adro-8k_20180301.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 1, 2018

 

Aduro Biotech, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-37345

 

 

94-3348934

(Commission

File No.)

 

 

(IRS Employer

Identification No.)

740 Heinz Avenue

Berkeley, California

(Address of principal executive offices)

94710

(Zip Code)

Registrant’s telephone number, including area code: (510) 848-4400

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 

 


 

Item 2.02.

Results of Operations and Financial Condition.

On March 1, 2018, Aduro Biotech, Inc. (“Aduro”) announced certain financial results for its fourth quarter and year ended December 31, 2017. A copy of Aduro’s press release, titled “Aduro Biotech Announces Fourth Quarter and Full Year 2017 Financial Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

 

 

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits.

 

Exhibit

 

Description

 

 

 

99.1

 

Press Release, dated March 1, 2018, titled “Aduro Biotech Announces Fourth Quarter and Full Year 2017 Financial Results

The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Aduro Biotech, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

 

 


 

EXHIBIT INDEX

 

Exhibit

 

Description

 

 

 

99.1

 

Press Release, dated March 1, 2018, titled “Aduro Biotech Announces Fourth Quarter and Full Year 2017 Financial Results”

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: March 1, 2018

 

 

 

Aduro Biotech, Inc.

 

 

 

 

 

 

 

By:

 

/s/ Jennifer Lew

 

 

 

 

Jennifer Lew

 

 

 

 

Chief Financial Officer

 

 

 

adro-ex991_6.htm

 

 

Exhibit 99.1

 

 

 

 

Contact:

 

Media Contact:

Jennifer Lew

 

Aljanae Reynolds

Chief Financial Officer

 

510-809-2452

510-809-4816

 

press@aduro.com


Aduro Biotech Announces Fourth Quarter and Full Year 2017 Financial Results

BERKELEY, Calif., March 1, 2018 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the year ended December 31, 2017. Net loss for the fourth quarter and year ended December 31, 2017 was $26.1 million, or $0.34 per share, and $91.9 million, or $1.26 per share, respectively. This compared to net loss of $29.6 million, or $0.44 per share, and $91.1 million, or $1.40 per share, respectively, for the same periods in 2016.

Cash, cash equivalents and marketable securities totaled $349.7 million at December 31, 2017, compared to $361.9 million at December 31, 2016.

“In 2017, we expanded clinical development activities of our STING agonist program with the initiation of a global combination trial of ADU-S100 with Novartis’ proprietary anti-PD-1 checkpoint inhibitor, PDR001. We also initiated clinical development of BION-1301, a novel anti-APRIL antibody, in multiple myeloma,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We believe we are well-positioned with the support of our collaboration partners and strong cash position to further advance our clinical programs, particularly in the activation of the STING pathway.”

2017

Development Achievements

 

Continued to advance ADU-S100 in a Phase 1 dose escalation in solid tumors and lymphomas

 

Initiated a global combination trial of ADU-S100 and Novartis’ anti-PD-1, PDR001, for the treatment of solid tumors and lymphomas

 

Presented preclinical data demonstrating anti-APRIL antibody blocking of TACI in addition to BCMA results in inhibition of regulatory T cells

 

Initiated Phase 1/2 clinical trial of novel anti-APRIL antibody, BION-1301, for the treatment of multiple myeloma

 

Initiated Phase 1 clinical trial of neoantigen-based personalized immunotherapy (pLADD)

Financial Performance

Revenues were $3.8 million for the fourth quarter of 2017 and $17.2 million for the full year 2017, compared to $3.9 million and $50.7 million, respectively, for the same periods in 2016. The decrease in revenue for the fourth quarter of 2017 was primarily due to a decrease in grant revenue. The decrease in revenue for the full year 2017 was primarily due to the recognition of a $35.0 million milestone payment in 2016 for the clinical advancement of ADU-S100 under our agreement with Novartis, partially offset by the recognition of a $2.0 million milestone payment in 2017 for progress in our anti-CD27 antibody program licensed to Merck.

Research and development expenses were $22.9 million for the fourth quarter of 2017 and $89.4 million for the full year 2017, compared to $20.9 million and $87.7 million, respectively, for the same periods in 2016. The increase in research and development expenses for the fourth quarter of 2017 was primarily due to higher contract manufacturing costs for our B-select antibodies and a related contingent payment obligation. The increase in research and development expenses for the full year 2017 was primarily due to higher personnel and allocated facility costs, as well as higher contract manufacturing costs associated with our B-select antibodies, partially offset by decreased manufacturing costs for a discontinued pancreatic cancer program.

General and administrative expenses were $8.8 million for the fourth quarter of 2017 and $33.8 million for the full year 2017, compared to $8.0 million and $34.3 million, respectively, for the same periods in 2016. The increase in general and administrative expenses for the fourth quarter of 2017 was primarily due to higher stock-based compensation expense and outside professional services. The decrease in general and administrative expenses for the full year 2017 was primarily due to a decrease in professional services and consulting fees.

