SEATTLE, May 12, 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 first quarter ended March 31, 2022.
"During the first quarter of 2022, we made strong progress advancing our pipeline of clinical, research and discovery programs for rare, severe chronic kidney diseases. We continue to enroll patients in the phase 3 ALIGN and phase 2 AFFINITY trials for atrasentan as well as the phase 1/2 trial of BION-1301, and we are pleased to have recently initiated the phase 1 healthy volunteer trial of CHK-336, our first internally-discovered program for the treatment of primary and idiopathic hyperoxaluria," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We look forward to the upcoming 59th ERA Congress being held May 19th – 22nd, where we will present clinical data from both our lead programs, atrasentan and BION-1301, in patients with IgA nephropathy (IgAN)."
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.
BION-1301
BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 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 preclinically as well as clinically in both healthy volunteers and patients with IgAN.
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), secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation.
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
First Quarter 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 other 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 healthy volunteer trial. 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. 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, 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 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 March 31, | ||||||||
| 2022 | 2021 | |||||||
| Collaboration and license revenue | $ | 2,697 | $ | 351 | ||||
| Operating expenses: | ||||||||
| Research and development | 26,252 | 25,697 | ||||||
| General and administrative | 7,868 | 9,543 | ||||||
| Change in fair value of contingent consideration and contingent value rights liabilities | (1,038 | ) | 1,839 | |||||
| Amortization of intangible assets | 429 | 420 | ||||||
| Total operating expenses | 33,511 | 37,499 | ||||||
| Loss from operations | (30,814 | ) | (37,148 | ) | ||||
| Other expense, net | (95 | ) | (67 | ) | ||||
| Loss before income taxes and share of net loss of equity method investment | (30,909 | ) | (37,215 | ) | ||||
| Share of net loss of equity method investment | (775 | ) | — | |||||
| Net loss | $ | (31,684 | ) | $ | (37,215 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.54 | ) | $ | (0.88 | ) | ||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 58,340 | 42,136 | ||||||
| CHINOOK THERAPEUTICS, INC. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 103,500 | $ | 181,724 | ||||
| Marketable securities | 172,599 | 105,113 | ||||||
| Accounts receivable | 2,947 | 10,061 | ||||||
| Prepaid expenses and other current assets | 6,727 | 3,741 | ||||||
| Total current assets | 285,773 | 300,639 | ||||||
| Marketable securities | 53,933 | 68,215 | ||||||
| Property and equipment, net | 18,263 | 18,935 | ||||||
| Restricted cash | 2,074 | 2,074 | ||||||
| Operating lease right-of-use assets | 53,922 | 55,385 | ||||||
| Investment in equity securities | 41,200 | 41,200 | ||||||
| Equity method investment | 7,201 | 8,205 | ||||||
| Intangible assets, net | 25,580 | 26,009 | ||||||
| In-process research & development | 36,550 | 36,550 | ||||||
| Goodwill | 117 | 117 | ||||||
| Other assets | 6,657 | 6,474 | ||||||
| Total assets | $ | 531,270 | $ | 563,803 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 9,039 | 8,580 | ||||||
| Accrued and other current liabilities | 12,946 | 17,104 | ||||||
| Operating lease liabilities | 4,581 | 4,401 | ||||||
| Contingent value rights liability | 10,000 | 10,000 | ||||||
| Total current liabilities | 36,566 | 40,085 | ||||||
| Contingent value rights liability - non-current | 23,963 | 24,591 | ||||||
| Contingent consideration liability | 4,750 | 5,160 | ||||||
| Deferred tax liabilities | 735 | 735 | ||||||
| Operating lease liabilities, net of current maturities | 38,461 | 39,589 | ||||||
| Total liabilities | 104,475 | 110,160 | ||||||
| Stockholders' equity | 426,795 | 453,643 | ||||||
| Total liabilities and stockholders' equity | $ | 531,270 | $ | 563,803 | ||||
Contact: Noopur Liffick Vice President, Investor Relations & Corporate Communications investors@chinooktx.com media@chinooktx.com