FibroGen (now Kyntra Bio) appeals Nasdaq delisting notice after missing minimum bid price deadline

FibroGen, Inc. (Nasdaq: FGEN), now Kyntra Bio, Inc. (KYNB), has appealed a Nasdaq decision that would have delisted its common stock. The company disclosed the appeal in a Form 8-K filed March 17, 2025, for an event dated March 12, 2025. Because of the appeal, the delisting is stayed and the stock stays listed while the Nasdaq Hearings Panel rules.

The bid price deadline and the appeal

Nasdaq's Listing Qualifications Staff wrote to FibroGen on September 12, 2024, saying the bid price of its common stock had closed below $1.00 for 30 consecutive business days. That fell short of Nasdaq listing rule 5450(a)(1). The company then had 180 calendar days, until March 11, 2025, to regain compliance.

On March 12, 2025, Nasdaq said the company had not regained compliance. Unless FibroGen requested an appeal, the stock would be subject to delisting from The Nasdaq Global Select Market at the opening of business on March 21, 2025. FibroGen appealed on March 14, 2025, which stayed the delisting.

The company says it believes it will succeed before the Hearings Panel and so be eligible for an additional 180-day period. It also says it believes it can cure the deficiency, including by effecting a reverse stock split if necessary. The filing adds that there can be no assurance the appeal will succeed, that the company will regain compliance, or that it will keep up with its other listing requirements.

Revenue, losses and the China sale

Revenue from continuing operations was $29.6 million for 2024, down from $46.8 million for 2023, and $3.1 million in the fourth quarter. In the press release that accompanied the 8-K, the company reported a fourth-quarter net loss from continuing operations of $8.7 million, or $0.08 per share, and a net loss from continuing operations of $153.1 million for the full year, or $1.53 per share, against $323.0 million for 2023. At December 31, 2024 it held $51.0 million in cash, cash equivalents and accounts receivable in the U.S. and $121.1 million in total consolidated cash, cash equivalents and accounts receivable. The release does not break out the difference, but the China sale price includes estimated net cash held in China.

The same release recapped the planned sale of FibroGen China to AstraZeneca for total consideration of about $160 million. That is an enterprise value of $85 million plus estimated net cash held in China at closing of about $75 million. The company expects the transaction to close by mid-2025. At closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value.

Chief Executive Officer Thane Wettig said that after the sale closes, the company will be "a leaner and more focused organization," with "a cash runway that takes us into 2027." That runway depends on a sale that had not closed when the release was issued.

Pipeline, regulatory steps and the signatory

FG-3246, an antibody-drug conjugate that targets CD46, is expected to start a Phase 2 monotherapy trial by mid-2025. Topline results from the Phase 2 portion of an investigator-sponsored study testing FG-3246 with enzalutamide in metastatic castration-resistant prostate cancer are expected in the second half of 2025.

FibroGen says it keeps rights to roxadustat in the United States and in all markets outside China, South Korea and those licensed to Astellas. It plans to meet the FDA in the second quarter of 2025 to decide the potential next steps for roxadustat in anemia associated with lower-risk myelodysplastic syndromes. That meeting is a regulatory step still ahead, and the release gives no outcome for it.

David DeLucia, senior vice president and chief financial officer, signed the 8-K on March 17, 2025. The release also records his appointment as chief financial officer among the company's 2024 developments. The next dated item is the China sale, expected by mid-2025. The Hearings Panel ruling has no date in the filing.

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