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8-K - 8-K - CHINOOK THERAPEUTICS, INC.adro-8k_20170502.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 First Quarter 2017 Financial Results

Ten Product Candidates Advancing with $356 Million in Total Cash

BERKELEY, Calif., May 2, 2017 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the first quarter ended March 31, 2017. Net loss for the first quarter of 2017 was $21.8 million, or $0.32 per share, compared to a net loss of $28.8 million, or $0.45 per share for the same period in 2016.  

Cash, cash equivalents and marketable securities totaled $356.0 million at March 31, 2017, compared to $361.9 million at December 31, 2016.  

“This will be an important year for Aduro, as we generate data in our ongoing ADU-S100/STING monotherapy trial and our planned Phase 2 trial in mesothelioma, as well as look for data from Janssen’s Phase 1 trials in lung and prostate cancers evaluating LADD therapeutic candidates,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We also plan to advance our STING program into additional clinical studies in collaboration with Novartis, and the first antibody from our B-select platform, the novel anti-APRIL antibody, is expected to be cleared for clinical testing this year. With ten product candidates in our diversified portfolio and a healthy balance sheet, we are in a strong position to continue to advance our pipeline and build a leading immunotherapy company.”

Key Recent Accomplishments

 

Established a clinical collaboration with Merck to evaluate the combination of Aduro’s LADD agent CRS-207 with Merck’s KEYTRUDA® (pembrolizumab) in a Phase 2 study in gastric cancer

 

Entered into an exclusive license agreement with Stanford University for the use of neoantigen identification technology in therapeutics using modified Listeria for our personalized LADD program, pLADD

 

Expanded Aduro’s Scientific Advisory Board with leading immunotherapy and oncology experts

 

Presented at the American Association for Cancer Research Annual Meeting on BION-1301, anti-APRIL antibody, and ADU-S100 STING agonist

 

Presented at the Keystone Symposia on Cancer Immunology and Immunotherapy Conference on ADU-S100 and pLADD

Anticipated 2017 Milestones

 

Initiate Phase 2 mesothelioma trial with CRS-207 in combination with anti-PD1 in the first half of 2017 and report early results in the second half of 2017

 

Initiate Phase 2 gastric trial with CRS-207 in combination with anti-PD1 in the first half of 2017

 

Initiate Phase 1 pLADD (personalized LADD) trial in advanced gastro-intestinal cancers in the second half of 2017

 

Janssen expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer and determine next steps for ADU-741 in prostate cancer in the second half of 2017

 

Report top-line findings from Phase 1 monotherapy trial of ADU-S100 in the second half of 2017

 

In collaboration with Novartis, initiate Phase 1b trial of ADU-S100 in combination with anti-PD1 in the second half of 2017

 

File Investigational New Drug Application for BION-1301, anti-APRIL antibody, in the second half of 2017

 

Initiate Phase 1 multiple myeloma trial with anti-APRIL antibody in the second half of 2017

First Quarter 2017 Financial Results

Revenue for the first quarter of 2017 was $3.8 million, compared to $4.0 million for the same period in 2016. The revenue recognized in both quarters primarily relates to deferred upfront payments under the Novartis collaboration agreement.  In addition, revenue in the first quarter of 2016 included reimbursed research services of $0.2 million.

 

 


 

 

Research and development expenses were $20.6 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. Research and development expenses incurred in the first quarter of 2016 included GVAX Pancreas manufacturing and pancreatic cancer clinical trial expenses, which did not occur in 2017. The decrease in expenses was partially offset by increased costs to manufacture our B-select antibodies and increased research and development expenses for the STING platform, as well as higher personnel and facility related costs in first quarter of 2017.

General and administrative expenses were $8.3 million for the first quarter of 2017, compared to $9.0 million for the same period in 2016.  This decrease was primarily due to lower consulting and professional fees.

Income tax benefit was $2.8 million for the first quarter of 2017, compared to a provision for income taxes of $3.2 million for the same period in 2016. The income tax benefit recorded for the first quarter of 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, ovarian, lung and prostate cancers. Additionally, a personalized form of LADD, or pLADD, is being developed 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 a Phase 1 study in patients with cutaneously accessible metastatic solid tumors or lymphomas. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. 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, 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 quarterly report on Form 10-Q for the quarter ended March 31, 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 March 31,

 

 

 

2017

 

 

2016

 

Revenue:

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

3,772

 

 

$

3,983

 

Grant revenue

 

 

 

 

 

47

 

Total revenue

 

 

3,772

 

 

 

4,030

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

20,572

 

 

 

20,927

 

General and administrative

 

 

8,278

 

 

 

8,999

 

Amortization of intangible assets

 

 

132

 

 

 

137

 

Total operating expenses

 

 

28,982

 

 

 

30,063

 

Loss from operations

 

 

(25,210

)

 

 

(26,033

)

Interest income, net

 

 

650

 

 

 

454

 

Other loss, net

 

 

(4

)

 

 

(22

)

Loss before income tax

 

 

(24,564

)

 

 

(25,601

)

Income tax (benefit) provision

 

 

(2,752

)

 

 

3,226

 

Net loss

 

$

(21,812

)

 

$

(28,827

)

Net loss per common share, basic and diluted

 

$

(0.32

)

 

$

(0.45

)

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

 

 

68,242,360

 

 

 

63,802,391

 

 


 

ADURO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

 

 

 

March 31,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

107,068

 

 

$

74,932

 

Short-term marketable securities

 

 

246,893

 

 

 

272,500

 

Accounts receivable

 

 

1,048

 

 

 

1,138

 

Prepaid expenses and other current assets

 

 

5,911

 

 

 

6,194

 

Total current assets

 

 

360,920

 

 

 

354,764

 

Long-term marketable securities

 

 

1,992

 

 

 

14,474

 

Property and equipment, net

 

 

26,443

 

 

 

26,384

 

Goodwill

 

 

7,779

 

 

 

7,658

 

Intangible assets, net

 

 

28,135

 

 

 

27,827

 

Restricted cash

 

 

468

 

 

 

468

 

Deferred tax assets

 

 

6,319

 

 

 

6,319

 

Other assets

 

 

3,438

 

 

 

717

 

Total assets

 

$

435,494

 

 

$

438,611

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,564

 

 

$

2,206

 

Accrued clinical trial and manufacturing expenses

 

 

4,846

 

 

 

4,777

 

Accrued expenses and other liabilities

 

 

6,428

 

 

 

8,597

 

Deferred revenue

 

 

14,983

 

 

 

15,052

 

Total current liabilities

 

 

28,821

 

 

 

30,632

 

Deferred rent

 

 

7,262

 

 

 

6,786

 

Contingent consideration

 

 

4,095

 

 

 

4,032

 

Deferred revenue

 

 

159,259

 

 

 

162,963

 

Deferred tax liabilities

 

 

5,931

 

 

 

5,869

 

Other long term liabilities

 

 

1,109

 

 

 

1,109

 

Total liabilities

 

 

206,477

 

 

 

211,391

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

7

 

 

 

7

 

Additional paid-in capital

 

 

444,165

 

 

 

420,897

 

Accumulated other comprehensive loss

 

 

(1,343

)

 

 

(1,684

)

Accumulated deficit

 

 

(213,812

)

 

 

(192,000

)

Total stockholders’ equity

 

 

229,017

 

 

 

227,220

 

Total liabilities and stockholders’ equity

 

$

435,494

 

 

$

438,611