On April 7, 2021 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the full year ended December 31, 2020 (Press release, Aduro Biotech, APR 7, 2021, View Source [SID1234577678]).
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"We are executing well on our goal of building Chinook into a leading kidney disease company. 2020 was a very busy and productive year, as we in-licensed atrasentan from AbbVie, closed a $115 million financing, brought BION-1301 into our pipeline through the merger with Aduro, unveiled CHK-336, our first internally-developed program, and bolstered our precision medicine discovery and research efforts," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We are excited to have recently initiated our atrasentan phase 3 ALIGN and phase 2 AFFINITY trials and announced our collaboration with Evotec. We look forward to multiple data announcements from our BION-1301 program this year, as well as continuing to move CHK-336 towards the clinic."
Mr. Dobmeier continued, "Our team has grown over 300 percent since the beginning of 2020, and we’re continuing to execute on our hiring plans to ensure we have strong resourcing in place to advance our pipeline. Our solid cash position, which we expect to fund our operations to the middle of 2023, enables us to achieve key milestones across our programs."
2020 and Recent Accomplishments
Atrasentan
Enrolled the first patient in the phase 2 AFFINITY basket trial of atrasentan, a highly potent and selective endothelin A receptor (ETA) antagonist (see www.clinicaltrials.gov, identifier NCT04573920). Chinook expects to report data from initial patient cohorts of this study in 2022.
Enrolled the first patient with IgA nephropathy in the phase 3 ALIGN trial of atrasentan, (see www.clinicaltrials.gov, identifier NCT04573478). Chinook expects to report top-line proteinuria data from this study in 2023, which could support accelerated approval from the FDA.
Delivered an oral presentation at the 3rd Annual Chronic Kidney Disease Drug Development (CKD3) Summit on selective ETA receptor antagonist atrasentan for the treatment of primary glomerular diseases.
Entered into a license agreement with Morehouse School of Medicine for patents supporting the development of therapies in kidney diseases that disproportionately affect people of West African descent and underserved communities, including focal segmental glomerulosclerosis (FSGS) and HIV-associated nephropathy (HIVAN).
Delivered a poster presentation at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined on the phase 3 ALIGN trial design for atrasentan.
Entered into a license agreement with AbbVie for worldwide, exclusive rights to atrasentan.
BION-1301
Completed enrollment and analysis of a phase 1 intravenous (IV) to subcutaneous (SC) bioavailability study of BION-1301, a novel anti-APRIL monoclonal antibody, in healthy volunteers.
Dosed the first patient with IgAN in Part 3 of the ongoing phase 1 study of BION-1301.
Delivered a poster presentation at the 57th ERA-EDTA Virtual Congress and ASN Kidney Week 2020 Reimagined 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.
Delivered a poster presentation at the 57th ERA-EDTA Virtual Congress on nonclinical toxicology studies of BION-1301 evaluating IV administration for up to six months and SC administration for up to one month.
CHK-336
Received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA), for primary hyperoxaluria (PH).
Delivered a preclinical poster presentation at the ASN Kidney Week 2020 Reimagined unveiling CHK-336 with the potential to treat all subtypes of PH and other disorders arising from excess oxalate.
Precision Medicine Research & Discovery
Participated in an expert panel discussion at the 3rd Annual CKD3 Summit on executing precision medicine in clinical trials.
Entered into a strategic collaboration with Evotec to discover and develop novel precision medicine therapies for polycystic kidney disease (PKD), lupus nephritis, IgAN and other primary glomerular diseases by leveraging the National Unified Renal Translational Research Enterprise (NURTuRE) patient biobank and Evotec’s proprietary PanHunter multi-omics platform.
Presented an oral abstract at the ASN Kidney Week 2020 Reimagined 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.
Corporate
Appointed healthcare financial expert, Eric Bjerkholt, as chief financial officer.
Appointed the following life sciences industry veterans to the Board of Directors: William M. Greenman, president and chief executive officer of Cerus Corporation; Michelle Griffin, director and audit committee chair for Adaptive Biotechnologies, Acer Therapeutics and HTG Molecular Diagnostics, Inc.; Ross Haghighat, founder, chairman and managing partner of Triton Systems, Inc.; and Dolca Thomas, M.D., executive vice president, head of research and development and chief medical officer of Equillium, Inc.
Closed the merger with Aduro Biotech, Inc. on October 5, 2020 and began trading on the Nasdaq Global Select Market under the symbol "KDNY."
Completed a $115 million private placement financing with top-tier healthcare investors concurrent with the merger closing.
Anticipated Upcoming Catalysts
Chinook expects to present Gd-IgA1 biomarker data in healthy volunteers from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1b study of BION-1301 at the ISN World Congress of Nephrology 2021 in April.
Chinook expects to present data from the BION-1301 phase 1 IV to SC bioavailability study in healthy volunteers at the ISN World Congress of Nephrology 2021 in April. Results from the study demonstrate the potential to transition to SC administration of BION-1301 in the long-term extension and phase 2 studies.
Part 3 of Chinook’s phase 1b study of BION-1301 is currently enrolling IgAN patients in an open-label setting, and Chinook expects to present a small subset of interim patient data in an oral presentation at the 58th ERA-EDTA Congress in June, as well as additional patient data at the ASN Kidney Week 2021 in November.
CHK-336 is currently in IND-enabling studies and advancing towards an expected IND submission in late 2021 or early 2022 for the treatment of primary hyperoxaluria.
Fourth Quarter and Full Year Financial Results
Cash Position – Cash, cash equivalents and marketable securities totaled $250.4 million at December 31, 2020, compared to $11.2 million at December 31, 2019.
Revenue – Total revenue increased by $0.8 million for both the fourth quarter of 2020 and year ended December 31, 2020 as compared to the fourth quarter of 2019 and year ended December 31, 2019. The increase was due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly.
Expenses –
Research and development expenses were $21.8 million for the fourth quarter of 2020 and $36.1 million for the year ended December 31, 2020, compared to $9.2 million and $17.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, the increases were primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher personnel expenses, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out our clinical and development capabilities; and increased spending for consulting and outside services. The year-over-year increase was partially offset by expenses in the prior year period for the in-license of atrasentan, the purchase of intellectual property and know-how from a related party to support the CHK-336 program and discovery research activities.
General and administrative expenses were $11.0 million for the fourth quarter of 2020 and $19.1 million for the year ended December 31, 2020, compared to $0.7 million and $3.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, costs increased primarily due to legal, consulting and accounting costs related to the merger; an increase in personnel costs, including salaries, benefits and stock-based compensation expense due to the addition of administrative staff to buildout our public-company infrastructure; and an increase in facilities and other costs.
Net Loss – Net loss for the fourth quarter of 2020 was $49.9 million or $1.24 per share and $81.6 million or $6.20 per share for the year ended December 31, 2020, compared to net loss of $34.2 million or $14.65 per share and $46.5 million or $25.48 per share, respectively, for the same periods in 2019.
Cash Used in Operations – For the fourth quarter ended December 31, 2020, cash used in operations totaled $41.3 million, of which $20.1 million were non-recurring expenses related to the merger and integration with Aduro Biotech.