Income tax benefit was $1.0 million for the fourth quarter of 2017 and $11.4 million for the full year 2017, compared to provision for income taxes of $5.1 million and $21.5 million, respectively, for the same periods in 2016. The income tax benefit recorded for the fourth quarter and full year 2017 was due to the current benefit of 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 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 development, including BION-1301, an anti-APRIL antibody. Aduro's pLADD program is based on proprietary attenuated strains of Listeria that have been engineered to express tumor neoantigens that are specific to an individual patient’s tumor. Other Listeria strains for lung and prostate cancers are being advanced by a partner. 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 annual report on Form 10-K for the year ended December 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)

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

(unaudited)

 

 

(unaudited)

 

 

(audited)

 

 

(audited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

$

3,756

 

 

$

3,878

 

 

$

17,109

 

 

$

50,593

 

Grant revenue

 

-

 

 

 

-

 

 

 

130

 

 

 

88

 

Total revenue

 

3,756

 

 

 

3,878

 

 

 

17,239

 

 

 

50,681

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

22,917

 

 

 

20,863

 

 

 

89,382

 

 

 

87,718

 

General and administrative

 

8,769

 

 

 

8,022

 

 

 

33,751

 

 

 

34,277

 

Amortization of intangible assets

 

146

 

 

 

134

 

 

 

559

 

 

 

549

 

Total operating expenses

 

31,832

 

 

 

29,019

 

 

 

123,692

 

 

 

122,544

 

Net loss from operations

 

(28,076

)

 

 

(25,141

)

 

 

(106,453

)

 

 

(71,863

)

Interest income, net

 

1,016

 

 

 

679

 

 

 

3,444

 

 

 

2,219

 

Other expense, net

 

(21

)

 

 

(8

)

 

 

(218

)

 

 

(40

)

Loss before income tax

 

(27,081

)

 

 

(24,470

)

 

 

(103,227

)

 

 

(69,684

)

Income tax benefit (provision)

 

950

 

 

 

(5,096

)

 

 

11,364

 

 

 

(21,464

)

Net loss

$

(26,131

)

 

$

(29,566

)

 

$

(91,863

)

 

$

(91,148

)

Net loss per common share, basic

$

(0.34

)

 

$

(0.44

)

 

$

(1.26

)

 

$

(1.40

)

Net loss income per common share, diluted

$

(0.34

)

 

$

(0.44

)

 

$

(1.26

)

 

$

(1.40

)

Shares used in computing net loss per common share, basic

 

77,350,401

 

 

 

67,368,385

 

 

 

72,901,215

 

 

 

65,200,762

 

Shares used in computing net loss per common share, diluted

 

77,350,401

 

 

 

67,368,385

 

 

 

72,901,215

 

 

 

65,200,762

 


 

ADURO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Audited)

 

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

157,614

 

 

$

74,932

 

Short-term marketable securities

 

 

168,489

 

 

 

272,500

 

Accounts receivable

 

 

989

 

 

 

1,138

 

Income tax receivable

 

 

17,495

 

 

 

 

Prepaid expenses and other current assets

 

 

5,544

 

 

 

6,194

 

Total current assets

 

 

350,131

 

 

 

354,764

 

Long-term marketable securities

 

 

23,614

 

 

 

14,474

 

Property and equipment, net

 

 

31,085

 

 

 

26,384

 

Goodwill

 

 

8,723

 

 

 

7,658

 

Intangible assets, net

 

 

31,107

 

 

 

27,827

 

Restricted cash

 

 

468

 

 

 

468

 

Deferred tax assets

 

 

 

 

 

6,319

 

Other assets

 

 

 

 

 

717

 

Total assets

 

$

445,128

 

 

$

438,611

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,150

 

 

$

2,206

 

Accrued clinical trial and manufacturing expenses

 

 

5,898

 

 

 

4,777

 

Accrued expenses and other liabilities

 

 

12,601

 

 

 

8,597

 

Contingent consideration

 

 

6,829

 

 

 

 

Deferred revenue

 

 

14,923

 

 

 

15,052

 

Total current liabilities

 

 

41,401

 

 

 

30,632

 

Deferred rent

 

 

9,991

 

 

 

6,786

 

Contingent consideration

 

 

759

 

 

 

4,032

 

Deferred revenue

 

 

148,148

 

 

 

162,963

 

Deferred tax liabilities

 

 

6,538

 

 

 

5,869

 

Other long-term liabilities

 

 

818

 

 

 

1,109

 

Total liabilities

 

 

207,655

 

 

 

211,391

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

8

 

 

 

7

 

Additional paid-in capital

 

 

519,435

 

 

 

420,897

 

Accumulated other comprehensive income (loss)

 

 

1,893

 

 

 

(1,684

)

Accumulated deficit

 

 

(283,863

)

 

 

(192,000

)

Total stockholders’ equity

 

 

237,473

 

 

 

227,220

 

Total liabilities and stockholders’ equity

 

$

445,128

 

 

$

438,611