On November 6, 2023 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the quarter ended September 30, 2023 (Press release, MacroGenics, NOV 6, 2023, View Source [SID1234637037]).

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"Since mid-2022, we have received $335 million in non-dilutive capital from our collaboration partners and reduced our quarterly cash burn, enabling us to extend our cash runway into 2026. Over the next two years, we anticipate having multiple data read-outs, the first of which we expect during the first half of 2024 related to the now fully-enrolled TAMARACK study of vobra duo in metastatic castration-resistant prostate cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During this two-year period, we also expect data from the LORIKEET Phase 2 study of lorigerlimab in prostate cancer, results from the dose escalation study of MGD024 and results from a planned vobra duo plus lorigerlimab dose expansion cohort. Also during this time, we anticipate advancing multiple new ADC molecules from our preclinical portfolio, the first of which (MGC026) recently progressed to IND submission."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation.
MacroGenics recently completed enrollment of the TAMARACK Phase 2 study of vobra duo ahead of schedule. This study is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses, 2.0 mg/kg or 2.7 mg/kg every four weeks, across a total of approximately 100 patients. MacroGenics anticipates providing a clinical update in the first half of 2024.
MacroGenics continues to enroll a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors. The Company anticipates commencing a dose expansion study of this combination in 2024.
Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. MacroGenics commenced enrollment of LORIKEET, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current trial design includes a primary study endpoint of radiographic progression-free survival (rPFS).
MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
MGC026 is an ADC with a topoisomerase inhibitor-based cytotoxic mechanism directed against an undisclosed solid tumor target. The Company recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration and, assuming acceptance, anticipates commencing a Phase 1 dose escalation study beginning in the first quarter of 2024. More details on this program will be provided in early 2024.
Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. MacroGenics’ academic collaborators plan to initiate the HEAT study, an investigator-sponsored, randomized Phase 2 clinical trial. This study is expected to commence enrollment in early 2024 and will evaluate the activity of neoadjuvant enoblituzumab given prior to radical prostatectomy in men with high-risk localized prostate cancer.
Other Corporate Updates

$15.7 Million Milestone Related to Gilead’s Nomination of a Bispecific Research Program. On September 5, 2023, MacroGenics announced that its partner, Gilead Sciences, Inc., nominated the first of two potential research programs, leveraging MacroGenics’ DART and TRIDENT platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program. MacroGenics received $15.7 million related to this nomination subsequent to September 30, 2023.
Third Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of September 30, 2023, was $256.4 million, compared to $154.3 million as of December 31, 2022. The Company’s cash balance as of September 30, 2023, did not include the $15.7 million milestone from Gilead subsequently received.
Revenue: Total revenue was $10.4 million for the quarter ended September 30, 2023, compared to total revenue of $41.7 million for the quarter ended September 30, 2022.
R&D Expenses: Research and development expenses were $30.1 million for the quarter ended September 30, 2023, compared to $48.2 million for the quarter ended September 30, 2022. The decrease was primarily related to decreased costs related to discontinued studies, partially offset by increased expenses related to preclinical ADC molecules and increased clinical expenses related to lorigerlimab.
SG&A Expenses: Selling, general and administrative expenses were $12.4 million for the quarter ended September 30, 2023, compared to $15.4 million for the quarter ended September 30, 2022. The decrease was primarily related to decreased selling costs for MARGENZA.
Other Income: During the quarter ended September 30, 2023, MacroGenics received a $50.0 million milestone payment from Sanofi S.A. related to the previously disclosed achievement of a primary endpoint in a TZIELD clinical study. The accounting treatment for this milestone is consistent with that for the $100.0 million proceeds received from the sale of the Company’s single-digit royalty interest on global net sales of TZIELD to DRI Healthcare Acquisitions LP in March 2023. Accordingly, $50.0 million was included in Other Income (as Gain on Royalty Monetization Arrangement) for the quarter ended September 30, 2023.
Net Income (Loss): Net income was $17.6 million for the quarter ended September 30, 2023, compared to net loss of $24.8 million for the quarter ended September 30, 2022.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2023 were 62,028,904.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $256.4 million as of September 30, 2023, plus the $15.7 million milestone subsequently received, in addition to projected and anticipated future payments from partners and product revenues should extend its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 LORIKEET study as well as MacroGenics’ other ongoing clinical and preclinical studies.

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