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8-K - 8-K - CHINOOK THERAPEUTICS, INC.adro-8k_20171031.htm

 

 

Exhibit 99.1

 

Contact:

 

Media Contact:

Sylvia Wheeler

 

Susan Lehner

Sr. VP, Corporate Affairs & Investor Relations

 

510 809 2137

510 809 9264

 

press@aduro.com

 

Aduro Biotech Reports Third Quarter 2017 Financial Results

BERKELEY, Calif., October 31, 2017 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the third quarter of 2017. Net loss for the third quarter of 2017 was $24.5 million, or $0.33 per share, and for the nine months ended September 30, 2017 net loss was $65.7 million, or $0.92 per share, compared to net loss of $35.1 million, or $0.54 per share, and net loss of $61.6 million, or $0.96 per share, respectively, for the same periods in 2016.

Cash, cash equivalents and marketable securities totaled $373.5 million at September 30, 2017, compared to $361.9 million at December 31, 2016.  

“This has been a solid year of progress in advancing our oncology pipeline, with the initiation of multiple new clinical trials across a number of indications,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “These activities position us well for upcoming data readouts that will inform our strategy as we seek to aggressively advance programs with the most potential to make a difference for patients.”

Key Recent Accomplishments

 

Initiated Phase 1b trial of ADU-S100 in combination with anti-PD-1 in collaboration with Novartis

 

Initiated Phase 1 study of personalized LADD (pLADD) using patient-specific neoantigens in adults with metastatic colorectal cancer that is microsatellite stable

 

Received FDA clearance of an Investigational New Drug Application for the Phase 1 study of BION-1301, an anti-APRIL antibody

 

Bolstered intellectual property position in STING field with two new patent issuances

Remaining Anticipated 2017 Milestones

 

Report early observations from the ongoing Phase 2 mesothelioma study evaluating CRS-207 in combination with pembrolizumab

 

Provide an update on the safety and tolerability of ADU-S100 in the ongoing dose-escalation Phase 1 monotherapy trial

 

Initiate Phase 1 multiple myeloma trial with BION-1301, an anti-APRIL antibody

 

Janssen expected to advance the ADU-214 program into a Phase 1b/2 trial in lung cancer

Third Quarter 2017 Financial Results

Revenue was $3.8 million for the third quarter of 2017 and $13.5 million for the nine months ended September 30, 2017, compared to $3.8 million and $46.8 million, respectively, for the same periods in 2016. There was no change in revenue for the third quarter of 2017 compared to the third quarter of 2016.  The decrease in revenue for the nine months ended September 30, 2017 was primarily due to the recognition of a $35.0 million milestone payment in the second quarter of 2016 in connection with the clinical advancement of ADU-S100 under our agreement with Novartis.

Research and development expenses were $24.5 million for the third quarter of 2017 and $66.5 million for the nine months ended September 30, 2017, compared to $19.0 million and $66.9 million, respectively, for the same periods in 2016. The increase in research and development expenses for the third quarter of 2017 was primarily related to increased costs to manufacture our B-select antibodies, as well as higher facility related costs.  The decrease in research and development costs for the nine months ended September 30, 2017 was primarily due to reduced GVAX Pancreas manufacturing and pancreatic cancer clinical trial expenses, partially offset by increased costs to manufacture our B-select antibodies as well as higher personnel and facility related costs in 2017.

 


 

General and administrative expenses were $8.5 million for the third quarter of 2017 and $25.0 million for the nine months ended September 30, 2017, compared to $8.6 million and $26.3 million, respectively, for the same periods in 2016. The decrease in general and administrative expenses in both periods was primarily related to lower professional services and consulting expenses in 2017.

Income tax benefit was $3.9 million for the third quarter of 2017 and $10.4 million for the nine months ended September 30, 2017, compared to a provision for income taxes of $11.7 million and $16.4 million, respectively, for the same periods in 2016. The income tax benefit recorded in 2017 was due to the current benefit of federal income taxes paid in 2016.

