An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).
2019-12-04·Journal for immunotherapy of cancer2区 · 医学
Functional characterization of the selective pan-allele anti-SIRPα antibody ADU-1805 that blocks the SIRPα-CD47 innate immune checkpoint.
2区 · 医学
作者: Erik Voets ; Marc Paradé ; David Lutje Hulsik ; Sanne Spijkers ; Wout Janssen ; Joost Rens ; Inge Reinieren-Beeren ; Gilbert van den Tillaart ; Sander van Duijnhoven ; Lilian Driessen ; Maurice Habraken ; Peter van Zandvoort ; Joost Kreijtz ; Paul Vink ; Andrea van Elsas ; Hans van Eenennaam
Accumulating preclinical data indicate that targeting the SIRPα/CD47 axis alone or in combination with existing targeted therapies or immune checkpoint inhibitors enhances tumor rejection. Although several CD47-targeting agents are currently in phase I clinical trials and demonstrate activity in combination therapy, high and frequent dosing was required and safety signals (acute anemia, thrombocytopenia) were recorded frequently as adverse events. Based on the restricted expression pattern of SIRPα we hypothesized that antibodies targeting SIRPα might avoid some of the concerns noted for CD47-targeting agents.
SIRPα-targeting antibodies were generated and characterized for binding to human SIRPα alleles and blockade of the interaction with CD47. Functional activity was established in vitro using human macrophages or neutrophils co-cultured with human Burkitt's lymphoma cell lines. The effect of SIRPα versus CD47 targeting on human T-cell activation was studied using an allogeneic mixed lymphocyte reaction and a Staphylococcus enterotoxin B-induced T-cell proliferation assay. Potential safety concerns of the selected SIRPα-targeting antibody were addressed in vitro using a hemagglutination assay and a whole blood cytokine release assay, and in vivo in a single-dose toxicity study in cynomolgus monkeys.
The humanized monoclonal IgG2 antibody ADU-1805 binds to all known human SIRPα alleles, showing minimal binding to SIRPβ1, while cross-reacting with SIRPγ, and potently blocking the interaction of SIRPα with CD47. Reduced FcγR binding proved critical to retaining its function towards phagocyte activation. In vitro characterization demonstrated that ADU-1805 promotes macrophage phagocytosis, with similar potency to anti-CD47 antibodies, and enhances neutrophil trogocytosis. Unlike CD47-targeting agents, ADU-1805 does not interfere with T-cell activation and is not expected to require frequent and extensive dosing due to the restricted expression of SIRPα to cells of the myeloid lineage. ADU-1805 is cross-reactive to cynomolgus monkey SIRPα and upon single-dose intravenous administration in these non-human primates (NHPs) did not show any signs of anemia, thrombocytopenia or other toxicities.
Blocking the SIRPα-CD47 interaction via SIRPα, while similarly efficacious in vitro, differentiates ADU-1805 from CD47-targeting agents with respect to safety and absence of inhibition of T-cell activation. The data presented herein support further advancement of ADU-1805 towards clinical development.
The monoclonal antibodies pipeline and clinical trial analysis report deliver important insights on ongoing research, clinical strategies, upcoming therapeutics, and commercial analysis.
LAS VEGAS, June 5, 2023 /PRNewswire/ -- DelveInsight's
Monoclonal Antibodies Competitive Landscape – 2023
' report provides comprehensive global coverage of available, marketed, and pipeline monoclonal antibodies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, company assessment, comparative assessment, and future growth potential of the monoclonal antibodies competitive domain.
Key Takeaways from the Monoclonal Antibodies Competitive Landscape Report
180+ monoclonal antibody companies are evaluating
230+ monoclonal antibody drugs in various stages of development, and their anticipated acceptance in the monoclonal antibodies market would significantly increase market revenue.
Key monoclonal antibody companies such as
Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Omeros Corporation, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals, Nectin Therapeutics Ltd, Y-mAbs Therapeutics, OncoResponse, Inc., Fate Therapeutics, Pelican Therapeutics, Inc., Heat Biologics, Oncternal Therapeutics, Phanes Therapeutics, Pharmacyclics LLC, Immunitas Therapeutics, Hummingbird Bioscience, Inc., Sanofi, Takeda, Agenus Inc., Aulos Bioscience, Inc., ChemomAb Ltd, Celldex Therapeutics, Celgene, Janssen Research & Development, LLC, Adaptive Biotechnologies, BeiGene, Vaccinex Inc., Jasper Therapeutics, Inc., Shanghai Junshi Bioscience Co., Ltd., TopAlliance Biosciences, Inc., and others are evaluating new monoclonal antibody drugs to improve the treatment landscape.
