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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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| Item 2.02. |
Results of Operations and Financial Condition.
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| Item 9.01. |
Financial Statements and Exhibits.
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Exhibit
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Description
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Press Release issued January 5, 2023.
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104
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Inline XBRL for the cover page of this Current Report on Form 8-K.
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Date: January 5, 2023
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Bionano Genomics, Inc.
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By:
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/s/ R. Erik Holmlin, Ph.D.
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R. Erik Holmlin, Ph.D.
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President and Chief Executive Officer
(Principal Executive Officer)
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| • |
Revenues for the fourth quarter 2022 are expected to be in the range of $8.1
million to $8.4 million, an estimated increase of 12% to 16% compared to $7.2 million in the third quarter of 2022 and an estimated increase of 27% to 33% compared to the fourth
quarter of 2021. Full year 2022 revenue is expected to be in the range of $27.7 million and $28.0 million, an estimated increase of between 54% and 56% compared to 2021.
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Installed base of Saphyr® systems totaled 240 at year-end, which was an increase of 23 systems over third quarter 2022 and represented a 46%
increase over the 164 installed systems reported at the end of 2021.
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Sold 4,781 flowcells, an increase of 49% over the fourth quarter of 2021.
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Completed acquisition of Purigen Biosystems, which is expected to accelerate the adoption of OGM due to anticipated improvements in Bionano’s ultra-high molecular weight (UHMW) DNA sample preparation
workflow.
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Launched OGM laboratory developed tests (LDTs) for hematological malignancy and genetic disorder applications through Bionano Laboratories
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Pre-commercial version of next generation OGM system running in the field with a planned commercial launch in first half of 2023
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Developed and released enhanced DLS G2 labeling and SP Next DNA isolation
kits which enable sample to results in as little as 3 days for cancer samples
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| o |
In partnership with Hamilton, released an automated version of Bionano’s DNA isolation chemistry
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NxClinical™ software version 7.0, which is the version of NxClinical software
enabled for OGM data analysis, is being used in the field and full commercial release for applications in hematological malignancies is planned for the first half of 2023
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Met all previously stated 2022 milestones for prenatal, postnatal and hematological clinical trials, including: study enrollment targets; completion of postnatal study, which has been submitted for publication as a pre-print; interim publication of the
prenatal study, which was published in December 2022 as a pre-print; and initiation of the solid tumor trial.
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