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 8, 2022, CytomX Therapeutics, Inc., a Delaware corporation (the “Company”) issued a press release reporting its unaudited financial results as of and for the three months and nine months ended September 30, 2022. 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 2022 Financial Results and Provides Business Update" issued by CytomX Therapeutics, Inc. on November 8, 2022. |
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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 8, 2022 |
By: |
/s/ Lloyd Rowland |
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Lloyd Rowland |
Exhibit 99.1
CytomX Therapeutics Reports Third Quarter 2022 Financial Results and
Provides Business Update
- Advancing wholly owned, next-generation conditionally activated therapeutics
CX-2051 (EpCAM-directed ADC) and CX-801 (Interferon alpha-2b), with INDs anticipated in 2023 -
- CX-904, Company’s first clinical stage Probody T-cell bispecific (EFGRxCD3), continues
to advance in Phase 1 dose escalation -
- Continued progress with Phase 2 collaborator programs CX-2029 (AbbVie, Phase 2)
and BMS-986249 (Bristol Myers Squibb, Phase 2) -
SOUTH SAN FRANCISCO, Calif., November 8, 2022 – CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, today reported third quarter 2022 financial results and provided a business update.
“CytomX’s progress in the third quarter highlights the potential of our pipeline as well as the breadth and versatility of the Probody® platform. CX-2051 and CX-801 are wholly owned, next generation therapeutic candidates that build on our deep experience with conditional activation,” said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. “We also continued to make progress in our collaborator programs, including CX-904, our first T-cell engager in the clinic, and BMS-986249, for which Bristol Myers Squibb presented updated Phase 1 safety and efficacy data at ESMO 2022.”
Third Quarter Business Highlights and Recent Developments
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Priorities for 2022-2023
Third Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $194.3 million as of September 30, 2022, compared to $305.2 million as of December 31, 2021.
Total revenue was $16.9 million for the three months ended September 30, 2022, compared to $17.6 million for the corresponding period in 2021.
Research and development expenses increased by $1.2 million during the three months ended September 30, 2022 to $30.4 million compared to $29.1 million for the third quarter of 2021. The increase was primarily due to restructuring expenses, offset by a decrease in personnel related expense and clinical trial expenses due to the workforce reduction and pipeline reprioritization announced in July 2022.
General and administrative expenses decreased by $0.6 million during the third quarter of 2022 to $10.5 million. The decrease was mainly driven by a decrease in personnel related expenses due to the workforce reduction announced in July 2022 and a decrease in outside consulting, legal and intellectual property services, partially offset by restructuring expenses.
Overall expenses related to the company restructuring announced in July 2022 were $7.1 million consisting primarily of employee-related expenses and severance benefits. Total anticipated expenses as a result of the restructuring are expected to be approximately $7.9 million.
Conference Call & Webcast Information
CytomX management will host a conference call and simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) 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, Inc.
CytomX is a clinical-stage, oncology-focused biopharmaceutical company dedicated to destroying cancer differently. 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 seven therapeutic candidates across multiple treatment
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modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). CX-2029 is an investigational conditionally activated antibody-drug conjugate (ADC) directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie. CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, as well as 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, which is 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-2051, a conditionally activated ADC directed toward EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. Praluzatamab ravtansine is an investigational conditionally activated ADC directed toward CD166 that demonstrated single agent clinical activity in a Phase 2 study for patients with advanced HR+/HER2-non-amplified breast cancer. Following the Phase 2 results, CytomX decided not to further progress praluzatamab ravtansine alone and is seeking a partner to further develop the molecule. CytomX has also established strategic collaborations with multiple leaders in oncology, including AbbVie, Amgen, Astellas, and Bristol Myers Squibb. 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 Twitter.
