UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of the Securities Exchange Act of 1934
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(Commission File No.) |
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(IRS Employer Identification No.) |
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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(The Nasdaq Global Select Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
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Item 2.02. |
Results of Operations and Financial Condition. |
On August 12, 2021, Chinook Therapeutics, Inc. (“Chinook”) announced certain financial results for the second quarter ended June 30, 2021. A copy of Chinook’s press release, titled “Chinook Therapeutics Provides Business Update and Reports Second Quarter 2021 Financial Results” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
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Item 9.01. |
Financial Statements and Exhibits. |
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(d) |
Exhibits. |
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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.
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Dated: August 12, 2021 |
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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 Provides Business Update and Reports Second Quarter 2021 Financial Results
SEATTLE August 12, 2021 – Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the second quarter ended June 30, 2021.
“During the second quarter of 2021, we made strong progress across our pipeline of programs for kidney diseases, including driving enrollment in the phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, presenting interim clinical data for BION-1301 demonstrating initial proof-of-concept in patients with IgA nephropathy and advancing key IND-enabling studies for CHK-336,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “Our solid cash position and resourcing enable us to continue executing on key priorities to advance our pipeline and build Chinook into a leading kidney disease company.”
Recent Highlights
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Enrolled the first patient in the phase 2 AFFINITY basket trial of atrasentan, a highly potent and selective endothelin A receptor (ETA) antagonist (see www.clinicaltrials.gov, identifier NCT04573920). |
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Presented interim data from the first several patients with IgA nephropathy (IgAN) enrolled in Cohort 1 of Part 3 of the ongoing phase 1/2 study of BION-1301 at the 58th ERA-EDTA conference, demonstrating durable reductions in Gd-IgA1, IgA, IgM, and to a lesser extent, IgG levels, as well as clinically meaningful reductions in 24-hour proteinuria (UPCR), providing initial proof-of-concept for BION-1301 in IgAN. |
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Presented Gd-IgA1 biomarker data in healthy volunteers from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1/2 study of BION-1301 at the ISN World Congress of Nephrology 2021, showing dose-dependent and durable reductions in Gd-IgA1 levels following administration of BION-1301. |
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Presented data from the BION-1301 phase 1 intravenous to subcutaneous bioavailability study in healthy volunteers at the ISN World Congress of Nephrology 2021. |
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Entered into an agreement for Sairopa B.V., or Sairopa, to acquire certain of Chinook’s non-renal assets in exchange for a 44 percent preferred equity position in Sairopa. Any future proceeds resulting from this transaction will be shared equally between the CVR holders and Chinook until October 4, 2030, after which 100 percent of the value will accrue to Chinook. |
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Announced promotions of Tom Frohlich to Chief Operating Officer and Andrew King, D.V.M., Ph.D., to Chief Scientific Officer. |
Anticipated Upcoming Catalysts
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Chinook expects to complete enrollment in Cohort 1 of Part 3 of the ongoing phase 1/2 study of BION-1301 in the third quarter of 2021 and to present additional patient data from this cohort at the ASN Kidney Week 2021 in November. |
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Chinook expects to initiate enrollment in Cohort 2 of Part 3 of the ongoing phase 1/2 study of BION-1301 in the third quarter of 2021. Patients in Cohort 2 will receive a subcutaneous dose of 600 mg of BION-1301 every two weeks for up to 52 weeks. Chinook expects to present patient data from Cohort 2 and provide an update on planned later-stage clinical trials of BION-1301 in the first half of 2022. |
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Chinook expects to present interim data from one or more patient cohorts of the ongoing phase 2 AFFINITY basket trial of atrasentan in the first half of 2022. |
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CHK-336 is currently in IND-enabling studies and is advancing towards expected initiation of a phase 1 clinical study in healthy volunteers in the first quarter of 2022 for the treatment of primary hyperoxaluria. |
Second Quarter 2021 Financial Results
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Cash Position – Cash, cash equivalents and marketable securities totaled $229.8 million at June 30, 2021, compared to $250.4 million at December 31, 2020. |
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Revenue – Total revenue increased by less than $0.1 million for the second quarter of 2021 and increased by $0.4 million for the six months ended June 30, 2021, compared to the same periods in 2020 due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly, which was acquired under the merger with Aduro. |
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Expenses – |
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Research and development expenses were $22.8 million for the second quarter of 2021 and $48.5 million for the six months ended June 30, 2021, compared to $3.9 million and $6.7 million, respectively, for the same periods in 2020. The increase was primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out Chinook’s clinical and development capabilities; increased spending for consulting and outside services; and an increase in facilities and other costs. The six months ended June 30, 2021 also includes an upfront fee of $3.3 million due to Evotech International GmbH under a research collaboration and license agreement entered into in February 2021. |
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General and administrative expenses were $7.8 million for the second quarter of 2021 and $17.3 million for the six months ended June 30, 2021, compared to $3.9 million and $5.2 million, respectively, for the same periods in 2020. The increase was primarily due to higher employee-related costs, including salaries, benefits and stock-based compensation expense associated with the addition of administrative staff to buildout Chinook’s public-company infrastructure; higher legal, consulting and outside services costs; and an increase in facilities and other costs. |
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Expenses due to the change in fair value of contingent consideration and contingent value rights liabilities were $19.6 million for the second quarter of 2021 and $21.4 million for the six months ended June 30, 2021, compared to nil for the same periods in 2020. These non-cash expenses are due to the quarterly revaluation of assets and liabilities related to the Sairopa transaction and an updated valuation of Chinook’s CVR liability under the Merck collaboration, as a result of the merger with Aduro. In the second quarter of 2021, Merck informed Chinook that it intends to explore the potential benefit of the product candidate MK-5890, previously out-licensed to Merck by Aduro, in a phase 2 clinical study for a new indication. This may result in potential milestone and royalty payments for the benefit of CVR holders. |
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Other – |
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The sale of certain of Chinook’s non-renal assets to Sairopa in the second quarter of 2021 resulted in a $7.2 million gain. |
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Net Loss – Net loss for the second quarter of 2021 was $42.6 million or $0.97 per share and $79.8 million or $1.86 per share for the six months ended June 30, 2021, compared to net loss of $7.7 million or $1.87 per share and $12.9 million or $3.12 per share, respectively, for the same periods in 2020. |
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Cash Used in Operations – For the six months ended June 30, 2021, cash used in operations totaled $55.5 million. |
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 1b trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with differentiating mechanisms of action 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. 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, whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, 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 COVID-19 on our clinical programs and business operations. 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 Liffick
Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
media@chinooktx.com
CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Collaboration and license revenue |
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$ |
34 |
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$ |
— |
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$ |
385 |
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$ |
— |
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Operating expenses: |
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Research and development |
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22,787 |
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3,870 |
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48,484 |
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6,688 |
