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Chinook Therapeutics, Inc. (KDNY) SEC Filing 10-K Annual Report for the fiscal year ending Saturday, December 31, 2022

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CIK: 1853860 Ticker: KDNY

Exhibit 99.1


 

 

 

Chinook Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates

 

SEATTLE February 27, 2023 – Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today reported financial results for the fourth quarter and year ended December 31, 2022 and provided corporate updates.

 

“During 2022, we made excellent progress across our pipeline, including driving strong enrollment of our phase 3 ALIGN, phase 2 AFFINITY and phase 1/2 BION-1301 clinical trials, generating compelling clinical data from our atrasentan and BION-1301 programs for IgA nephropathy (IgAN), initiating our phase 1 clinical trial of CHK-336 in healthy volunteers and continuing to advance our preclinical programs for rare, severe chronic kidney diseases,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “Our mission at Chinook is to change the course of kidney care by developing therapies that make dialysis and transplant unnecessary for patients living with kidney disease. With our strong financial position and growing team, we look forward to an exciting 2023 when we will be presenting data from all three of our clinical programs at medical conferences, commencing a phase 3 study of BION-1301 in patients with IgAN mid-year and reporting topline proteinuria data from the ongoing phase 3 ALIGN study of atrasentan.”

 

2022 and Recent Accomplishments

 

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has potential therapeutic 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 is evaluating atrasentan in patients with IgAN and the phase 2 AFFINITY basket trial is evaluating atrasentan in patients with proteinuric glomerular diseases.

 

 

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Enrollment in the phase 3 ALIGN trial of atrasentan now exceeds 270 patients. The interim proteinuria endpoint analysis will be performed on the first 270 patients enrolled.

 

 

•

In response to review of the statistical analysis plan for the ALIGN trial, Chinook received correspondence from the U.S. Food and Drug Administration (FDA) last week recommending that evaluation of the interim proteinuria endpoint analysis for accelerated approval in the ALIGN trial be delayed from week 24 to week 36. The FDA referenced the likelihood that the later timepoint would allow for a greater amount of eGFR data to be evaluated at the time of accelerated approval. Chinook plans to engage with the FDA as soon as possible to discuss their advice. If Chinook shifts the interim proteinuria endpoint analysis of the ALIGN trial to 36 weeks, topline proteinuria data would be expected in the fourth quarter of 2023. Therefore, Chinook is updating its timing to report topline proteinuria data from the ALIGN trial to the second half of 2023.

 

 

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Chinook has completed enrollment of the IgAN patient cohort of the AFFINITY trial, and continues to enroll the other cohorts, including patients with focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors. Chinook plans to report additional data from cohorts of the AFFINITY trial in the second half of 2023.

 

The following information was filed by Aduro Biotech, Inc. (KDNY) on Monday, February 27, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Aduro Biotech, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statement Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Operations And Comprehensive Loss (Parenthetical)
Consolidated Statements Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit)
Accrued And Other Current Liabilities
Accrued And Other Current Liabilities (Tables)
Cash, Cash Equivalents And Marketable Securities
Cash, Cash Equivalents And Marketable Securities (Tables)
Cash, Cash Equivalents And Marketable Securities - Additional Information (Details)
Cash, Cash Equivalents And Marketable Securities - Summary Of Amortized Cost And Estimated Fair Value Of Available-For-Sale Marketable Securities By Contractual Maturity (Details)
Cash, Cash Equivalents And Marketable Securities - Summary Of Cash, Cash Equivalents And Marketable Securities (Details)
Collaboration And License Agreements
Collaboration And License Agreements - Additional Information (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Schedule Of Additional Information Related To Operating Leases (Details)
Commitments And Contingencies - Schedule Of Maturity Of Company's Operating Lease Liabilities (Details)
Common Stock
Common Stock (Tables)
Common Stock - Additional Information (Details)
Common Stock - Summary Of Rsa Activity (Details)
Defined Contribution Plans
Defined Contribution Plans - Additional Information (Details)
Description Of Business
Equity Method Investment
Equity Method Investment - Additional Information (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Details)
Fair Value Measurements - Financial Assets And Liabilities Measured At Fair Value On A Recurring Basis (Details)
Fair Value Measurements - Summary Of Changes In Fair Value Of Level 3 Financial Instruments (Details)
Goodwill And Intangible Assets
Goodwill And Intangible Assets (Tables)
Goodwill And Intangible Assets - Additional Information (Details)
Goodwill And Intangible Assets - Schedule Of Finite-Lived Intangible Assets Estimated Future Amortization Expense (Details)
Goodwill And Intangible Assets - Schedule Of Intangible Assets (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Components Of Deferred Tax Assets And Liabilities (Details)
Income Taxes - Components Of Federal, State, And Foreign Income Tax (Expense) Benefit (Details)
Income Taxes - Components Of Loss Before Income Taxes (Details)
Income Taxes - Schedule Of Effective Tax Rate Of Provision For Income Taxes Differed From Federal Statutory Rate (Details)
Income Taxes - Summary Of Activities Related To Unrecognized Benefits (Details)
Investment In Equity Securities
Investment In Equity Securities - Additional Information (Details)
Net Loss Per Common Share
Net Loss Per Common Share (Tables)
Net Loss Per Common Share - Additional Information (Details)
Net Loss Per Common Share - Schedule Of Computation Of Basic And Diluted Net Loss Per Share (Details)
Net Loss Per Common Share - Schedule Of Potentially Dilutive Securities Excluded From Computation Of Diluted Net Loss Per Share (Details)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Details)
Property And Equipment, Net - Summary Of Property And Equipment, Net (Details)
Reverse Merger And Contingent Value Rights
Reverse Merger And Contingent Value Rights (Tables)
Reverse Merger And Contingent Value Rights - Additional Information (Details)
Reverse Merger And Contingent Value Rights - Summary Of Fair Value Of Consideration Transferred (Details)
Reverse Merger And Contingent Value Rights - Summary Of Fair Value Of Consideration Transferred - Parenthetical (Details)
Reverse Merger And Contingent Value Rights - Summary Of Final Allocation Of Purchase Price (Details)
Schedule Of Accrued And Other Current Liabilities (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Schedule Of Black Scholes Option-Pricing Model (Details)
Stock-Based Compensation - Schedule Of Weighted-Average Assumptions Used To Estimate Fair Value Of Stock Options Using Black Scholes Option-Pricing Model (Details)
Stock-Based Compensation - Summary Of Psu Activity (Details)
Stock-Based Compensation - Summary Of Rsu Activity (Details)
Stock-Based Compensation - Summary Of Stock Option Activity (Details)
Stock-Based Compensation - Summary Of Stock-Based Compensation (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Summary Of Useful Live Of Property And Equipment (Details)
Ticker: KDNY
CIK: 1435049
Form Type: 10-K Annual Report
Accession Number: 0001564590-23-002589
Submitted to the SEC: Mon Feb 27 2023 5:06:08 PM EST
Accepted by the SEC: Mon Feb 27 2023
Period: Saturday, December 31, 2022
Industry: Pharmaceutical Preparations

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