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Exhibit 99.1
Chinook Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results
SEATTLE August 8, 2022 – Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the quarter and six months ended June 30, 2022.
“During the second quarter of 2022, we executed well on advancing our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases. We continue to ramp up enrollment of patients in the phase 3 ALIGN trial for atrasentan, and the data we presented at ERA from the ongoing phase 2 AFFINITY trial of atrasentan demonstrated consistent and clinically meaningful proteinuria reductions in patients with IgAN,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “For BION-1301, the additional data presented at ERA from the ongoing phase 1/2 trial reaffirms its disease-modifying potential in IgAN by demonstrating durable reductions in mechanistic biomarkers and corresponding impressive proteinuria reductions. We look forward to advancing BION-1301 into a phase 3 study for patients with IgAN in 2023. We are also continuing to make progress with dose escalation in the ongoing phase 1 trial of CHK-336 in healthy volunteers and expect to report data in the first half of 2023.”
Recent Accomplishments and Updates
Atrasentan
Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial of atrasentan is currently enrolling patients with IgAN, and the phase 2 AFFINITY basket trial of atrasentan is currently enrolling patients with proteinuric glomerular diseases.
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Enrollment of the phase 3 ALIGN trial of atrasentan continues to advance with the activation of new trial sites and expansion into additional countries. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis in 2023 to support an application for accelerated approval under Subpart H in the United States. |
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Chinook presented data from the IgAN patient cohort of the phase 2 AFFINITY trial in an oral presentation at the 59th ERA Congress in May 2022, demonstrating consistent and clinically meaningful proteinuria reductions at weeks six, 12 and 24 of treatment in patients with IgAN already on a maximally tolerated and stable dose of a RAS inhibitor. Specifically, atrasentan demonstrated a 38.0% geometric mean reduction in 24-hour urine protein creatinine ratio (UPCR) in 20 patients at six weeks of treatment, 49.9% geometric mean reduction in 24-hour UPCR in 18 patients at 12 weeks of treatment and 58.5% geometric mean reduction in 24-hour UPCR in 11 patients at 24 weeks of treatment. After 24 weeks of treatment, ten of the 11 patients (91%) who had completed this visit had greater than a 40% cumulative reduction in UPCR. There were no meaningful changes in blood pressure or acute eGFR effects, suggesting proteinuria reductions were not primarily due to hemodynamic effects of atrasentan. There were no increases in BNP or mean bodyweight, suggesting minimal fluid retention. As of the April 22, 2022 data cutoff, atrasentan was well-tolerated in patients with IgAN, with no treatment-related serious adverse events. |
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The increase was primarily due to net proceeds of $113.5 million received from the sale of common stock in the May 2022 underwritten public offering, option exercises during the six months ended June 30, 2022, which increased over the prior period by $1.0 million, and an increase in proceeds from the employee stock purchase plan.
Change in fair value of contingent consideration and contingent value rights liabilities Change in fair value of contingent consideration and contingent value rights liabilities was a benefit of $2.0 million for the three months ended June 30, 2022, a decrease of $21.5 million compared to expense of $19.6 million the three months ended June 30, 2021.
Change in fair value of contingent consideration and contingent value rights liabilities Change in fair value of contingent consideration and contingent value rights liabilities was a benefit of $3.0 million for the six months ended June 30, 2022, a decrease of $24.4 million compared to expense of $21.4 million for the three months ended June 30, 2021.
Research and development costs include employee-related costs; licensing costs; materials and supplies; contracted research and manufacturing; consulting arrangements; allocated costs, such as facility costs; and other expenses incurred to advance our research and development activities.
At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our product candidates.
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Ticker: KDNY
CIK: 1435049
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-22-028434
Submitted to the SEC: Mon Aug 08 2022 4:02:42 PM EST
Accepted by the SEC: Mon Aug 08 2022
Period: Thursday, June 30, 2022
Industry: Pharmaceutical Preparations