|4.50 in here on DD...ILMN BPTH implications with Innovatus, Aspire news -|
Aspire Common Stock Purchase Agreement and Registration Rights Agreement
On March 14, 2019, Bionano Genomics, Inc. (the “Company”), entered into a common stock purchase agreement (the “Purchase Agreement”) with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of the Company’s common stock, par value $0.0001 per share, at the Company’s request from time to time during a 30 month period. Upon execution of the Purchase Agreement, the Company agreed to sell to Aspire Capital 272,479 shares of common stock at $3.67 per share for proceeds of $1.0 million. Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the “Registration Rights Agreement”), in which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended (the “Securities Act”), registering the sale of the shares of the Company’s common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.
Under the Purchase Agreement, after the Securities and Exchange Commission (the “SEC”) has declared effective the registration statement referred to above, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a “Purchase Notice”), directing Aspire Capital (as principal) to purchase up to 60,000 shares of the Company’s common stock per business day, up to $9.0 million of the Company’s common stock in the aggregate at a per share price (the “Purchase Price”) equal to the lesser of:
the lowest sale price of the Company’s common stock on the purchase date; or
the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date.
In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount equal to 60,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a “VWAP Purchase Notice”) directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on its principal market on the next trading day (the “VWAP Purchase Date”), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company’s common stock traded on its principal market on the VWAP Purchase Date.
Innovatus Debt Facility
On March 14, 2019, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) by and among Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent and the Lenders listed on Schedule 1.1 thereto, including East West Bank (the “Bank”, and together with the Lenders, the “Lenders”). Under the Loan Agreement, Innovatus, as a Lender, has agreed to make certain term loans to the Company in the aggregate principal amount of up to $25,000,000 and Bank has agreed to make available to the Company a revolving line of credit in an amount not to exceed $5,000,000 (the “Revolver”). Funding of the Term A-1 Loan of $17,500,000 is expected to occur upon satisfaction of customary funding conditions as set forth in the Loan Agreement. The Company will be eligible to draw a Term A-2 Loan of $2,500,000 and a Term B Loan of $5,000,000 upon achievement of certain financial milestones. Availability under the Revolver is subject to customary limitations. The Company is required to make monthly interest payments for up to thirty-six (36) months, and at the end the interest-only period, the Company will be required to repay the term loans over a two-year period based on a twenty-four (24) month amortization schedule, with a final maturity date occurring on the fifth anniversary of the initial funding date.
Bionano Genomics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2018
Record quarterly revenue of $4.0 million; 41% increase over 4Q17
Record annual revenue of $12.0 million; 26% increase over 2017
Substantial improvement to essentially many aspects of the Saphyr workflow; capability of processing 42 whole human genomes per week; clinical-grade sensitivity at as low as 5% allele fraction; prices below $500 per genome
Record number of publications; a 70% increase of human-centered publications over 2017; studies validating the use of Saphyr as an alternative to traditional cytogenetics technologies
SAN DIEGO, Mar. 14, 2019 (GLOBE NEWSWIRE) - Bionano Genomics, Inc. (NASDAQ: BNGO), a life sciences instrumentation company that develops and markets Saphyr, a platform for ultra-sensitive and ultra-specific structural variation detection in genome analysis, today reported financial results for the fourth quarter and year ended December 31, 2018.
Accomplishments and Recent Business Highlights
Bionano continued its focus on advancing the capabilities of its Saphyr system for whole genome mapping of structural variations. Throughout 2018 and culminating in a series of product launches in February 2019, Bionano has simplified the Saphyr workflow making it easier to run, return faster results, and cost less than $500 per sample. Saphyr is now capable of processing 42 whole human genomes per week with a workflow that can be automated from sample to answer. We believe these improvements are driving Saphyr
adoptions among clinical and translational research centers as well as cytogenetics labs as a digital cytogenetics platform.
Bionano expanded the capabilities of its data analysis solutions, improving their sensitivity to all types of structural variations, including those that are present at very low abundance. Access to tools for Bionano data analysis was enhanced through the development of a cloud-based implementation of the analysis pipeline. In addition, the suite now includes a novel routine that has been tested in different leukemias and shown to have high sensitivity for structural variation detection even when the variant of interest is present in as low as 5% allele fraction, which is a critical capability for analysis of cancer samples.
