Alumis (ALMS) investor relations material

Key clinical updates and data insights

• Envu, a TYK2 inhibitor, showed consistent PASI 100 rates of 40%+ at week 24 in psoriasis, rising to 54% in ONWARD3 and nearly 50% at week 48 ITT analysis, indicating strong efficacy and clinical cure rates.

• Rapid and significant itch relief was observed, with over 70% of patients achieving a clinically meaningful 4-point NRS improvement.

• LUMUS lupus trial data confirmed strong safety, with no new signals, MACE, malignancies, or concerning lab changes, supporting NDA finalization.

• Phase II LUMUS did not meet primary endpoints in all-comers but showed strong efficacy in interferon signature-positive lupus patients, guiding future trial focus.

• Placebo response in lupus was high among signature-negative patients, reinforcing the need for biomarker-driven enrollment in future studies.

Regulatory and development plans

• NDA filing for envu in psoriasis is on track for Q4, with standard FDA review timelines expected.

• Label differentiation from SOTYKTU is anticipated due to selective TYK2 inhibition and absence of JAK-related side effects or TB reactivation.

• Once-daily formulation development is ongoing, with multiple candidates entering clinical testing; selection and timeline updates expected after PK/PD work over the coming quarters.

• Phase III lupus trial design will focus on interferon signature-positive patients, with agency discussions planned for early next year.

Strategic outlook and pipeline

• Commercial opportunity in psoriasis is considered substantial, with analogs like ICOTYDE and Takeda's asset projected at $3–6 billion; strong efficacy and itch relief position envu competitively.

• Lupus market remains high unmet need; future trials will leverage biomarker insights to optimize efficacy.

• Partnership strategy is flexible, ranging from regional to global deals, with earlier partnering preferred to maximize strategic input.

• Pipeline update: A5 program pivoted from MS to Parkinson's, with a phase II-A biomarker study planned for 2027; another molecule to enter clinic next year.

• Cash runway extends into Q4 2027, supporting ongoing and planned trials, with partnership and financial strategy under review.