• New therapeutics in development for autoimmune disease and oncology
• Lead therapeutic BRZ-101 designed to restore immune tolerance in type 1 diabetes, advancing into IND-enabling studies
• Expanding platform capabilities for NanoGalaxy®, including targeted delivery for in vivo CAR

BreezeBio, Inc., formerly known as GenEdit, today announced the close of $60 million in Series B financing to advance its first internal therapeutic programs toward the clinic and to continue expansion of the company’s NanoGalaxy delivery platform. The new BreezeBio name reflects the company’s momentum in translating powerful delivery technologies into practical, scalable genetic medicines with curative potential.

“Now that we can deliver genetic payloads to the right cells with precision, we are building genetic medicines designed to make a real difference for patients,” said Kunwoo (Ryan) Lee, Ph.D., Chief Executive Officer of BreezeBio. “We’ve completed our transition from a delivery platform to a therapeutics company, and this financing allows us to advance our first internal programs toward the clinic while continuing to expand the reach of NanoGalaxy.”

The company’s lead therapeutic candidate, BRZ-101, is a novel immune modulation therapy designed to restore tolerance in type 1 diabetes. The therapy delivers autoantigens encoded by mRNA and tolerogenic co-factors to antigen-presenting cells, which in turn present the antigens to T cells in the context of tolerance. The process induces antigen-specific regulatory T cells (Tregs) that block the autoimmune response precisely without affecting the functioning of the immune system. In preclinical testing, BRZ-101 induced antigen-specific immune tolerance in multiple models of autoimmune disease, including the NOD mouse model of diabetes, and was well tolerated in mice and non-human primates. The company is advancing BRZ-101 into IND-enabling studies.

“BreezeBio is solving one of the most significant challenges in gene therapy, targeted delivery, and in doing so is helping define the next generation of genetic medicines,” said Vincent Jeong, Managing Director at Yuanta Investment, manager of the Ministry of Health, and lead investor in the Series B financing. “With platform validation through the company’s strategic collaboration and milestone achievement with a global biotech partner and clear progress toward clinical development, BreezeBio is approaching an important inflection point as it advances a differentiated internal pipeline designed to address significant unmet needs in autoimmune and other serious diseases. We believe BreezeBio is positioned to become a global genetic medicines developer, and Yuanta is committed to supporting that journey.”

The engine for BreezeBio’s therapeutic programs is the company’s proprietary NanoGalaxy platform, which has demonstrated targeted delivery to the immune, cardiac, pulmonary, and central nervous systems based on the physiochemical properties of the polymers that encapsulate the payloads and form the nanoparticles. In addition, BreezeBio is expanding the platform with ligands conjugated to the nanoparticles for additional tissue and cell specificity, including delivery to T cells to enable in vivo CAR-T therapeutic development.

In parallel with its internal programs, BreezeBio continues to advance its multi-year collaboration and licensing agreement with Genentech, a member of the Roche Group. Following the initial milestone achievement and associated payment last year, R&D activities under the collaboration continue to progress.

The Series B financing is led by new investors, Yuanta Investment and DSC Investment, with participation from SV investment, Kiwoom Investment, STIC Ventures, Top Harvest Capital, and others. Existing investors, including DAYLI Partners, Pathway Investment, Loftyrock Investment, Korea Investment Partners, WOORI Venture Partners, KDB Silicon Valley, and ACVC Partners also participated.

About BreezeBio

BreezeBio is a biotechnology company developing genetic medicines enabled by precise, non-viral delivery across biologically relevant tissues. Using its proprietary NanoGalaxy® platform, BreezeBio engineers nanoparticles designed to deliver genetic payloads, including mRNA, to specific cell types, with demonstrated delivery to immune cells as well as select tissues in the heart, lung, and central nervous system. The company is advancing an internal therapeutic pipeline focused on autoimmune diseases and oncology, led by BRZ-101 to restore immune tolerance in type 1 diabetes. BreezeBio is headquartered in California in the South San Francisco area. For more information, visit www.breezebio.com.

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We’ve completed our transition from a delivery platform to a therapeutics company, and this financing allows us to advance our first internal programs toward the clinic while continuing to expand the reach of NanoGalaxy,” said Kunwoo (Ryan) Lee, CEO.