Chinook Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results
“We are executing well on our goal of building Chinook into a leading kidney disease company. 2020 was a very busy and productive year, as we in-licensed atrasentan from AbbVie, closed a
2020 and Recent Accomplishments
- 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). Chinook expects to report data from initial patient cohorts of this study in 2022.
- Enrolled the first patient with IgA nephropathy in the phase 3 ALIGN trial of atrasentan, (see www.clinicaltrials.gov, identifier NCT04573478). Chinook expects to report top-line proteinuria data from this study in 2023, which could support accelerated approval from the FDA.
- Delivered an oral presentation at the 3rd Annual Chronic Kidney Disease Drug Development (CKD3) Summit on selective ETA receptor antagonist atrasentan for the treatment of primary glomerular diseases.
- Entered into a license agreement with
Morehouse School of Medicinefor patents supporting the development of therapies in kidney diseases that disproportionately affect people of West African descent and underserved communities, including focal segmental glomerulosclerosis (FSGS) and HIV-associated nephropathy (HIVAN).
- Delivered a poster presentation at the
American Society of Nephrology (ASN) Kidney Week2020 Reimagined on the phase 3 ALIGN trial design for atrasentan.
- Entered into a license agreement with AbbVie for worldwide, exclusive rights to atrasentan.
- Completed enrollment and analysis of a phase 1 intravenous (IV) to subcutaneous (SC) bioavailability study of BION-1301, a novel anti-APRIL monoclonal antibody, in healthy volunteers.
- Dosed the first patient with IgAN in Part 3 of the ongoing phase 1 study of BION-1301.
- Delivered a poster presentation at the 57th
ERA-EDTA Virtual Congress and ASN Kidney Week2020 Reimagined on healthy volunteer data from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1 study of BION-1301.
- Delivered a poster presentation at the 57th
ERA-EDTA Virtual Congresson nonclinical toxicology studies of BION-1301 evaluating IV administration for up to six months and SC administration for up to one month.
- Received rare pediatric disease designation from the
U.S. Food and Drug Administration(FDA) for CHK-336, an investigational oral small molecule inhibitor of lactate dehydrogenase A (LDHA), for primary hyperoxaluria (PH).
- Delivered a preclinical poster presentation at the ASN Kidney Week 2020 Reimagined unveiling CHK-336 with the potential to treat all subtypes of PH and other disorders arising from excess oxalate.
- Participated in an expert panel discussion at the 3rd Annual CKD3 Summit on executing precision medicine in clinical trials.
- Entered into a strategic collaboration with Evotec to discover and develop novel precision medicine therapies for polycystic kidney disease (PKD), lupus nephritis, IgAN and other proteinuric glomerular diseases by leveraging the National Unified Renal Translational Research Enterprise (NURTuRE) patient biobank and Evotec’s proprietary PanHunter multi-omics platform.
- Presented an oral abstract at the ASN Kidney Week 2020 Reimagined on a single cell transcriptomic atlas of human autosomal dominant polycystic kidney disease (ADPKD) through Chinook's academic collaboration with the laboratory of
Benjamin Humphreys, M.D., Ph.D., Joseph Friedman Professorof Renal Diseases in Medicine and Chief of Nephrology at Washington University School of Medicinein St. Louis.
- Appointed healthcare financial expert,
Eric Bjerkholt, as chief financial officer.
- Appointed the following life sciences industry veterans to the Board of Directors:
William M. Greenman, president and chief executive officer of Cerus Corporation; Michelle Griffin, director and audit committee chair for Adaptive Biotechnologies, Acer Therapeutics and HTG Molecular Diagnostics, Inc.; Ross Haghighat, founder, chairman and managing partner of Triton Systems, Inc.; and Dolca Thomas, M.D., executive vice president, head of research and development and chief medical officer of Equillium, Inc.
- Closed the merger with
Aduro Biotech, Inc.on October 5, 2020and began trading on the Nasdaq Global Select Market under the symbol "KDNY."
- Completed a
$115 millionprivate placement financing with top-tier healthcare investors concurrent with the merger closing.
Anticipated Upcoming Catalysts
- Chinook expects to present Gd-IgA1 biomarker data in healthy volunteers from Part 1 (single ascending dose) and Part 2 (multiple ascending dose) of the ongoing phase 1b study of BION-1301 at the
ISN World Congress of Nephrology2021 in April.
- Chinook expects to present data from the BION-1301 phase 1 IV to SC bioavailability study in healthy volunteers at the
ISN World Congress of Nephrology2021 in April. Results from the study demonstrate the potential to transition to SC administration of BION-1301 in the long-term extension and phase 2 studies.
- Part 3 of Chinook's phase 1b study of BION-1301 is currently enrolling IgAN patients in an open-label setting, and Chinook expects to present a small subset of interim patient data in an oral presentation at the 58th
ERA-EDTA Congressin June, as well as additional patient data at the ASN Kidney Week 2021 in November.
- CHK-336 is currently in IND-enabling studies and advancing towards an expected IND submission in late 2021 or early 2022 for the treatment of primary hyperoxaluria.
Fourth Quarter and Full Year Financial Results
- Cash Position – Cash, cash equivalents and marketable securities totaled
$250.4 millionat December 31, 2020, compared to $11.2 millionat December 31, 2019.
