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8-K - 8-K - CHINOOK THERAPEUTICS, INC.adro-8k_20170301.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 Announces Fourth Quarter and Full Year 2016 Financial Results

-Progress in 2016 Has Positioned the Company to Have Six Agents in the Clinic for Eight Different Cancer Types-

BERKELEY, Calif., March 1, 2017 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the year ended December 31, 2016. Net loss for the fourth quarter and year ended December 31, 2016 was $29.6 million, or $0.44 per share, and $91.1 million, or $1.40 per share, respectively. This compared to net income of $3.1 million, or $0.05 per share, and net loss of $39.2 million, or $0.88 per share, respectively, for the same periods in 2015.

Cash, cash equivalents and marketable securities totaled $361.9 million at December 31, 2016, compared to $431.0 million at December 31, 2015.

“In 2016, we made a number of advancements to position us as a leader in the discovery and development of immunotherapies, and in 2017, we expect to have multiple agents across all three of our platforms advancing through the clinic,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “With a diversified and robust pipeline, strong cash position and validating pharmaceutical partnerships for each of our technologies, we believe we are poised to bring innovative therapies to patients.”

Key 2016 Accomplishments

Development achievements

 

Unprecedented disease control rate in Phase 1b mesothelioma trial presented at the American Society of Clinical Oncology (ASCO) annual meeting

 

First patient dosed in a Phase 1 study of ADU-S100, the first STING Pathway Activator compound to enter the clinic, for treatment of cutaneously accessible tumors and receipt of $35 million development milestone from Novartis

 

Preclinical data demonstrated acute and systemic immune activation with ADU-S100

 

Anti-CD27 agonist advancing through preclinical development towards the clinic under licensing agreement with Merck

 

Preclinical data presented supporting clinical development of anti-APRIL antibody in multiple myeloma

 

Personalized LADD therapy (pLADD) featured in an oral presentation at the Society for Immunotherapy of Cancer (STIC) meeting  

 

Investigational New Drug application cleared for pLADD clinical development

 

Preclinical data demonstrated synergy of Aduro’s immunotherapies with checkpoint inhibitors

Corporate achievements and notable news

 

Steve Isaacs named 2016 Visionary Leader by Berkeley Chamber of Commerce

 

Oncology expert and industry veteran Natalie Sacks, M.D. joined as chief medical officer

 

Hans van Eenennaam, Ph.D., and John Dulos, Ph.D., honored with award for contributions in discovery of KEYTRUDA®

 

Launched industry-leading Immunotherapeutics and Vaccine Research Initiative with U.C. Berkeley

 

Expanded patent portfolio with key composition and methods patents

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 trial in advanced gastro-intestinal cancers in the second half of 2017

 

Janssen to assess data from Phase 1 trial of ADU-741 in prostate cancer

 

Janssen expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer in the second half of 2017

 

Report top-line findings from Phase 1 monotherapy trial of ADU-S100 (STING) 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

 


Financial Performance

Revenues were $3.9 million for the fourth quarter of 2016 and $50.7 million for the full year 2016, compared to $34.4 million and $73.0 million, respectively, for the same periods in 2015. The decrease in revenue for the fourth quarter of 2016 was primarily due to recognition of milestones and a portion of upfront fees under Aduro’s research and license agreements with Janssen in 2015. The decrease in revenue for the full year 2016 was also due to recognition of milestones and a portion of upfront fees under the Janssen agreements in 2015 partially offset by a $35.0 million payment recognized in 2016 upon achievement of a milestone under Aduro’s collaboration and license agreement with Novartis.

Research and development expenses were $20.9 million for the fourth quarter of 2016 and $87.7 million for the full year 2016, compared to $22.7 million and $58.6 million, respectively, for the same periods in 2015. The decrease in research and development expenses for the fourth quarter of 2016 was primarily due to higher licensing fees paid in 2015. The increase in research and development expenses for the full year 2016 was primarily due to contract manufacturing and research expenses associated with our ongoing studies and increased personnel and facility-related costs.

General and administrative expenses were $8.0 million for the fourth quarter of 2016 and $34.3 million for the full year 2016, compared to $8.8 million and $27.8 million, respectively, for the same periods in 2015. The decrease in general and administrative expenses for the fourth quarter of 2016 was primarily due to lower professional fees in 2016. The increase in general and administrative expenses for the full year 2016 was primarily due to higher personnel and facility related costs. There was no loss from remeasurement of fair value of warrants during the fourth quarter or full year 2016. There was a $26.1 million loss from remeasurement of fair value of warrants in the full year 2015 that occurred in April 2015 when certain outstanding warrants were no longer subject to future remeasurement.

