- Upon closing of the merger with Aduro on October 5th, Chinook had approximately $290 million in cash, cash equivalents and marketable securities to fund advancement of its pipeline of precision medicines for kidney diseases through the first half of 2023
- Company is on track to initiate the phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan in early 2021, as well as a phase 1 clinical trial of CHK-336 in the second half of 2021
- Data expected from Part 3 of the ongoing phase 1 trial of BION-1301 in IgA Nephropathy (IgAN) patients in 2021
VANCOUVER, British Columbia and SEATTLE, Nov. 05, 2020 (GLOBE NEWSWIRE) — Chinook Therapeutics, Inc. (NASDAQ: KDNY), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced third quarter 2020 financial results and provided a business update.
“With a strong cash position, broad pipeline and productive research and development engine, Chinook is on a path to becoming a leading company developing precision medicines for kidney disease. We’re employing a number of approaches to build our pipeline and address large unmet clinical needs, including utilizing biomarkers, novel translational platforms and patient stratification tools as well as targeting causal mutations and new accelerated regulatory pathways available in the kidney disease space,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “Next year we expect to have four ongoing clinical trials for our lead atrasentan, BION-1301 and CHK-336 programs, and plan to report multiple clinical and preclinical datasets across our pipeline.”
- Closed the merger with Aduro Biotech, Inc. on October 5th and began trading on the Nasdaq Global Select Market under the symbol “KDNY,” with approximately $290 million in cash, cash equivalents and marketable securities.
- Completed a $115 million private placement financing with top-tier healthcare investors concurrent with the merger closing.
- Presented a preclinical poster at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined unveiling CHK-336, a first-in-class oral small molecule lactate dehydrogenase A (LDHA) inhibitor with the potential to treat all subtypes of primary hyperoxaluria (PH) and other disorders arising from excess oxalate.
- Presented additional information on Chinook’s emerging pipeline at ASN Kidney Week 2020 Reimagined, including:
° a poster presentation on the phase 3 ALIGN trial design for atrasentan, a potent, selective endothelin A receptor (ETA) antagonist,
° a poster presentation on healthy volunteer data from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1 study of BION-1301, a novel anti-APRIL monoclonal antibody, and
° an oral presentation on a single cell transcriptomic atlas of human autosomal dominant polycystic kidney disease (ADPKD) through Chinook’s academic collaboration with the laboratory of Benjamin Humphreys, M.D., Ph.D., Joseph Friedman Professor of Renal Diseases in Medicine and Chief of Nephrology at Washington University School of Medicine in St. Louis.
Anticipated Upcoming Catalysts
- Chinook plans to begin enrollment of its phase 3 ALIGN trial (see www.clinicaltrials.gov, identifier NCT04573478) in early 2021 to assess the efficacy, safety and tolerability of atrasentan in IgAN patients at risk of progressive kidney function loss. Atrasentan has previously been evaluated in over 5,300 diabetic kidney disease (DKD) patients in studies that demonstrated clinically significant and sustained reductions in proteinuria, as well as reduced risk of kidney function decline, when administered on top of a maximally tolerated dose of a RAS inhibitor (RASi).
- Chinook plans to begin enrollment of its phase 2 AFFINITY basket trial of atrasentan in the first half of 2021 to evaluate its therapeutic potential in multiple types of chronic kidney disease. Cohorts in the basket study include patients with: IgAN with proteinuria between 0.5 grams to less than one gram per day, focal segmental glomerular sclerosis (FSGS), Alport Syndrome and DKD in combination with SGLT2 inhibitors.
- Part 3 of Chinook’s phase 1 study of BION-1301 is currently enrolling adult patients with IgAN in an open-label setting and Chinook expects to present data in 2021. A phase 1 IV to subcutaneous (SC) bioavailability study in healthy volunteers is ongoing with the potential to transition to SC administration of BION-1301 in the long-term extension and phase 2 studies.
- Chinook plans to begin enrollment of its phase 1 study of CHK-336 in the second half of 2021.
Unaudited financial statements for Aduro Biotech, Inc. (Aduro) for the quarter and nine months ended September 30, 2020 can be found in our quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC). As the merger between Aduro and Chinook did not close until October 5, 2020, the historical financial statements presented on Form 10-Q reflect the financial position, results of operations and cash flows of Aduro.
Unaudited financial statements for Chinook Therapeutics U.S., Inc. for the nine months ended September 30, 2020 can be found in our Form 8-K/A filed with the SEC. The historical financial statements presented on Form 8-K/A reflect those of private Chinook Therapeutics U.S., Inc. Unaudited pro forma combined financial information for Chinook Therapeutics U.S., Inc. and Aduro for the nine months ended September 30, 2020 can also be found in our Form 8-K/A filed with the SEC.
The audited financial statements for Chinook Therapeutics, Inc., which will reflect the impact of the merger, will be filed in the Annual Report on Form 10-K for the year ending December 31, 2020.
About Chinook Therapeutics, Inc.
Chinook Therapeutics, Inc. is a clinical-stage biotechnology 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, an investigational Phase 3-ready endothelin receptor antagonist for the treatment of IgA nephropathy and other primary glomerular diseases. BION-1301, an investigational anti-APRIL monoclonal antibody is being evaluated in a Phase 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, a small-molecule preclinical development candidate for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases, including polycystic kidney disease. 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 timing of initiation and results of clinical trials. 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, 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.