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General and administrative |
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7,768 |
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3,879 |
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17,311 |
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5,150 |
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Change in fair value of contingent consideration and contingent value rights liabilities |
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19,557 |
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— |
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21,396 |
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— |
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Amortization of intangible assets |
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422 |
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— |
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842 |
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— |
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Total operating expenses |
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50,534 |
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7,749 |
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88,033 |
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11,838 |
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Gain on sale of assets to equity method investment |
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7,227 |
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— |
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7,227 |
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— |
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Loss from operations |
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(43,273 |
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(7,749 |
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(80,421 |
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(11,838 |
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Other income (expense), net |
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(39 |
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(4 |
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(106 |
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115 |
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Change in fair value of redeemable convertible preferred stock tranche liability |
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— |
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10 |
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— |
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(1,169 |
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Loss before income taxes |
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(43,312 |
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(7,743 |
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(80,527 |
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(12,892 |
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Income tax benefit |
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741 |
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— |
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741 |
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— |
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Net loss |
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$ |
(42,571 |
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$ |
(7,743 |
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$ |
(79,786 |
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$ |
(12,892 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.97 |
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$ |
(1.87 |
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$ |
(1.86 |
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$ |
(3.12 |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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43,861 |
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4,151 |
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43,004 |
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4,128 |
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CHINOOK THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(In thousands)
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June 30, |
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December 31, |
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2021 |
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2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
135,466 |
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$ |
187,750 |
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Marketable securities |
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61,684 |
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59,622 |
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Accounts receivable |
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467 |
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262 |
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Prepaid expenses and other current assets |
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5,710 |
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6,447 |
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Total current assets |
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203,327 |
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254,081 |
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Marketable securities |
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32,682 |
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3,000 |
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Property and equipment, net |
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19,359 |
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20,626 |
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Restricted cash |
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2,074 |
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1,750 |
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Operating lease right-of-use assets |
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53,157 |
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55,673 |
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Equity method investment |
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9,972 |
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— |
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Intangible assets, net |
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26,854 |
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27,696 |
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In process research & development |
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36,550 |
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39,295 |
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Goodwill |
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18,541 |
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22,441 |
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Other assets |
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5,349 |
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4,440 |
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Total assets |
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$ |
407,865 |
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$ |
429,002 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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9,221 |
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3,995 |
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Accrued and other current liabilities |
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11,269 |
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15,674 |
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Operating lease liabilities |
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3,280 |
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3,045 |
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Deferred revenue |
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— |
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95 |
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Total current liabilities |
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23,770 |
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22,809 |
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Contingent value rights liability |
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29,050 |
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13,780 |
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Contingent consideration liability |
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4,780 |
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1,800 |
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Deferred tax liabilities |
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15,635 |
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16,377 |
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Operating lease liabilities |
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37,147 |
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38,709 |
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Other long-term liabilities |
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754 |
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905 |
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Total liabilities |
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111,136 |
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94,380 |
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Stockholders’ equity |
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296,729 |
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334,622 |
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Total liabilities and stockholders’ equity |
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$ |
407,865 |
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$ |
429,002 |
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