SanReno Therapeutics(Shanghai)Co.,Ltd

Novartis to acquire SanReno's product pipeline and capabilities, including the exclusive rights for Greater China and Singapore Transaction reflects the Novartis commitment to the Chinese market and complements existing pipeline in renal diseases. SHANGHAI, Jan. 5, 2024 /PRNewswire/ -- SanReno Therapeutics, a clinical-stage company specializing in the discovery, development, and commercialization of innovative therapies for kidney diseases, today announces its acquisition by Novartis, a global medicines company. Following the acquisition's closure, SanReno becomes an indirect, wholly-owned subsidiary of Novartis. The founding investors of SanReno, including Pivotal bioVenture Partners China, Frazier Life Sciences, Samsara BioCapital, and Versant Ventures, have sold their equity securities in SanReno. Established in late 2021 as a joint venture between the investor consortium and Chinook Therapeutics (now part of Novartis), SanReno holds exclusive rights in Greater China and Singapore for two late-stage assets targeting Immunoglobulin A Nephropathy (IgAN): atrasentan and zigakibart. Atrasentan, an oral endothelin A receptor antagonist (ERA), is presently undergoing Phase 3 development for IgAN. It demonstrated clinically meaningful and highly statistically significant proteinuria reduction at the 36-weeks interim analysis, successfully meeting the primary endpoint of its Phase 3 study. Zigakibart (BION-1301), a subcutaneously administered monoclonal antibody targeting APRIL (A Proliferation Inducing Ligand), obtained approval from China CDE for entry into the Phase 3 study in October 2023. Completed within the first two years of SanReno's formation, this acquisition is one of the few transactions where a Chinese biotech company has been acquired by a multinational pharmaceutical company. The transaction underscores China's substantial market potential within the global renal market and is in strategic alignment with the Novartis commitment to pioneering innovative therapies for kidney diseases. "The acquisition of SanReno by Novartis is a testament to the unwavering dedication and relentless innovation of the SanReno team. It validates our commitment to pushing the boundaries in kidney disease therapeutics," said Haoyu Huang, Chief Executive Officer of SanReno Therapeutics. "We are thrilled to join forces with Novartis, a global pharmaceutical leader, in our shared mission to bring forth potentially transformative medicines for patients battling kidney diseases in China and beyond. Today marks an exciting new chapter in our journey to making a meaningful impact in the field of renal health." About Atrasentan and Zigakibart At the core of our innovative portfolio is a targeted clinical approach to Immunoglobulin A Nephropathy (IgAN). Our flagship asset, Atrasentan, an oral endothelin A receptor antagonist (ERA), is advancing through Phase 3 development for IgAN and achieved the primary endpoint in proteinuria reduction. In addition, Zigakibart (BION-1301), our subcutaneously administered anti-APRIL (A Proliferation Inducing Ligand) monoclonal antibody, received regulatory approval from China CDE to commence Phase 3 studies. About SanReno Therapeutics SanReno Therapeutics is a leading clinical-stage enterprise specializing in the strategic development, exploration, and commercialization of revolutionary therapies tailored for kidney diseases. Our key assets focus on treating Immunoglobulin A Nephropathy (IgAN). Atrasentan, an oral endothelian A receptor antagonist (ERA), has reached Phase 3 with success in reducing proteinuria. Zigakibart, our anti-APRIL (A Proliferation Inducing Ligand) antibody, received regulatory approval for Phase 3 studies. SanReno is dedicated to delivering transformative medicines for critical unmet needs in kidney disease therapeutics, driving advancements and setting new benchmarks in the field. SOURCE SanReno

