KYNTRA BIO, INC.

Kyntra Bio, Inc. received a delisting determination from Nasdaq for failing to meet listing rule 5450(b). The company has requested a hearing to appeal this decision and seek additional time to regain compliance. Trading of its common stock will continue on the Nasdaq Global Select Market pending the outcome of the hearing.

Kyntra Bio reported a net income of $11.97 million for the second quarter of 2026, a significant improvement from a net loss of $7.60 million in the prior year, primarily driven by a $30.94 million gain from the deconsolidation of its European subsidiary due to bankruptcy. For the six months ended June 30, 2026, the company recorded a net loss of $3.22 million. The company also received a final $4.0 million payment related to the divestiture of its China operations and continues to advance its roxadustat program, aiming to initiate a Phase 3 trial in Q4 2026.

Kyntra Bio reported its second quarter 2026 financial results, achieving a net income from continuing operations of $12.0 million, or $2.96 per basic and diluted share, a significant improvement from a net loss of $13.7 million in the prior year period. Total revenue from continuing operations for the quarter was $(1.5) million. The company also provided business updates, confirming that the interim analysis for its Phase 2 FG-3246 trial and the initiation of the Phase 3 roxadustat study are both on track for Q4 2026. Kyntra Bio ended the quarter with $95.7 million in cash, cash equivalents, investments, and accounts receivable, which is expected to fund operating plans into 2028.

Kyntra Bio reported significant progress in its clinical pipeline and financial results for Q2 2026. The company finalized the Phase 3 protocol for roxadustat in lower-risk myelodysplastic syndromes (LR-MDS) and expects to initiate the study in 4Q 2026. Enrollment continues for the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC), with interim analysis on track for 4Q 2026. Financially, Kyntra Bio achieved a net income from continuing operations of $12.0 million ($2.96 EPS) for Q2 2026, a substantial improvement from a net loss of $13.7 million in the prior year, despite total revenue from continuing operations being $(1.5) million. The company reported $95.7 million in cash and equivalents, projecting sufficient funds into 2028.

Kyntra Bio, Inc. announced it will release its second quarter 2026 financial results on Thursday, August 13, after the market closes. Following the release, the company will host a conference call and webcast presentation at 5:00 PM Eastern Time to discuss its corporate and financial performance. The event will include a business update and a live Q&A session for the investment community.

Kyntra Bio announced additional post hoc analysis data from the Phase 3 MATTERHORN trial for roxadustat, demonstrating durable and clinically meaningful improvements in transfusion independence (TI) for patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden (HTB). The data showed similar TI rates in both ring sideroblast positive (RS+) and ring sideroblast negative (RS-) disease, an important finding given limited options for RS- patients. The company is finalizing the pivotal Phase 3 trial protocol based on FDA feedback and expects to initiate it in the second half of 2026, with these findings to be presented at the EHA Congress 2026.

Kyntra Bio, Inc. announced it received the final $4.0 million holdback payment from AstraZeneca Treasury Limited on June 2, 2026. This payment completes all owed amounts under the Share Purchase Agreement related to the sale of Kyntra Bio's China operations, which closed on August 29, 2025. The total consideration for the sale was approximately $220 million, with $210 million paid at closing and the remaining $10.0 million subject to two holdbacks, both of which have now been fully satisfied.

Kyntra Bio, Inc. reported a net loss of $15.2 million for the first quarter of 2026, a significant change from a net income of $4.6 million in the prior year. Total revenue increased by 36% to $3.7 million, driven by higher drug product revenue, but was offset by a substantial increase in cost of goods sold and a shift to net cash used in operating activities. The company also noted its rebranding from FibroGen, Inc. in January 2026 and its continued focus on oncology and rare disease assets, including advancing its FG-3246 and roxadustat programs.

Kyntra Bio reported first-quarter 2026 financial results, with total revenue increasing to $3.7 million from $2.7 million year-over-year. The net loss from continuing operations improved to $15.1 million, or $3.74 per share, compared to a $16.8 million loss in the prior year. The company also provided positive business updates, including progress in its Phase 2 trial for FG-3246 in mCRPC, with interim analysis expected in Q4 2026, and finalization of the Phase 3 trial protocol for roxadustat following FDA feedback, targeting a H2 2026 initiation. Kyntra Bio maintains a strong cash position of $100.3 million, providing a cash runway into 2028.

Kyntra Bio reported its first quarter 2026 financial results, showing increased revenue and a reduced net loss compared to the prior year. The company also provided positive updates on its pipeline, with the Phase 2 trial of FG-3246 progressing towards an interim analysis in Q4 2026 and the pivotal Phase 3 trial protocol for roxadustat being finalized with FDA feedback for a 2H 2026 initiation. Kyntra Bio maintains a strong financial position with $100.3 million in cash and equivalents, providing a runway into 2028.