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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Trading |
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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 7, 2023, CytomX Therapeutics, Inc., a Delaware corporation (the “Company”) issued a press release reporting its unaudited financial results as of and for the three and nine months ended September 30, 2023. A copy of the press release is furnished herewith as Exhibit 99.1.
The information in Item 2.02 of this Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished as part of this report.
Exhibit No. |
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Description |
99.1 |
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Press release titled "CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update" issued by CytomX Therapeutics, Inc. on November 7, 2023. |
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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CYTOMX THERAPEUTICS, INC. |
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Date: |
November 7, 2023 |
By: |
/s/ Lloyd Rowland |
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Lloyd Rowland |
Exhibit 99.1
CytomX Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
- CX-904 (EGFRxCD3 T-cell engager) initial Phase 1 dose escalation data anticipated in the first half of 2024 -
- CX-2051 (EpCAM-directed ADC) comprehensive preclinical profile presented at 14th Annual World ADC Conference; IND filing on track for year-end -
- Updated CX-801 (conditionally activated interferon alpha-2b) preclinical data presented at SITC 2023; IND filing for CX-801 also on track for year-end -
- Management to hold conference call today at 5 p.m. EDT / 2 p.m. PDT -
SOUTH SAN FRANCISCO, Calif., November 7, 2023 – CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today reported third quarter 2023 financial results and provided a business update.
“2023 has been a year of highly focused execution against our key priorities, including continued progress in Phase 1 dose escalation for CX-904 and the advancement of our next-generation molecules CX-2051 and CX-801 towards IND filings later this year. We have continued to diligently manage our financial resources and drive towards value-inflecting pipeline milestones,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.
Continued Dr. McCarthy, “Looking ahead to 2024, we are on track to provide initial CX-904 Phase 1 dose escalation data and to initiate our clinical evaluation of CX-2051 and CX-801, leading to a potentially milestone-rich 2024 and 2025.”
Third Quarter Business Highlights and Recent Developments
Pipeline
1
Corporate Alliances
Company Priorities and Potential Milestones for 2023 and 2024
___________________________
1 Bristol Myers Squibb Research and Development Day, September 14, 2023
2
Third Quarter 2023 Financial Results
Cash, cash equivalents and investments totaled $194.1 million as of September 30, 2023, compared to $180.9 million as of June 30, 2023. The cash balance as of September 30, 2023, includes approximately $30.0 million of gross proceeds from the financing transaction that closed with BVF Partners L.P. in July of 2023, partially offset by cash burn of $16.8 million during the third quarter of 2023.
Total revenue was $26.4 million for the three months ended September 30, 2023, compared to $11.1 million for the corresponding period in 2022 and was driven primarily by a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and Moderna.
Research and development expenses decreased by $14.0 million during the three months ended September 30, 2023, to $16.4 million, compared to $30.4 million for the corresponding period in 2022. The reduction in research and development expenses was primarily due to a decrease in personnel related expenses, as well as winding down of laboratory contract services and clinical study activities related to the CX-2009 and CX-2029 programs, partially offset by an increase in laboratory contract services related to IND enabling activities.
General and administrative expenses decreased by $3.7 million during the three months ended September 30, 2023, to $6.8 million, compared to $10.5 million for the corresponding period in 2022. The reduction in general and administrative expenses was primarily due to a decrease in personnel related expenses as a result of the workforce reduction in 2022, reduced external vendor services, and lower building rent as a result of a partial sublease of the Company’s headquarters.
Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at https://ir.cytomx.com/events-and-presentations. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website.
About CytomX Therapeutics
CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated biologics localized to the tumor microenvironment. By pioneering a novel class of conditionally activated biologics, powered by its Probody® technology platform, CytomX’s goal is to transcend the limits of current cancer treatments. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies, and immune modulators such as cytokines and checkpoint inhibitors. CX-2029 is an investigational conditionally activated ADC directed toward CD71. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutic BMS-986288, partnered with Bristol Myers Squibb, and CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, partnered with Amgen. In addition, CytomX has a diverse preclinical portfolio of wholly-owned assets including CX-801, an interferon alpha-2b Probody cytokine that has broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors and CX-20512, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter).