SEATTLE, May 09, 2023 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2023 and provided corporate updates. “During the first quarter of 2023, we continued to advance our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases. We recently completed full enrollment of the phase 3 ALIGN clinical trial, are on track to initiate the phase 3 BION-1301 IgAN clinical trial mid-year and expect to report topline ALIGN results in the fourth quarter of this year,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “We also look forward to the upcoming 60th European Renal Association (ERA) Congress being held June 15th - 18th, where we will present clinical data from the phase 1/2 trial of BION-1301 as well as the phase 1 trial of CHK-336 in healthy volunteers.” Recent Accomplishments and Updates AtrasentanAtrasentan 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. Chinook has completed enrollment of the phase 3 ALIGN trial, including 320 patients in the main stratum and 64 patients in the SGLT2 inhibitor (SGLT2i) combination stratum. Following a Type D meeting with the U.S. Food and Drug Administration (FDA), Chinook has agreed to change the primary proteinuria endpoint in the ALIGN study to be evaluated at 36 weeks, and plans to report topline data from this endpoint in the fourth quarter of 2023 to potentially support an application for accelerated approval with the FDA.Chinook has completed enrollment of the first four cohorts of the AFFINITY trial, including patients with IgAN, focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors, and is continuing to enroll the fifth cohort of FSGS patients at a 1.5 mg dose of atrasentan. Chinook plans to present data from one or more additional cohorts of the AFFINITY trial in the second half of 2023.Chinook is preparing to initiate the phase 2 ASSIST trial evaluating atrasentan in patients with IgAN on stable doses of a renin-angiotensin system inhibitor (RASi) and an SGLT2i. The goal of the ASSIST trial is to generate proteinuria data with the combination that will be available at the time of atrasentan’s launch. More details of the ASSIST trial design will be presented in June at the ERA Congress in Milan. BION-1301 (Zigakibart)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) has been demonstrated clinically in both healthy volunteers and patients with IgAN. Chinook has finalized trial design and is completing site and country feasibility and global regulatory interactions to enable initiation of the phase 3 BEYOND trial of BION-1301 in mid-2023. More details of the BEYOND trial design will be presented in June at the ERA Congress in Milan.Chinook has completed enrollment of 30 patients in Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301. Patients in Cohort 2 receive a subcutaneous (SC) dose of 600 mg of BION-1301 every two weeks. Chinook plans to report additional data from Cohorts 1 and 2 in June at the ERA Congress in Milan as well as in the second half of 2023. CHK-336CHK-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 other kidney stone disorders driven by endogenous overproduction of oxalate. In April 2022 Chinook initiated a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy volunteers evaluating the safety, tolerability and pharmacokinetic profile of CHK-336. Initial data from this trial will be presented in June at the ERA Congress in Milan.In April 2023 Chinook voluntarily paused dosing in the phase 1 clinical trial of CHK-336 in healthy volunteers to allow for a thorough investigation of a serious adverse event that occurred in a single subject following the first dose in the 125 mg MAD group. Based on information available thus far, we believe the subject may have had a hypersensitivity reaction shortly after receiving their first dose of 125 mg of CHK-336. Comprehensive follow-up of this subject is ongoing, and Chinook is determining next steps for the program. Corporate Chinook recently announced the appointment of Robert W. Azelby to its Board of Directors. Mr. Azelby brings more than 20 years of executive leadership and commercial experience in the biopharmaceutical industry to Chinook, including chief executive officer roles at Eliem Therapeutics and Alder Biopharmaceuticals, as well as chief commercial officer at Juno Therapeutics and commercial positions across Amgen’s nephrology and oncology business units.In November 2022, Sairopa B.V., in which Chinook owns approximately a 36 percent equity interest, entered into an exclusive license and option agreement with Exelixis, Inc. for the development of ADU-1805, a monoclonal antibody targeting SIRPα. Under this agreement, Sairopa received an upfront payment of $40.0 million and an additional $35.0 million milestone payment when the FDA cleared Sairopa's Investigational New Drug (IND) Application for a phase 1 trial of ADU-1805 in adults with advanced solid tumors in the first quarter of 2023. First Quarter 2023 Financial Results Cash Position – Cash, cash equivalents and marketable securities totaled $357.4 million at March 31, 2023, compared to $385.3 million at December 31, 2022.Revenue – Revenue for the quarter ended March 