What Caldera Therapeutics does

Caldera Therapeutics is a clinical-stage biotechnology company founded in 2025 and officially launched in January 2026, headquartered at 300 Technology Square in Cambridge, Massachusetts. The company is developing CLD-423, a first-in-class bispecific antibody that simultaneously targets the IL-23p19 and TL1A pathways — two clinically validated mechanisms in autoimmune disease. Caldera acquired the program by in-licensing exclusive global development and commercialization rights to CLD-423 from Qyuns Therapeutics Co., Ltd., and the asset is currently in a Phase 1 healthy volunteer trial.

The underlying technology is a rationally engineered bispecific antibody designed to deliver a best-in-disease profile across efficacy, safety, pharmacokinetics, and developability. By combining IL-23p19 and TL1A inhibition in a single molecule, Caldera is positioning the program to address what the company characterizes as an efficacy ceiling in single-target IBD therapies, with stated optionality to expand into other immunologic and inflammatory diseases. Caldera has assembled a leadership team anchored by individuals with prior exits and large-pharma experience, including CEO Praveen Tipirneni, who previously led Morphic Therapeutic through its $3.2 billion acquisition by Eli Lilly.

Caldera is pre-revenue and operates as a venture-backed development-stage biotech. It funds operations through institutional venture capital — having raised $112.5 million across a $75 million Series A (Atlas Venture, LAV, venBio) and a $37.5 million Series A-1 (Omega Funds lead, with Wellington Management and Janus Henderson Investors). The company serves an end-patient population of IBD patients (Crohn's disease and ulcerative colitis), and upon regulatory approval will distribute CLD-423 through standard pharmaceutical channels — specialty pharmacy networks and hospital purchasing systems — with no pricing or commercial details disclosed today.

Name

Caldera Therapeutics

Legal name

Caldera Therapeutics, Inc.

Website

https://calderatx.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

1–10 employees

Short description

Caldera Therapeutics is a clinical-stage biotechnology company developing CLD-423, a first-in-class bispecific antibody targeting IL-23p19 and TL1A pathways for inflammatory bowel disease, with a Phase 1 healthy volunteer trial currently ongoing.

Ownership category

akta.pro rank

Product category

Bispecific Antibody Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

akta.pro secondary industry

Blood Factors & Hemostasis Biologics (recombinant clotting factors, thrombolytics) (HLAAAAAL)

Keywords

• Bispecific antibodies
• Inflammatory bowel disease
• Immunology therapeutics
• Biologics development
• Clinical stage biotechnology

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Pharmaceutical Drug Sales: Pre-revenue clinical stage biotechnology company. The company will generate revenue through the eventual commercialization of its bispecific antibody therapeutic CLD-423 upon regulatory approval. Revenue model will follow traditional pharmaceutical sales channels for prescription biologics.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Caldera Therapeutics is a clinical-stage biotechnology company developing CLD-423, a first-in-class bispecific antibody that simultaneously targets the IL-23p19 and TL1A pathways for the treatment of inflammatory bowel disease (IBD) and other immunologic and inflammatory diseases. The molecule is rationally designed to achieve a best-in-disease profile with optimized efficacy, safety, pharmacokinetics, and developability. The company in-licensed global development and commercialization rights to CLD-423 from Qyuns Therapeutics Co., Ltd.

Product overview

Caldera Therapeutics is a clinical-stage biotechnology company developing a single product, CLD-423, which is a first-in-class bispecific antibody. CLD-423 is the company's sole pipeline asset, targeting the IL-23p19 and TL1A pathways for treatment of inflammatory bowel disease and other immunologic/inflammatory diseases. The company launched in January 2026 with $112.5 million in funding and a Phase 1 healthy volunteer trial is ongoing for CLD-423.

Differentiator

Problem solved

Functional benefit

Products and services

• CLD-423 CLD-423 is a first-in-class bispecific antibody that targets both the IL-23p19 and TL1A pathways for the treatment of inflammatory bowel disease (IBD) and other immunologic and inflammatory diseases. It is rationally designed to achieve a best-in-disease profile with optimized efficacy, safety, pharmacokinetics, and developability, and is currently in a Phase 1 healthy volunteer trial.

Quantifiable outcome

• Phase 1 healthy volunteer trial initiated with first subjects dosed

Segments1 record

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

One partnership is on record.

• Qyuns Therapeutics Co., Ltd.coreStrategic or Co-development Partner · 1 January 2025Caldera Therapeutics in-licensed exclusive global development and commercialization rights to CLD-423 from Qyuns Therapeutics Co., Ltd. This licensing agreement provides Caldera with the foundational intellectual property for its lead bispecific antibody program targeting IL-23p19 and TL1A pathways.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Bristol Myers Squibb: Markets Zeposia (ozanimod, S1P modulator) for ulcerative colitis and runs active Phase 2–3 gastroenterology programs. Caldera's SVP Clinical Development (Danny Oh) previously led IBD trials at BMS, indicating a competitor with operational overlap.
• Roivant Sciences: Houses multiple Vant subsidiaries developing IBD and immunology therapies (including TL1A-focused programs). A broader, well-capitalized player pursuing adjacent mechanisms in the same indication space.
• AbbVie: Markets Humira and Skyrizi (risankizumab, anti-IL-23) — the leading IL-23p19 inhibitor approved for Crohn's disease and ulcerative colitis. Sets the efficacy/safety bar CLD-423 must exceed to differentiate in IBD.
• Johnson & Johnson: Markets Stelara (ustekinumab) and Tremfya (guselkumab) for IBD. A leading immunology incumbent whose IL-23 pathway franchise overlaps with one of CLD-423's targets.
• Eli Lilly: Acquired Morphic Holding in 2024 for its IBD integrin program; large pharma with growing immunology franchise. Relevant as a likely strategic acquirer profile for Caldera.
• Takeda Pharmaceutical: Markets Entyvio (vedolizumab), the leading integrin antagonist for IBD; Caldera's CPO (Colm White) previously led Entyvio's global launch at Takeda. A major incumbent in the same therapeutic class.

Direct peers

• Landos Biopharma: Clinical-stage biotech developing novel oral therapeutics for IBD (e.g., omilancor, NX-13); acquired by AbbVie in 2024. Comparable as a small-cap IBD biotech with a single mechanistic thesis acquired by a major player.
• Morphic Holding: Developed oral integrin inhibitors for IBD; acquired by Eli Lilly in 2024 for $3.2B. Direct comparator for an IBD-focused clinical-stage biotech with a single-asset profile and is the prior company of Caldera's CEO and several executives.
• Prometheus Biosciences: Developed PRA023, an anti-TL1A monoclonal antibody for IBD and other immunologic diseases; acquired by Merck in 2023 for ~$10.8B. Highly comparable as a TL1A-pathway IBD biologic at similar clinical-stage risk profile.

Emerging players

• Sorriso Pharmaceuticals: Clinical-stage biotech developing oral immunology therapies for IBD, including ulcerative colitis. Caldera's SVP of Clinical Development Operations (Pam Wedel) most recently led early-phase IBD work at Sorriso, signaling direct operational comparability.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat2 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds2 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Caldera Therapeutics