BLN-326 / BMS, Beeline Medicines - LARVOL DELTA

Beeline Medicines…announced the closing of a $126.3 million Series A extension, bringing its total Series A financing round to $426.3 million. (GlobeNewswire) - "The proceeds from the upsized Series A will support the initiation of several clinical studies across the Company’s broad immunology portfolio, including planned pivotal development of its lead program, afimetoran, in lupus...The Company has commenced pivotal development preparations in lupus ahead of the expected Phase 2 readout of afimetoran in systemic lupus erythematosus in the second half of 2026...Over the next 12 months, the Company expects to initiate additional clinical trials across its pipeline, including for lomedeucitinib...and BLN-481 (formerly BMS-986481)."

Financing • P2 data • Pipeline update • Atopic Dermatitis • Immunology • Inflammation • Systemic Lupus Erythematosus

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Completed

Trial completion • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Beeline Medicines formally launched Wednesday with $300 million in series A financing and a ready-made pipeline of immunology assets in-licensed from Bristol Myers Squibb that it hopes will help reshape how autoimmune and inflammatory diseases are treated. (Firstwordpharma Press Release) - "Beeline's lead programme, afimetoran (BMS-986256), is a once-daily oral small molecule designed to inhibit toll-like receptors 7 and 8 (TLR7/8), components of the innate immune system linked to the aberrant activation seen in systemic lupus erythematosus...'we expect several additional clinical trials to start across our pipeline over the next 12 months.'...Beyond afimetoran, the pipeline also includes an IL-2-CD25 fusion protein dubbed BMS-986326...The company is also working on a once-daily oral TYK2 inhibitor called lomedeucitinib (BMS-986322)....Additionally, the pipeline includes two IND-stage biologics, BMS-986481 and BMS-986498..."

Financing • New trial • Atopic Dermatitis • Immunology • Psoriasis • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Bristol Myers Squibb and Bain Capital Create New Company Dedicated to Developing Innovative Immunology Therapies that Address the Unmet Medical Needs of Patients (The Globe and Mail) - "Bristol Myers Squibb...and Bain Capital today announced the creation of a new independent biopharmaceutical company ('NewCo') focused on developing new therapies for autoimmune diseases that address significant unmet needs of patients. The newly formed company launches with five immunology assets in-licensed from BMS and a $300 million financing commitment that was led by Bain Capital...The NewCo has a broad pipeline consisting of three clinical-stage and two Phase 1-ready investigational medicines that each target promising mechanisms in autoimmune diseases. The most advanced assets in the NewCo’s portfolio are afimetoran, an oral, potential best-in-class TLR7/8 inhibitor that is currently being studied in a Phase 2 clinical trial for systemic lupus erythematosus (SLE), and BMS-986322, an oral TYK2 inhibitor, which successfully established proof-of-concept in a positive plaque psoriasis Phase 2 trial..."

Commercial • Atopic Dermatitis • Psoriasis • Systemic Lupus Erythematosus

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Nov 2025 ➔ Apr 2026 | Trial primary completion date: Nov 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2025 ➔ Nov 2025 | Trial primary completion date: Aug 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants (clinicaltrials.gov) - P1 | N=88 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Phase classification: P1b ➔ P1

Phase classification • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

BMS-986326 is a novel IL-2/CD25 fusion protein that induces highly selective and durable expansion of regulatory T cells in vitro and following single doses in healthy volunteers (EADV 2023) - P1 | "In whole blood from patients with immune-mediated disease, BMS-986326 induced comparable maximal IL-2R signaling to that in blood from HVs. In a SAD study in HVs, BMS-986326 was generally well-tolerated with robust, selective, durable, and dose- dependent Treg expansion. Further clinical studies are warranted to investigate how BMS-986326 may restore immune homeostasis by Treg expansion in patients with immune-mediated dermatologic diseases."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilia • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD8 • IL2 • IL2RA • ISG20 • STAT5

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1b | N=60 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus (clinicaltrials.gov) - P1b | N=60 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P1 trial • Cutaneous Lupus Erythematosus • Discoid Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus