UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15th(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 7, 2021

Bionano Genomics, Inc
(Exact Name of Registrant as Specified in its Charter)

Delaware
 
001-38613
 
26-1756290
(State or Other Jurisdiction of Incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
9540 Towne Centre Drive, Suite 100
San Diego, California
 
92121
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant’s telephone number, including area code: (858) 888-7600

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:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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.

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, $0.0001 par value per share
 
BNGO
 
The Nasdaq Stock Market, LLC
Warrants to purchase Common Stock
 
BNGOW
 
The Nasdaq Stock Market, LLC



 
In this report, “we,” “us” and “our” refer to Bionano Genomics, Inc.

Item 2.02 Results of Operations and Financial Condition.

On January 7, 2021, we announced the commencement of a proposed underwritten public offering of our common stock. In connection with the proposed offering, we filed a preliminary prospectus supplement in which we disclosed that we expect to report that our total revenue for the three months ended December 31, 2020, was between $3.8 and $4.2 million and cash and cash equivalents as of December 31, 2020, was between $38.0 and $39.0 million. This amount of cash and cash equivalents excludes approximately $15.0 million of additional cash received between January 1, 2021 and January 6, 2021 pursuant to the exercise of warrants to purchase our common stock. These amounts reflect our estimates based solely upon information available to us as of the date of this Current Report on Form 8-K, are not a comprehensive statement of our financial results or position as of or for the quarter ended December 31, 2020, and have not been audited, reviewed or compiled by our independent registered public accounting firm. Our financial closing procedures for the quarter ended December 31, 2020 are not yet complete and, as a result, our final results upon completion of our closing procedures may vary from this preliminary estimate, and any such differences may be material.

Item 8.01 Other Events.

The information contained in Item 2.02 above is incorporated herein by reference.

On January 7, 2021, we made available on our website the slide presentation attached hereto as Exhibit 99.1. Information contained in this slide presentation may be used in meetings with institutional investors or analysts.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this report that are not historical facts may be considered “forward-looking statements,” including, but not limited to, statements regarding our preliminary estimates of revenue and cash and cash equivalents as of December 31, 2020. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology. Forward-looking statements are based on current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from the expectations set forth in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to preliminary financial results, including the risks that the preliminary financial results reported herein reflect information available to us only at this time and may differ from actual results, including in connection with our completion of financial closing procedures, risks associated with market conditions, risks and uncertainties associated with our business and finances in general, risks associated with the COVID-19 global pandemic, as well as other risks detailed in our recent filings on Forms 10-K and 10-Q with SEC. We undertake no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, which is being made only by means of a written prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
 
Description
 
Slide Presentation.
104
 
Inline XBRL for the cover page of this Current Report on Form 8-K.




 
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 hereunto duly authorized.


 
Bionano Genomics, Inc.
     
Date: January 7, 2021
By:
 /s/ R. Erik Holmlin, Ph.D.
   
 R. Erik Holmlin, Ph.D.
   
 President and Chief Executive Officer
(Principal Executive Officer)



Exhibit 99.1

 January 2021R. Erik Holmlin, CEOChris Stewart, CFO  Corporate Overview 
 

 Legal DisclaimerThis presentation contains forward-looking statements. Forward-looking statements describe future expectations, plans, results or strategies and are generally preceded by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including the negative thereof). Forward-looking statements in this presentation include, but are not limited to, statements regarding: (i) growth drivers and expected levels of our organic growth; (ii) improvements to our manufacturing cost efficiency; (iii) the impact of our investment in R&D and commercial initiatives; (iv) our ability to stay in front of competitors’ improvements in technologies; and (v) other statements that are not historical facts.Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Forward-looking statements are based only on current information, assumptions and expectations, and involve a number of risks and uncertainties relating to (i) challenges inherent in developing, manufacturing and commercializing products; (ii) the timing and mix of customer orders among our products; (iii) our ability to further deploy new products and applications and expand the markets for our technology platforms; (iv) third parties’ abilities to manufacture our instruments and consumables; (v) the success of products competitive with our own; (vi) our expectations and beliefs regarding future growth of the business and the markets in which we operate; (vii) the accuracy of our estimates, (viii) our ability to fund our operations and (ix) the application of generally accepted accounting principles which are highly complex and involve many subjective assumptions. We are under no duty to update any of these forward-looking statements after the date of this presentation to conform these statements to actual results or revised expectations, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements contained in this presentation. More information about these and other statements, risks and uncertainties is contained in our filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this presentation speak only as of the date on which they were made. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, occurrence of future events or otherwise except as required by applicable law. 
 

 Creating a Market Leader in Cytogenomics 
 

 The Diagnostic Journey Often Ends in Frustration, Disappointment and Premature Death Because the Current Tools are Insufficient  Constitutional Genetic DiseasesNeuro-developmental disorders (NDDs) occur at a rate of 1 in 6A substantial fraction (50 – 70%) of test results are negativeWithout a definitive molecular diagnosis, these patients may not get optimal treatment and their diagnostic odyssey continues  Blood Cancers200,000 new cases diagnosed each year in US among approximately 1 million patients testedAgain, most test results are negativeEven with a definitive diagnosis and good prognosis, average survival in leukemia tends to be split between good outcomes (long survival) and poor outcomes (short survival) – current methods are insufficient 
 

 Better Tools are Needed Because the Genome Variations that Cause Disease Are Not All the Same!   Insertion  Deletion  Translocation  Inversion  Repeat Expansion  Single NucleotidePolymorphisms(SNPs)1 base pair (bp)  StructuralVariations(SVs)100s bp to Millions bp  AneuploidyFull Chromosomes 
 

 Sequencers Cannot Reliably Detect Structural Variations    1 to 100s base pairs (bp)  100s bp to Millions bp  Insertion  Deletion  Repeats  Translocation  Inversion  Sequencers can detect these  Sequencers are BLIND to these        ONLY Saphyr detects these large SVs that cause disease*  ✓  SNPs to Small Structural Variants  Large Structural Variations (SVs)    ✘    ✓    1 to 10,000 bp  We believe that Saphyr is the only genome analysis platform capable of comprehensive, cost effective & efficient detection of large SVs (500 bp and larger) 
 

 ACMG, AMP, AAN, AAP recommend KT/FISH/CMA/Frag-X as the standard of care for constitutional disordersWHO/NCCN/NCI/NHS recommend KT/FISH/CMA as standard of care for hematologic malignancies.  Cytogenetics & Cytogenomics are the Current Paradigm in Testing for SVs  Cytogenetics means the detection of chromosomal disorders in the laboratory by karyotyping (examining the chromosomes within a cell). Molecular cytogenetics involves testing of a specific disease locus by fluorescence-in-situ hybridization (FISH) assay.         What is CytogeneticAnalysis?  What does it test for?  Why sequencing cannot address Cytogenetics?  Diseases caused by large genomic aberrations also known as structural abnormalities (not sequence abnormalities). Structural abnormalities include translocations, insertions, deletions and other chromosomal rearrangement of genomic information.  The human genome is highly repetitive and large structural abnormalities are often hidden among repeats. Reads from NGS and even long-read sequencing are too short to span the repetitive sections and thus are unable to capture the large structural abnormalities/genomic aberrations.    What do Medical Guidelines say? 
 

     The Cytogenetics Workflow is a Nightmare!  Based on the Cyto worklow at NHS Lothian, Edinburgh Scotland,per Dr. Eddy Maher       
 

   Saphyr offers an Alternative to Traditional Cyto Methods by Offering a One-Stop-Shop for Detecting all SVs Recommended by Medical Guidelines 
 

 We Estimate our Market Opportunity to be $2.6B – $3.8B Based on Selling As Many as 10,000 Saphyr Systems  CYTOGENETICS(Digital Cytogenetics)  2,500+ cytogenetics labs worldwide  $0.5B-$0.6B  Estimated revenues  $0.2B-$0.4B  Estimated annual recurring revenues      DISCOVERY RESEARCH(Complement Sequencing)  7,000+(and quickly growing) high-throughput sequencers worldwide  $1.4B-$1.8B  Estimated revenues  $0.5B-$1.1B  Estimated annual recurring revenues     
 

 We Believe Bionano is Alone in Addressing SVs and Digital Cytogenetics  Comprehensive SVs+ Digital Cyto  Single Cell Analysis  SNPs Exomes WGS  TranscriptomeRNA SEQ Spatial Analysis  DNA  RNA 
 

 Studies Show 100% Concordance with the Standard of Care Methods  BIONANO FOUND ALL clinically reported variants detected by Karyotype, FISH and Chromosomal Microarray  NO OTHER TECH has been shown, in a single assay, to deliver results of all 3 traditional technologies 
 

 Consortium of US Thought Leaders Recommend Saphyr as an Alternative to Karyotyping in AML     
 

 Case Study: Saphyr Found the SV that Was Responsible, Helping Solve This Case in Pediatric Genetic Disease    Chromosome 15  Chromosome X  410 kbp duplication/insertion  Destroys normal function of the DMD   Saphyr detected a 410kbp duplication & insertion in the DMD gene which provided a definitive molecular diagnosis of Duchenne’s Muscular Dystrophy    ✓  Juvenile male patient suffering from muscular weakness and developmental delayPatient tested negative by standard and advanced molecular methods    ✘  Chromosomal Microarray        PCR and Sanger Sequencing  Multiplexed Ligation Polymorphism Assay (MLPA)  Whole Exon & Whole Genome Sequencing  ✘  ✘  ✘    ✘ 
 

 UCSF & Children’s Hospital of Oakland Study – Largest study of Dx Yield - Shows Saphyr can Diagnose Additional 18% of Undiagnosed Patients     
 

 Bionano Data are Proving to be Essential in Advancing Discovery Research  ALS Resolved mosaic repeat expansions  Alzheimer’s DiseaseIdentified deletions in CR1  Leukemia In 12 patients, found dozens of novel genes with recurring structural variants  Hepatocellular CarcinomaIdentified Hep B Virus insertion that caused tumor and replication stress  Congenital Diaphragmatic HerniaRevealed complex genome structures and new candidate genes  Epilepsy and Developmental DelayDetected 90 kbp mosaic deletion in CDKL5  3q29 Microdeletion SyndromeCharacterized large, complex repeats and rearrangements in parents of 3q29 patients  Disorder of Sex Development Identified 6 kbp insertion in WDR11  In results expected to be published, based on comparative studies against one or more of NGS, CMAs, FISH & Karyotoping 
 

 Saphyr will be used to identify variants in host genomes that influence COVID-19 response, severity, progression and drug response  First study in Wuhan with Bionano service provider GrandOmics is underway  European study involving University of Hannover genomic epidemiologists launched March 2020  CHINA  EUROPE  COMPUTE PARTNERS  Bionano Saphyr is Prominently Involved in the Search for Risk Markers that Stratify COVID-19 Patients by Risk and May Help Vaccine and Rx Development  Rescale, together with Amazon, Google and Microsoft, are donating compute capacity  US-BASED CONSORTIUM  COVID19HostGenomeSV.com  Consortium founded by Dr Ravi Kolhe at Augusta is enrolling 100s to 1000s of patients in a study that has shown preliminary promise 
 

 In August 2020, We Acquired the Diagnostics Service Provider, Lineagen, a Leader in Diagnostic Services for Pediatric Neurodevelopmental Disorders  FROM ONE BUCCAL SWAB . . .  Multiple revenue streamsCLIA-certified LDTs and servicesPersonalized, easy-to-understand results  Genetic counseling and clinical educationEnd-to-end support with reimbursementTest menu that matters  FSDx  Chromosomal Microarray (CMA) designed to detect larger deletions and duplications in the genome  FRx  Screening and diagnosis of Fragile X syndrome, the most common known genetic cause of ASD/ID that runs in families Ordered with 75% of FirstStepDx PLUS CMA cases.  PGx  Testing of genes that can impact dosage and choice of drug types, including Anti-Epilepsy and ADHD drugs  NSDx  Next generation whole exome gene sequencing (WES) to detect single genome letter changes undetectable by CMA  WGDx  Most comprehensive genetic test that can detect majority of genome mutations (deletions/duplications/single base changes)  EPDx  A comprehensive and proprietary panel of over 220 curated genes associated with epilepsy-related conditions  Fragile X Syndrome  Whole Genome Diagnostic  Pharmacogenetics Testing  
 