Bionano collaborated with Genoox, a company that manages next-generation sequencing data analysis, to develop and launch a platform that combines raw sequencing reads with Bionano-based structural calls from a single patient. Children's National Health System in Washington D.C., which is ranked #1 in the U.S. for infant care, became the initial adopter of the Genoox integrated platform. The new technology offers Children’s National a single platform for sensitive, accurate detection of structural variations and genetic mutations for rare disease, not previously practicable, helping to accelerate genetic diagnosis for children and their families.
Bionano users published a record number of papers detailing the application of Bionano technology. In particular, 70% more human-centric publications were released in 2018 over 2017. One such publication detailed the largest study conducted on Bionano’s platform, which was comprised of 154 humans across 26 distinct ethnic populations. This publication revealed never-before-seen human genomic variations and genome sequence not represented in the human genome reference, which demonstrated that the widely used method of aligning short sequencing reads to a static reference genome may be inadequate.
Another key paper showed Saphyr’s ability to provide accurate molecular diagnoses of facioscapulohumeral muscular dystrophy (FSHD) patients. Saphyr was shown to be an alternative to the Southern blot method, a traditional cytogenetics technique, by offering a simplified workflow that yields highly accurate results with the potential to increase clinical
performance by readily adding new clinical markers without modifying the assay or workflow. The replacement of traditional cytogenetics workflows with Saphyr represents the transition to digital cytogenetics where Saphyr modernizes the entire cytogenetic workflow.
Adoption of Saphyr in 2018 by top thought leaders in cytogenetics such as Dr. Brynn Levy at Columbia University and Dr. Alex Hoeschin at Radboud University Medical Center in the Netherlands, and others, has enabled Bionano to initiate a number of studies designed to show equivalency of Saphyr to traditional cytogenetic methods in hematologic oncology indications such as Acute lymphocytic leukemia (ALL) and Acute myelocytic leukemia (AML). We expect initial results from these studies to be presented at scientific meetings beginning in the third quarter of this year and throughout the second half of 2019. We believe these studies will lay the groundwork for Saphyr to penetrate labs that may develop assays for cytogenetic applications, making Saphyr the first digital cytogenetics platform.
Bionano expanded its commercial team with the addition of key senior executives, including the addition of a head of commercial operations and a seasoned sales team in China as well as a new global head of marketing.
In August 2018, Bionano completed its initial public offering, raising $23.7 million in gross proceeds.
“We are very pleased with how Saphyr is becoming an essential tool for genome analysis and digital cytogenetics worldwide,” said Erik Holmlin, Ph.D., CEO of Bionano. “We are seeing accelerated interest in our Saphyr system, as our differentiated capabilities, the unique detection of structural variations, and our new price point below $500 per whole human genome sample continues to drive demand.”
Dr. Holmlin added, “We continue to focus on expanding and executing on our commercial plan. We plan to continue building our commercial team, and look forward to executing on our strategies to make structural variation analysis as commonplace as next-generation sequencing and to lead the emergence of digital cytogenetics.”
Fourth Quarter Financial Highlights
Total Revenue. Total revenue for the fourth quarter 2018 was $4.0 million compared to $2.8 million in the fourth quarter 2017, or an increase of 41%. Growth over the fourth quarter of 2017 was predominantly due to an increase in product sales.
Product Revenue. Product revenue for the fourth quarter 2018 was $3.8 million compared to $2.6 million in the fourth quarter 2017, or an increase of 50%.
Cost of Revenues. Cost of revenues for the fourth quarter 2018 was $3.0 million compared to $1.5 million in the fourth quarter 2017. The cost of revenue was higher in the fourth quarter of 2018 primarily due to increased sales.
Operating Expenses. Operating expenses for the fourth quarter 2018 were $7.1 million compared to $6.6 million in the fourth quarter 2017, or an increase of 8%. The increase was primarily due to an increase in SG&A resulting from the additional costs of being a public company.
Full-Year 2018 Financial Highlights
Total Revenue. Total revenue for 2018 was $12.0 million compared to $9.5 million in 2017, or an increase of 26%. The increase was predominantly due to significant increases in sales of instruments and consumables.
Product Revenue. Product revenue for 2018 was $11.5 million compared to $8.8 million in 2017, an increase of 31%. The majority of the increase in product revenue was due to a 29% increase in instrument unit sales and a 63% increase in consumable unit sales.
Cost of Revenues. Cost of revenues for 2018 was $8.7 million compared to $6.0 million for 2017. The increase in cost was primarily due to increased sales of instruments and consumables and predecessor instrument inventory write-offs of $1.3 million in 2018 as compared to $0.4 million in 2017.
