Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On September 30, 2026, Kyntra Bio, Inc. (the “Company” or “Kyntra Bio”) received a determination letter (“Determination”) from the Listing Qualifications Staff (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it had not yet demonstrated compliance with Na…
Filed Oct 6, 2026Accepted Oct 6, 2026, 4:05 PM EDTCIK 921299Accession 0001193125-26-415545
Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officerir@kyntrabio.com
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Item 3.01Item 3.01 - Notice of Delisting
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On September 30, 2026, Kyntra Bio, Inc. (the “Company” or “Kyntra Bio”) received a determination letter (“Determination”) from the Listing Qualifications Staff (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it had not yet demonstrated compliance with Nasdaq Listing Rule 5450(b) as of the September 29, 2026 deadline and that, as a result, the Staff had determined to delist the Company’s common stock from the Nasdaq Global Select Market.
The Company has timely requested a hearing before a Nasdaq Hearings Panel (the “Panel”) to review the Staff Determination and to seek additional time to regain compliance with Nasdaq’s continued listing requirements. The hearing request stays the suspension of the Company’s securities and the filing of a Form 25-NSE pending the Panel’s written decision. An extension period could be up to 180 days from the Staff delisting Determination pursuant to Listing Rule 5815(c)(1)(A). Accordingly, the Company’s common stock will remain listed and continue to trade on the Nasdaq Global Select Market under the symbol “KYNB” pending the Panel’s decision.
As previously disclosed, on April 2, 2026, Kyntra Bio received notice from the Staff of Nasdaq that the Company was not in compliance with the continued listing requirements of Nasdaq Listing Rule 5450(b)(3)(A), which requires total assets and total revenue of at least $50 million each for the most recently completed fiscal year or two of the three most recently completed fiscal years. The Company also did not satisfy the alternative stockholders’ equity or market value of listed securities standards under Nasdaq Listing Rule 5450(b).
The Company is actively preparing a compliance plan for the Panel; however, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will be able to regain compliance with the applicable continued listing requirements within any extension period that may be granted by the Panel.