Qyuns Therapeutics Co., Ltd.

Caldera Therapeutics\' funds were split between an initial $75 million series A round in April 2025 and a more recent $37.5 million A-1 raise.\n Caldera Therapeutics has burst onto the scene with $112.5 million in combined series A cash the Massachusetts biotech will use to fund development of an inflammatory bowel disease (IBD) drug licensed from China.The bispecific antibody—which targets the IL-23p19 and TL1A pathways—was licensed from China’s Qyuns Therapeutics. Since being founded last year, Caldera has already taken the therapy, dubbed CLD-423, into a phase 1 study of healthy volunteers.“By elegantly combining two powerful autoimmune targets in a single molecule, CLD-423 represents the next frontier in IBD treatment,” Caldera CEO Praveen Tipirneni, M.D., said in a Jan. 14 release.“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,” the CEO added.Tipirneni previously headed up Morphic Therapeutic, the integrin-focused biotech that was scooped up by Eli Lilly for $3.2 billion in 2024.Lilly has itself seen some success targeting IL-23p19—one of the pathways targeted by Caldera’s CLD-423—thanks to the pharma’s approved ulcerative colitis med Omvoh. It’s also the target of Johnson & Johnson’s Tremfya and AbbVie’s Skyrizi for Crohn’s disease. TL1A, the other target of Caldera’s drug, has seen increased interest from Big Pharma in the wake of Roche\'s $7 billion acquisition of Roivant subsidiary Telavant in 2023. Since then, Sanofi and Teva’s anti-TL1A antibody duvakitug performed well in a phase 2 IBD trial, while AbbVie got in on the action by buying a preclinical IBD candidate from China’s FutureGen Biopharmaceutical in 2024.Caldera is well financed to take forward its own IL-23p19 and TL1A clinical ambitions thanks to an initial $75 million series A round from founding investors Atlas Venture, LAV and venBio in April 2025. The biotech recently topped up this funding pot with a $37.5 million A-1 round led by Omega Funds, which saw Wellington Management and Janus Henderson Investors also come on board.“We see CLD-423 as a program that has the potential to change the IBD treatment paradigm,” Michelle Doig, a partner at Omega Funds, said in a statement. “Caldera’s scientific strategy, execution focus and leadership team truly distinguish the company and position CLD-423 as a new standard of care.”

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Caldera Therapeutics, Inc. (Caldera), a clinical stage biotechnology company developing the first-in-class bispecific antibody CLD-423 for inflammatory bowel disease (IBD) and other immunologic and inflammatory diseases, today launched with $112.5 million total capital raised and announced that the first subjects have been dosed in the Phase 1 trial of its lead program, CLD-423. Caldera raised a $75 million Series A round from Atlas Venture, LAV and venBio, and most recently a $37.5 million Series A-1 round led by Omega Funds, with participation from new investors Wellington Management and Janus Henderson Investors. Caldera raised a $75 million Series A round from Atlas Venture, LAV and venBio, and most recently a $37.5 million Series A-1 round led by Omega Funds, with participation from new investors Wellington Management and Janus Henderson Investors. Caldera also announced that the first subjects have been dosed in a Phase 1 healthy volunteer trial of CLD-423, a bispecific antibody targeting the clinically validated IL-23p19 and TL1A pathways. “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 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.” “We see CLD-423 as a program that has the potential to change the IBD treatment paradigm,” said Michelle Doig, Partner, 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.” Caldera was founded in 2025 to advance innovative biologics in IBD, assembling a senior leadership team with deep experience in the discovery and development of IBD therapeutics and a proven track record of building biotechnology companies through to successful exits. The company in-licensed exclusive global development and commercialization rights to CLD-423 from Qyuns Therapeutics Co., Ltd., following a comprehensive evaluation of the evolving IBD bispecific landscape. About Caldera Caldera Therapeutics is a clinical stage company developing CLD-423, a first-in-class bispecific antibody targeting the clinically validated IL-23p19 and TL1A pathways for the treatment of inflammatory bowel disease (IBD) and other immunologic and inflammatory diseases. Supported by leading biotech investors Atlas Venture, LAV, venBio, Omega Funds, Wellington Management and Janus Henderson Investors, 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 through to successful exits.

