discuss its financial results or corporate progress for the quarter due to the embargoed TAMARACK data being presented at the ESMO Congress. The company plans to resume its quarterly results conference calls in the future.