31, 2023 was $1.8 million compared to $2.7 million for the same period in 2022. The decrease was primarily due to revenue recognized under Chinook’s license agreement with SanReno.Expenses – Research and development expenses for the quarter ended March 31, 2023 were $50.9 million compared to $26.3 million for the same period in 2022. The increase was primarily due to higher licensing, contract research and manufacturing costs, employee-related costs, including stock-based compensation expense, as well as spending for consulting, outside services and other costs. These higher costs primarily resulted from completing enrollment of the phase 3 ALIGN trial, startup activities for additional atrasentan and BION-1301 clinical trials and an increase in hiring to support our clinical programs. General and administrative expenses for the quarter ended March 31, 2023 were $11.4 million compared to $7.9 million for the same period in 2022. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, and higher consulting and outside services costs.The change in fair value of contingent consideration and contingent value rights liabilities for the quarter ended March 31, 2023 was an expense of $0.5 million compared to a benefit of $1.0 million for the same period in 2022. The increase in this non-cash expense primarily resulted from a change in estimate of the potential future proceeds derived from the Merck collaboration. Net Loss – Net loss for the first quarter of 2023 was $60.2 million, or $0.85 per basic share, compared to a net loss of $31.7 million, or $0.54 per share for the same period in 2022. 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 in phase 1 development. In addition, Chinook's research and discovery efforts are focused on building a pipeline of precision medicines for rare, severe chronic kidney diseases with defined genetic and molecular drivers. Chinook is leveraging insights from kidney single cell RNA sequencing and large CKD patient cohorts that have been comprehensively panomically phenotyped, with retained biosamples and prospective clinical follow-up, to discover and develop therapeutic candidates with mechanisms of action targeted 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 3 clinical trial of BION-1301, phase 1/2 trial of BION-1301, phase 1 clinical trial of CHK-336, and submission for potential accelerated approval for atrasentan. 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, including our phase 3 ALIGN trial, 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 macroeconomic conditions on our business operations, including rising interest rates and inflation. 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, 2023 2022 Collaboration and license revenue $1,828 $2,697 Operating expenses: Research and development 50,883 26,252 General and administrative 11,404 7,868 Change in fair value of contingent consideration and contingent value rights liabilities 526 (1,038)Amortization of intangible assets 433 429 Total operating expenses 63,246 33,511 Loss from operations (61,418) (30,814)Investment and other income (expense), net 3,102 (95)Loss before income taxes and equity method investment loss (58,316) (30,909)Equity method investment loss (1,861) (775)Net loss $(60,177) $(31,684)Net loss per share attributable to common stockholders, basic and diluted $(0.85) $(0.54)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 70,703 58,340 CHINOOK THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands)(Unaudited) March 31, December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $118,495 $115,438 Marketable securities 231,881 262,887 Accounts receivable 2,444 1,091 Prepaid expenses and other current assets 5,824 6,176 Total current assets 358,644 385,592 Marketable securities 7,002 6,989 Property and equipment, net 16,974 16,908 Restricted cash 2,074 2,074 Operating lease right-of-use assets 47,345 48,970 Investment in equity securities 41,200 41,200 Equity method investment 2,653 4,071 Intangible assets, net 23,854 24,287 In-process research & development 36,550 36,550 Goodwill 117 117 Other assets 7,462 7,326 Total assets $543,875 $574,084 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable 9,774 9,751 Accrued and other current liabilities 33,605 33,636 Operating lease liabilities 5,085 4,948 Contingent value rights liability 2,500 2,500 Total current liabilities 50,964 50,835 Contingent value rights liability - non-current 37,794 37,318 Contingent consideration liability 4,470 4,420 Deferred tax liabilities 5,076 5,076 Operating lease liabilities, net of current maturities 33,178 34,494 Total liabilities 131,482 132,143 Stockholders’ equity 412,393 441,941 Total liabilities and stockholders’ equity $543,875 $574,084

