BERKELEY, Calif., Feb. 27, 2019 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the
fourth quarter and full year ended December 31, 2018.
“2018 was an important year for Aduro as we prioritized our core technologies and determined a go-forward strategy that is
committed to maintaining a leadership role in the STING and APRIL pathways and advancing our clinical programs in areas of high
unmet medical need,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “With our strategic focus
established and $277.9 million in cash taking us into 2022, we are eager to execute on our clinical development plans for 2019 and
beyond.”
Key Accomplishments in Fiscal Year 2018
STING
- Presented first-in-human monotherapy clinical data for ADU-S100, a novel stimulator of interferon genes (STING) pathway
activator, and preliminary observations of ADU-S100 in combination with spartalizumab during the Society for Immunotherapy of
Cancer’s (SITC) 33rd Annual Meeting
- Entered into a research collaboration and exclusive license agreement with Eli Lilly and Company (Lilly) for the cGAS-STING
pathway inhibitor program for autoimmune and inflammatory diseases
- Presented preclinical data on the role of intratumoral STING activation by ADU-S100 in combination with checkpoint inhibitors
in anti-tumor immunity at the American Association for Cancer Research (AACR) Annual Meeting 2018 and the SITC 33rd Annual
Meeting
- Published a paper titled, “Magnitude of Therapeutic STING Activation Determines CD8+ T-Cell Mediated Anti-Tumor Immunity,” in
the peer-reviewed journal, Cell Reports
APRIL
- Presented preclinical data on BION-1301 for the treatment of IgA nephropathy at the American Society of Nephrology (ASN)
Kidney Week 2018
- Presented preclinical data on BION-1301 for the treatment of multiple myeloma at the AACR Annual Meeting 2018 and 60th
American Society of Hematology (ASH) Annual Meeting and Exposition
- Published a paper titled, “APRIL signaling via TACI mediates immunosuppression by T regulatory cells in multiple myeloma:
therapeutic implications,” in the peer-reviewed journal, Leukemia
Financial Results
- Cash Position – Cash, cash equivalents and marketable securities totaled $277.9 million at December 31,
2018, compared to $349.7 million at December 31, 2017. In the fourth quarter of 2018, Aduro collected an $18.1 million cash tax
refund from the Internal Revenue Service related to its carryback claim for 2017 losses.
- Revenue – Revenues were $2.8 million for the fourth quarter of 2018 and $15.1 million for the full year
2018, compared to $3.8 million and $17.2 million, respectively, for the same periods in 2017. The decrease in revenue in both
periods was primarily due to the adoption of the ASC 606 accounting standard on January 1, 2018, which resulted in a change in
revenue recognition methodology under our Novartis collaboration agreement.
- Expenses – Research and development expenses were $17.6 million for the fourth quarter of 2018 and $75.8
million for the full year 2018, compared to $22.9 million and $89.4 million, respectively, for the same periods in 2017. The
decrease in research and development expenses for both periods was primarily due to lower expenses for our antibody and LADD
programs.
- General and administrative expenses were $9.0 million for the fourth quarter of 2018 and $36.0 million for the full year
2018, compared to $8.8 million and $33.8 million, respectively, for the same periods in 2017. The increase in general and
administrative expenses for both periods was primarily due to higher professional services and consulting costs as well as
stock-based compensation expense.
- Loss on impairment of intangible assets was $4.0 million for the fourth quarter and full year 2018. This expense was recorded
due to the discontinuation of one of our acquired early research programs.
- Net Loss – Net loss for the fourth quarter and year ended December 31, 2018 was $26.3 million, or $0.33 per
share, and $95.4 million, or $1.21 per share, respectively. This compared to net loss of $26.1 million, or $0.34 per share, and
$91.9 million, or $1.26 per share, respectively, for the same periods in 2017. The increase in net loss for the year was
primarily due to the income tax benefit recorded in 2017.
