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Beeline Medicines Debuts to Deliver Category-Leading Precision Therapies for People Living with Autoimmune and Inflammatory Diseases

– Advancing a broad portfolio designed to deliver multiple paradigm-shifting therapies for devastating and underserved immune-mediated diseases – 

– Lead program afimetoran, a potential best-in-disease oral therapy for lupus, to complete Phase 2 trial in 2H 2026 before commencing pivotal development program –

– Saqib Islam, Chief Executive Officer, leads established executive team with proven track record in drug development and global commercialization of first- and best-in-class medicines –

– $300 million Series A financing led by Bain Capital supports operations into late-stage clinical development –

STAMFORD, Conn. and BOSTON, April 15, 2026 (GLOBE NEWSWIRE) -- Beeline Medicines Corporation (“Beeline Medicines” or “the Company”), a clinical-stage biotechnology company, today announced its official debut with the mission of developing and delivering category-leading precision therapies to transform the lives of people with autoimmune and inflammatory diseases. Originally formed in July 2025, the Company’s initial portfolio is comprised of five programs in-licensed from Bristol Myers Squibb (NYSE: BMY, “BMS”), each of which is a mechanistically-guided, highly-selective therapeutic candidate with the potential to meaningfully improve the long-term health and outlook for patients living with a broad array of devastating immune-mediated conditions. With an established executive team and backed by a $300 million Series A financing led by Bain Capital, Beeline Medicines is poised to define the future of care for patients in need of life-changing treatments.

“Today marks an important milestone as Beeline Medicines debuts with a clear purpose: to deliver new, clinically significant treatment options for people living with autoimmune and inflammatory diseases,” said Saqib Islam, Chief Executive Officer of Beeline Medicines. “We are building a company with the scientific and operational rigor required to urgently deliver durable, transformative innovations to address the substantial unmet needs of this patient community. Our lead program, afimetoran, is a once-daily oral investigational therapy with the potential to change the treatment paradigm for lupus patients. As our Phase 2 trial nears completion, we are preparing for pivotal development of afimetoran, and we expect several additional clinical trials to start across our pipeline over the next 12 months.”

Differentiated Pipeline of Precision Therapies

Beeline Medicines is advancing a differentiated pipeline of precision therapies grounded in validated biology, powered by potential best-in-class molecular designs, and driven by an efficient clinical development strategy that prioritizes addressing high unmet patient needs. This mechanistically informed approach enables targeting of the underlying causes of immune-mediated diseases, restoration of immune balance, and the opportunity to dramatically improve outcomes for patients.

  • Afimetoran: Beeline Medicines’ lead program is a selective, small molecule, once-daily, equipotent TLR7/8 inhibitor that has the potential to be a best-in-disease oral therapy for lupus. Afimetoran established early clinical proof-of-concept in a Phase 1b study in cutaneous lupus erythematosus (CLE), and in May 2025 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of systemic lupus erythematosus (SLE). A Phase 2 study in SLE is ongoing and expected to complete in the second half of 2026, after which Beeline Medicines intends to commence its pivotal development program.
  • BMS-986326: A novel IL-2-CD25 fusion protein in Phase 1b development for atopic dermatitis and lupus (CLE and SLE); it is designed to address limitations of prior IL-2-directed therapies through improved selectivity for regulatory T cells (Treg) by slowly releasing IL-2 and providing pharmacokinetic (PK)/pharmacodynamic (PD) properties that drive potential for best-in-class Treg expansion and extended dosing intervals.
  • Lomedeucitinib (formerly BMS-986322): A potent, small molecule, once-daily, oral, allosteric TYK2 inhibitor that achieved positive proof-of-concept in a placebo-controlled Phase 2 study in plaque psoriasis, with potential for first-in-class development in rare immunological diseases.
  • Beeline Medicines’ emerging pipeline includes two IND-stage next-generation biologics with novel mechanisms focused on the IL-18 and IL-10 pathways, both validated approaches for addressing inflammation across multiple indications, including in gastrointestinal inflammatory conditions.

The shared disease biology across the Company’s pipeline enables long-term, sustained growth through indication expansion, combination approaches, and business development.

“Immune-mediated diseases remain an area of profound need, and we believe that Beeline Medicines is positioned to redefine treatment across multiple underserved autoimmune and inflammatory conditions,” said Dr. Nathalie Franchimont, Chief Medical Officer of Beeline Medicines. “We believe afimetoran, our lead program in lupus, reflects the differentiated, patient-centered approach that we will bring to this field: a precision oral therapy designed to address the underlying drivers of lupus biology in a way that improves clinical outcomes and fits into patients’ lives. With three programs in the clinic and two additional candidates advancing toward first-in-human studies, we aim to move care beyond symptom management to immune system recalibration, durable disease control, and meaningful improvements for patients.”

Industry-Leading Management Team and Board of Directors

In conjunction with the official launch, Beeline Medicines announced its founding executive leadership team, bringing deep experience across autoimmune and inflammatory disease drug discovery and development, regulatory approvals, global commercialization, capital formation, and business and corporate development. Beeline Medicines’ executive team has contributed to the approval and launch of over a dozen medicines combined over their careers, impacting the lives of millions of people worldwide.

Beeline Medicines has also assembled a seasoned Board of Directors spanning renowned R&D leaders, pharmaceutical executives, and life science investors to support the Company’s strategic direction and growth. The Board is chaired by Daniel S. Lynch, who has served alongside Robert Plenge, M.D., Ph.D., Nicholas Downing, M.D., Adam M. Koppel, M.D., Ph.D., and Andrew Kaplan since the closing of the Company’s Series A financing in July 2025. Saqib Islam, Chief Executive Officer of Beeline Medicines, also serves as a Board member. More recently, Martin Mackay, Ph.D., has joined the Board of Directors, bringing more than three decades of global R&D leadership experience, including executive roles at Pfizer, AstraZeneca, and Alexion Pharmaceuticals, and Board positions at Novo Nordisk, Charles River Labs, and Kailera Therapeutics.

“With a category-defining portfolio, world-class executive leadership team, and operational excellence, Beeline Medicines is positioned to deliver medicines that can change the lives of people with devastating immunological conditions,” said Mr. Lynch. “I look forward to supporting Beeline Medicines in building an impactful immunology company that develops these urgently needed therapies.”

About Beeline Medicines

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

For more information, visit www.BeelineMedicines.com and follow on LinkedIn.

Beeline Medicines Contact Information

Samantha Sandler
Head of Communications and Investor Relations

Media:
media@beelinemedicines.com

Investors:
investors@beelinemedicines.com


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