Chinook Therapeutics Provides Business Update and Reports First Quarter 2021 Financial Results
May 12 2021 - 4:05PM
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 first
quarter ended March 31, 2021.
“During the first quarter of 2021, Chinook made strong progress
with its pipeline of programs for kidney diseases, including
initiating the phase 3 ALIGN and phase 2 AFFINITY trials of
atrasentan, presenting encouraging clinical data from the BION-1301
program and entering into a strategic collaboration with Evotec,”
said Eric Dobmeier, president and chief executive officer of
Chinook Therapeutics. “We are well-capitalized and resourced to
execute across our programs to generate additional data catalysts
and continue building Chinook into a leading kidney disease
company.”
Recent Highlights
- Presented 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 Nephrology 2021, showing dose-dependent and durable
reductions in Gd-IgA1 levels following administration of
BION-1301.
- Presented data from the BION-1301 phase 1 intravenous to
subcutaneous bioavailability study in healthy volunteers at the ISN
World Congress of Nephrology 2021, demonstrating our ability to
transition to subcutaneous administration of BION-1301 in cohort 2
of the ongoing phase 1b and future studies.
- 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 (IgAN) 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 to support potential
accelerated approval from the FDA.
- Entered into a strategic collaboration with Evotec to discover
and develop novel precision medicine therapies for lupus nephritis,
IgAN, polycystic kidney disease (PKD) and other primary glomerular
diseases by leveraging the National Unified Renal Translational
Research Enterprise (NURTuRE) patient biobank and Evotec’s
proprietary PanHunter multi-omics platform.
- 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).
Anticipated Upcoming Catalysts
- 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 Congress in 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.
First Quarter 2021 Financial Results
- Cash Position – Cash, cash equivalents and
marketable securities totaled $222.6 million at March 31, 2021,
compared to $250.4 million at December 31, 2020.
- Revenue – Total revenue increased by $0.4
million for the first quarter of 2021 compared to the same period
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.
- Expenses –
- Research and development expenses were $25.7 million for the
first quarter of 2021 compared to $2.8 million for the same period
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 our clinical and development
capabilities; increased spending for consulting and outside
services; and higher facilities and other costs. The three months
ended March 31, 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.
- General and administrative expenses were $9.5 million for the
first quarter of 2021 compared to $1.3 million for the same period
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 our public-company infrastructure; higher legal,
consulting and outside services costs; and an increase in
facilities and other costs.
- Expenses due to change in fair value of contingent
consideration and amortization of intangibles were $2.3 million for
the first quarter of 2021 compared to nil for the same period in
2020. These non-cash expenses are due to the quarterly revaluation
of assets and liabilities related to the merger with Aduro.
- Net Loss – Net loss for the first quarter of
2021 was $37.2 million or $0.88 per share compared to net loss of
$5.1 million or $1.25 per share for the same period in 2020.
- Cash Used in Operations – For the first
quarter ended March 31, 2021, cash used in operations totaled $28.1
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 LiffickVice President, Investor
Relations & Corporate Communicationsinvestors@chinooktx.com
media@chinooktx.com
|
|
CHINOOK THERAPEUTICS, INC.Consolidated
Statements of Operations(In thousands, except per
share amounts) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
Collaboration and license revenue |
|
$ |
351 |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
25,697 |
|
|
|
2,818 |
|
General and administrative |
|
|
9,543 |
|
|
|
1,271 |
|
Change in fair value of contingent consideration |
|
|
1,839 |
|
|
|
- |
|
Amortization of intangible assets |
|
|
420 |
|
|
|
- |
|
Total operating expenses |
|
|
37,499 |
|
|
|
4,089 |
|
Loss from operations |
|
|
(37,148 |
) |
|
|
(4,089 |
) |
Other expense, net |
|
|
67 |
|
|
|
1,060 |
|
Net loss |
|
$ |
(37,215 |
) |
|
$ |
(5,149 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.88 |
) |
|
$ |
(1.25 |
) |
Weighted-average shares used in
computing net loss per share attributable to common stockholders,
basic and diluted |
|
|
42,136 |
|
|
|
4,104 |
|
|
|
|
|
|
|
|
|
|
|
CHINOOK THERAPEUTICS, INC.Consolidated
Balance Sheets(In thousands) |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
168,092 |
|
|
$ |
187,750 |
|
Marketable securities |
|
|
51,478 |
|
|
|
59,622 |
|
Accounts receivable |
|
|
256 |
|
|
|
262 |
|
Prepaid expenses and other current assets |
|
|
6,174 |
|
|
|
6,447 |
|
Total current assets |
|
|
226,000 |
|
|
|
254,081 |
|
Marketable securities |
|
|
2,999 |
|
|
|
3,000 |
|
Property and equipment, net |
|
|
19,860 |
|
|
|
20,626 |
|
Restricted cash |
|
|
1,750 |
|
|
|
1,750 |
|
Operating lease right-of-use assets |
|
|
54,420 |
|
|
|
55,673 |
|
Intangible assets, net |
|
|
27,277 |
|
|
|
27,696 |
|
In process research & development |
|
|
39,295 |
|
|
|
39,295 |
|
Goodwill |
|
|
22,441 |
|
|
|
22,441 |
|
Other assets |
|
|
4,731 |
|
|
|
4,440 |
|
Total assets |
|
$ |
398,773 |
|
|
$ |
429,002 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
7,363 |
|
|
|
3,995 |
|
Accrued and other current liabilities |
|
|
14,486 |
|
|
|
15,674 |
|
Operating lease liabilities |
|
|
3,135 |
|
|
|
3,045 |
|
Deferred revenue |
|
|
— |
|
|
|
95 |
|
Total current liabilities |
|
|
24,984 |
|
|
|
22,809 |
|
Contingent value right liability |
|
|
15,589 |
|
|
|
13,780 |
|
Contingent consideration related to acquisition |
|
|
1,830 |
|
|
|
1,800 |
|
Deferred tax liabilities |
|
|
16,377 |
|
|
|
16,377 |
|
Operating lease liabilities |
|
|
37,966 |
|
|
|
38,709 |
|
Other long-term liabilities |
|
|
1,508 |
|
|
|
905 |
|
Total liabilities |
|
|
98,254 |
|
|
|
94,380 |
|
Stockholders’ equity |
|
|
300,519 |
|
|
|
334,622 |
|
Total liabilities and stockholders’ equity |
|
$ |
398,773 |
|
|
$ |
429,002 |
|
|
|
|
|
|
|
|
|
|
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