- 28-day data from global Phase 1 proof-of-concept study of CLY-124 in Sickle Cell Disease expected in Q4 2026
- In vivo preclinical data assessing new compounds vs. standard of care in gold-standard, translatable myelofibrosis model expected in Q2 2026
- Advancing existing discovery and development collaborations in MASH and IBD
- Ted Myles, CEO, presenting at J.P. Morgan Healthcare conference on January 12, 2026 at 10:00 a.m. PT (1 p.m. ET)
SOMERVILLE, Mass.–(BUSINESS WIRE)–Cellarity, a clinical-stage biotechnology company developing Cell State-Correcting therapies through integrated multi-omics and AI modeling, today provided a 2026 corporate outlook and update on key strategic priorities.
“We begin 2026 with momentum from strong execution across our business in 2025, including moving CLY-124 into the clinic with a Phase 1 proof-of-concept study, identifying new therapeutic candidates to advance our pipeline of Cell State-Correcting small molecule therapies, and continued progress of our MASH program in partnership with Novo Nordisk,” said Ted Myles, Chief Executive Officer at Cellarity. “We look forward to presenting the results of the ongoing Phase 1 study at the end of this year, highlighting 28-day data of CLY-124 and its therapeutic potential in treating sickle cell disease, as well as continuing to advance our myelofibrosis program with the goal of nominating a development candidate in the fourth quarter.”
2026 Strategic Priorities and Upcoming Milestones
Cellarity has created a novel approach to drug discovery that focuses on understanding the holistic cell state. The Company’s platform leverages high-dimensional transcriptomics and AI predictive algorithms to discover new biological pathways and to create novel, oral therapeutics that can effectively and safely switch disease mechanisms to healthy cell function, termed as “Cell State-Correcting.” This has resulted in a growing pipeline of differentiated drug candidates, with the lead candidate, CLY-124, a first-in-class globin switching oral therapy for the treatment of sickle cell disease (SCD), in clinical development.
The Company is focused on achieving the following priorities in 2026:
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Deliver 28-day data from our global Phase 1 proof-of-concept study of CLY-124 for the treatment of sickle cell disease (SCD)
- Initiate multiple ascending dose cohorts in SCD in the U.S., Kenya and other countries
- Deliver 28-day data from SCD multiple ascending dose cohorts (monotherapy and in combination with hydroxyurea) in Q4 2026 with the goal of showing meaningful elevation of fetal hemoglobin, with continued demonstration of safety from our non-cytotoxic approach
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Expand hematology strategy with novel program in myelofibrosis
- Conduct in vivo preclinical head-to-head studies versus the current standard of care (JAK2 inhibitor) using a gold-standard transplant V617F model, with data expected in Q2 2026
- Nominate a development candidate for myelofibrosis in Q4 2026
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Advance pipeline by driving progress across existing partnerships and establishing new collaborations in hematology, immune and metabolic disorders
- Continue to advance MASH program in partnership with Novo Nordisk
- Progress research collaboration with Pioneering Medicines to develop novel, small molecule therapeutics for inflammatory bowel disease (IBD)
- Leverage Cellarity’s platform to form new partnerships and collaborations that discover biological pathways and create new chemical entities with differentiated therapeutic potential
2025 Highlights and Accomplishments
- Initiated the Phase 1 study of CLY-124, a first-in-class globin switching oral therapy for the treatment of SCD
- Publications highlighting Cellarity’s drug discovery platform in Science and Nature Communications
- SCD and myelofibrosis programs presented in oral sessions at the 67th American Society of Hematology Annual Meeting
- Executed research collaboration with Pioneering Medicines for IBD
- Strengthened management team with appointments of Ted Myles to Chief Executive Officer; Atli Thorarensen to Chief Scientific Officer; and Rushmie Nofsinger to Chief Corporate Affairs Officer
About Cellarity
Founded by Flagship Pioneering in 2019, Cellarity is pioneering a fundamentally new approach to drug discovery that corrects whole cell-state dysfunction to solve complex diseases. The Company’s proprietary drug discovery platform leverages advanced transcriptomics to comprehensively understand gene networks and applies the power of dynamic AI modeling to predict and design oral Cell State-Correcting therapeutics that can precisely regulate genetic switch mechanisms to restore proper cell function. The Company’s lead asset, CLY-124, is designed to treat sickle cell disease through a novel globin-switching mechanism and is under evaluation in a Phase 1 clinical study. Additional candidates are advancing for indications in hematology, immunology and metabolic disorders. For more information visit www.cellarity.com.
Contacts
Media Contact:
Rushmie Nofsinger
rnofsinger@cellarity.com