Provision for income taxes was $5.1 million for the fourth quarter of 2016 and $21.5 million for the full year 2016. There was no provision for income taxes for the comparable periods in 2015. The income tax expense recorded for the fourth quarter and full year 2016 was primarily related to current and deferred federal income taxes.

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 inability 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, 2016, 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,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

(unaudited)

 

 

(unaudited)

 

 

(audited)

 

 

(audited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

$

3,878

 

 

$

34,108

 

 

$

50,593

 

 

$

71,689

 

Grant revenue

 

-

 

 

 

268

 

 

 

88

 

 

 

1,290

 

Total revenue

 

3,878

 

 

 

34,376

 

 

 

50,681

 

 

 

72,979

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

20,863

 

 

 

22,657

 

 

 

87,718

 

 

 

58,649

 

General and administrative

 

8,022

 

 

 

8,805

 

 

 

34,277

 

 

 

27,805

 

Amortization of intangible assets

 

134

 

 

 

89

 

 

 

549

 

 

 

89

 

Total operating expenses

 

29,019

 

 

 

31,551

 

 

 

122,544

 

 

 

86,543

 

Net (loss) income from operations

 

(25,141

)

 

 

2,825

 

 

 

(71,863

)

 

 

(13,564

)

Loss from remeasurement of fair value of warrants

 

 

 

 

 

 

 

 

 

 

(26,077

)

Interest income

 

679

 

 

 

338

 

 

 

2,219

 

 

 

494

 

Other (expense) income, net

 

(8

)

 

 

(162

)

 

 

(40

)

 

 

(161

)

Net (loss) income before income tax

 

(24,470

)

 

 

3,001

 

 

 

(69,684

)

 

 

(39,308

)

Income tax (provision) benefit

 

(5,096

)

 

 

99

 

 

 

(21,464

)

 

 

99

 

Net (loss) income

$

(29,566

)

 

$

3,100

 

 

$

(91,148

)

 

$

(39,209

)

Net (loss) income per common share, basic

$

(0.44

)

 

$

0.05

 

 

$

(1.40

)

 

$

(0.88

)

Net (loss) income per common share, diluted

$

(0.44

)

 

$

0.04

 

 

$

(1.40

)

 

$

(0.88

)

Shares used in computing net loss per common share, basic

 

67,368,385

 

 

 

62,604,226

 

 

 

65,200,762

 

 

 

44,706,393

 

Shares used in computing net loss per common share, diluted

 

67,368,385

 

 

 

71,647,930

 

 

 

65,200,762

 

 

 

44,706,393

 


 

ADURO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Audited)

 

 

 

December 31,

 

 

 

2016

 

 

2015

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

74,932

 

 

$

150,456

 

Short-term marketable securities

 

 

272,500

 

 

 

265,198

 

Accounts receivable

 

 

1,138

 

 

 

4,846

 

Prepaid expenses and other current assets

 

 

6,194

 

 

 

4,004

 

Total current assets

 

 

354,764

 

 

 

424,504

 

Long-term marketable securities

 

 

14,474

 

 

 

15,391

 

Property and equipment, net

 

 

26,384

 

 

 

3,986

 

Goodwill

 

 

7,658

 

 

 

8,469

 

Intangible assets, net

 

 

27,827

 

 

 

29,400

 

Restricted cash

 

 

468

 

 

 

 

Deferred tax assets

 

 

6,319

 

 

 

 

Other assets

 

 

717

 

 

 

75

 

Total assets

 

$

438,611

 

 

$

481,825

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,206

 

 

$

5,086

 

Accrued clinical trial and manufacturing expenses

 

 

4,777

 

 

 

5,522

 

Accrued expenses and other liabilities

 

 

8,597

 

 

 

5,412

 

Deferred revenue

 

 

15,052

 

 

 

15,046

 

Total current liabilities

 

 

30,632

 

 

 

31,066

 

Deferred rent

 

 

6,786

 

 

 

 

Contingent consideration

 

 

4,032

 

 

 

3,750

 

Deferred revenue

 

 

162,963

 

 

 

178,037

 

Deferred tax liabilities

 

 

5,869

 

 

 

7,350

 

Other long term liabilities

 

 

1,109

 

 

 

 

Total liabilities

 

 

211,391

 

 

 

220,203

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

7

 

 

 

6

 

Additional paid-in capital

 

 

420,897

 

 

 

362,807

 

Accumulated other comprehensive loss

 

 

(1,684

)

 

 

(339

)

Accumulated deficit

 

 

(192,000

)

 

 

(100,852

)

Total stockholders’ equity

 

 

227,220

 

 

 

261,622

 

Total liabilities and stockholders’ equity

 

$

438,611

 

 

$

481,825