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. 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-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801, CX-2051, and praluzatamab ravtansine, 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 CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, and praluzatamab ravtansine, and the timing of the commencement of clinical trials, initial and ongoing data availability, investigational new drug applications 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 risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of CytomX or its partners, including the development of preclinical drug candidates due to delays in and disruption of research activities and the development of clinical drug candidates due to delays in or disruption of clinical trials, including impacts on the enrollment of patients in clinical trials or other clinical trial disruptions; the possibility that the results of preclinical research and early clinical trials may not be predictive of future results; the
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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-986249, BMS-986288, pacmilimab, CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for the manufacture of the Company’s product candidates; and possible regulatory developments in the United States and foreign countries. 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 8, 2022. 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.
CytomX Contact:
Chris Ogden
SVP, Finance and Accounting
cogden@cytomx.com
(317) 767-4764
Investor and Media Contact:
Stern Investor Relations
Stephanie Ascher
stephanie.ascher@sternir.com
212-362-1200
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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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2022 |
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2021 |
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2022 |
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2021 |
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Revenues |
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$ |
16,915 |
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$ |
17,587 |
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$ |
52,217 |
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$ |
49,846 |
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Operating expenses: |
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Research and development |
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30,367 |
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29,143 |
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92,085 |
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77,615 |
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General and administrative |
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10,490 |
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11,085 |
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32,782 |
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29,704 |
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Total operating expenses |
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40,857 |
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40,228 |
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124,867 |
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107,319 |
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Loss from operations |
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(23,942 |
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(22,641 |
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(72,650 |
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(57,473 |
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Interest income |
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616 |
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70 |
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946 |
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182 |
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Other income (expense), net |
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30 |
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(13 |
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339 |
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(90 |
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Net loss |
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$ |
(23,296 |
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$ |
(22,584 |
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$ |
(71,365 |
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$ |
(57,381 |
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Other comprehensive loss: |
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Unrealized gain (loss) on investments, net of tax |
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367 |
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37 |
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(553 |
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99 |
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Comprehensive loss |
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$ |
(22,929 |
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$ |
(22,547 |
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$ |
(71,918 |
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$ |
(57,282 |
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Net loss per share: |
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Basic and diluted net loss per share |
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$ |
(0.35 |
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$ |
(0.35 |
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$ |
(1.09 |
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$ |
(0.90 |
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Shares used in computing basic and diluted net loss per share |
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65,912,334 |
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65,208,066 |
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65,618,162 |
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63,759,585 |
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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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2022 |
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2021 |
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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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$ |
95,036 |
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$ |
205,530 |
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Short-term investments |
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99,254 |
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99,696 |
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Accounts receivable |
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1,712 |
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790 |
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Prepaid expenses and other current assets |
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4,278 |
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4,285 |
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Total current assets |
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200,280 |
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310,301 |
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Property and equipment, net |
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5,710 |
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5,960 |
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Intangible assets, net |
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911 |
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1,021 |
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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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16,830 |
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19,362 |
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Other assets |
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895 |
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901 |
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Total assets |
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$ |
226,492 |
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$ |
339,411 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
5,176 |
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$ |
2,818 |
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Accrued liabilities |
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31,340 |
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34,236 |
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Deferred revenue, current portion |
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61,325 |
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69,262 |
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Total current liabilities |
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97,841 |
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106,316 |
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Deferred revenue, net of current portion |
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85,122 |
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125,660 |
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Operating lease liabilities - long term |
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15,055 |
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18,056 |
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Total liabilities |
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198,018 |
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250,032 |
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Commitments and contingencies |
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Stockholders' equity: |
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Convertible preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued and outstanding at September 30, 2022 and December 31, 2021. |
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— |
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— |
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Common stock, $0.00001 par value; 150,000,000 shares authorized and 65,950,242 and 65,392,758 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively |
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1 |
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1 |
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Additional paid-in capital |
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634,357 |
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623,344 |
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Accumulated other comprehensive loss |
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(795 |
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(242 |
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Accumulated deficit |
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(605,089 |
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(533,724 |
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Total stockholders' equity |
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28,474 |
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89,379 |
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Total liabilities and stockholders' equity |
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$ |
226,492 |
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$ |
339,411 |
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__________________
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