# Orca Bio

> Orca Bio is a late-stage biotechnology company in Menlo Park, California, building high-precision allogeneic cell therapies. Its proprietary single-cell sorting platform purifies donor immune and stem cells to engineer optimized therapeutic mixtures aimed at curing blood cancers and autoimmune diseases, with its lead candidate Orca-T currently under FDA priority review.

- **Founded:** 2016
- **Headquarters:** Menlo Park, California, United States
- **Founders:** Ivan Dimov (Co-Founder & CEO), Nathaniel (Nate) Fernhoff (Co-Founder & Chief Scientific Officer), Jeroen Bekaert (Co-Founder & Chief Operating Officer)
- **Team size:** ~290 employees
- **Products:** Orca-T, Orca-Q, Precision Manufacturing Platform
- **Notable:** Completed enrollment of 187 patients in Phase 3 Precision-T study, exceeding the 174-patient target., BLA for Orca-T accepted for FDA priority review with PDUFA action date set for April 2026., Raised $442M in total funding across multiple rounds.

## Products & services

- **Orca-T** — Lead investigational allogeneic T-cell immunotherapy combining purified regulatory T cells, conventional T cells and stem cells. In Phase 3 Precision-T study for AML, ALL, and high-risk MDS; BLA under FDA priority review.
- **Orca-Q** — Next-generation high-precision allogeneic cell therapy designed to deliver therapeutic benefit without requiring a fully matched donor, expanding access for high-risk blood disease patients.
- **Precision Manufacturing Platform** — Proprietary single-cell sorting and engineering platform that purifies and recomposes donor cells into optimal therapeutic mixtures at clinical scale.

## Achievements

- Completed enrollment of 187 patients in Phase 3 Precision-T study, exceeding the 174-patient target.
- BLA for Orca-T accepted for FDA priority review with PDUFA action date set for April 2026.
- Raised $442M in total funding across multiple rounds.
- Demonstrated improved chronic GvHD-free survival vs. standard allogeneic HSCT in Phase 3 data.

## Latest updates

- **2025-12** — Announced $250M aggregate financing led by Lightspeed plus up to $100M credit facility to prepare for potential commercial launch.
- **2026-01** — FDA extended review timeline for Orca-T BLA; PDUFA date targeted April 6, 2026.
- **2025** — Expanded manufacturing footprint with planned East Coast facility.

## Links

- Website: https://orcabio.com
- LinkedIn: https://www.linkedin.com/company/orcabio
- Twitter/X: https://twitter.com/orcabio
- Facebook: https://facebook.com/orcabiosystems

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Profile page: https://yespress.io/orca-bio
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Last updated: 2026-05-19