SEATTLE, Feb. 27, 2023 (GLOBE NEWSWIRE) -- 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 AtrasentanAtrasentan 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. 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.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.In November 2022, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,491,137, titled, “Methods of Improving Renal Function,” which is directed to methods of treating patients with IgAN with atrasentan, and expires in 2040 absent any patent term extensions.Several presentations on atrasentan were delivered at nephrology conferences throughout 2022, including: Updated interim data from the IgAN patient cohort of the phase 2 AFFINITY trial demonstrated consistent and clinically meaningful proteinuria reductions in patients with IgAN already on a maximally tolerated and stable dose of a RAS inhibitor. Specifically, atrasentan demonstrated mean reductions in 24-hour urine protein creatinine ratio (UPCR) of 38.1% at six weeks of treatment, 48.3% at 12 weeks of treatment and 54.7% at 24 weeks of treatment. After 24 weeks of treatment, 15 of the 19 patients (79%) who had completed this visit had greater than a 40% reduction in UPCR. There were no meaningful changes in blood pressure or acute eGFR effects, suggesting proteinuria reductions were not primarily due to hemodynamic effects of atrasentan, and there were no increases in BNP or mean bodyweight, suggesting minimal fluid retention. Atrasentan was well-tolerated, with no treatment-related serious adverse events. (ASN Kidney Week 2022)Preclinical research on single-cell RNA-seq of a mouse model of IgAN, revealing a prominent expansion of failed repair proximal tubular epithelial cells, which was reversed by atrasentan but not by ACE inhibition. (ASN Kidney Week 2022)Preclinical mechanistic data describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system. (59th ERA Congress) BION-1301BION-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) has been demonstrated clinically in both healthy volunteers and patients with IgAN. Chinook has finalized trial design, is conducting site and country feasibility and completing global regulatory interactions to enable initiation of a phase 3 trial of BION-1301 in mid-2023.Chinook has completed enrollment of 30 patients in Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301. Patients in Cohort 2 receive a subcutaneous (SC) dose of 600 mg of BION-1301 every two weeks. Chinook plans to report additional data from Cohorts 1 and 2 in the first and second half of 2023.Chinook presented interim data from Cohorts 1 and 2 in a poster presentation at ASN Kidney Week 2022 in November, further demonstrating BION-1301’s disease-modifying potential in IgAN by generating rapid and durable reductions in mechanistic biomarkers and corresponding clinically meaningful proteinuria reductions within three months of initiating treatment, which was consistent across both cohorts. 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 eight patients at 24 weeks of treatment, 66.9% in 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 observed. BION-1301 was granted orphan drug designation for the treatment of primary IgAN by the European Commission in July 2022. CHK-336CHK-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 other kidney stone disorders driven by endogenous overproduction of oxalate. The phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial evaluating CHK-336 in healthy volunteers is ongoing, and initial data from this trial is expected in the first half of 2023. Chinook presented a poster on CHK-336 at ASN Kidney Week 2022, demonstrating preclinical efficacy in PH1 and PH2 mouse models, and the potential for benefit in non-genetic hyperoxalurias caused by oxalate overproduction was also described. Precision Medicine Research & DiscoveryChinook 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. Chinook delivered an oral presentation at ASN Kidney Week 2022 in November on a multi-omics approach to the characterization of IgAN in the NURTuRE cohort, integrating clinical, histological, transcriptomic and serum proteomic data to gain deeper insights into patient stratification and IgAN disease pathogenesis. Also at ASN, Chinook presented a poster in collaboration with Evotec on a human