 Lineagen Adds Revenue & Accelerates Clinical Adoption of Saphyr  ESSENTIAL COMPONENTS FOR BUILDING REIMBURSED DX MENU ON SAPHYR  Trained billing specialists lay groundwork for reimbursement of Saphyr LDTs  COMBINING PRODUCT-AND SERVICE-BASED BUSINESSES  Proprietary database from Toronto Sick Kids Hospital provides basis for differentiated tests, current and future  +60,000 tests performed on +30,000 patients, and counting   Proprietary Content in Pediatric Neuro Developmental Disorders  Patient Samples & Database  Provide expertise for improved Saphyr Dx and workflow integration  Differentiated service and critical link between physicians, patients and families  Leverage existing relationships and contracts with payors   Clinical Cytogeneticists & Custom Interpretation Software  Genetic Counseling  Certified Coders  3rd Party Payor Contracts  REVENUE: IMMEDIATE IMPACT  Lineagen adds new revenue streams to help support growth of the combined business  Provides centralized and decentralized offerings to support the broader market  Development of proprietary LDTs helps drive Saphyr adoptionEnhances Bionano offering to pharma customers seeking new therapeutic targets  CLIA Certification  Accelerates Saphyr entry into the clinic by adding content, skills, expertise and sample archives 
 

 2020 Corporate Highlights     Q1    Q2    Q3    Q4    Landmark Publication: Concordance with Cyto in Leukemias  Initiated COVID-19 Host Genome Studies  5694  19  Increased Throughput/output  Presentations  Saphyr Shipped83 installed   New Go to Market – Bionano Data CentricServices, Reagent Rentals & Capital Purchase  Consortium Presentation: Saphyr Concordance with Cytogenomics Standard of Carein Constitutional Disorders   NHS Hospital (UK) adopts Saphyr  Largest US FSHD testing site  BOARD OF DIRECTORS NEW ADDITIONS  Yvonne Linney  Hannah Mamuszka  Landmark Publication: Concordance with Cyto in Constitutional Disorders             Consortium Formation: COVID-19 Host Genetics SV Consortium  Acquisition of CLIA business w Clinical Sales   German accreditation for Saphyr LDTs  Addition of Key New Executives  Alka Chaubey, PhD, Chief Medical Officier  Chris Stewart, Chief Financial Officer            COVID Consortium Adds Studies in Comparative Genomics and MIS-C  Improved and Simplified Clinical Analysis Tools   Landmark Publication: in Acute Myeloid Leukemia;Authors recommend Saphyr as Karyotype replacement  UCSF Publication: Saphyr Increases Diagnostic Yield  SAPHYR ADOPTION                                                         SAPHYR ADOPTION                                      Saphyr Throughput – 96 human genomes per week    FCs SoldVS 468 in Q1 2019  61424  Saphyr Shipped87 installed   FCs SoldVS 493 in Q2 2019  111785  Saphyr Shipped93 installed   FCs SoldVS 1332 in Q3 2019  12*2362*  Saphyr Shipped97 installed   FCs SoldVS 1332 in Q3 2019   Revenue: $0.9M   Revenue: $1.2M   Revenue: $2.2M   Revenue*: $3.8M to $4.2M  18  Presentations  *Preliminary estimates for Q4 2020 
 

 Experienced Management Team and Board  Albert Luderer, PhDCEO – Integrated Dx  David Barker, PhDChairman of Bionano; former CSO of Illumina  Yvonne Linney, PhDFounder – Linney BioConsulting  Erik Holmlin, PhDPresident, CEO & Board Member  Mark OldakowskiChief Operating Officer  Christopher TwomeyFormer CFO of Biosite; Ernst & Young  Executive Management Team  Board of Directors (Non-Executive)  Kristiina Vuori, MD, PhDPresident – Sanford Burnham Prebys MDI  Christopher StewartChief Financial Officer  Alka Chaubey, PhDChief Medical Officer  Hannah MamuszkaCEO – Alva10 
 

 Thank You  Contact:R. Erik HolmlinCEOeholmlin@bionanogenomics.com  Chris StewartCFOcstewart@bionanogenomics.com