EX-99.1 2 adro-ex991_7.htm EX-99.1 adro-ex991_7.htm

 

 

Exhibit 99.1

 

 

 

 

Investor Relations Contact:

 

Media Contact:

Noopur Liffick

 

Aljanae Reynolds

510-809-2465

investors@aduro.com

 

510-809-2452

press@aduro.com

 

 

 

 

 

 

 

Aduro Biotech Reports Fourth Quarter and Full Year 2018 Financial Results

 

BERKELEY, Calif., February 27, 2019 – 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