# NIH Awards Arkayli $2.98M SBIR Grant

On October 6, 2026, Arkayli Biopharma received a **$2.98 million NIH Small Business Innovation Research (SBIR) grant** (1R44 HL184627-01) to advance ARK001 for infantile hemangioma and prepare for a Phase 1b study. Arkayli also reported that FDA authorized the study to proceed. The announcement describes a grant award, not an open solicitation, and does not provide a procurement contact.

- The funding supports drug development and trial preparation; the National Heart, Lung, and Blood Institute is identified among the federal entities involved.
- Clinical-trial, drug-development, and manufacturing firms may view Arkayli’s planned Phase 1b work as a potential source of future commercial opportunities, but the announcement does not identify subcontracting needs or solicit providers.
- Arkayli’s CEO said the company is also seeking Series A financing, indicating that the SBIR award is part of a broader effort to advance its development pipeline.

**Jurisdictions:** federal
**Industries:** Healthcare
**Topics:** Grants & Funding
**Published:** October 06, 2026

### Government Entities
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- U.S. Food and Drug Administration (FDA)

### Vendors
- Arkayli Biopharma, Inc. (SBIR grant awardee)

### Key Quotes
> With the NIH grant, we are focused on preparing for the Phase 1b trial, and we also are looking to accelerate our pipeline development through a Series A financing round.
> — Katie MacFarlane, Chief Executive Officer of Arkayli Biopharma

> We look forward to entering the clinic with ARK001.
> — Thomas Rossi, Chairman of the Board of Arkayli Biopharma

### Sources
- [Arkayli Biopharma Inc. Receives Study May Proceed Response to IND from FDA and SBIR Grant from NIH to Advance Clinical Development of ARK001 for a Rare Pediatric Disease | Press Releases | thejewishnews.com](https://www.thejewishnews.com/online_features/press_releases/arkayli-biopharma-inc-receives-study-may-proceed-response-to-ind-from-fda-and-sbir-grant/article_3bed27ed-5002-5aff-9a40-f99cace14df7.html) - thejewishnews.com