1Q26 Reports: IND Filing for Efzofitimod's New & Improved Ph3 On-Track for June

研报英文原文证据摘录

1Q26 Reports: IND Filing for Efzofitimod's New & Improved Ph3 On-Track for June

C O M PA N Y N O T E

M a y 1 5 , 2 0 2 6

...population to be tested in the new Ph3. For context, recognize the upcoming Ph3 trial is

designed to recruit a more homogeneous patient population focused on patients who have

restrictive lung function whereas the prior Ph3 EFZO-FIT (NCT05415137; note here) recruited all

pulmonary phenotypes. In fact, EFZO-FIT only recruited n=44 (16.7% of patients with this more

restrictive phenotype, which is defined as FVC <LLN with FEV1/FVC ≥LLN. With this in mind,

we believe FVC is already de-risked to demonstrate benefit given efzofitimod's Ph3 EFZO-FIT

showed a clinically meaningful benefit in this subgroup of +124 mL at Day 365 (vs no FVC benefit

among pulmonary sarcoidosis patients without a restrictive phenotype; note here). Beyond these

attributes, the new study is also designed as a larger Ph3 (target recruitment of n=~372) and is

designed for more frequent dosing at Q3W 5.0 mg/kg efzofitimod. Altogether, these modifications

to the new Ph3 design set efzofitimod up to demonstrate stat sig in pulmonary sarcoidosis and

thus de-risk the path towards regulatory approval (pending positive results).

Catalysts

• Efzofitimod (HARS immunomodulator) 48-week (up-to 52-week) Ph3 EFZO-FIT

(NCT05415137) in n=268 pulmonary sarcoidosis patients with primary endpoint of absolute

change in mean oral corticosteroid dose has primary completion listed as July 31, 2025 (per

clinicaltrials.gov) missed stat sig at topline (additional data disclosed here) with development

planning ongoing following the Type C meeting with the FDA — Active, not recruiting (status

changed on July 22, 2024)

• Efzofitimod (HARS immunomodulator) 24-week Ph2 EFZO-CONNECT (NCT05892614) in