UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 9, 2023, Chinook Therapeutics, Inc. (“Chinook”) announced certain financial results for the first quarter ended March 31, 2023. A copy of Chinook’s press release, titled “Chinook Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Updates” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
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99.1 |
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104 |
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Cover Page Interactive File (the cover page tags are embedded within the Inline XBRL document) |
The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Chinook Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: May 9, 2023 |
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Chinook Therapeutics, Inc. |
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By: |
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/s/ Eric L. Dobmeier |
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Eric L. Dobmeier |
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President and Chief Executive Officer |
Exhibit 99.1
Chinook Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Updates
SEATTLE May 9, 2023 – 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
Atrasentan
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.
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.
CHK-336
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.
Corporate
First Quarter 2023 Financial Results
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.
Investor Contact:
Noopur Liffick
Senior Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
Media Contact:
Kelly North
Senior Manager, Investor Relations & Corporate Communications
media@chinooktx.com
CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Collaboration and license revenue |
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$ |
1,828 |
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$ |
2,697 |
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Operating expenses: |
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Research and development |
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50,883 |
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26,252 |
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General and administrative |
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11,404 |
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7,868 |
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Change in fair value of contingent consideration and |
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526 |
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(1,038 |
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Amortization of intangible assets |
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433 |
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429 |
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Total operating expenses |
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63,246 |
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33,511 |
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Loss from operations |
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(61,418 |
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(30,814 |
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Investment and other income (expense), net |
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3,102 |
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(95 |
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Loss before income taxes and equity method investment loss |
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(58,316 |
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(30,909 |
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Equity method investment loss |
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(1,861 |
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(775 |
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Net loss |
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$ |
(60,177 |
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$ |
(31,684 |
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Net loss per share attributable to common stockholders, basic and |
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$ |
(0.85 |
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$ |
(0.54 |
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Weighted-average shares used in computing net loss per share |
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70,703 |
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58,340 |
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CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
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March 31, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
118,495 |
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$ |
115,438 |
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Marketable securities |
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231,881 |
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262,887 |
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Accounts receivable |
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2,444 |
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1,091 |
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Prepaid expenses and other current assets |
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5,824 |
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6,176 |
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Total current assets |
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358,644 |
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385,592 |
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Marketable securities |
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7,002 |
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6,989 |
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Property and equipment, net |
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16,974 |
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16,908 |
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Restricted cash |
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2,074 |
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2,074 |
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Operating lease right-of-use assets |
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47,345 |
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48,970 |
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Investment in equity securities |
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41,200 |
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41,200 |
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Equity method investment |
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2,653 |
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4,071 |
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Intangible assets, net |
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23,854 |
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24,287 |
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In-process research & development |
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36,550 |
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36,550 |
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Goodwill |
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117 |
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117 |
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Other assets |
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7,462 |
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7,326 |
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Total assets |
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$ |
543,875 |
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$ |
574,084 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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9,774 |
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9,751 |
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Accrued and other current liabilities |
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33,605 |
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33,636 |
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Operating lease liabilities |
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5,085 |
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4,948 |
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Contingent value rights liability |
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2,500 |
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2,500 |
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Total current liabilities |
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50,964 |
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50,835 |
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Contingent value rights liability - non-current |
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37,794 |
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37,318 |
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Contingent consideration liability |
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4,470 |
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4,420 |
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Deferred tax liabilities |
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5,076 |
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5,076 |
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Operating lease liabilities, net of current maturities |
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33,178 |
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34,494 |
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Total liabilities |
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131,482 |
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132,143 |
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Stockholders’ equity |
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412,393 |
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441,941 |
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Total liabilities and stockholders’ equity |
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$ |
543,875 |
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$ |
574,084 |
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