data-driven, patient-centric and multi-omics-enabled target identification framework focused on common cellular and molecular mechanisms of CKD by leveraging the NURTuRE and QUOD patient cohorts. Chinook delivered an oral presentation at the 59th ERA Congress in May 2022 on the approach used in collaboration with Evotec to leverage the NURTuRE CKD biobank to generate mechanistic disease understanding for patient-centric, integrated target and biomarker discovery that will enable the development of novel precision treatments for CKD patient subsets. Corporate Chinook recently announced the appointment of Andrew Oxtoby as Chief Commercial Officer. Under Andrew’s leadership, Chinook will develop its go-to-market strategy and build a commercial organization in preparation for the potential launch of atrasentan and future pipeline products. Andrew brings to Chinook over 20 years of experience in marketing, sales, finance and commercial leadership roles at Aimmune Therapeutics and Eli Lilly and Company.Sairopa B.V. (Sairopa) entered into an exclusive agreement with Exelixis, Inc. in November 2022 for the development of ADU-1805, a monoclonal antibody targeting SIRPα, and received an upfront payment of $40.0 million. The U.S. Food and Drug Administration (FDA) recently cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors, which triggers a $35.0 million milestone payment that will be paid to Sairopa in the first quarter of 2023. Under the terms of the agreement, Sairopa is eligible to receive additional payments if Exelixis exercises its option and upon achievement of specified development, commercial and net sales milestones, as well as tiered royalties on net sales worldwide. As of December 31, 2022, Chinook owned approximately a 36% interest in Sairopa and has one seat on its board of directors. Chinook will hold its shares in Sairopa until there is a liquidation event, at which time, in accordance with the CVR agreement, 50% of any net proceeds will accrue to the benefit of the CVR holders, net of deductions permitted, including taxes and certain other expenses.Chinook closed a $120.7 million public offering in May 2022, which included the exercise in full of the underwriters’ option to purchase additional shares of common stock. Chinook announced an outreach initiative in collaboration with the IgA Nephropathy Foundation and Komodo Health in April 2022, leveraging data and technology to drive awareness of IgAN and engage key medical providers at nephrology practices across the U.S., with the goal of ensuring patients have access to optimal support and treatment options earlier in their disease journey. Fourth Quarter and Full Year Ended December 31, 2022 Financial Results Cash Position – Cash, cash equivalents and marketable securities totaled $385.3 million as of December 31, 2022, compared to $355.1 million as of December 31, 2021. Revenue – Revenue for the quarter and year ended December 31, 2022 was $0.5 million and $6.1 million, respectively, compared to $51.2 million and $51.6 million for the same periods in 2021. The higher revenue amounts in 2021 were primarily due to $41.2 million non-cash revenue recognized under Chinook’s license agreement with SanReno Therapeutics and a $10.0 million milestone payment earned under the collaboration agreement with Merck.Expenses – Research and development expenses for the quarter and year ended December 31, 2022 were $43.0 million and $141.2 million, respectively, compared to $24.9 million and $97.0 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, an increase in licensing and contract research and manufacturing costs, consulting and outside services fees, as well as facilities and other costs to continue the progression of our research and clinical programs. General and administrative expenses for the quarter and year ended December 31, 2022 were $9.8 million and $36.3 million, respectively, compared to $7.7 million and $31.9 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, higher consulting and outside services costs to support our operations, and other costs. These increases were partially offset by a decrease in facilities costs. The change in fair value of contingent consideration and contingent value rights liabilities for the quarter and year ended December 31, 2022 resulted in expenses of $7.3 million and $12.0 million, respectively, compared to expenses of $5.8 million and $27.3 million, respectively, for the same periods in 2021. The increase in these non-cash expenses in the quarter ended December 31, 2022 was