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SEATTLE, Nov. 10, 2022 (GLOBE NEWSWIRE) -- 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 nine months ended September 30, 2022.
“During the third quarter of 2022, we continued advancing our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases. We are pleased with the strong data presented at ASN Kidney Weekend 2022 from both our lead programs, atrasentan and BION-1301, in IgA nephropathy (IgAN), as well as from CHK-336 and our preclinical research approach,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “We look forward to 2023, when we plan to initiate a phase 3 study of BION-1301 in patients with IgAN, present data from the ongoing phase 1 clinical trial of CHK-336 in healthy volunteers in the first half and report topline proteinuria data from the ongoing phase 3 ALIGN study of atrasentan in the third quarter.”
Recent Accomplishments and Updates
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 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.
BION-1301
BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) to prevent the formation of pathogenic immune complexes has been demonstrated clinically in both healthy volunteers and patients with IgAN.
In Cohort 1, patients transitioned from intravenous (IV) dosing at 450 mg every two weeks to SC dosing at 600 mg every two weeks after at least 24 weeks of treatment. Reductions in IgA and Gd-IgA1 were maintained beyond 52 weeks of treatment. Reductions in IgM, and to a lesser extent IgG, were also observed. BION-1301 demonstrated mean reductions in 24-hour UPCR of 30.4% in seven patients at 12 weeks of treatment, 48.8% in all eight patients at 24 weeks of treatment, 66.9% in all eight patients at 52 weeks of treatment, 67.4% in four patients at 76 weeks of treatment and 71.0% in two patients at 100 weeks of treatment.
In Cohort 2, SC BION-1301 treatment resulted in rapid and sustained reductions in IgA and Gd-IgA1, IgM, and to a lesser extent IgG, through 24 weeks of treatment, highly consistent with Cohort 1. BION-1301 demonstrated mean reductions in 24-hour UPCR of 28.7% in 15 patients at 12 weeks of treatment and 53.8% in 9 patients at 24 weeks of treatment, similar to reductions observed at the same timepoints in Cohort 1.
In both cohorts, BION-1301 was well-tolerated, with no serious adverse events or treatment discontinuations due to adverse events, and no anti-drug antibodies were observed.
CHK-336
CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH) and secondary hyperoxalurias driven by endogenous overproduction of oxalate.
Precision Medicine Research & Discovery
Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths. Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates. Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.
Corporate
Quarter and Nine Months Ended September 30, 2022 Financial Results
About Chinook Therapeutics, Inc.
Chinook Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. CHK-336, an oral small molecule LDHA inhibitor for the treatment of hyperoxalurias, is being evaluated in a phase 1 clinical trial in healthy volunteers. In addition, Chinook is advancing research programs for other rare, severe chronic kidney diseases. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. To learn more, visit www.chinooktx.com.
Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward looking, including those relating to Chinook’s business, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding cash forecasts and timing of initiation and results of clinical trials, and regulatory submissions, including the timing of the results of our phase 3 ALIGN trial and phase 2 AFFINITY trial of atrasentan, phase 1 clinical trial of CHK-336, and submission for potential accelerated approval. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, including initiation of clinical trials of our existing product candidates or those developed as part of the Evotec collaboration or other strategic collaborations, whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that may be more advanced or have greater resources than we do, our ability to obtain and adequately protect intellectual property rights for our product candidates, and the effects of COVID-19 and macroeconomic conditions on our clinical programs and business operations. Many of these risks are described in greater detail in our filings with the SEC. Any forward-looking statements in this press release speak only as of the date of this press release. Chinook assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021Collaboration and license revenue $2,501 $4 $5,616 $389 Operating expenses: Research and development 41,984 23,573 98,259 72,057 General and administrative 10,023 6,847 26,526 24,158 Change in fair value of contingent consideration and contingent value rights liabilities 7,741 167 4,719 21,563 Amortization of intangible assets 431 423 1,289 1,265 Total operating expenses 60,179 31,010 130,793 119,043 Gain on sale of assets to equity method investment — — — 7,227 Loss from operations (57,678) (31,006) (125,177) (111,427)Other income (expense), net 1,690 (69) 2,362 (175)Loss before income taxes and equity method investment gain (loss) (55,988) (31,075) (122,815) (111,602)Income tax benefit — 463 — 1,204 Equity method investment gain (loss) 9 (84) (2,496) (84)Net loss $(55,979) $(30,696) $(125,311) $(110,482)Net loss per share attributable to common stockholders, basic and diluted $(0.83) $(0.69) $(2.00) $(2.54)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 67,779 44,661 62,736 43,563
CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited) September 30, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $126,072 $181,724 Marketable securities 247,211 105,113 Accounts receivable: 2,919 10,061 Prepaid expenses and other current assets 5,468 3,741 Total current assets 381,670 300,639 Marketable securities 24,412 68,215 Property and equipment, net 16,827 18,935 Restricted cash 2,074 2,074 Operating lease right-of-use assets 50,546 55,385 Investment in equity securities 41,200 41,200 Equity method investment 5,118 8,205 Intangible assets, net 24,720 26,009 In-process research & development 36,550 36,550 Goodwill 117 117 Other assets 7,102 6,474 Total assets $590,336 $563,803 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable 11,843 8,580 Accrued and other current liabilities 25,583 17,104 Operating lease liabilities 4,810 4,401 Contingent value rights liability 2,500 10,000 Total current liabilities 44,736 40,085 Contingent value rights liability - non-current 30,430 24,591 Contingent consideration liability 4,040 5,160 Deferred tax liabilities 735 735 Operating lease liabilities, net of current maturities 35,759 39,589 Total liabilities 115,700 110,160 Stockholders’ equity: 474,636 453,643 Total liabilities and stockholders’ equity $590,336 $563,803
Contact: Noopur Liffick Vice President, Investor Relations & Corporate Communications investors@chinooktx.com media@chinooktx.com