After selling Morphic Therapeutic to Eli Lilly for $3.2 billion, Praveen Tipirneni is back a year and a half later with a new biotech working in Morphic’s old wheelhouse of inflammatory bowel disease. Caldera Therapeutics emerged from stealth Wednesday with a total of $112.5 million in funding for a bispecific licensed from the Chinese biotech Qyuns Therapeutics. Last April, Caldera raised a $75 million Series A round funded by Atlas Venture, LAV and venBio. Clearly deciding this was not quite enough, it has just closed a $37.5 million Series A-1 round led by Omega Funds. New investors Wellington Management and Janus Henderson Investors joined the investor lineup. “The top-up is really to provide us with runway deep into 2027,” Caldera’s chief business officer Aaron Pelta — also formerly of Morphic — told Endpoints News . “Raising the additional cash allows us a lot of operating and strategic flexibility.” The initial funding will take Caldera through its Phase 1 study of its lead candidate, a first-in-class bispecific antibody named CLD-423. This targets IL-23p19, one of the two subunits of the cytokine IL-23, and TL1A. “This is kind of the VEGFxPD-L1 for autoimmune,” Tipirneni said in the same interview, describing IL-23 and TL1A as “the two most obvious targets” in immunology. It is true that these mechanisms have seen great success. IL-23 inhibitors such as Johnson & Johnson’s Stelara and AbbVie’s Skyrizi have racked up billions of dollars in sales for immune diseases, including forms of IBD. As for the anti-TL1A pathway, it “has demonstrated incredibly strong Phase 2 clinical data over the past couple of years, and multiple pharmas have monoclonals targeting TL1A,” Pelta said. Merck bought Prometheus Biosciences for $10.8 billion in April 2023 in order to get its hands on a TL1A, and Roche paid $7.1 billion for Roivant’s TL1A six months later. Both of the drugs had posted encouraging mid-stage data in ulcerative colitis and/or Crohn’s disease. Sanofi also licensed a Phase 2-stage TL1A from Teva in late 2023. Pelta pointed out that Phase 3 studies of some of these products are due to read out this year, “and the expectation is that they will have very strong data.” The idea is that inhibiting both these pathways with a single molecule can allow potentially synergistic efficacy, Pelta said. “There’s a general belief that targeting single pathways has hit the therapeutic ceiling — efficacy has basically been capped,” he said. “The next horizon of treatment of IBD and other I&I diseases is combining complementary pathways into single bispecific molecules, to really have a step change in the efficacy.” Caldera licensed CLD-423 from Qyuns in April, paying $10 million upfront for worldwide rights. Qyuns is making a name for itself as a bispecific powerhouse. Last year, it licensed bispecifics to Roche and the Swiss biotech Windward Bio , in deals that could be worth up to $1.7 billion collectively. Pelta said that Caldera’s deal with Qyuns also provides for milestone and royalty payments, but details are under wraps. The Phase 1 trial of CLD-423 is in healthy volunteers and should conclude by the second half of this year. Phase 2 trials in IBD patients should kick off in 2027. “Depending on the final design of those studies, it could be 18 to 24 months before we see results there,” Pelta said. He added that the company is considering running a smaller Phase 1b study in patients in China, which could yield efficacy data in the first half of 2027. Long-term, Tipirneni said Caldera is focused on being the first to market with its novel mechanism rather than selling to a larger company. But having sold one company, the team will likely be expected to repeat the trick, by at least some of their backers. And Pelta points out that competing in the crowded IBD space will require more marketing might than Caldera can muster. Pending decent mid-stage data, a deal of some sort seems inevitable. Editor’s note: This article and its headline was updated to correct the total funding Caldera raised.