primarily due to an increase in the fair value of the contingent value rights liability related to the preferred shares in Sairopa mainly as a result of Sairopa entering into a license agreement with Exelixis in November 2022. The decrease in the year ended December 31, 2022 was primarily due to a higher fair value in 2021 that included the impact of earning a milestone payment under the license agreement with Merck. Net Loss – Net loss for the quarter ended December 31, 2022 was $62.6 million, or $0.90 per share, compared to net income of $7.5 million, or $0.15 per basic share for the same period in 2021. Net loss for the year ended December 31, 2022 was $187.9 million, or $2.92 per share, compared to $102.9 million, or $2.26 per share for the same period in 2021. 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’s research and discovery efforts are focused on building a pipeline of precision medicines for rare, severe chronic kidney diseases with defined genetic and molecular drivers. Chinook is leveraging insights from kidney single cell RNA sequencing and large CKD patient cohorts that have been comprehensively panomically phenotyped, with retained biosamples and prospective clinical follow-up, to discover and develop therapeutic candidates with mechanisms of action targeted 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 3 clinical trial of BION-1301, phase 1/2 trial of BION-1301, phase 1 clinical trial of CHK-336, and submission for potential accelerated approval for atrasentan. 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, including our phase 3 ALIGN trial, 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 macroeconomic conditions on our business operations, including rising interest rates and inflation. 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. Contact:Noopur LiffickSenior Vice President, Investor Relations & Corporate Communications CHINOOK THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) Three Months Ended December 31, Year Ended December 31, 2022 2021 2022 2021 Collaboration and license revenue $512 $51,236 $6,128 $51,625 Operating expenses: Research and development 42,952 24,930 141,211 96,987 General and administrative 9,765 7,741 36,291 31,899 Change in fair value of contingent consideration and contingent value rights liabilities 7,268 5,754 11,987 27,317 Amortization of intangible assets 433 422 1,722 1,687 Total operating expenses 60,418 38,847 191,211 157,890 Gain on sale of assets to equity method investment — — — 7,227 Income (loss) from operations (59,906) 12,389 (185,083) (99,038)Investment and other income (expense), net 2,447 5 4,809 (170)Income (loss) before income taxes and equity method investment loss (57,459) 12,394 (180,274) (99,208)Income tax expense (4,341) (3,297) (4,341) (2,093)Equity method investment loss (754) (1,552) (3,250) (1,636)Net income (loss) $(62,554) $7,545 $(187,865) $(102,937)Net income (loss) per share attributable to common stockholders: Basic $(0.90) $0.15 $(2.92) $(2.26)Diluted $(0.90) $0.14 $(2.92) $(2.26)Weighted-average shares used in computing net income (loss) per share attributable to common stockholders: Basic 69,217 51,675 64,370 45,607 Diluted 69,217 53,690 64,370 45,607 CHINOOK THERAPEUTICS, INC.Condensed Consolidated Balance Sheets(In thousands)(Unaudited) December 31, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $115,438 $181,724 Marketable securities 262,887 105,113 Accounts receivable 1,091 10,061 Prepaid expenses and other current assets 6,176 3,741 Total current assets 385,592 300,639 Marketable securities 6,989 68,215 Property and equipment, net 16,908 18,935 Restricted cash 2,074 2,074 Operating lease right-of-use assets 48,970 55,385 Investment in equity securities 41,200 41,200 Equity method investment 4,071 8,205 Intangible assets, net 24,287 26,009 In-process research & development 36,550 36,550 Goodwill 117 117 Other assets 7,326 6,474 Total assets $574,084 $563,803 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $9,751 $8,580 Accrued and other current liabilities 33,636 17,104 Operating lease liabilities 4,948 4,401 Contingent value rights liability 2,500 10,000 Total current liabilities 50,835 40,085 Contingent value rights liability - non-current 37,318 24,591 Contingent consideration liability 4,420 5,160 Deferred tax liabilities 5,076 735 Operating lease liabilities, net of current maturities 34,494 39,589 Total liabilities 132,143 110,160 Stockholders’ equity 441,941 453,643 Total liabilities and stockholders’ equity $574,084 $563,803