Aduro Biotech Provides Business Update and Reports Second Quarter 2019 Financial Results
02 August 2019 - 6:05AM
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 second quarter ended
June 30, 2019.
“Several important clinical study results have
helped inform the development of our STING and APRIL programs thus
far in 2019. We look forward to initiating the study of ADU-S100
and pembrolizumab in head and neck cancer as we continue to explore
the synergies of STING agonists with checkpoint inhibitors,” said
Stephen T. Isaacs, chairman, president and chief executive officer
of Aduro. “We continue to focus our development efforts for
BION-1301 on IgA nephropathy, the most common type of
glomerulonephritis worldwide for which there is no approved drug
treatment option. We look forward to advancing the development of
our STING and APRIL programs to provide the greatest potential
benefit to patients.” Isaacs continued, “Our cash position remains
strong with $251.6 million at the end of the second quarter, and we
will continue investing in our lead assets to generate additional
meaningful data read-outs over the next 12 to 24 months.”
Recent Highlights
- Cleared three of five healthy volunteer dose cohorts in the
single ascending dose portion of the Phase 1 clinical trial of
BION-1301 for the treatment of IgA nephropathy
- Presented findings from the ongoing Phase 1b study of ADU-S100
(MIW815) in combination with spartalizumab (PDR001) in patients
with advanced, metastatic treatment-refractory solid tumors or
lymphomas in an oral presentation at the 2019 American Society of
Clinical Oncology (ASCO) Annual Meeting
- Presented findings from the dose escalation portion of the
Phase 1/2 study of BION-1301 in patients with relapsed or
refractory multiple myeloma in two poster presentations at the 2019
ASCO Annual Meeting
- Presented three abstracts at the American Association for
Cancer Research (AACR) Annual Meeting 2019, including updated
preclinical data on ADU-S100
- Appointed immuno-oncology drug development expert, Dimitry
Nuyten, M.D., Ph.D., as chief medical officer
- Appointed financial and life sciences industry expert, James
Welch, as interim chief financial officer
- Appointed life sciences industry veteran, Frank Karbe, to the
board of directors
Financial Results
- Cash Position – Cash, cash equivalents and
marketable securities totaled $251.6 million at June 30, 2019,
compared to $277.9 million at December 31, 2018. Cash spend year to
date was offset by the receipt of a $12 million upfront payment
received in the first quarter of 2019 from the 2018 license
agreement with Eli Lilly.
- Revenue – Revenue was $4.9 million for the
second quarter of 2019 and $8.8 million for the six months ended
June 30, 2019, compared to $2.6 million and $9.3 million,
respectively, for the same periods in 2018. The increase in revenue
for the quarter was primarily due to ratable recognition of the
upfront payment received from Eli Lilly in the first quarter of
2019. The decrease in revenue year to date was primarily due to
fluctuations in revenue recognized under our Novartis
collaboration, which is dependent on the clinical timelines and
progress under the research and collaboration agreement.
- Expenses –
- Research and development expenses were $16.9 million for the
second quarter of 2019 and $36.4 million for the six months ended
June 30, 2019, compared to $19.4 million and $39.5 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 $8.0 million for the
second quarter of 2019 and $17.2 million for the six months ended
June 30, 2019, compared to $8.8 million and $17.9 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.
