Aduro Biotech Provides Business Update and Reports Third Quarter 2019 Financial Results
November 07 2019 - 4:05PM
Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage
biopharmaceutical company focused on developing therapies targeting
the Stimulator of Interferon Genes (STING) and A Proliferation
Inducing Ligand (APRIL) pathways for the treatment of cancer,
autoimmune and inflammatory diseases, today provided a business
update and reported financial results for the third quarter ended
September 30, 2019.
Cash, cash equivalents and short term and long term marketable
securities totaled $235.4 million at September 30, 2019, compared
to $277.9 million at December 31, 2018.
“We remain highly focused on the development of our STING and
APRIL programs, with the initiation of our Phase 2 study of
ADU-S100 in combination with pembrolizumab in head and neck
squamous cell carcinoma and continued progress of our Phase 1 study
of BION-1301 in IgA nephropathy,” said Stephen T. Isaacs, chairman,
president and chief executive officer of Aduro. “Our strong cash
position of $235.4 million at the end of the third quarter enables
us to continue investing in our STING and APRIL programs with the
ultimate goal of providing therapeutic benefit to patients.”
Recent Highlights
- Cleared four healthy volunteer dose cohorts in the single
ascending dose portion and one healthy volunteer dose cohort in the
multiple ascending dose portion of the Phase 1 clinical trial of
BION-1301 for the treatment of IgA nephropathy.
- First patient dosed in Phase 2 clinical trial of ADU-S100
(MIW815) in combination with Keytruda® (pembrolizumab), an approved
anti-PD-1 antibody, as a first-line treatment for recurrent or
metastatic head and neck squamous cell carcinoma.
Financial Results
- Revenue – Revenue was $4.8 million for the
third quarter of 2019 and $13.6 million for the nine months ended
September 30, 2019, compared to $3.1 million and $12.3 million,
respectively, for the same periods in 2018. The increase in revenue
for the quarter and the year to date was primarily due to ratable
recognition of the upfront payment received from Eli Lilly in the
first quarter of 2019.
- Expenses –
- Research and development expenses were $15.5 million for the
third quarter of 2019 and $51.9 million for the nine months ended
September 30, 2019, compared to $18.7 million and $58.2 million,
respectively, for the same periods in 2018. The quarter and year to
date costs decreased primarily due our strategic reset in January
2019, which resulted in reduced headcount and stock-based
compensation expense. The reset also resulted in reduced spending
towards deprioritized programs partially offset by higher spending
towards our STING and APRIL programs.
- General and administrative expenses were $8.7 million for the
third quarter of 2019 and $25.8 million for the nine months ended
September 30, 2019, compared to $9.1 million and $27.0 million,
respectively, for the same periods in 2018. The quarter and year to
date costs decreased primarily due to our strategic reset in
January 2019, which resulted in reduced headcount and stock-based
compensation expense.
- Loss on impairment of intangible assets was $5.0 million for
the third quarter of 2019. This expense was recorded due to the
discontinuation of one of our acquired early research
programs.
- Net Loss – Net loss for the third quarter of
2019 was $21.0 million or $0.26 per share and $63.0 million or
$0.79 per share for the nine months ended September 30, 2019,
compared to net loss of $23.1 million or $0.29 per share and $69.0
million or $0.88 per share, respectively, for the same periods in
2018.
About Aduro
Aduro Biotech, Inc. is a clinical-stage biopharmaceutical
company focused on the discovery, development and commercialization
of therapies that are designed to harness the body’s natural immune
system for the treatment of patients with challenging diseases.
Aduro’s product candidates in the Stimulator of Interferon Genes
(STING) and A Proliferation Inducing Ligand (APRIL) pathways are
being investigated in cancer, autoimmune and inflammatory diseases.
ADU-S100 (MIW815), which potentially activates the intracellular
STING receptor for a potent tumor-specific immune response, is
being evaluated in patients with cutaneously accessible metastatic
solid tumors or lymphomas. BION-1301, a first-in-class humanized
IgG4 monoclonal antibody that fully blocks APRIL binding to both
the BCMA and TACI receptors, is being evaluated in IgA nephropathy.
