Chinook Therapeutics Reports First Quarter 2023 Financial Results and Provides 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
Recent Accomplishments and Updates
Atrasentan 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 Congressin Milan.
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 Congressin 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 Congressin Milanas well as in the second half of 2023.
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) and other kidney stone disorders driven by endogenous overproduction of oxalate.
April 2022Chinook 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 Congressin Milan.
April 2023Chinook 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.
- Chinook recently announced the appointment of
Robert W. Azelbyto its Board of Directors. Mr. Azelbybrings 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 Therapeuticsand commercial positions across Amgen’s nephrology and oncology business units.
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 millionand an additional $35.0 millionmilestone 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 millionat March 31, 2023, compared to $385.3 millionat December 31, 2022.
- Revenue – Revenue for the quarter ended
March 31, 2023was $1.8 millioncompared to $2.7 millionfor 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, 2023were $50.9 millioncompared to $26.3 millionfor 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, 2023were $11.4 millioncompared to $7.9 millionfor 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, 2023was an expense of $0.5 millioncompared to a benefit of $1.0 millionfor 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.
- Research and development expenses for the quarter ended
- Net Loss – Net loss for the first quarter of 2023 was
$60.2 million, or $0.85per basic share, compared to a net loss of $31.7 million, or $0.54per share for the same period in 2022.
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
|Condensed Consolidated Statements of Operations
|(In thousands, except per share amounts)
|Three Months Ended March 31,|
|Collaboration and license revenue||$||1,828||$||2,697|
|Research and development||50,883||26,252|
|General and administrative||11,404||7,868|
|Change in fair value of contingent consideration and
contingent value rights liabilities
|Amortization of intangible assets||433||429|
|Total operating expenses||63,246||33,511|
|Loss from operations||(61,418||)||(30,814||)|
|Investment and other income (expense), net||3,102||(95||)|
|Loss before income taxes and equity method investment loss||(58,316||)||(30,909||)|
|Equity method investment loss||(1,861||)||(775||)|
|Net loss per share attributable to common stockholders, basic and
|Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted
|Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||118,495||$||115,438|
|Prepaid expenses and other current assets||5,824||6,176|
|Total current assets||358,644||385,592|
|Property and equipment, net||16,974||16,908|
|Operating lease right-of-use assets||47,345||48,970|
|Investment in equity securities||41,200||41,200|
|Equity method investment||2,653||4,071|
|Intangible assets, net||23,854||24,287|
|In-process research & development||36,550||36,550|
|Liabilities and Stockholders’ Equity|
|Accrued and other current liabilities||33,605||33,636|
|Operating lease liabilities||5,085||4,948|
|Contingent value rights liability||2,500||2,500|
|Total current liabilities||50,964||50,835|
|Contingent value rights liability - non-current||37,794||37,318|
|Contingent consideration liability||4,470||4,420|
|Deferred tax liabilities||5,076||5,076|
|Operating lease liabilities, net of current maturities||33,178||34,494|
|Total liabilities and stockholders’ equity||$||543,875||$||574,084|
Noopur LiffickSenior Vice President, Investor Relations & Corporate Communications email@example.com Media Contact: Kelly NorthSenior Manager, Investor Relations & Corporate Communications firstname.lastname@example.org
Source: Chinook Therapeutics, Inc.