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 fully blocking monoclonal antibody that blocks APRIL binding to both
the BCMA and TACI receptors, is being evaluated in multiple myeloma and as a potential treatment for 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 intentions or current expectations
concerning, among other things, our ability to execute on our strategy, our ability to maintain a leadership role in the STING and
APRIL pathways, the potential benefits from prioritizing our core technologies, our ability to fund our operations into 2022, the
potential for our technology, our ability to execute on our development plans, timing and the availability of results of our
clinical trials and those of our collaborators, and the potential for eventual regulatory approval of our product candidates. 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 annual report on Form 10-K for the year ended December 31, 2018, to be filed with the Securities
and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations,
financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the
forward-looking statements contained in this press release. 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. |
Condensed Consolidated Statements of Operations |
(In thousands, except share and per share amounts) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(audited) |
|
|
(audited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
2,758 |
|
|
$ |
3,756 |
|
|
$ |
15,087 |
|
|
$ |
17,109 |
|
Grant revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
130 |
|
Total revenue |
|
2,758 |
|
|
|
3,756 |
|
|
|
15,087 |
|
|
|
17,239 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
17,614 |
|
|
|
22,917 |
|
|
|
75,836 |
|
|
|
89,382 |
|
General and administrative |
|
9,014 |
|
|
|
8,769 |
|
|
|
36,035 |
|
|
|
33,751 |
|
Loss on impairment of intangible assets |
|
3,992 |
|
|
|
— |
|
|
|
3,992 |
|
|
|
— |
|
Amortization of intangible assets |
|
141 |
|
|
|
146 |
|
|
|
584 |
|
|
|
559 |
|
Total operating expenses |
|
30,761 |
|
|
|
31,832 |
|
|
|
116,447 |
|
|
|
123,692 |
|
Net loss from operations |
|
(28,003 |
) |
|
|
(28,076 |
) |
|
|
(101,360 |
) |
|
|
(106,453 |
) |
Interest income, net |
|
1,392 |
|
|
|
1,016 |
|
|
|
5,284 |
|
|
|
3,444 |
|
Other expense, net |
|
(49 |
) |
|
|
(21 |
) |
|
|
(64 |
) |
|
|
(218 |
) |
Loss before income tax |
|
(26,660 |
) |
|
|
(27,081 |
) |
|
|
(96,140 |
) |
|
|
(103,227 |
) |
Income tax benefit |
|
339 |
|
|
|
950 |
|
|
|
783 |
|
|
|
11,364 |
|
Net loss |
$ |
(26,321 |
) |
|
$ |
(26,131 |
) |
|
$ |
(95,357 |
) |
|
$ |
(91,863 |
) |
Net loss per common share, basic |
$ |
(0.33 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.26 |
) |
Net loss income per common share, diluted |
$ |
(0.33 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.26 |
) |
Shares used in computing net loss per common share, basic |
|
79,421,381 |
|
|
|
77,350,401 |
|
|
|
78,812,407 |
|
|
|
72,901,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ADURO BIOTECH, INC. |
Condensed Consolidated Balance Sheets |
(In thousands) |
(Audited) |
|
|
|
|
December 31, |
|
|
2018 |
|
|
2017 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
126,310 |
|
|
$ |
157,614 |
|
Short-term marketable securities |
|
140,129 |
|
|
|
168,489 |
|
Accounts receivable |
|
12,037 |
|
|
|
989 |
|
Income tax receivable |
|
— |
|
|
|
17,495 |
|
Prepaid expenses and other current assets |
|
4,500 |
|
|
|
5,544 |
|
Total current assets |
|
282,976 |
|
|
|
350,131 |
|
Long-term marketable securities |
|
11,434 |
|
|
|
23,614 |
|
Property and equipment, net |
|
29,157 |
|
|
|
31,085 |
|
Goodwill |
|
8,334 |
|
|
|
8,723 |
|
Intangible assets, net |
|
25,135 |
|
|
|
31,107 |
|
Restricted cash |
|
468 |
|
|
|
468 |
|
Total assets |
$ |
357,504 |
|
|
$ |
445,128 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,457 |
|
|
$ |
1,150 |
|
Accrued clinical trial and manufacturing expenses |
|
2,542 |
|
|
|
5,898 |
|
Accrued expenses and other liabilities |
|
10,518 |
|
|
|
12,601 |
|
Contingent consideration |
|
— |
|
|
|
6,829 |
|
Deferred revenue |
|
16,000 |
|
|
|
14,923 |
|
Total current liabilities |
|
30,517 |
|
|
|
41,401 |
|
Deferred rent |
|
11,063 |
|
|
|
9,991 |
|
Contingent consideration |
|
998 |
|
|
|
759 |
|
Deferred revenue |
|
172,671 |
|
|
|
148,148 |
|
Deferred tax liabilities |
|
6,104 |
|
|
|
6,538 |
|
Other long-term liabilities |
|
840 |
|
|
|
818 |
|
Total liabilities |
|
222,193 |
|
|
|
207,655 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
8 |
|
|
|
8 |
|
Additional paid-in capital |
|
538,895 |
|
|
|
519,435 |
|
Accumulated other comprehensive income |
|
940 |
|
|
|
1,893 |
|
Accumulated deficit |
|
(404,532 |
) |
|
|
(283,863 |
) |
Total stockholders’ equity |
|
135,311 |
|
|
|
237,473 |
|
Total liabilities and stockholders’ equity |
$ |
357,504 |
|
|
$ |
445,128 |
|
|
|
|
|
|
|
|
|
|
|
Investor Relations Contact: |
Media Contact: |
Noopur Liffick |
Aljanae Reynolds |
510-809-2465
|
510-809-2452
|
investors@aduro.com |
press@aduro.com |
|
|