- Revenue – Total revenue increased by
$0.8 millionfor both the fourth quarter of 2020 and year ended December 31, 2020as compared to the fourth quarter of 2019 and year ended December 31, 2019. The increase was due to revenue recognized related to research and development services provided under the collaboration agreement with Lilly.
- Expenses –
- Research and development expenses were
$21.8 millionfor the fourth quarter of 2020 and $36.1 millionfor the year ended December 31, 2020, compared to $9.2 millionand $17.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, the increases were primarily due to external clinical and manufacturing expenses related to the atrasentan and BION-1301 clinical programs; higher personnel expenses, including salaries, benefits and stock-based compensation expense associated with hiring staff to build out our clinical and development capabilities; and increased spending for consulting and outside services. The year-over-year increase was partially offset by expenses in the prior year period for the in-license of atrasentan, the purchase of intellectual property and know-how from a related party to support the CHK-336 program and discovery research activities.
- General and administrative expenses were
$11.0 millionfor the fourth quarter of 2020 and $19.1 millionfor the year ended December 31, 2020, compared to $0.7 millionand $3.0 million, respectively, for the same periods in 2019. For the quarter and year ended December 31, 2020, costs increased primarily due to legal, consulting and accounting costs related to the merger; an increase in personnel costs, including salaries, benefits and stock-based compensation expense due to the addition of administrative staff to buildout our public-company infrastructure; and an increase in facilities and other costs.
- Research and development expenses were
- Net Loss – Net loss for the fourth quarter of 2020 was
$49.9 millionor $1.24per share and $81.6 millionor $6.20per share for the year ended December 31, 2020, compared to net loss of $34.2 millionor $14.65per share and $46.5 millionor $25.48per share, respectively, for the same periods in 2019.
- Cash Used in Operations – For the fourth quarter ended
December 31, 2020, cash used in operations totaled $41.3 million, of which $20.1 millionwere non-recurring expenses related to the merger and integration with Aduro Biotech.
Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward looking, including those relating to Chinook’s business, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding cash forecasts and timing of initiation and results of clinical trials. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, including initiation of clinical trials of our existing product candidates or those developed as part of the Evotec collaboration, whether results of early clinical trials or preclinical studies will be indicative of the results of future trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that may be more advanced or have greater resources than we do, our ability to obtain and adequately protect intellectual property rights for our product candidates and the effects of COVID-19 on our clinical programs and business operations. Many of these risks are described in greater detail in our filings with the
Consolidated Statements of Operations
(in thousands, except share and per share amounts)
|Three Months Ended
|Collaboration and license revenue||$||827||$||—||$||827||$||—|
|Research and development||21,788||9,195||36,051||17,010|
|General and administrative||11,023||695||19,071||2,956|
|Change in fair value of contingent consideration||1,510||—||1,510||—|
|Amortization of intangible assets||422||—||422||—|
|Total operating expenses||34,743||9,890||57,054||19,966|
|Net loss from operations||(33,916||)||(9,890||)||(56,227||)||(19,966||)|
|Other income (expense):|
|Interest expense – related party||(2||)||(7||)||(15||)||(33||)|
|Other income (expense), net||165||44||313||299|
|Change in fair value of redeemable convertible preferred stock tranche liability||(18,163||)||(24,352||)||(27,696||)||(26,819||)|
|Loss before income tax benefit||(51,916||)||(34,205||)||(83,625||)||(46,519||)|
|Income tax benefit||2,003||—||2,003||—|
|Net loss per common share, basic and diluted||$||(1.24||)||$||(14.65||)||$||(6.20||)||$||(25.48||)|
|Shares used in computing net loss per common share,
basic and diluted
Consolidated Balance Sheets
|Cash and cash equivalents||$||187,750||$||11,203|
|Prepaid expenses and other current assets||6,447||1,174|
|Total current assets||254,081||12,531|
|Property and equipment, net and finance right-of-use asset||20,626||1,311|
|Operating lease right-of-use assets||55,673||1,880|
|Intangible assets, net||27,696||—|
|Liabilities, Redeemable Convertible Preferred Stock and Stockholders’
|Accounts payable (including amounts due to related party of
|Accrued and other current liabilities (including amounts due to related party of
|Operating lease liabilities (including amounts due to related party of
|Finance lease liabilities – related party||—||75|
|Total current liabilities||22,809||2,427|
|Redeemable convertible preferred stock tranche liability||—||32,733|
|Contingent value right liability||13,780||—|
|Contingent consideration related to acquisition||1,800||—|
|Deferred tax liabilities||16,377||—|
|Operating lease liabilities, net of current maturities (including amounts due
to related party of
|Finance lease liabilities, net of current maturities – related party||—||114|
|Other long-term liabilities||905||—|
|Commitments and contingencies|
|Redeemable convertible preferred stock,
shares authorized as of
7,596,886 shares issued and outstanding as of
respectively; liquidation preference
and 2019, respectively
|Stockholders’ equity (deficit):|
and outstanding as of
|Additional paid-in capital||463,436||6,095|
|Accumulated other comprehensive income (loss)||11||(7||)|
|Total stockholders’ equity (deficit)||334,622||(41,119||)|
|Total liabilities, redeemable convertible preferred stock and stockholders’
Source: Chinook Therapeutics, Inc.