_________________________
2 Licensed from Immunogen
3
CytomX Therapeutics Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to the future potential of partnerships or collaboration agreements. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX’s or any of its collaborative partners’ product candidates, including CX-2051, CX-2029, BMS-986288, CX-904, and CX-801, the potential benefits or applications of CytomX’s Probody platform technology, CytomX’s ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of BMS-986288, and CX-904, the timing of the commencement of clinical trials or initial and ongoing data availability, and the timing of investigational new drug applications, including for CX-801 and CX-2051, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX’s novel Probody Platform technology; CytomX’s clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the possibility that CytomX’s clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX’s dependence on the success of CX-2029, BMS-986288, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; possible regulatory developments in the United States and foreign countries; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading "Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q filed with the SEC on November 7, 2023. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Probody is a U.S. registered trademark of CytomX Therapeutics, Inc.
Investor Contact:
Chris Ogden
SVP, Finance and Accounting
cogden@cytomx.com
Direct: (317) 767-4764
Investor and Media Contact:
Stern Investor Relations
Stephanie Ascher
stephanie.ascher@sternir.com
(212) 362-1200
4
CYTOMX THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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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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$ |
26,384 |
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$ |
11,147 |
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$ |
74,607 |
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$ |
33,040 |
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Operating expenses: |
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Research and development |
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16,448 |
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30,367 |
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58,294 |
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92,085 |
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General and administrative |
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6,813 |
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10,490 |
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22,191 |
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32,782 |
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Total operating expenses |
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23,261 |
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40,857 |
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80,485 |
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124,867 |
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Income (loss) from operations |
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3,123 |
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(29,710 |
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(5,878 |
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(91,827 |
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Interest income |
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2,699 |
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616 |
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7,334 |
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946 |
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Other (expense) income, net |
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(7 |
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30 |
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(39 |
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339 |
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Income (loss) before income taxes |
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5,815 |
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(29,064 |
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1,417 |
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(90,542 |
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Provision for income taxes |
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2,823 |
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— |
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2,823 |
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— |
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Net income (loss) |
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$ |
2,992 |
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$ |
(29,064 |
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$ |
(1,406 |
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$ |
(90,542 |
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Other comprehensive income (loss): |
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Unrealized (loss) gain on short term investments, net of tax |
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(98 |
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367 |
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(73 |
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(553 |
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Comprehensive income (loss) |
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$ |
2,894 |
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$ |
(28,697 |
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$ |
(1,479 |
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$ |
(91,095 |
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Net income (loss) per share: |
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Basic |
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$ |
0.04 |
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$ |
(0.44 |
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$ |
(0.02 |
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$ |
(1.38 |
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Diluted |
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$ |
0.04 |
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$ |
(0.44 |
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$ |
(0.02 |
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$ |
(1.38 |
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Shares used to compute net income (loss) per share |
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Basic |
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80,731,951 |
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65,912,334 |
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71,225,433 |
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65,618,162 |
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Diluted |
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80,991,722 |
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65,912,334 |
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71,225,433 |
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65,618,162 |
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5
CYTOMX THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
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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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(Unaudited) |
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(1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
26,024 |
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$ |
193,650 |
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Short-term investments |
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168,086 |
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— |
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Accounts receivable |
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2,419 |
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35,986 |
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Prepaid expenses and other current assets |
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4,675 |
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7,466 |
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Total current assets |
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201,204 |
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237,102 |
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Property and equipment, net |
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4,060 |
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5,072 |
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Intangible assets, net |
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766 |
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875 |
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Goodwill |
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949 |
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949 |
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Restricted cash |
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917 |
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917 |
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Operating lease right-of-use asset |
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13,184 |
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15,949 |
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Other assets |
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87 |
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27 |
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Total assets |
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$ |
221,167 |
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$ |
260,891 |
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Liabilities and Stockholders' Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
1,705 |
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$ |
2,809 |
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Accrued liabilities |
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20,689 |
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28,532 |
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Deferred revenue, current portion |
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124,396 |
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121,267 |
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Total current liabilities |
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146,790 |
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152,608 |
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Deferred revenue, net of current portion |
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112,261 |
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180,059 |
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Operating lease liabilities - long term |
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10,597 |
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13,975 |
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Other long-term liabilities |
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2,757 |
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— |
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Total liabilities |
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272,405 |
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346,642 |
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Commitments and contingencies |
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Stockholders' deficit: |
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Convertible preferred stock |
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— |
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— |
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Common stock |
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1 |
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1 |
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Additional paid-in capital |
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673,109 |
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637,117 |
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Accumulated other comprehensive (loss) income |
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(63 |
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10 |
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Accumulated deficit |
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(724,285 |
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(722,879 |
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Total stockholders' deficit |
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(51,238 |
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(85,751 |
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Total liabilities and stockholders' deficit |
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$ |
221,167 |
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$ |
260,891 |
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__________________
6