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(Incorporated in Delaware)
We are a clinical biotech developing engineered peptide therapies for cancer. Through our proprietary Helicon platform, we are producing helical peptides to modulate intracellular protein interactions that are inaccessible to small-molecule therapies or biologic drugs.
Our lead drug candidate, zolucatetide, targets the Wnt/β-catenin pathway, which drives a broad range of solid tumors.
We plan to start a Phase 3 registrational trial in desmoid tumors in the first half of 2027.
Our lead product candidate, zolucatetide, is, to our knowledge, the first and only investigational therapy that inhibits the b-catenin:TCF interaction, the critical downstream node of the Wnt/b-catenin pathway. Activating mutations in this pathway, gain of function b-catenin mutations, or loss of function Adenomatous Polyposis Coli (“APC”) mutations, are present in over 10% of all cancers and span a broad range of tumor types.
We are evaluating zolucatetide in ongoing clinical trials across multiple solid tumor indications, with more than 150 patients dosed to date. Zolucatetide has been observed to be well tolerated across the therapeutic dose range. We believe the data generated to date, along with our understanding of the underlying Wnt/b-catenin pathway, support zolucatetide’s potential to benefit patients across multiple tumor types driven by b-catenin or APC alterations and its advancement into a Phase 3 registrational trial. Our target indications include:
• Desmoid Tumors: Our lead indication for zolucatetide is desmoid tumors, which are rare, locally invasive soft tissue tumors driven by somatic or germline b-catenin pathway mutations. We estimate that approximately 11,000 desmoid tumor patients in the United States are actively managed under physician care. Desmoid tumors impose substantial and long-term morbidity, including pain, functional and mobility impairment, and the potential for life-threatening complications depending on tumor location. Given the chronic nature of the disease and onset in a predominantly young patient demographic with a near-normal life expectancy, prolonged or lifelong management is typically required. The only existing U.S. Food and Drug Administration (“ FDA”) approved therapy for desmoid tumors, a GSI, does not address the underlying Wnt/b-catenin-driven disease biology. In our ongoing clinical trials, as of February 16, 2026, 38 desmoid patients have been enrolled and treated with zolucatetide, of which 25 had sufficient follow up to be response-evaluable, and all 25 patients showed tumor reductions (disease control rate (“DCR”) of 100%). Of the 19 patients with at least two post-baseline scans, 74% (14/19) had an objective response per RECIST 1.1. We have observed responses in patients naive to GSI therapy, those who had progressed on GSI therapy, as well as patients that discontinued GSI therapy due to tolerability issues. To date, we have observed a tolerability profile that we believe compares favorably to the tolerability profile associated with GSIs and other off-label therapies, and supports continued development. We believe a medicine for the treatment of desmoid tumors with a superior efficacy and safety profile, compared to the existing systemic therapy, could significantly improve patient outcomes and expand the desmoid tumor commercial opportunity. We plan to initiate a registrational Phase 3 trial for zolucatetide in patients with desmoid tumors in the first half of 2027.
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Familial Adenomatous Polyposis (“FAP”): We are evaluating zolucatetide’s potential in FAP, an orphan disease that impacts an estimated 34,000 people in the United States. FAP is characterized by extensive precancerous polyps in the gastrointestinal tract, with a near-inevitable risk of polyp progression to colorectal cancer in the absence of life-altering colon-removal surgery. There is currently no approved treatment for FAP. As of Feb. 16, 2026, we have enrolled six desmoid tumor patients with FAP in our ongoing clinical trial and are also planning to enroll a separate dedicated cohort of patients with FAP beginning in the second half of 2026.
Note: Net loss is for the 12 months that ended March 31, 2026. The company has not generated any product revenue to date.
(Note: Parabilis Medicines filed its S-1 on May 19, 2026, for its IPO without disclosing the terms. Estimated proceeds are $100 million, a placeholder figure.)
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