Aduro is collaborating with a number of leading global
pharmaceutical companies to help expand and drive its product
pipeline. For more information, please visit www.aduro.com.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include
statements regarding our current intentions or expectations
concerning, among other things, the potential for our technology,
continued advancement of our programs, continued investment in our
lead assets and collaborations with leading global pharmaceutical
companies to help expand and drive our product pipeline. 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 history of net operating losses and uncertainty regarding our
ability to achieve profitability, our ability to develop and
commercialize our product candidates, our ability to use and expand
our technology platforms to build a pipeline of product candidates,
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 have
greater resources than we do, our reliance on third parties, and
our ability to obtain and adequately protect intellectual property
rights for our product candidates. We discuss many of
these risks in greater detail under the heading “Risk Factors”
contained in our quarterly report on Form 10-Q for the quarter
ended September 30, 2019, to be filed with the Securities and
Exchange Commission (SEC), and our other filings with the SEC. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
ADURO BIOTECH,
INC.Consolidated Statements of
Operations(In thousands, except share and per
share amounts)(Unaudited)
|
Three Months Ended September
30, |
|
|
Nine Months Ended September 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
4,799 |
|
|
$ |
3,063 |
|
|
$ |
13,625 |
|
|
$ |
12,329 |
|
Total revenue |
|
4,799 |
|
|
|
3,063 |
|
|
|
13,625 |
|
|
|
12,329 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
15,510 |
|
|
|
18,675 |
|
|
|
51,916 |
|
|
|
58,223 |
|
General and administrative |
|
8,683 |
|
|
|
9,149 |
|
|
|
25,845 |
|
|
|
27,021 |
|
Loss on impairment of intangible assets |
|
5,006 |
|
|
|
— |
|
|
|
5,006 |
|
|
|
— |
|
Amortization of intangible assets |
|
138 |
|
|
|
144 |
|
|
|
417 |
|
|
|
443 |
|
Total operating expenses |
|
29,337 |
|
|
|
27,968 |
|
|
|
83,184 |
|
|
|
85,687 |
|
Loss from operations |
|
(24,538 |
) |
|
|
(24,905 |
) |
|
|
(69,559 |
) |
|
|
(73,358 |
) |
Interest income |
|
1,366 |
|
|
|
1,353 |
|
|
|
4,334 |
|
|
|
3,892 |
|
Other (loss) income, net |
|
(32 |
) |
|
|
21 |
|
|
|
(54 |
) |
|
|
(15 |
) |
Loss before income tax |
|
(23,204 |
) |
|
|
(23,531 |
) |
|
|
(65,279 |
) |
|
|
(69,481 |
) |
Income tax benefit |
|
2,252 |
|
|
|
385 |
|
|
|
2,322 |
|
|
|
444 |
|
Net loss |
$ |
(20,952 |
) |
|
$ |
(23,146 |
) |
|
$ |
(62,957 |
) |
|
$ |
(69,037 |
) |
Net loss per common share, basic
and diluted |
$ |
(0.26 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.88 |
) |
Shares used in computing net loss
per common share, basic and diluted |
|
80,232,739 |
|
|
|
79,086,841 |
|
|
|
79,940,155 |
|
|
|
78,607,180 |
|
ADURO BIOTECH,
INC.Consolidated Balance
Sheets(In
thousands)(Unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
53,605 |
|
|
$ |
126,310 |
|
Short-term marketable securities |
|
|
178,182 |
|
|
|
140,129 |
|
Accounts receivable |
|
|
222 |
|
|
|
12,037 |
|
Prepaid expenses and other current assets |
|
|
3,805 |
|
|
|
4,500 |
|
Total current assets |
|
|
235,814 |
|
|
|
282,976 |
|
Long-term marketable
securities |
|
|
3,593 |
|
|
|
11,434 |
|
Property and equipment, net |
|
|
25,534 |
|
|
|
29,157 |
|
Operating lease right-of-use
assets |
|
|
21,346 |
|
|
|
— |
|
Goodwill |
|
|
7,949 |
|
|
|
8,334 |
|
Intangible assets, net |
|
|
18,608 |
|
|
|
25,135 |
|
Restricted cash |
|
|
468 |
|
|
|
468 |
|
Total assets |
|
$ |
313,312 |
|
|
$ |
357,504 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,643 |
|
|
$ |
1,457 |
|
Accrued clinical trial and manufacturing expenses |
|
|
4,012 |
|
|
|
2,542 |
|
Accrued expenses and other liabilities |
|
|
9,125 |
|
|
|
10,518 |
|
Operating lease liabilities |
|
|
1,700 |
|
|
|
— |
|
Deferred revenue |
|
|
16,000 |
|
|
|
16,000 |
|
Total current liabilities |
|
|
32,480 |
|
|
|
30,517 |
|
Deferred rent |
|
|
— |
|
|
|
11,063 |
|
Contingent consideration |
|
|
975 |
|
|
|
998 |
|
Deferred revenue |
|
|
161,203 |
|
|
|
172,671 |
|
Deferred tax liabilities |
|
|
3,522 |
|
|
|
6,104 |
|
Operating lease liabilities |
|
|
32,120 |
|
|
|
— |
|
Other long-term liabilities |
|
|
966 |
|
|
|
840 |
|
Total liabilities |
|
|
231,266 |
|
|
|
222,193 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
8 |
|
|
|
8 |
|
Additional paid-in capital |
|
|
549,705 |
|
|
|
538,895 |
|
Accumulated other comprehensive (loss) income |
|
|
(178 |
) |
|
|
940 |
|
Accumulated deficit |
|
|
(467,489 |
) |
|
|
(404,532 |
) |
Total stockholders’ equity |
|
|
82,046 |
|
|
|
135,311 |
|
Total liabilities and
stockholders’ equity |
|
$ |
313,312 |
|
|
$ |
357,504 |
|
Contact:Noopur
Liffick510-809-2465investors@aduro.com
press@aduro.com
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