Three biotech companies, Bicara Therapeutics, Zenas Biopharma, and MBX Biosciences, have successfully launched initial public offerings (IPOs), collectively raising $703 million to advance their clinical programs in cancer, immunology, and endocrine disorders.
Bicara Therapeutics Secures $315 Million for HNSCC Therapy
Bicara Therapeutics, based in Boston, raised $315 million to finance a pivotal study of its lead drug candidate, ficerafusp alfa, for the treatment of head and neck squamous cell carcinoma (HNSCC). The company offered 17.5 million shares at $18 each, trading on the Nasdaq under the symbol "BCAX."
Ficerafusp alfa is a bifunctional antibody designed to bind to epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-beta). Bicara is focusing on HPV-negative recurrent or metastatic HNSCC, where current treatment options are limited. In an ongoing Phase 1/1b study, the combination of ficerafusp alfa and pembrolizumab (Keytruda) demonstrated a 54% overall response rate in previously untreated HNSCC patients, with a 64% response rate in HPV-negative patients. This compares favorably to the 19% response rate observed with Keytruda monotherapy in a Phase 3 trial.
The company plans to initiate a pivotal Phase 2/3 clinical trial evaluating ficerafusp alfa in combination with pembrolizumab as a first-line treatment for advanced HNSCC by the end of this year or in the first quarter of 2025. Bicara intends to allocate approximately $265 million of the IPO proceeds to the development of ficerafusp alfa in HNSCC, including the pivotal study and a biologics license application filing. An additional $30 million is earmarked for expanding the drug's use in other HNSCC patient groups, and $25 million is set aside for clinical development in other solid tumors, such as colorectal cancer and other squamous cell carcinomas.
Zenas Biopharma Raises $225 Million for Immunology Pipeline
Zenas Biopharma, focused on developing antibody drugs for immunology and inflammation (I&I) disorders, raised $225 million. The company priced over 13.23 million shares at $17 each, trading on the Nasdaq under the symbol "ZBIO."
Zenas's lead drug candidate, obexelimab, is a bifunctional antibody designed to bind to CD19 and Fc gamma receptor IIb on B cells. This mechanism aims to inhibit B cell activity without complete depletion, potentially reducing the risk of infection and improving vaccine response compared to existing B cell-depleting therapies. Zenas acquired global rights to obexelimab from Xencor in 2021.
The company is initially focusing on four indications: immunoglobulin G4-related disease (IgG4-RD), multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia (wAIHA). Obexelimab is furthest along in development for IgG4-RD, with an ongoing Phase 3 trial. Zenas plans to allocate approximately $100 million of the IPO proceeds to clinical development of obexelimab, including the completion of the Phase 3 study in IgG4-RD and Phase 2 trials in multiple sclerosis, lupus, and wAIHA.
MBX Biosciences Lands $163 Million for Peptide Therapeutics
MBX Biosciences, specializing in peptide therapeutics with extended duration of action, raised $163 million. The company priced its offering of 10.2 million shares at $16 each, trading on the Nasdaq under the symbol "MBX."
MBX's lead program, MBX 2109, is a potential treatment for chronic hypoparathyroidism. In Phase 1 testing, the company reported that its engineered peptide achieved parathyroid hormone levels comparable to those achieved by continuous infusion. A Phase 2 study dosed its first patient last month, with preliminary data expected in the third quarter of next year. Another engineered peptide, MBX 1416, is in Phase 1 development for post-bariatric hypoglycemia (PBH).
MBX plans to allocate $148.6 million to advance MBX 2109 through mid-stage development and into Phase 3 testing for chronic hypoparathyroidism, and to advance MBX 1416 through Phase 1 and Phase 2 testing for PBH. An additional $31.2 million is set aside to advance the obesity program into the clinic.
