MACROGENICS INC Q2 FY2023 earnings call

• Clinical programs: Vobra duo's Phase 2 TAMARACK study in metastatic castration-resistant prostate cancer (mCRPC) had enrollment proceeding nicely, aiming to enroll 100 patients by year-end 2023 with data update in 2024. Lorigerlimab, a bispecific tetravalent PD-1 x CTLA-4 DART molecule, plans to commence a randomized Phase 2 study in combination with docetaxel for mCRPC. Enrollment ongoing in Phase 1 dose escalation of Vobra duo with lorigerlimab. MGD-024 Phase 1 study ongoing for CD123 positive hematologic malignancies. Enoblituzumab plans for investigator-sponsored neoadjuvant prostate cancer study. - Technology partnerships: Collaborations with Synaptics for ADC technology, leveraging target discovery and antibody engineering expertise. Plan to submit IND for first ADC by end of 2023.

MacroGenics reported total revenue of $13.1 million for the quarter ended June 30, 2023, compared to $26 million in Q2 2022. Contract manufacturing revenue was $1.6 million, and MARGENZA net sales were $5.1 million (vs $4.7 million in Q2 2022). Research and development expenses were $43.2 million in Q2 2023, down from $51.7 million in Q2 2022. Selling, general, and administrative expenses were $13.7 million in both Q2 2023 and 2022. Net income was $57.5 million in Q2 2023 vs a net loss of $41.3 million in Q2 2022. Cash, cash equivalents, and marketable securities balance as of June 30, 2023, was $240.3 million.

• Cash runway extended into 2026 with $240.3 million cash balance as of June 30, 2023, plus $50 million milestone from Sanofi. - Plan to submit investigational new drug (IND) application to US FDA by end of 2023 for first ADC incorporating topoisomerase inhibitor payload.

• Actual results may differ materially from forward-looking statements due to factors in SEC Risk Factors. - Uncertainties in clinical trial outcomes and regulatory approvals for new products.

Q: How confident are you that the two doses of vobra duo will guide moving forward?

A: Doses selected based on analysis of side effect profiles, tumor responses, and pharmacokinetics; hoping the selection will provide clarity on safety and activity profile, with potential modifications if needed based on data.