Caldera Therapeutics Launches With $112.5 Million, Doses First Subjects in Phase 1 IBD Trial

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Praveen Tipirneni, M.D.
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CAMBRIDGE, Mass. — Caldera Therapeutics has launched with $112.5 million in total financing and has dosed the first subjects in a Phase 1 clinical trial of its lead investigational therapy, CLD-423, a first-in-class bispecific antibody being developed for inflammatory bowel disease.

The clinical-stage biotechnology company said it initially closed a $75 million Series A financing in April 2025 from founding investors Atlas Venture, LAV, and venBio. That round was later expanded with a $37.5 million Series A-1 financing led by Omega Funds, with participation from new investors Wellington Management and Janus Henderson Investors.

The proceeds will be used to advance the clinical development of CLD-423, which is designed to simultaneously target the clinically validated IL-23p19 and TL1A inflammatory pathways. Caldera said the first subjects have now been dosed in a Phase 1 study in healthy volunteers evaluating the safety and pharmacokinetics of the bispecific antibody.

“By elegantly combining two powerful autoimmune targets in a single molecule, CLD-423 represents the next frontier in IBD treatment,” said Praveen Tipirneni, M.D., chief executive officer of Caldera and former CEO of Morphic Therapeutic. “Bispecifics have the potential to redefine the efficacy bar in IBD, and CLD-423 is rationally designed to achieve a best-in-disease profile with optimized efficacy, safety, pharmacokinetics and developability. CLD-423 is advancing through Phase 1 with the goal of enabling clinical evaluation in patients with IBD.”

Omega Funds said it views CLD-423 as having the potential to significantly reshape treatment options for patients with inflammatory bowel disease.

“We see CLD-423 as a program that has the potential to change the IBD treatment paradigm,” said Michelle Doig, partner at Omega Funds. “Caldera’s scientific strategy, execution focus and leadership team truly distinguish the company and position CLD-423 as a new standard of care. We are excited to lead this financing and partner with Praveen and a top-tier syndicate to unlock meaningful clinical and commercial value.”

Founded in 2025, Caldera Therapeutics is focused on developing new biologic therapies for inflammatory bowel disease and related inflammatory conditions. The company said its leadership team brings extensive experience in IBD drug discovery and development, as well as a track record of building biotechnology companies through successful exits.

Caldera has in-licensed exclusive global development and commercialization rights to CLD-423 from Qyuns Therapeutics Co., Ltd., following an evaluation of emerging bispecific antibody approaches in inflammatory bowel disease.

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