MacroGenics, Inc. Q3 FY2023 earnings call

• Clinical programs: Vobramitamab duocarmazine (vobra duo) completed enrollment of TAMARACK Phase 2 study in mCRPC; Lorigerlimab's LORIKEET Phase 2 trial in chemo-naive mCRPC started; MGD024 Phase 1 ongoing; Enoblituzumab's HEAT study expected in early 2024; Preclinical ADC MGC026 submitted IND to FDA, with second topoisomerase inhibitor-based ADC expected in late 2024.
• Milestones: Received $50 million milestone from Sanofi and $15.7 million from Gilead; Since mid-2022, received $335 million in non-dilutive capital from various partners.

MacroGenics reported total revenue of $10.4 million for the quarter ended September 30, 2023, down from $41.7 million in Q3 2022. The decrease was due to the absence of the $30 million Incyte license agreement revenue in 2023. Q3 2023 revenue included $4.5 million in contract manufacturing revenue and $4.7 million in MARGENZA net sales (vs. $4.4 million in Q3 2022). R&D expenses were $30.1 million in Q3 2023 vs. $48.2 million in Q3 2022, driven by decreased costs from discontinued studies but increased expenses for preclinical ADCs and lorigerlimab clinical trials. SG&A expenses were $12.4 million in Q3 2023 vs. $15.4 million in Q3 2022, mainly due to decreased selling costs for MARGENZA. Net income was $17.6 million in Q3 2023 vs. a net loss of $24.8 million in Q3 2022. Cash, cash equivalents, and marketable securities balance was $256.4 million as of September 30, 2023, with cash runway expected to extend into 2026.

• Cash runway expected to extend into 2026 based on cash balance and projected future payments.
• Anticipates data from TAMARACK study in first half of 2024.
• Plans to provide updates on lorigerlimab's additional indications and ADC pipeline in 2024.

• Uncertainty around clinical trial outcomes and regulatory approvals for pipeline candidates.
• Dependence on partner milestones and potential changes in partner priorities.
• Competition in the biopharmaceutical space affecting market adoption of products.

Q: How are you thinking about potential longer term registrational development for vobra duo within prostate cancer?

A: Scott Koenig mentioned evaluating control population options, will select dose for Phase 3 study after TAMARACK data.

Q: How are you thinking about competition from radiopharmaceuticals for lorigerlimab and docetaxel combination trial?

A: Scott Koenig stated study includes patients exposed to radiopharm, opportunities exist despite pluvicto data, and will provide updates in 2024.

Q: Why did TAMARACK enroll faster than expected and what data to expect from it in first half 2024?

A: Scott Koenig noted enthusiasm from investigators and patients, expects sizable data in 2024 related to PSA50 responses and rPFS.

Q: On the MGD024 program, when will Gilead have opt-in rights and public-facing data?

A: Gilead can opt in any time during Phase 1, controls data presentation before Phase 1 completion.

Q: Thoughts on competitive landscape for vobra duo and other assets?

A: Scott Koenig mentioned B7-H3's broad expression across solid tumors provides opportunities, differing from PSMA ADC's specificity.