Operating Expenses. Operating expenses for 2018 were $23.7 million compared to $26.7 million in 2017. This represents a decrease of 11% in operating expenses for 2018 compared to 2017. The decrease in operating expenses was primarily due a $2.5 million decrease in spending for research & development.
Cash and Cash Equivalents Balance on December 31, 2018
At December 31, 2018, the Company had cash and cash equivalents of $16.5 million, compared to cash and cash equivalents of $1.0 million at December 31, 2017.
"We believe that the discovery research and cytogenetics segments together comprise an addressable opportunity for us to sell up to approximately 8,500 Saphyr systems, representing a current total instrument market opportunity of approximately $2.1 billion. Importantly, we expect this market opportunity to expand at the rate of adoption of new RUO high throughput sequencers which we estimate is over 15% per year. While we do not expect the number of cytogenetics labs to increase significantly, we do expect our growth in this market to be driven by conversion of traditional cytogenetics methodologies to our Saphyr system."
In addition to the instrument sales opportunity, Saphyr instruments generate recurring revenue from chip consumables that are used on a per-sample basis. We believe each Saphyr instrument has the potential to create recurring revenue in a range of approximately $75,000 to approximately $150,000 per year, suggesting a potential annual recurring revenue opportunity of approximately $0.6 billion to approximately $1.3 billion.
Therefore, we believe that our currently addressable portion of the genome analysis market is estimated to be between $2.7 billion and $3.4 billion.
Bionano and Genoox Launch Integrated Platform for Identification of Structural Variants in DNA
October 17, 2018 11:00 ET | Source: Bionano Genomics
SAN DIEGO, Oct. 17, 2018 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (NASDAQ: BNGO), a life sciences instrumentation company that develops and markets Saphyr, a platform for ultra-sensitive and ultra-specific structural variation detection in genome analysis, and Genoox, the healthcare technology company on a mission to make it easier for doctors, clinicians and researchers to run clinical genetic applications and act on genetic sequencing results, announced today the launch of the Genoox Integrated Platform for identification of structural variants.
While Next-Generation Sequencing (NGS) made the detection of single nucleotide variants (SNV) affordable and straightforward, identifying structural variants (SVs) from NGS data has proven much harder. Despite large scale efforts, algorithmically inferring SVs has limited sensitivity and typically generates large numbers of false positives. Bionano’s Saphyr system combined with its new DLS labeling chemistry and a suite of analysis tools performs much better at calling structural variants of all types than sequencing based methods. By using Genoox technology for aligning short read sequence data with Bionano’s SV calls, the high sensitivity of Bionano calls will be combined with the basepair precision of NGS. The Genoox Integrated Platform further automatically validates and confirms SV calls and integrates and annotates SVs with smaller sequence variants in the same genome. It provides sensitive, accurate detection of structural variation and genetic mutations, not previously possible, helping to speed genetic diagnosis.
The new platform combines raw NGS read data with Bionano-based SV calls from a single patient. Bionano’s SV data are used to guide the alignment of NGS reads. Evidence from both technologies is used simultaneously to provide increased breakpoint accuracy and confidence. Detected SVs, copy number variants, indels and single nucleotide variants are then annotated by aggregating data from multiple clinical and population frequency databases, and automated AI-based classification according to ACMG guidelines. A customizable clinical report on all variants is generated, including Bionano-only and NGS-only calls, reducing the complexity of determining and reporting the pathogenicity of genomic variants.
Mark Borodkin, COO of Bionano, commented: “Bionano genome mapping is the gold standard for comprehensive SV detection, but clinical analysis of patient genomes often requires a complete view of the genome. The Genoox Integrated Platform with Bionano data allows researchers and clinicians to detect, annotate and report on all variants; from SNPs to SVs. We believe this platform will provide an important tool in disease research.”
“Genoox and Bionano are solving some of the biggest problems in genomics with our new integrated platform,” said Amir Trabelsi, co-founder and CEO of Genoox. “The product launch now allows researchers to quickly and easily detect smaller, SNV type mutations, as well as larger, structural variants on one software platform. This will empower researchers and clinicians to gain a deeper understanding of the human genome, more accurately assess impact on biological function, and enable personalized medicine and treatment.”
Genoox and Bionano will begin to co-sell and co-market the integrated platform immediately.
------------------- "Opportunities multiply as they are seized" -- Sun Tzu circa 500 B.C. -------------------