- Net Loss – Net loss for the second quarter of
2019 was $18.6 million or $0.23 per share and $42.0 million or
$0.53 per share for the six months ended June 30, 2019, compared to
net loss of $24.4 million or $0.31 per share and $45.9 million or
$0.59 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 to generate clinical data read-outs
over the next 12 to 24 months 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 June 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 June
30, |
|
|
Six Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
4,888 |
|
|
$ |
2,639 |
|
|
$ |
8,826 |
|
|
$ |
9,266 |
|
Total revenue |
|
4,888 |
|
|
|
2,639 |
|
|
|
8,826 |
|
|
|
9,266 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
16,876 |
|
|
|
19,420 |
|
|
|
36,406 |
|
|
|
39,547 |
|
General and administrative |
|
7,980 |
|
|
|
8,827 |
|
|
|
17,162 |
|
|
|
17,872 |
|
Amortization of intangible assets |
|
139 |
|
|
|
147 |
|
|
|
279 |
|
|
|
299 |
|
Total operating expenses |
|
24,995 |
|
|
|
28,394 |
|
|
|
53,847 |
|
|
|
57,718 |
|
Loss from operations |
|
(20,107 |
) |
|
|
(25,755 |
) |
|
|
(45,021 |
) |
|
|
(48,452 |
) |
Interest income |
|
1,497 |
|
|
|
1,340 |
|
|
|
2,968 |
|
|
|
2,539 |
|
Other loss, net |
|
(3 |
) |
|
|
(20 |
) |
|
|
(22 |
) |
|
|
(36 |
) |
Loss before income tax |
|
(18,613 |
) |
|
|
(24,435 |
) |
|
|
(42,075 |
) |
|
|
(45,949 |
) |
Income tax benefit |
|
35 |
|
|
|
38 |
|
|
|
70 |
|
|
|
59 |
|
Net loss |
$ |
(18,578 |
) |
|
$ |
(24,397 |
) |
|
$ |
(42,005 |
) |
|
$ |
(45,890 |
) |
Net loss per common share, basic
and diluted |
$ |
(0.23 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.59 |
) |
Shares used in computing net loss
per common share, basic and diluted |
|
80,032,022 |
|
|
|
78,817,840 |
|
|
|
79,847,960 |
|
|
|
78,364,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADURO BIOTECH,
INC.Consolidated Balance
Sheets(In
thousands)(Unaudited)
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
79,561 |
|
|
$ |
126,310 |
|
Short-term marketable securities |
|
172,072 |
|
|
|
140,129 |
|
Accounts receivable |
|
1,363 |
|
|
|
12,037 |
|
Prepaid expenses and other current assets |
|
3,779 |
|
|
|
4,500 |
|
Total current assets |
|
256,775 |
|
|
|
282,976 |
|
Long-term marketable
securities |
|
— |
|
|
|
11,434 |
|
Property and equipment, net |
|
26,177 |
|
|
|
29,157 |
|
Operating lease right-of-use
assets |
|
21,609 |
|
|
|
— |
|
Goodwill |
|
8,277 |
|
|
|
8,334 |
|
Intangible assets, net |
|
24,684 |
|
|
|
25,135 |
|
Restricted cash |
|
468 |
|
|
|
468 |
|
Total assets |
$ |
337,990 |
|
|
$ |
357,504 |
|
Liabilities and
Stockholders’
Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,000 |
|
|
$ |
1,457 |
|
Accrued clinical trial and manufacturing expenses |
|
3,894 |
|
|
|
2,542 |
|
Accrued expenses and other liabilities |
|
7,881 |
|
|
|
10,518 |
|
Operating lease liabilities |
|
1,630 |
|
|
|
— |
|
Deferred revenue |
|
16,000 |
|
|
|
16,000 |
|
Total current liabilities |
|
30,405 |
|
|
|
30,517 |
|
Deferred rent |
|
— |
|
|
|
11,063 |
|
Contingent consideration |
|
1,015 |
|
|
|
998 |
|
Deferred revenue |
|
165,908 |
|
|
|
172,671 |
|
Deferred tax liabilities |
|
5,992 |
|
|
|
6,104 |
|
Operating lease liabilities |
|
32,599 |
|
|
|
— |
|
Other long-term liabilities |
|
1,021 |
|
|
|
840 |
|
Total liabilities |
|
236,940 |
|
|
|
222,193 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
8 |
|
|
|
8 |
|
Additional paid-in capital |
|
546,537 |
|
|
|
538,895 |
|
Accumulated other comprehensive income |
|
1,042 |
|
|
|
940 |
|
Accumulated deficit |
|
(446,537 |
) |
|
|
(404,532 |
) |
Total stockholders’ equity |
|
101,050 |
|
|
|
135,311 |
|
Total liabilities and
stockholders’ equity |
$ |
337,990 |
|
|
$ |
357,504 |
|
Contact: |
Media Contact: |
Noopur
Liffick |
Aljanae
Reynolds |
Investor Relations &
Corporate Affairs |
510-809-2452 |
510-809-2465 |
press@aduro.com |
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