Program Updates and Key Highlights: AVTX-002 Phase 1b Crohn's Disease (CD) Clinical Trial Results: The Phase 1b, open-label, dose-escalation, signal-finding, multi-center study evaluated the safety, tolerability, pharmacokinetics, and short-term efficacy of AVTX-002 in adults with moderate to severe, active CD who have previously failed anti-tumor necrosis factor alpha (anti-TNFa) treatment. The study evaluated two different doses of AVTX-002 (1.0 mg/kg and 3.0 mg/kg) in which all subjects received a total of four doses of AVTX-002 by subcutaneous (SQ) injection at 14-day intervals and underwent colonoscopies at baseline and again at eight weeks; Clinically meaningful mucosal healing, determined by colonoscopy and adjudicated by a central reader, was observed in 50% (4/8) of subjects with one subject achieving remission (SES-CD = 0). Additionally, patients responded rapidly to treatment within eight weeks and free LIGHT levels decreased in all subjects; 75% (3/4) of patients that demonstrated mucosal healing by colonoscopy reported they had returned to doing poorly two to three months after cessation of study drug, suggesting a drug-related effect; follow-up is ongoing for the remaining responder.

Data continued to show that treatment with AVTX-002 was safe and well tolerated with no drug-related serious adverse events observed; Avalo continues to evaluate the biomarker data from this study; The Company is currently evaluating AVTX-002 in a cohort of ulcerative colitis (UC) patients with moderate to severe UC who are refractory to biologic therapy, including anti-TNFa, with data anticipated in the third quarter of 2022. Data from the CD and UC studies will inform the design for a subsequent randomized controlled clinical study in moderate to severe refractory patients. AVTX-002 for the treatment of non-eosinophilic asthma (NEA): NEA is a significant subtype of asthma with a poor prognosis that encompasses approximately half of asthma patients.

Biomarker data suggests that LIGHT plays a strong role in inflammation and airway remodeling in NEA and support the development of AVTX-002 for poorly controlled NEA patients; An investigational new drug (IND) application has been cleared by the FDA. The Company expects top-line data from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in 80 patients with poorly-controlled NEA in the second half of 2022; AVTX-007 in Multiple Myeloma and Adult Onset Still's Disease (AOSD): Multiple Myeloma: The multicenter, open-label, dose-escalation Phase 1b study of AVTX-007 (anti-IL-18 mAb) in subjects with relapsed and refractory multiple myeloma is nearing completion. Three doses (4 mg/kg, 9 mg/kg and 14 mg/kg every 4 weeks) of AVTX-007 as a single agent were evaluated.

AVTX-007 was generally safe and well tolerated, but no efficacy signal was seen in the high dose cohort or expansion phase. Based on these results, the Company is discontinuing the multiple myeloma program; AOSD: AVTX-007 is being evaluated in a multicenter, Phase 1b study in 12 refractory or steroid-dependent patients with AOSD in two cohorts. Top-line data for both cohorts of the trial are anticipated by mid-year 2022.

AVTX-800 programs (AVTX-801, AVTX-802, and AVTX-803) for Congenital Disorders of Glycosylation: Avalo plans to initiate the single-center (US), double-blind (plus open-label extension) pivotal study of AVTX-803 in patients with leukocyte adhesion deficiency type II (LAD II) caused by loss-of-function mutation in the SLC35C1 gene in the first quarter of 2022, with data expected in the third quarter of 2022; The Company remains in dialogue with the FDA to align on suitable clinical study designs for AVTX-801 (loss-of-function mutation in the PGM1 gene) and AVTX-802 (loss-of-function mutation in the MPI gene); All three of these programs have received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) which make them eligible for Priority Review Vouchers upon approval. AVTX-006 in Complex Lymphatic Malformations: The Company expects top-line data from its Phase 1b proof-of-concept of AVTX-006 (dual mTORc1/c2 small molecule inhibitor) for complex lymphatic malformations in mid-year 2022; AVTX-006 has received ODD and RPDD making it eligible for Priority Review Voucher upon approval.