About Aduro

Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro's technology platforms, which are designed to harness the body's natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro's LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. This platform is being developed as a treatment for multiple indications, including mesothelioma, gastric, ovarian, lung and prostate cancers. Additionally, a personalized form of LADD, or pLADD, is in Phase 1 development utilizing tumor neoantigens that are specific to an individual patient’s tumor. Aduro's STING Pathway Activator platform is designed to activate the STING receptor in immune cells, resulting in a potent tumor-specific immune response. ADU-S100 is the first STING Pathway Activator compound to enter the clinic and is currently being evaluated in both a Phase 1 monotherapy study as well as a Phase 1b combination study with an anti-PD1 immune checkpoint inhibitor. Aduro’s B-select monoclonal antibody platform is comprised of a number of immune modulating assets in research and preclinical development, including BION-1301, an anti-APRIL antibody. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. 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, the potential for our technology, our ability to advance our drug development programs, plans, timing and the availability of observations, updates and results for our clinical trials and those of our collaborators, the timing and receipt of milestone payments, 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 quarterly report on Form 10-Q for the quarter ended September 30, 2017, 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)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

3,704

 

 

$

3,794

 

 

$

13,352

 

 

$

46,715

 

Grant revenue

 

 

90

 

 

 

 

 

 

131

 

 

 

88

 

Total revenue

 

 

3,794

 

 

 

3,794

 

 

 

13,483

 

 

 

46,803

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

24,454

 

 

 

19,046

 

 

 

66,464

 

 

 

66,855

 

General and administrative

 

 

8,458

 

 

 

8,556

 

 

 

24,982

 

 

 

26,255

 

Amortization of intangible assets

 

 

145

 

 

 

138

 

 

 

413

 

 

 

415

 

Total operating expenses

 

 

33,057

 

 

 

27,740

 

 

 

91,859

 

 

 

93,525

 

Loss from operations

 

 

(29,263

)

 

 

(23,946

)

 

 

(78,376

)

 

 

(46,722

)

Interest income

 

 

998

 

 

 

566

 

 

 

2,428

 

 

 

1,540

 

Other loss, net

 

 

(129

)

 

 

(1

)

 

 

(197

)

 

 

(32

)

Loss before income tax

 

 

(28,394

)

 

 

(23,381

)

 

 

(76,145

)

 

 

(45,214

)

Income tax (benefit) provision

 

 

(3,874

)

 

 

11,670

 

 

 

(10,414

)

 

 

16,368

 

Net loss

 

$

(24,520

)

 

$

(35,051

)

 

$

(65,731

)

 

$

(61,582

)

Net loss per common share, basic and diluted

 

$

(0.33

)

 

$

(0.54

)

 

$

(0.92

)

 

$

(0.96

)

Shares used in computing net loss per common share, basic and

   diluted

 

 

75,167,334

 

 

 

65,134,102

 

 

 

71,529,043

 

 

 

64,472,947

 

 


 

ADURO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

159,040

 

 

$

74,932

 

Short-term marketable securities

 

 

186,467

 

 

 

272,500

 

Accounts receivable

 

 

1,348

 

 

 

1,138

 

Income tax receivable

 

 

12,509

 

 

 

 

Prepaid expenses and other current assets

 

 

4,597

 

 

 

6,194

 

Total current assets

 

 

363,961

 

 

 

354,764

 

Long-term marketable securities

 

 

27,999

 

 

 

14,474

 

Property and equipment, net

 

 

28,280

 

 

 

26,384

 

Goodwill

 

 

8,602

 

 

 

7,658

 

Intangible assets, net

 

 

30,822

 

 

 

27,827

 

Restricted cash

 

 

468

 

 

 

468

 

Deferred tax assets

 

 

4,283

 

 

 

6,319

 

Other assets

 

 

716

 

 

 

717

 

Total assets

 

$

465,131

 

 

$

438,611

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,479

 

 

$

2,206

 

Accrued clinical trial and manufacturing expenses

 

 

6,616

 

 

 

4,777

 

Accrued expenses and other liabilities

 

 

11,249

 

 

 

8,597

 

Deferred revenue

 

 

14,945

 

 

 

15,052

 

Total current liabilities

 

 

34,289

 

 

 

30,632

 

Deferred rent

 

 

8,471

 

 

 

6,786

 

Contingent consideration

 

 

6,250

 

 

 

4,032

 

Deferred revenue

 

 

151,852

 

 

 

162,963

 

Deferred tax liabilities

 

 

6,481

 

 

 

5,869

 

Other long-term liabilities

 

 

1,374

 

 

 

1,109

 

Total liabilities

 

 

208,717

 

 

 

211,391

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

8

 

 

 

7

 

Additional paid-in capital

 

 

512,436

 

 

 

420,897

 

Accumulated other comprehensive income (loss)

 

 

1,701

 

 

 

(1,684

)

Accumulated deficit

 

 

(257,731

)

 

 

(192,000

)

Total stockholders’ equity

 

 

256,414

 

 

 

227,220

 

Total liabilities and stockholders’ equity

 

$

465,131

 

 

$

438,611