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Dec 31, 2023
Apogee Q4 2023 Earnings Report
Apogee Therapeutics reported its Q4 and full year 2023 financial results and provided pipeline progress.
Key Takeaways
Apogee Therapeutics reported a net loss of $31.7 million for the fourth quarter of 2023. The company's cash, cash equivalents, and marketable securities totaled $395.5 million as of December 31, 2023, which is expected to fund operations into 4Q 2026.
Positive interim results from APG777 Phase 1 healthy volunteer clinical trial exceeded objectives with approximately 75-day half-life.
APG777 Phase 1 interim data support advancement of a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe atopic dermatitis in 1H 2024 ahead of schedule.
Phase 1 healthy volunteer clinical trial set to start ahead of schedule for APG808, a subcutaneous extended half-life antibody targeting IL-4Rα, following receipt of regulatory clearance in February.
Total cash of $395.5 million at year end 2023 with expected cash runway into 4Q 2026.
Apogee
Apogee
Forward Guidance
Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into 4Q 2026.
Positive Outlook
- APG777 demonstrated a favorable safety profile.
- APG777 exceeded trial objectives on both pharmacokinetics and pharmacodynamics.
- APG777 supports a path forward into a Phase 2 trial for APG777 in patients with AD in the first half of this year.
- APG808 is set to start a Phase 1 healthy volunteer clinical trial ahead of schedule.
- Apogee continues to make progress with APG808 while advancing earlier programs, APG990 and APG222.
Challenges Ahead
- Global macroeconomic conditions and related volatility.
- The unpredictable relationship between preclinical study results and clinical study results.
- Timing or likelihood of regulatory filings and approvals.
- Liquidity and capital resources.
- Risks and uncertainties identified in Apogee’s Quarterly Report on 10-Q for the quarterly period ended September 30, 2023, filed with the SEC on November 13, 2023, and subsequent disclosure documents.