Avalo Therapeutics (NasdaqCM:AVTX) Conference Transcript

Summary of Avalo Therapeutics Conference Call - September 15, 2025 Company Overview - Company: Avalo Therapeutics (NasdaqCM:AVTX) - Location: Outside of Philadelphia - Employee Count: Approximately 30 - Current Development: AVTX-009 in Phase 2b for hidradenitis suppurativa (HS) with expectations for full enrollment by the end of 2025 and data release by mid-2026 [3][19] Core Points and Arguments - Mechanism of Action: AVTX-009 is a high-affinity human antibody targeting IL-1, a key driver of inflammation in HS, with IL-1 expression over 100-fold higher in HS lesions compared to normal skin [5][12] - Clinical Validation: Previous studies, including AbbVie's lutacisumab, demonstrated significant efficacy in HS, particularly in patients with TNF inhibitor failures [8][9] - Efficacy Expectations: Avalo believes AVTX-009 will show higher efficacy than lutacisumab due to its pure targeting of IL-1, higher affinity, and better pharmacokinetics [10][11][22] - Phase 2b Study Design: The study will include 222 patients across three arms (two active drug, one placebo) with a 16-week duration, focusing on HiSCR75 as the primary endpoint [17][18] - Enrollment Status: Enrollment is progressing well, with 75% completion reported, and confidence in full enrollment by fall 2025 [19] Competitive Landscape - Market Dynamics: The market is shifting from TNF inhibitors to IL-17 inhibitors, but there remains a need for alternative mechanisms like IL-1 targeting [20][21] - Safety Profile: IL-1 inhibitors are perceived favorably due to a lack of associated risks such as increased cancer or cardiovascular risks, making them attractive to physicians [21] Future Indications and Opportunities - Expansion Plans: Avalo is exploring potential indications beyond HS, including conditions like ulcerative colitis, rheumatoid arthritis, and crystal arthropathy [25][26][27] - Cash Position: Avalo reported $125 million in cash, sufficient to fund operations through 2028 and the Phase 2 data readout, with plans to raise funds for Phase 3 trials later [28] Additional Important Points - Dosing Regimen: The preferred dosing regimen for AVTX-009 is once a month, which is more favorable compared to the more frequent dosing required for lutacisumab [18] - Statistical Analysis: The company emphasizes the importance of proper statistical methods to avoid misinterpretation of efficacy data [24] This summary encapsulates the key insights from the conference call, highlighting Avalo Therapeutics' strategic focus on IL-1 targeting in HS and its broader implications in the therapeutic landscape.