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Combined company to operate asCaldera Therapeutics, developing CLD-423, a potential first-in-class TL1A x IL-23p19 bispecific antibody for inflammatory bowel disease and other immune-mediated diseases
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Concurrent upsized$278 millionprivate placement committed by a syndicate of leading healthcare institutional investors and mutual funds expected to fund operations through Phase 2 clinical trials in ulcerative colitis and Crohn’s disease, with cash runway projected into 2029
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 29, 2026--Synlogic, Inc.(OTC: SYBX) (“Synlogic”) andCaldera Therapeutics, Inc.(“Caldera”), a privately held clinical-stage biotechnology company developing CLD-423, a potential first-in-class TL1A x IL-23p19 bispecific antibody for inflammatory bowel disease (IBD) and other immune-mediated diseases, today announced that they have entered into a definitive merger agreement to combine in an all-stock transaction. The combination will be accomplished by both companies becoming wholly-owned subsidiaries of a newly formed holding company. Upon closing, the combined company plans to operate under the nameCaldera Therapeutics, Inc.and intends to apply to trade on the Nasdaq Capital Market under the ticker symbol “CALD.”
In support of the proposed merger, Caldera has secured commitments for an upsized concurrent private placement expected to generate approximately$278 millionin gross proceeds from a syndicate of leading healthcare institutional investors and mutual funds, including Bain Capital Life Sciences, TCGX,Atlas Venture, venBio Partners,Omega Funds, Blackstone Multi-Asset Investing, LAV,Wellington Management,Janus Henderson Investors,Sirenia Capital Management LP,Vivo Capital, several additional mutual funds and other institutional investors.
The financing is expected to support the Phase 2 clinical development of CLD-423 in ulcerative colitis and Crohn’s disease, as well as potential development in additional immune-mediated diseases. The combined company's cash and cash equivalents at closing, together with the proceeds from the concurrent private placement, are expected to fund the combined company’s operations into 2029. The financing is expected to close concurrently with the merger, subject to the satisfaction of customary closing conditions.
“In just over a year, we’ve shown our team’s ability to open up a lead with compelling data from a molecule poised to deliver the next horizon of I&I therapy,” saidPraveen Tipirneni, MD, MBA, Chief Executive Officer of Caldera. “These transactions provide the capital and public company platform to advance our vision as we move into Phase 2 development in IBD and continue exploring the potential of CLD-423 across additional immune-mediated diseases.”
“Following our evaluation of strategic alternatives, we believe this transaction represents the best path forward for our shareholders and an exciting opportunity to support the advancement of an innovative program with the potential to break through the current efficacy ceiling in inflammatory bowel disease,” saidMary Beth Dooley, Principal Executive Officer and Principal Financial Officer ofSynlogic. "We are impressed by the strength of Caldera's team, CLD-423’s differentiated profile, and the clear development strategy for the combined company. We look forward to supporting this next chapter and the important work ahead."
About CLD-423
CLD-423 is an investigational bispecific antibody designed to simultaneously inhibit the clinically validated TL1A and IL-23p19 pathways for the treatment of inflammatory bowel disease (IBD) and other immune-mediated diseases. By combining both mechanisms in one molecule, CLD-423 has the potential to deliver greater efficacy than single-targeted standards of care. CLD-423 was rationally designed with a natural IgG structure and a monovalent 1+1 format to reduce TL1A target-based immunogenicity liabilities. In addition, CLD-423 incorporates the YTE half-life extension mutation to enable a competitive dosing profile.
CLD-423 is currently being evaluated in a Phase 1 healthy volunteer clinical trial inAustralia. The trial commenced inJanuary 2026and has completed dosing. Unblinded data from the first four single ascending dose (SAD) cohorts through 85 days (cohorts 1 and 2) and 57 days (cohorts 3 and 4) support trial objectives and provide a strong foundation for future efficacy trials. In these SAD cohorts, CLD-423 was generally well tolerated with no dose-limiting toxicities. CLD-423 demonstrated a favorable pharmacokinetic (PK) profile, with approximately dose-proportional exposure, a serum half-life exceeding 40 days within the anticipated therapeutic exposure range, and approximately 80% subcutaneous bioavailability. These properties support the potential for a convenient maintenance dosing regimen of once every 8 or 12 weeks in IBD patients. CLD-423 demonstrated rapid and sustained TL1A target engagement as measured by inhibition of pNF-kB signaling in whole blood. Anti-drug antibody (ADA) incidence was low in the SAD cohorts, with late onset and low titers, reflecting a favorable immunogenicity profile consistent with well-behaved therapeutic antibodies and not characteristic of bivalent anti-TL1A antibodies. Caldera expects to report additional data from all five SAD cohorts and data from the multiple-dose cohorts later in 2026.
Caldera holds exclusive worldwide rights to develop and commercialize CLD-423 under a license agreement with Qyuns Therapeutics Co., Ltd. Caldera plans to initially develop CLD-423 in ulcerative colitis and Crohn’s disease before potentially expanding into additional immune-mediated diseases.
About the Proposed Transaction
Under the terms of the merger agreement, as of the closing of the proposed merger, pre-mergerSynlogicstockholders are expected to own approximately 2.3% of the combined company, pre-merger Caldera stockholders are expected to own approximately 62.8% of the combined company, and investors participating in the concurrent private placement are expected to own approximately 34.9% of the combined company.
The percentage ownership of the combined company thatSynlogicstockholders will own as of the closing of the proposed merger is subject to adjustment based on the estimated amount ofSynlogic'snet cash immediately prior to the closing date.
The transaction has been approved by the Board of Directors of both companies and is expected to close by early 2027, subject to the satisfaction of customary closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (“SEC”) to register the securities to be issued in connection with the proposed acquisitions of Caldera andSynlogicand the satisfaction of other customary closing conditions.
Following the closing, the combined company will operate under the nameCaldera Therapeutics, Inc.and intends to apply to trade on the Nasdaq Capital Market under the ticker symbol “CALD.” The combined company will be led byPraveen Tipirneni, MD, MBA, Caldera's current Chief Executive Officer. Caldera’s Board of Directors will become the directors of the combined company.
Lucid Capital Marketsis serving as exclusive financial advisor toSynlogic, andMintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel toSynlogic.
Jefferies,TD Cowen,Guggenheim Securities,UBS Investment Bank, andLifeSci Capitalare serving as placement agents to Caldera.Fenwick & West LLPis serving as legal counsel to Caldera.Cooley LLPis serving as legal counsel to the placement agents.
AboutCaldera Therapeutics, Inc.
Caldera Therapeuticsis a clinical-stage company developing CLD-423, a potential first-in-class bispecific antibody targeting the clinically validated IL-23p19 and TL1A pathways for the treatment of inflammatory bowel disease (IBD) and other immune-mediated diseases. Caldera has assembled a senior leadership team with deep experience in the discovery and development of IBD therapeutics and a proven track record of building biotechnology companies.
About Synlogic
Synlogic is a biopharmaceutical company historically focused on advancing novel therapeutics to transform the care of serious disease in need of new treatment options.