Promising monoclonal antibodies pipeline drugs such as
Ianalumab, GMA-131, anti-MASP-2 monoclonal antibody, MK-2060, DISC-0974, AT-1501, Ravulizumab, BION 1301, Narsoplimab, Pembrolizumab, Ziltivekimab, Opdivo, Avelumab, JAB-BX102, and others are under different phases of monoclonal antibodies clinical trials.
March 2023, Shanghai - Jacos Pharmaceuticals announced a clinical collaboration with Merck to evaluate the combination therapy of Si's CD73 monoclonal antibody JAB-BX102 and Merck's PD-1 inhibitor KEYTRUDA (pembrolizumab). This clinical study will evaluate the clinical effect of JAB-BX102 in combination with KEYTRUDA in advanced solid tumors. Under the terms of the agreement, Merck will provide KEYTRUDA.
March 2023, Simcere Pharmaceutical Group Limited announced that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL).
March 2023, BioNTech SE and OncoC4 announced that they had entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4's next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.
February 2023, Vir Biotechnology announced that the research collaboration agreement established with GSK in 2020 had been amended to reflect that Vir will continue its ongoing efforts to discover, develop and advance next-generation solutions for COVID-19 and other potential coronavirus outbreaks, independently or with other partners. Together, the Companies will continue working to ensure ongoing access to sotrovimab for patients around the world, where authorized, and to develop new therapies for influenza and other respiratory diseases.
January 2023, CARsgen Therapeutics Holdings Limited announced CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd to evaluate CARsgen's investigational drug AB011, which received IND clearance globally, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma. Under the terms of the agreement, Roche will be responsible for the operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen's proprietary CLDN18.2 IHC test kit, which has shown excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in gastric cancer patients.
November 2022, Exelixis and Sairopa announced that the companies had entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPa. SIRPa expressed on myeloid cells interacts with CD47 on the surface of cancer cells, blocks the ability of macrophages to clear tumor cells via phagocytosis, and inhibits tumor antigen presentation to T-cells. Blocking SIRPa has the potential to improve the immune system's ability to attack tumors by addressing a significant immune-suppressive component of the tumor microenvironment.
October 2022, Compass Therapeutics announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The collaboration enables the evaluation of the safety and efficacy of Compass' CTX-471, a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137 (expressed on T cells and NK cells) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in Phase Ib trial. Under the agreement, Compass is the study sponsor, and Merck will provide the clinical supply of KEYTRUDA; the companies will form a Joint Development Committee to review the clinical trial results.
September 2022, Abpro announced a strategic partnership with Celltrion for its cancer molecule ABP 102, an antibody therapy for patients suffering from HER2+ cancer, including breast, gastric, and pancreatic cancer. Through this global partnership, Abpro will receive payments from Celltrion of up to $1.75 Billion, including an equity investment, development and commercial milestone payments, and worldwide profit sharing. Celltrion will be in charge of developing ABP 102 following the completion of in vitro studies by Abpro and will have worldwide commercialization rights. HER2+ type cancer is implicated in up to 30% of all cases of breast, gastric, pancreatic, and other forms of cancer.
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Monoclonal Antibodies Competitive Landscape Report
Monoclonal Antibodies Overview
Monoclonal antibody (mAb) allows for a far more accurate understanding of the humoral immune response by dissecting it into specific B-lymphocyte populations. A wide variety of mAbs have been developed to target antigens found in the kidney, bladder, and prostate. The importance of therapeutic monoclonal antibodies is growing year by year. Their very specific antigen targeting can give very effective medical treatment, and the advent of molecular-targeted medicine is enabling the development of a new generation of therapeutic medicines. However, there is one major hurdle to overcome. Although all proteins have original native intact structures for their own distinct functions, the majority of developed therapeutic monoclonal antibodies exhibit selectivity for the primary structures of target antigens. Stereo-specific monoclonal antibodies that recognize target antigen conformational features may thus provide a far more diverse approach. Their use may alter the fundamental assumptions underlying the use of therapeutic antibodies.
