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 August 9, 2023, Gritstone bio, Inc. issued a press release announcing its financial results for the second quarter ended June 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: |
August 9, 2023 |
By: |
/s/ Andrew Allen |
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Andrew Allen |
Exhibit 99.1
Gritstone bio Reports Second Quarter 2023 Financial Results and Provides Corporate Updates
-- Enrollment completed in Phase 2 portion of Phase 2/3 study evaluating GRANITE (personalized cancer vaccine [PCV]) in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC); preliminary efficacy data expected in 1Q 2024 --
-- Gritstone partnering with Friends of Cancer Research (Friends) on Friends’ ctDNA for Monitoring Treatment Response (ctMoniTR) Project, a collaborative research initiative to inform use of ctDNA change as surrogate for survival benefit --
-- Publication in Nature Communications of interim CORAL-BOOST results highlights the potential of Gritstone’s self-amplifying mRNA (samRNA) candidates to serve as next-generation vaccine against SARS-CoV-2 --
-- Cash, cash equivalents, marketable securities, and restricted cash of $122.3 million as of June 30, 2023 --
EMERYVILLE, CALIF. – August 9, 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 second quarter ended June 30, 2023 and provided recent corporate and clinical updates.
“We are pleased with the pace at which our randomized GRANITE Phase 2/3 trial is advancing. Completing enrollment for the Phase 2 portion underscores the enthusiasm for this trial, related to the high unmet need for better treatments in common, immunologically cold tumors, such as CRC,” said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. “Our partnership with Friends of Cancer Research on ctMoniTR, a project to collate data across the industry to validate the use of circulating tumor DNA (ctDNA) as an early predictor of treatment outcomes, will help further define the emerging potential of ctDNA as a superior method over radiology-based approaches to evaluate early treatment effects of immunotherapy. Molecular response, or reduction in ctDNA, is the primary efficacy endpoint for the Phase 2 portion of the GRANITE trial. GRANITE has the potential to be the first neoantigen-based PCV to demonstrate efficacy in a randomized study against a cold tumor, which would be a transformational advance for the field. We look forward to sharing preliminary Phase 2 efficacy data in frontline MSS-CRC in the first quarter of 2024.”
Dr. Allen continued, “Additionally, the promising data we continue to see from our CORAL (SARS-CoV-2 vaccine) program highlights the differentiation and potential advantages of self-amplifying mRNA (samRNA) over current vaccines against infectious diseases. Our recent publication in Nature Communications demonstrates the scientific rigor of our work to date and the ability of our samRNA platform to drive potent and durable immune responses. We believe our samRNA vaccine candidates have demonstrated strong potential to serve as next-generation vaccine solutions to COVID-19 and other infectious diseases.”
Corporate Update
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs
GRANITE - Individualized neoantigen vaccine against cold tumors
SLATE - “Off-the-shelf” neoantigen vaccine program
Infectious Disease Programs
CORAL – Second-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s infectious disease approach and the potential application of samRNA in infectious diseases.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment.
Second Quarter 2023 Financial Results
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 and have programs in viral diseases and solid tumors. Independently and with our partners, we are advancing a portfolio of product candidates with the aim 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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June 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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$ |
41,414 |
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$ |
55,498 |
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Marketable securities |
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73,119 |
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116,389 |
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Restricted cash |
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2,437 |
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3,977 |
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Prepaid expenses and other current assets |
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5,406 |
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7,014 |
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Total current assets |
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122,376 |
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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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20,443 |
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21,335 |
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Lease right-of-use assets |
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71,985 |
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17,481 |
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Deposits and other long-term assets |
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2,529 |
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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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$ |
222,623 |
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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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$ |
4,925 |
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$ |
8,694 |
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Accrued compensation |
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6,036 |
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8,215 |
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Accrued liabilities |
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1,452 |
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4,124 |
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Accrued research and development expenses |
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2,042 |
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3,343 |
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Lease liabilities, current portion |
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4,838 |
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5,294 |
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Deferred revenue, current portion |
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2,818 |
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5,131 |
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Total current liabilities |
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22,111 |
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34,801 |
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Other liabilities, noncurrent |
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398 |
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150 |
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Lease liabilities, net of current portion |
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60,824 |
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15,673 |
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Debt, noncurrent |
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29,723 |
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19,349 |
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Total liabilities |
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113,056 |
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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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699,979 |
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691,910 |
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Accumulated other comprehensive loss |
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(125 |
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(80 |
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Accumulated deficit |
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(590,309 |
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(521,071 |
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Total stockholders’ equity |
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109,567 |
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170,781 |
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Total liabilities and stockholders’ equity |
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$ |
222,623 |
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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 June 30, |
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Six Months Ended June 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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$ |
400 |
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$ |
2,761 |
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$ |
941 |
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$ |
7,506 |
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Grant revenues |
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1,555 |
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2,710 |
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3,456 |
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5,156 |
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Total revenues |
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1,955 |
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5,471 |
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4,397 |
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12,662 |
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Operating expenses: |
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Research and development |
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30,967 |
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27,347 |
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61,481 |
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55,546 |
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General and administrative |
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6,716 |
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7,792 |
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13,461 |
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15,747 |
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Total operating expenses |
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37,683 |
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35,139 |
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74,942 |
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71,293 |
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Loss from operations |
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(35,728 |
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(29,668 |
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(70,545 |
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(58,631 |
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Interest income |
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1,479 |
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153 |
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3,157 |
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200 |
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Interest expense |
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(985 |
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— |
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(1,828 |
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— |
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Other expense |
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(22 |
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— |
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(22 |
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— |
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Net loss |
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(35,256 |
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(29,515 |
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(69,238 |
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(58,431 |
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Other comprehensive loss: |
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Unrealized loss on marketable securities |
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(73 |
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(19 |
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(45 |
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(337 |
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Comprehensive loss |
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$ |
(35,329 |
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$ |
(29,534 |
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$ |
(69,283 |
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$ |
(58,768 |
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Net loss per share, basic and diluted |
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$ |
(0.31 |
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$ |
(0.34 |
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$ |
(0.60 |
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$ |
(0.68 |
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Weighted-average number of shares used in |
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114,929,523 |
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86,448,632 |
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114,676,261 |
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86,363,116 |
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