MacroGenics, Inc. - MGNX STOCK NEWS

MacroGenics (NASDAQ: MGNX) reported Q3 2024 financial results with total revenue of $110.7 million, up from $10.4 million in Q3 2023, primarily due to $100 million in milestones from Incyte. The company posted net income of $56.3 million compared to $17.6 million in Q3 2023. Cash position stood at $200.4 million as of September 30, 2024.

Key developments include the pending MARGENZA transaction with TerSera for $40 million upfront plus potential milestone payments up to $35 million, and the submission of an IND application for MGC028, their ADAM9-directed ADC. The company expects its cash runway to extend into 2026.

MacroGenics (NASDAQ: MGNX) announced that CEO Scott Koenig will step down in early 2025. The Board has engaged Heidrick & Struggles to search for a new CEO and formed a special committee to oversee the transition. Under Koenig's 24-year leadership, MacroGenics developed three FDA-approved therapeutics: MARGENZA®, ZYNYZ® for cancer treatment, and TZIELD® for Type 1 diabetes. The company secured over $1 billion in non-dilutive capital through partnerships since its 2013 IPO and maintains a strong balance sheet with multiple antibody-based therapeutics in development.

MacroGenics (MGNX) has scheduled its Q3 2024 financial results conference call for Tuesday, November 5, 2024, after market close. The company will host a conference call at 4:30 pm ET to discuss financial results and recent corporate progress. Participants can register in advance for telephone access, and a webcast will be available under the Investor Relations section of MacroGenics' website. A replay will be archived for 30 days following the call.

Rigrodsky Law, P.A. has announced an investigation into potential claims against MacroGenics (NASDAQ: MGNX) officers and directors on behalf of stockholders. The investigation concerns shareholders who purchased or acquired MacroGenics shares on or before March 7, 2024. Shareholders are encouraged to learn more about their rights through the law firm's website or by contacting their representative.

MacroGenics (NASDAQ: MGNX) has entered into an agreement with TerSera Therapeutics to sell the global rights to MARGENZA® (margetuximab-cmkb), an FDA-approved treatment for metastatic HER2-positive breast cancer. TerSera will pay $40 million at closing, with potential additional sales milestone payments of up to $35 million. The transaction is expected to close in Q4 2024.

MARGENZA, approved in December 2020, is used in combination with chemotherapy for adult patients who have received two or more prior anti-HER2 regimens. This deal allows MacroGenics to focus on advancing its pipeline of oncology product candidates, while TerSera's established U.S. commercial infrastructure may broaden patient access to MARGENZA.

MacroGenics (NASDAQ: MGNX) presented updated efficacy and safety results from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) for metastatic castration-resistant prostate cancer (mCRPC) at the ESMO Congress 2024. Key findings include:

- 6-month radiographic progression-free survival (rPFS) rate: 69% for 2.0 mg/kg arm, 70% for 2.7 mg/kg arm
- Median rPFS: ~8.5 months (2.0 mg/kg), ~7.5 months (2.7 mg/kg)
- Confirmed objective response rate: 20% (2.0 mg/kg), 40.6% (2.7 mg/kg)
- Median 6 doses administered, extending treatment duration compared to Phase 1

The company expects to have mature median rPFS data by early 2025, which will inform future development decisions.

MacroGenics (NASDAQ: MGNX) announced a poster presentation of Phase 2 data for vobramitamab duocarmazine in metastatic castration-resistant prostate cancer (mCRPC) at the ESMO Congress 2024. The TAMARACK trial results will be presented on September 15, 2024, featuring updated safety and efficacy data, including the primary endpoint of 6-month radiographic progression-free survival (rPFS).

The company will host an investor call on September 16, 2024, at 8:00 a.m. ET to discuss the TAMARACK poster data and provide a corporate update. The call will be led by key executives including CEO Scott Koenig. The poster will be available on MacroGenics' website, and a webcast of the conference call will be accessible for 30 days following the event.

MacroGenics (NASDAQ: MGNX) provided an update on its corporate progress and Q2 2024 financial results. Key highlights include:

• Upcoming poster presentation of TAMARACK Phase 2 mCRPC study data at ESMO in September
• Receipt of $100 million in milestones from Incyte for ZYNYZ® (retifanlimab-dlwr) advancement
• Confirmed cash runway guidance into 2026
• Q2 2024 revenue of $10.8 million, down from $13.1 million in Q2 2023
• Net loss of $55.7 million for Q2 2024, compared to net income of $57.5 million in Q2 2023
• Cash position of $140.4 million as of June 30, 2024, not including the $100 million milestone payment

The company continues to advance its proprietary and partnered programs, including vobra duo, lorigerlimab, and MGC028.

MacroGenics (NASDAQ: MGNX) announced a poster presentation of clinical data from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) at the upcoming ESMO Congress 2024. The presentation will include safety, efficacy, and landmark 6-month radiographic progression-free survival (rPFS) data for metastatic castration-resistant prostate cancer (mCRPC) patients.

In late July 2024, MacroGenics discontinued treatment for remaining TAMARACK study participants following a review of accumulated data and the IDMC's recommendation. Most participants had received 8-12 cycles of vobra duo. The company plans to host an investor update call following the ESMO presentation in September to discuss the TAMARACK data and potential next steps for the vobra duo program.