Avalo Therapeutics (AVTX) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Financial position and milestones

• Raised $430M after positive LOTUS data in early May; $462M cash at end-September is expected to fund Phase III top-line in 2029, a second indication and AVTX-010.

• No additional raises are needed currently; FDA and EMA feedback is expected before year-end, with Phase III preparations targeting an early-2027 start.

• AVTX-010 is an engineered, high-affinity antibody with extended PK; CMC work is underway, with a PK study, IND filing and clinical entry planned for 2027.

LOTUS efficacy and dose

• LOTUS tested placebo and two regimens: 600 mg loading/300 mg every four weeks and 300 mg loading/150 mg every two weeks; efficacy was similar, with a slight efficacy advantage for the higher loading dose.

• The proposed Phase III regimen is 600 mg loading followed by 300 mg; both LOTUS regimens were well tolerated, with SAEs, neutropenia and infections similar to placebo.

• Biologic-experienced patients were 37% of the study; responses were described as similar in biologic-naive and previously TNF- or IL-17-exposed patients.

• EADV late-breaker IHS4-75 results were described as the highest response rates among drugs; pain and flare outcomes showed positive trends but were not powered for significance.

Phase III plans

• Two studies are proposed rather than one; LOTUS was run and analyzed to pivotal standards and could potentially serve as a pivotal study under the cited MoonLake precedent.

• Expected total study population is 1,200–1,600, including at least 100 patients followed for a year; FDA discussions are ongoing.

• HiSCR75 is the planned primary endpoint, with step-down analysis to HiSCR50; IHS4, skin pain and quality-of-life measures are also planned.

• Phase III plans include greater stratification to balance baseline severity and manage placebo response; LOTUS was described as able to withstand a 30% placebo rate.