Apogee Therapeutics Inc - APGE STOCK NEWS

Apogee Therapeutics (NASDAQ: APGE) reported significant pipeline progress and 2024 financial results. The company's Phase 2 APEX clinical trial for APG777 has exceeded enrollment in Part A, with Part B initiated ahead of schedule. Topline Part A 16-week data is expected mid-2025.

Key financial highlights include $731.1 million in cash and equivalents, providing runway into Q1 2028. R&D expenses increased to $167.9 million in 2024 (vs $68.4M in 2023), while G&A expenses rose to $49.0 million (vs $24.6M in 2023). Net loss widened to $182.1 million in 2024 from $84.0 million in 2023.

The company reported positive interim results for APG990, with a 60-day half-life supporting three- and six-month dosing potential. APG279 (APG777 + APG990) head-to-head study versus DUPIXENT is planned, with readout expected in H2 2026. Additional pipeline developments include progress in respiratory indications and positive interim data for APG808.

Apogee Therapeutics (NASDAQ: APGE) announced positive interim Phase 1 results for APG990, their novel half-life extended OX40L antibody. The trial demonstrated an approximately 60-day half-life, supporting potential maintenance dosing every three and six months.

Key findings include:

• APG990 showed favorable tolerability across all five cohorts up to 1,200mg doses
• 53% of participants experienced at least one TEAE, with headache being most common
• No Grade 3 TEAEs or severe adverse events related to study drug
• No study discontinuations due to adverse events

The company plans to initiate a Phase 1b head-to-head study of APG279 (APG777 + APG990 combination) versus DUPIXENT in 2025, with data expected in second half of 2026. The combination therapy could potentially offer improved clinical outcomes by addressing multiple inflammation pathways with a single 2 mL coformulated injection administered 2-4 times per year.

Apogee Therapeutics (Nasdaq: APGE) has scheduled a conference call and webcast for March 3, 2025, at 8:30 a.m. ET to present interim results from its Phase 1 healthy volunteer trial of APG990. The clinical-stage biotechnology company, which focuses on developing novel biologics for inflammatory and immunology (I&I) conditions, will also discuss combination strategy plans for APG777 + APG990.

The company's therapeutic pipeline targets major I&I markets, including:

• Atopic dermatitis (AD)
• Asthma
• Eosinophilic esophagitis (EoE)
• Chronic obstructive pulmonary disease (COPD)

The live webcast will be accessible through the company's investor relations website, with a replay available after the call.

Apogee Therapeutics (Nasdaq: APGE) has announced that its management team will be participating in two major investor conferences in March 2025. The company will attend the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025, at 2:30 p.m. ET, followed by the Leerink Global Healthcare Conference on Tuesday, March 11, 2025, at 8:40 a.m. ET.

For interested parties, both events will feature fireside chats that will be available through live and archived webcasts. These webcasts can be accessed via the News & Events page in the Investors section of the Apogee Therapeutics website, providing an opportunity for investors to gain insights into the company's developments and strategies.

Apogee Therapeutics (NASDAQ: APGE) announced significant progress in its Phase 2 APEX clinical trial of APG777 for moderate-to-severe atopic dermatitis (AD). The company has completed Part A enrollment ahead of schedule with 123 patients, exceeding the target of 110 patients, and has begun dosing patients in Part B.

The trial evaluates APG777, a novel subcutaneous extended half-life monoclonal antibody targeting IL-13. Part A randomized patients 2:1 to APG777 versus placebo, with APG777 patients receiving 720mg at weeks 0 and 2, followed by 360mg at weeks 4 and 12. Part B will involve approximately 280 patients randomized 1:1:1:1 to high, medium, or low dose APG777 versus placebo.

Key upcoming milestones include Part A 16-week data in mid-2025, maintenance data in H1 2026, and Part B 16-week data in H2 2026. The company also plans to initiate Phase 1b trials in asthma and a combination study with APG990 in 2025.

Apogee Therapeutics (Nasdaq: APGE) has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's management team will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 1:00 p.m. E.T. Interested parties can access both live and archived versions of the presentation through the News & Events page in the Investors section of the Apogee Therapeutics website.

Apogee Therapeutics (APGE) has initiated dosing in its Phase 1 clinical trial of APG333, a novel subcutaneous half-life extended monoclonal antibody targeting TSLP for respiratory and inflammatory conditions. The trial marks the company's fourth clinical program in under 18 months.

The Phase 1 trial is designed as a double-blind, placebo-controlled study in healthy volunteers, evaluating safety, tolerability, and pharmacokinetics. The study will enroll approximately 32 healthy adults across 4 cohorts, with interim data expected in second half of 2025.

The company plans to explore APG333 initially for asthma treatment, with potential combination therapy with APG777. Preclinical studies of the APG777 + APG333 combination have shown promising results in inhibiting inflammation with potential for less frequent dosing.

Apogee Therapeutics (APGE) shared positive updates during its 2024 R&D Day, highlighting progress across its inflammatory and immunology pipeline. APG808 showed positive Phase 1 data with a 55-day half-life, supporting 2-3 month dosing potential. APG777 demonstrated promising 12-month data with a 77-day half-life, suggesting possible annual dosing. The company accelerated its APG777 Phase 2 Part A trial topline data to mid-2025.

The company achieved preclinical proof-of-concept for both APG777 + APG990 and APG777 + APG333 combinations for various conditions including atopic dermatitis, asthma, and COPD. A Phase 1b head-to-head trial against DUPIXENT is planned for 2025 with data expected in 2H 2026.

Apogee Therapeutics (Nasdaq: APGE) announced the agenda for its upcoming virtual R&D Day scheduled for December 2, 2024. The event will feature presentations from key opinion leaders including Dr. Emma Guttman-Yassky and Dr. David Singh, alongside the company's management team. The agenda includes discussions on APG808 Phase 1 clinical trial interim results, APG777 updates, and strategies for addressing atopic dermatitis, asthma, and COPD treatments. The presentations will focus on the company's approach to inflammatory and immunology conditions, particularly through IL-13 and combination therapies.