# Nathaniel Fernhoff

> Nathaniel Fernhoff is the CEO and Co-founder of Orca Bio, a late-stage biotechnology company headquartered in Menlo Park, California, developing high-precision allogeneic T-cell immunotherapies to treat blood cancers and autoimmune diseases. Holding a Ph.D. in Molecular and Cell Biology from UC Berkeley and dual Bachelor's degrees in Biological Sciences and Mathematics from Stanford, Fernhoff co-founded Orca Bio in 2016 based on decades-old Stanford research. He rose from Chief Scientific Officer to CEO in May 2025, leading the company through a landmark Phase 3 clinical trial for Orca-T - showing 78% survival free from chronic graft-versus-host disease versus 38% for standard-of-care - a BLA submission under FDA Priority Review, and a $250M Series F round bringing total funding to over $625M. With a 100,000-square-foot manufacturing facility in Sacramento capable of producing ~3,000 cell therapy products per year, Fernhoff is steering Orca Bio toward potential commercialization and a cure for blood diseases without compromise.

- **Role:** CEO and Co-founder at Orca Bio
- **Organizations:** Orca Bio, Stanford University (Institute for Stem Cell Biology and Regenerative Medicine), Ludwig Center for Cancer Stem Cell Research and Medicine, Stanford, Stanford Cancer Institute, ML4 Foundation (Board Member)
- **Nationality:** American
- **Education:** Bachelor of Science in Biological Sciences, Stanford University, Bachelor of Science in Mathematics, Stanford University, Ph.D. in Molecular and Cell Biology, University of California, Berkeley, Ruth L. Kirchstein NRSA Postdoctoral Scholar, Stanford University (Irving Weissman Laboratory)
- **Known for:** Co-founded Orca Bio in 2016, growing it to 290+ employees and $625M in total funding, Led development of Orca-T, which achieved 78% survival free from chronic GvHD vs 38% for standard care in Phase 3, Secured FDA Priority Review for Orca-T BLA with target action date of April 6, 2026

## Career timeline

- **2000s** — Completed dual B.S. degrees in Biological Sciences and Mathematics at Stanford University
- **2010s** — Earned Ph.D. in Molecular and Cell Biology from UC Berkeley
- **2013** — Published research on engineered SIRP-alpha molecules to enhance macrophage attack on cancer in Science journal
- **2013-2016** — Postdoctoral scholar in Irving Weissman's lab at Stanford University, researching hematopoietic stem cells and immunosurveillance
- **2016** — Co-founded Orca Bio (formerly Orca Biosystems) based on Stanford research into precision cell sorting
- **2016-2025** — Served as Chief Scientific Officer of Orca Bio, overseeing R&D including development of Orca-T and Orca-Q
- **2023** — Orca Bio's 100,000 sq ft Sacramento manufacturing facility became operational
- **2024** — Completed enrollment of 187 patients in Precision-T Phase 3 clinical trial
- **2025-05** — Appointed CEO of Orca Bio, succeeding co-founder Ivan Dimov
- **2025-10** — FDA accepted and granted Priority Review for Orca-T BLA; target action date April 6, 2026
- **2025-12** — Orca-T Phase 3 results published in Blood journal, showing 78% vs 38% cGFS improvement
- **2026-01** — Secured $250M Series F, bringing total Orca Bio funding to over $625M
- **2026-04** — FDA granted Orca-Q Regenerative Medicine Advanced Therapy (RMAT) designation

## Achievements

- Co-founded Orca Bio in 2016, growing it to 290+ employees and $625M in total funding
- Led development of Orca-T, which achieved 78% survival free from chronic GvHD vs 38% for standard care in Phase 3
- Secured FDA Priority Review for Orca-T BLA with target action date of April 6, 2026
- Built a 100,000 sq ft cGMP manufacturing facility in Sacramento capable of ~3,000 cell therapy products/year with 72-hour vein-to-vein turnaround
- Secured $250M Series F financing from Lightspeed Venture Partners, Illinois Municipal Retirement Fund, and Kaiser Foundation Hospitals
- Co-invented Orca-Q, which received FDA RMAT designation in April 2026
- Published research in Science journal on SIRP-alpha molecules and macrophage cancer attack (2013)
- 3,700+ research reads and 1,608+ citations on ResearchGate
- Board member of ML4 Foundation supporting research for Mucolipidosis Type IV
- Named CEO at Orca Bio following landmark Phase 3 clinical trial results

## Latest updates

- **2026-04** — FDA granted RMAT designation to Orca-Q, Orca Bio's second-generation allogeneic T-cell immunotherapy
- **2026-01** — Orca Bio raised $250M in Series F financing led by Lightspeed Venture Partners, bringing total funding past $625M
- **2025-12** — Phase 3 data for Orca-T published in Blood journal showing 78% survival free from chronic GvHD vs 38% for standard-of-care
- **2025-10** — FDA accepted Orca-T BLA and granted Priority Review with target action date of April 6, 2026
- **2025-05** — Appointed CEO of Orca Bio, transitioning from Chief Scientific Officer

## Links

- Website: https://orcabio.com
- LinkedIn: https://www.linkedin.com/in/nathaniel-fernhoff-7552b416/
- Twitter/X: https://twitter.com/etanfer

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Profile page: https://yespress.io/nathaniel-fernhoff
Published by YesPress — https://yespress.io
Last updated: 2026-05-11