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Monoclonal Antibodies Treatment
Monoclonal Antibodies Pipeline Analysis: Drug Profile
Ianalumab (VAY736) is a novel, defucosylated human IgG1 monoclonal antibody that targets the TNF family's human B cell-activating factor (BAFF). The BAFF receptor is mostly expressed in B cells and plays an important role in B cell maturation, activation, and survival. VAY736 binds to the BAFF receptor and inhibits BAFF binding to the BAFF-R, preventing BAFF-R-mediated signaling in B cells. It is also designed to eradicate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC). By removing fucose residues from the carbohydrate moiety connected to the Fc component of the antibody, ianalumab's ADCC activity is considerably increased. It is now being studied in Phase III clinical trials for the treatment of Sjögren's syndrome, Lupus nephritis, Immune thrombocytopenia, Systemic Lupus Erythematosus, and warm autoimmune hemolytic anemia. In addition, the molecule is being evaluated in Phase II development for Idiopathic pulmonary fibrosis, Multiple Sclerosis, and other diseases.
Ziltivekimab: Novo Nordisk
Ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb) that targets residual inflammatory cardiovascular risk in patients with severe chronic kidney disease (CKD). Ziltivekimab is being developed as a medication to minimize the incidence of significant cardiovascular adverse events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation. Patients with moderate to severe CKD, ASCVD, and inflammation are at high risk of an adverse cardiovascular event, and there are no licensed medications to reduce this risk. Interleukin-6 (IL-6) has been established to be an independent, causative component of ASCVD in human genetic research and preclinical studies. The drug is currently in Phase III testing for the treatment of patients with moderate to severe chronic renal disease.
A snapshot of the Monoclonal Antibodies Pipeline Drugs mentioned in the report:
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Monoclonal Antibodies Clinical Trials
Scope of the Monoclonal Antibodies Competitive Landscape Report
Key Monoclonal Antibodies Companies: Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Omeros Corporation, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals, Nectin Therapeutics Ltd, Y-mAbs Therapeutics, OncoResponse, Inc., Fate Therapeutics, Pelican Therapeutics, Inc., Heat Biologics, Oncternal Therapeutics, Phanes Therapeutics, Pharmacyclics LLC, Immunitas Therapeutics, Hummingbird Bioscience, Inc., Sanofi, Takeda, Agenus Inc., Aulos Bioscience, Inc., ChemomAb Ltd, Celldex Therapeutics, Celgene, Janssen Research & Development, LLC, Adaptive Biotechnologies, BeiGene, Vaccinex Inc., Jasper Therapeutics, Inc., Shanghai Junshi Bioscience Co., Ltd., TopAlliance Biosciences, Inc., and others
Key Monoclonal Antibodies Pipeline Drugs: Ianalumab, GMA-131, anti-MASP-2 monoclonal antibody, MK-2060, DISC-0974, AT-1501, Ravulizumab, BION 1301, Narsoplimab, Pembrolizumab, Ziltivekimab, Opdivo, Avelumab, JAB-BX102, and others
Company Analysis, Therapeutic Assessment, Pipeline Assessment, Inactive drugs assessment, Unmet Needs
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Monoclonal Antibodies Drugs
Table of Contents
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Monoclonal Antibodies Treatment Drugs
Sjogren's Syndrome Pipeline
Sjogren's Syndrome Pipeline Insight
– 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Sjogren's syndrome companies, including Novartis
, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, among others.
Bladder Cancer Market
Bladder Cancer Market Insights, Epidemiology, and Market Forecast
– 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies including
RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others.
Multiple Sclerosis Pipeline
Multiple Sclerosis Pipeline Insight
– 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple sclerosis companies, including
TG Therapeutics, Immunic, Atara Biotherapeutics, ANOKION, ImStem Biotechnology, Merck Serono, CinnaGen, Immune Response BioPharma, Inc., Clene Nanomedicine, GeNeuro SA, Sanofi, Bristol-Myers Squibb, HuniLife Biotechnology, Inc., among others.
Colorectal Cancer Market
Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies including
Qilu Pharmaceutical, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., PharmaMar, Suzhou Zelgen Biopharmaceuticals, among others.
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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
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
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