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): August 1, 2018
Aduro Biotech, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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001-37345 |
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94-3348934 |
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(Commission File No.) |
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(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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. ☑
On August 1, 2018, Aduro Biotech, Inc. (“Aduro”) announced certain financial results for the second quarter ended June 30, 2018. A copy of Aduro’s press release, titled “Aduro Biotech Reports Second Quarter 2018 Financial Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
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Item 9.01. |
Financial Statements and Exhibits. |
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(d) |
Exhibits. |
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Exhibit |
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Description |
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99.1 |
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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.
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.
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Dated: August 1, 2018 |
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Aduro Biotech, Inc. |
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By: |
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/s/ Jennifer Lew |
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Jennifer Lew |
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Chief Financial Officer |
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Exhibit 99.1 |
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Contact: |
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Media Contact: |
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Jennifer Lew |
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Aljanae Reynolds |
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Chief Financial Officer |
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510-809-2452 |
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510-809-4816 |
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press@aduro.com |
Aduro Biotech Reports Second Quarter 2018 Financial Results
BERKELEY, Calif., August 1, 2018 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the second quarter ended June 30, 2018. Net loss for the second quarter of 2018 was $24.4 million, or $0.31 per share, and for the six months ended June 30, 2018 net loss was $45.9 million, or $0.59 per share, compared to net loss of $19.4 million, or $0.27 per share, and net loss of $41.2 million, or $0.59 per share, respectively, for the same periods in 2017.
Recent Developments:
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Presented updated preclinical data for ADU-S100, a first-in-class small molecule therapeutic in Phase 1 studies targeting the STING pathway at the American Association for Cancer Research Annual Meeting (AACR) held on April 14-18, 2018 |
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Presented at AACR preclinical data for BION-1301, an anti-APRIL antibody currently in a Phase 1/2 study for the treatment of patients with multiple myeloma |
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Presented at AACR preclinical data for ADU-1604, an anti-CTLA-4 antibody scheduled to enter clinical development in the second half of 2018 |
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Presented preliminary observations from case study of a patient with metastatic colorectal cancer treated in ongoing proof-of-concept Phase 1 trial of personalized neoantigen-based immunotherapy (pLADD) program at the European Neoantigen Summit held on April 24-26, 2018 |
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Announced initiation of Phase 1b study of ADU- 214 in combination with nivolumab for the treatment of advanced lung cancer under strategic partnership with Janssen |
Cash, cash equivalents and marketable securities totaled $305.9 million at June 30, 2018, compared to $349.7 million at December 31, 2017.
Revenue was $2.6 million for the second quarter of 2018 and $9.3 million for the six months ended June 30, 2018, compared to $5.9 million and $9.7 million, respectively, for the same periods in 2017. The variation in collaboration and license revenue for the quarter was primarily due to the timing of milestone payments earned from Merck for advancement of its anti-CD27 antibody, which entered clinical development in early 2018. The decrease in revenue for the first half of 2018 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 for our Novartis collaboration revenue.
Research and development expenses were $19.4 million for the second quarter of 2018 and $39.5 million for the six months ended June 30, 2018, compared to $21.4 million and $42.0 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 programs, including contingent consideration and contract manufacturing related to ADU-1604 and BION-1301, respectively. In addition, clinical development expenses declined in 2018 following the wind down of CRS-207 development activities, partially offset by increased expenses for our ongoing clinical programs including ADU-S100, BION-1301, ADU-1604 and our personalized neoantigen-based immunotherapy.
General and administrative expenses were $8.8 million for the second quarter of 2018 and $17.9 million for the six months ended June 30, 2018, compared to $8.2 million and $16.5 million, respectively, for the same periods in 2017. The increase in general and administrative expenses for both periods was primarily due to outside professional services, legal fees associated with our patent portfolio and higher stock-based compensation expense.
About Aduro
Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that are intended to 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, including BION-1301, an anti-APRIL antibody, is comprised of a number of immune modulating assets in research and development. 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 and our ability to advance our drug development programs on our own or with our collaborators. 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 June 30, 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.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenue: |
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Collaboration and license revenue |
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$ |
2,639 |
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$ |
5,876 |
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$ |
9,266 |
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$ |
9,648 |
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Grant revenue |
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— |
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41 |
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— |
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41 |
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Total revenue |
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2,639 |
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5,917 |
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9,266 |
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9,689 |
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Operating expenses: |
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Research and development |
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19,420 |
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21,440 |
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39,547 |
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42,011 |
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General and administrative |
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8,827 |
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8,245 |
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17,872 |
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16,523 |
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Amortization of intangible assets |
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147 |
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136 |
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299 |
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268 |
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Total operating expenses |
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28,394 |
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29,821 |
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57,718 |
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58,802 |
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Loss from operations |
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(25,755 |
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(23,904 |
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(48,452 |
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(49,113 |
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Interest income |
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1,340 |
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780 |
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2,539 |
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1,430 |
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Other loss, net |
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(20 |
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(64 |
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(36 |
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(68 |
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Loss before income tax |
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(24,435 |
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(23,188 |
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(45,949 |
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(47,751 |
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Income tax benefit |
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38 |
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3,788 |
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59 |
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6,540 |
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Net loss |
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$ |
(24,397 |
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$ |
(19,400 |
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$ |
(45,890 |
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$ |
(41,211 |
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Net loss per common share, basic and diluted |
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$ |
(0.31 |
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$ |
(0.27 |
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$ |
(0.59 |
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$ |
(0.59 |
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Shares used in computing net loss per common share, basic and diluted |
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78,817,840 |
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71,101,336 |
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78,364,914 |
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69,679,746 |
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Condensed Consolidated Balance Sheets
(In thousands, except share amounts)
(Unaudited)
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June 30, |
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December 31, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
114,401 |
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$ |
157,614 |
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Short-term marketable securities |
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174,711 |
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168,489 |
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Accounts receivable |
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1,042 |
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989 |
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Income tax receivable |
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17,495 |
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17,495 |
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Prepaid expenses and other current assets |
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4,606 |
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5,544 |
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Total current assets |
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312,255 |
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350,131 |
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Long-term marketable securities |
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16,783 |
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23,614 |
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Property and equipment, net |
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30,331 |
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31,085 |
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Goodwill |
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8,506 |
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8,723 |
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Intangible assets, net |
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30,044 |
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31,107 |
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Restricted cash |
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468 |
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468 |
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Total assets |
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$ |
398,387 |
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$ |
445,128 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
992 |
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$ |
1,150 |
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Accrued clinical trial and manufacturing expenses |
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4,110 |
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5,898 |
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Accrued expenses and other liabilities |
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8,801 |
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12,601 |
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Contingent consideration |
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6,799 |
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6,829 |
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Deferred revenue |
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17,613 |
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14,923 |
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Total current liabilities |
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38,315 |
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41,401 |
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Deferred rent |
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10,955 |
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9,991 |
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Contingent consideration |
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947 |
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759 |
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Deferred revenue |
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164,586 |
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148,148 |
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Deferred tax liabilities |
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6,319 |
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6,538 |
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Other long-term liabilities |
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831 |
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818 |
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Total liabilities |
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221,953 |
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207,655 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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8 |
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8 |
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Additional paid-in capital |
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530,312 |
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519,435 |
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Accumulated other comprehensive income |
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1,179 |
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1,893 |
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Accumulated deficit |
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(355,065 |
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(283,863 |
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Total stockholders’ equity |
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176,434 |
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237,473 |
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Total liabilities and stockholders’ equity |
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$ |
398,387 |
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$ |
445,128 |
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