Caldera Launches with $112.5M to Redefine IBD Treatment

CAMBRIDGE, Mass. – January 14, 2026 – Biotechnology startup Caldera Therapeutics officially launched today, stepping onto the clinical stage with a formidable $112.5 million in capital and the announcement that its first-in-class drug candidate for inflammatory bowel disease (IBD) has been administered to its first human subjects. The company is poised to challenge the current standards of care for millions of patients suffering from chronic and debilitating autoimmune conditions like Crohn's disease and ulcerative colitis.

The financing, a clear signal of investor confidence, consists of a $75 million Series A round from biotech stalwarts Atlas Venture, LAV, and venBio, followed by a recent $37.5 million Series A-1 round. The latter was led by Omega Funds and saw participation from new institutional investors Wellington Management and Janus Henderson Investors. This substantial backing will fuel the clinical development of Caldera’s lead program, CLD-423, which has now entered a Phase 1 trial in healthy volunteers.

A New Strategy for a Persistent Challenge

Inflammatory bowel disease affects millions globally, creating a significant and growing therapeutic market valued at over $31 billion. Despite the availability of multiple treatments, including advanced biologics, a substantial unmet need persists. Many patients face a frustrating reality known as the "therapeutic ceiling," where even the most effective current drugs achieve clinical remission in only 30% to 50% of individuals. Furthermore, a significant portion of initial responders lose efficacy over time, forcing them to cycle through different medications in search of lasting relief.

These limitations are compounded by potential side effects and the high cost of treatment, leaving patients and clinicians eager for more effective and durable options. Caldera Therapeutics aims to break through this ceiling by targeting the disease from a novel angle. Its lead asset, CLD-423, is not just another single-target biologic; it is a bispecific antibody engineered to simultaneously block two distinct and clinically validated inflammatory pathways.

The Science of a Dual-Pronged Attack

At the heart of Caldera's strategy is the unique design of CLD-423. The bispecific antibody is engineered to neutralize both the IL-23p19 and TL1A pathways, two key drivers of the chronic inflammation that characterizes IBD.

The IL-23 pathway is already a well-established target in autoimmune disease. Several approved and successful drugs for IBD and psoriasis work by inhibiting this cytokine, confirming its central role in orchestrating the inflammatory response. By blocking IL-23, CLD-423 aims to suppress a major source of inflammation.

The TL1A pathway is an emerging and highly promising target that has garnered significant attention in the field. TL1A not only amplifies inflammation but is also implicated in fibrosis, the development of scar tissue in the intestines. This fibrotic process is a major complication of IBD, leading to strictures, blockages, and often the need for surgical intervention. By targeting TL1A, CLD-423 holds the potential to not only reduce inflammation but also mitigate the long-term tissue damage that is a hallmark of progressive disease.

“By elegantly combining two powerful autoimmune targets in a single molecule, CLD-423 represents the next frontier in IBD treatment,” said Praveen Tipirneni, MD, CEO of Caldera. “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.”

This dual-target approach represents a synergistic strategy. Instead of hitting one switch, Caldera aims to flip two at once, potentially delivering a more profound and sustained anti-inflammatory effect than could be achieved with single-target monotherapies.

Backed by Biotech Heavyweights and Proven Leadership

The significant capital raised by Caldera is a testament to both its scientific premise and its leadership. The syndicate of investors includes some of the most respected names in life sciences venture capital, known for identifying and building transformative companies. Their collective backing provides Caldera not only with financial runway but also with deep strategic and operational expertise.

“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.”

Leading the company is CEO Praveen Tipirneni, whose previous role as CEO of Morphic Therapeutic gives him directly relevant experience. At Morphic, he successfully guided the development of an oral IBD drug candidate, MORF-057, from early stages through clinical trials and a successful IPO, demonstrating a keen ability to navigate the complex landscape of IBD drug development and company building.

The Road Ahead: From Lab to Clinic

The initiation of the Phase 1 trial for CLD-423 marks a critical milestone, transitioning the program from a preclinical concept to a clinical-stage asset. This initial study in healthy volunteers is designed primarily to evaluate the drug's safety, tolerability, and pharmacokinetic profile—how the drug is absorbed, distributed, metabolized, and excreted by the body. The data gathered will be crucial for determining appropriate dosing for future studies in patients.

A successful outcome, or a 'win,' from this Phase 1 trial would involve demonstrating a clean safety profile with no unexpected adverse events and a pharmacokinetic profile that supports a convenient dosing schedule, such as subcutaneous injections administered weekly or even less frequently. Such a profile is essential for any therapy intended for the chronic management of IBD.

Caldera in-licensed the exclusive global rights to CLD-423 from Qyuns Therapeutics Co., Ltd., a strategic move that allowed the new company to acquire a promising, first-in-class asset after a thorough evaluation of the competitive landscape. With robust funding, a novel scientific approach, and an experienced team, Caldera is now focused on executing this first clinical study, the results of which will pave the way for subsequent trials in IBD patients and could mark the beginning of a new era for treatment.