UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 November 8, 2023, Gritstone bio, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2023 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 thereunto duly authorized.
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Gritstone bio, Inc. |
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Date: |
November 8, 2023 |
By: |
/s/ Andrew Allen |
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Andrew Allen |
Exhibit 99.1
Gritstone bio Reports Third Quarter 2023 Financial Results and Provides Corporate Updates
-- BARDA contract and IDWeek presentations position Gritstone’s self-amplifying mRNA (samRNA) as a leading next-generation approach to COVID-19 prevention; preparations underway for Phase 2b head-to-head study evaluating samRNA candidate versus an approved COVID-19 vaccine --
-- Preliminary data from Phase 2 portion of Phase 2/3 study evaluating Gritstone’s personalized cancer vaccine (PCV), GRANITE, in first-line metastatic, microsatellite stable colorectal cancer (MSS-CRC) remain expected in 1Q 2024 --
-- Investigational new drug application (IND) cleared for National Cancer Institute (NCI)-run Phase 1 study evaluating an autologous T cell therapy in combination with Gritstone’s “off-the-shelf" cancer vaccine, SLATE-KRAS --
-- Cash, cash equivalents, marketable securities and restricted cash of $90.5 million as of September 30, 2023 --
EMERYVILLE, CALIF. – November 8, 2023 (GLOBE NEWSWIRE) – Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the third quarter ended September 30, 2023 and provided recent corporate and clinical updates.
“As cancer and infectious diseases continue to challenge human health across the globe, we at Gritstone continue advancing our vision to deliver more potent and durable vaccines,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. “The ongoing advancement of our CORAL program positions our infectious disease approach, which combines self-amplifying mRNA (samRNA) with novel B and T cell targets, as a leading potential next-generation vaccine platform for COVID-19 and beyond. We believe the data recently shared at IDWeek underscore the promise of this novel approach to drive broad and long-lasting clinical protection against COVID-19 with vaccine-elicited neutralizing antibodies against the virus persisting at high concentrations for at least 12 months, unlike current approved vaccines. In oncology, preliminary findings from the randomized Phase 2/3 study of our personalized cancer vaccine, GRANITE, in MSS-CRC are rapidly approaching. This is important data not only for Gritstone but for the field, as GRANITE represents an opportunity to bring a new class of therapy to patients with ‘cold’ solid tumors, for whom the benefits of today’s immunotherapies are minimal. The scientific bedrock of GRANITE extends to SLATE, where our collaboration with Steven A. Rosenberg and the NCI is now advancing. With GRANITE and CORAL now in or entering randomized Phase 2 studies, Gritstone stands at the precipice of unlocking the full potential of our novel vaccine platforms in both oncology and infectious diseases.”
Corporate Update
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)
GRANITE – Personalized neoantigen vaccine program
SLATE – “Off-the-shelf” neoantigen vaccine program
Infectious Disease Programs
CORAL – Next-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s samRNA platform and novel approach in infectious diseases
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment
Third Quarter 2023 Financial Results
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(a)This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00062.
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About Gritstone bio
Gritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. www.gritstonebio.com
Gritstone Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to our clinical and regulatory development plans for our product candidates; our expectations regarding the data to be derived in our ongoing and planned clinical trials; the timing of commencement of our future nonclinical studies, clinical trials and research and development programs; our ability to discover, develop and advance product candidates into, and successfully complete, clinical trials; and our plans and strategy regarding maintaining existing and entering into new collaborations and/or partnerships. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstone’s programs’ clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstone’s ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstone’s most recent Annual Report on Form 10-K filed on March 9, 2023 and any subsequent current and periodic reports filed with the Securities and Exchange Commission.
Gritstone Contacts
Investors:
George E. MacDougall
Gritstone bio, Inc.
ir@gritstone.com
Media:
Dan Budwick
1AB
(973) 271-6085
dan@1abmedia.com
Gritstone bio, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands)
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September 30, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
29,539 |
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$ |
55,498 |
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Marketable securities |
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54,409 |
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116,389 |
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Restricted cash |
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1,242 |
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3,977 |
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Prepaid expenses and other current assets |
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5,630 |
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7,014 |
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Total current assets |
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90,820 |
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182,878 |
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Long-term restricted cash |
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5,290 |
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5,290 |
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Property and equipment, net |
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18,952 |
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21,335 |
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Lease right-of-use assets |
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70,909 |
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17,481 |
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Deposits and other long-term assets |
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1,246 |
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9,739 |
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Long-term marketable securities |
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— |
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4,031 |
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Total assets |
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$ |
187,217 |
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$ |
240,754 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
4,265 |
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$ |
8,694 |
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Accrued compensation |
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7,772 |
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8,215 |
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Accrued liabilities |
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1,660 |
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4,124 |
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Accrued research and development expenses |
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2,382 |
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3,343 |
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Lease liabilities, current portion |
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6,003 |
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5,294 |
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Deferred revenue, current portion |
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1,301 |
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5,131 |
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Total current liabilities |
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23,383 |
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34,801 |
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Other liabilities, noncurrent |
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554 |
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150 |
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Lease liabilities, net of current portion |
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59,430 |
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15,673 |
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Debt, noncurrent |
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29,868 |
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19,349 |
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Total liabilities |
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113,235 |
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69,973 |
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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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22 |
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22 |
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Additional paid-in capital |
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702,755 |
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691,910 |
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Accumulated other comprehensive loss |
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(52 |
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(80 |
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Accumulated deficit |
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(628,743 |
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(521,071 |
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Total stockholders’ equity |
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73,982 |
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170,781 |
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Total liabilities and stockholders’ equity |
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$ |
187,217 |
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$ |
240,754 |
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Gritstone bio, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenues: |
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Collaboration and license revenues |
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$ |
361 |
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$ |
436 |
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$ |
1,302 |
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$ |
7,942 |
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Grant revenues |
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1,204 |
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2,585 |
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4,659 |
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7,741 |
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Total revenues |
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1,565 |
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3,021 |
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5,961 |
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15,683 |
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Operating expenses: |
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Research and development |
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32,763 |
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26,436 |
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94,244 |
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81,983 |
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General and administrative |
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7,406 |
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6,462 |
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20,867 |
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22,209 |
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Total operating expenses |
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40,169 |
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32,898 |
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115,111 |
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104,192 |
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Loss from operations |
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(38,604 |
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(29,877 |
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(109,150 |
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(88,509 |
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Interest income |
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1,167 |
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462 |
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4,324 |
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663 |
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Interest expense |
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(991 |
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(551 |
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(2,818 |
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(551 |
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Other expense |
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(6 |
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— |
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(28 |
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— |
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Net loss |
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(38,434 |
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(29,966 |
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(107,672 |
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(88,397 |
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Other comprehensive loss: |
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Unrealized gain (loss) on marketable securities |
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73 |
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129 |
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28 |
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(208 |
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Comprehensive loss |
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$ |
(38,361 |
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$ |
(29,837 |
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$ |
(107,644 |
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$ |
(88,605 |
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Net loss per share, basic and diluted |
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$ |
(0.33 |
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$ |
(0.35 |
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$ |
(0.94 |
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$ |
(1.02 |
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Weighted-average number of shares used in |
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115,342,613 |
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86,597,405 |
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114,898,379 |
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86,441,212 |
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