Core Viewpoint - Bionano Genomics' optical genome mapping (OGM) technology has demonstrated the ability to identify a specific variant in acute promyelocytic leukemia (APL) that is often missed by traditional cytogenetic methods, suggesting OGM could enhance therapy selection and patient management in blood cancers [1][2][3]. Group 1: OGM Technology and Findings - OGM successfully detected a PML::RARA fusion variant in APL that was not identified by karyotyping and was non-informative by FISH [2][7]. - APL, a subtype of acute myelogenous leukemia (AML), has a treatment response rate to all-trans retinoic acid (ATRA) and arsenic trioxide (ATO), but conventional cytogenetics fails to identify actionable variants in approximately 13% of APL cases [2][7]. - The identification of the PML::RARA fusion variant by OGM aligns with previous findings that OGM can detect both variants identified by standard cytogenetics and additional pathogenic variants that are often missed [2][7]. Group 2: Company Overview - Bionano Genomics specializes in genome analysis solutions aimed at transforming genomic insights through OGM, diagnostic services, and software [4]. - The company provides OGM solutions applicable across various research domains, along with a platform-agnostic genome analysis software and nucleic acid extraction solutions utilizing proprietary isotachophoresis technology [4]. - Bionano also offers OGM-based diagnostic testing services through its subsidiary, Lineagen, Inc. [4].

Core Viewpoint - Bionano Genomics, Inc. has successfully closed a registered direct offering, raising approximately $10 million, with potential additional proceeds from warrants also amounting to around $10 million if fully exercised [1][3]. Group 1: Offering Details - The offering consisted of 39,682,540 shares of common stock and warrants to purchase an equal number of shares, priced at $0.252 per share [1]. - The warrants have an exercise price of $0.252 per share and will be exercisable upon stockholder approval, expiring five years after such approval [1]. - H.C. Wainwright & Co. served as the exclusive placement agent for this offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for general corporate purposes, including working capital, research and development, repayment of existing debt, and capital expenditures [3]. Group 3: Regulatory Information - The securities were offered under a shelf registration statement filed with the SEC, which became effective on May 8, 2023 [4]. - A final prospectus supplement related to the offering has been filed with the SEC and is available on their website [4]. Group 4: Company Overview - Bionano Genomics provides genome analysis solutions aimed at enhancing research and clinical applications, focusing on optical genome mapping and diagnostic services [6]. - The company also offers a platform-agnostic genome analysis software solution and nucleic acid extraction services using proprietary technology [6].

SAN DIEGO, Jan. 03, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that it has entered into a definitive agreement with certain institutional investors for the purchase and sale of an aggregate of 39,682,540 shares of its common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 39,682,540 shares of common stock (the “Warrants”), at a combined offering price of $0.252 per share of common stock (or per common stock equivalent) and accompanying W ...

In the largest study to date of bone and soft tissue tumors, OGM detected 100% of the variants found by multiple standard techniques, including karyotyping, fluorescent in-situ hybridization (FISH) & gene fusion assaysOGM was also more sensitive, including detection of diagnostic or pathogenic variants missed by karyotype in 74% (14/19) of cases that failed or were negative by karyotypingWhen OGM results and next-generation sequencing (NGS) results were combined, diagnostic and pathogenic structural variant ...

SAN DIEGO, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (BNGO), today announced that on December 19, 2024, it published an open letter to stockholders in support of its proposals at its upcoming special meeting of stockholders, a copy of which is included at the end of this press release. Details of the Special Meeting of Stockholders The special meeting of stockholders will be held virtually, via live webcast at www.virtualshareholdermeeting.com/BNGO2025SM, on January 15, 2025, at 10:00 a.m. Pa ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________________________________ FORM 10-Q _________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file numb ...

Financial Data and Key Metrics - Q3 2024 revenue was $6.1 million, a 35% YoY decrease, driven by a 29% reduction from discontinued clinical services and a 6% decrease from delayed instrument sales [10] - GAAP operating expenses decreased by 69% to $35.5 million, while non-GAAP operating expenses decreased by 49% to $16.1 million [17] - Operating cash burn reduced by 46% to $14 million compared to $26 million in the prior year [17] - GAAP gross margin was negative 139%, impacted by $9.8 million in one-time charges, while non-GAAP gross margin was 26% [18] - Cash and cash equivalents stood at $23.4 million as of September 30, 2024, with $11.4 million subject to restrictions [17] Business Line Data and Key Metrics - Core product and software sales were $6.6 million, offset by a $500,000 write-down of aged receivables [10] - OGM installed base grew to 368 systems, a 22% increase YoY, with 7,835 flow cells sold, a 27% increase YoY [11][12] - Publications grew by 12% YoY to 83 in Q3, with clinical research subjects covered increasing by 82% [13] - Stratys system shipments continued, with demand strong in Europe, the US, Canada, and Israel [16] Market Data and Key Metrics - The company shifted its go-to-market strategy to focus on conserving cash and driving utilization among routine users, particularly in cytogenomics [8] - The OGM installed base growth rate slowed due to the strategic shift and cost-saving initiatives [11] - Reimbursement initiatives progressed, with a Category 1 CPT code established for OGM in hematologic malignancies [15] Company Strategy and Industry Competition - The company reduced headcount from 426 in May 2023 to 125 as of September 2024, with further reductions expected to below 100 by 2025 [7] - The focus is on driving adoption of VIA software and increasing utilization among existing customers, with an emphasis on adding new assays [20] - The company aims to improve gross margins by reducing COGS and increasing sample pull-through [20] Management Commentary on Operating Environment and Future Outlook - Management highlighted the challenges of transitioning to a streamlined team but noted signs of stability, including growth in consumable sales [9] - The company expects Q4 revenues to be between $6 million and $7 million, with full-year revenues projected at $28 million to $30 million [21] - Management emphasized the importance of cash preservation and reaching profitability over growth at any cost [21] Other Important Information - The company completed two registered direct offerings, raising $10 million in July and $3 million in October, with potential additional proceeds from warrants [19] - A special meeting of stockholders is scheduled for November 27, 2024, to approve the warrants [19] Q&A Session Summary Question: Status of the Ionic sample prep system - The Ionic sample prep system is progressing, with a full commercial rollout expected in 2025 [25] Question: Growth potential for target accounts - The 150 target customers account for approximately 80% of consumables revenue, with significant growth potential as they add more indications [27][28] Question: COGS reduction levers - COGS reduction will come from transitioning to lower-cost foundries, consolidating facilities, and spreading overhead over more units [30] Question: Consumables growth rate in 2025 - Growth in consumables is expected to accelerate due to reimbursement initiatives, routine use adoption, and VIA software adoption [33][35] Question: Delays impacting top line - Delays in system purchases were due to customers underestimating approval times, with some expected to be completed in Q4 [36] Question: Partnership opportunities - The company remains opportunistic about partnerships but has no definitive plans currently [37] Question: System placements and Stratys launch - The company expects system placements to remain around 5 per quarter in 2025, with Stratys demand driven by higher throughput and workflow advantages [39][42] Question: Guidance reduction components - Guidance reduction factors in lower capital equipment sales, discontinued clinical services, and potential additional write-downs [45]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 10, 2024 Bionano Genomics, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) Delaware 001-38613 26-1756290 9540 Towne Centre Drive, Suite 100 San Diego, California 92121 ( ...

Q3 2024 revenue was $6.1 million, which comprises $6.6 million in core product and software sales which is offset by $0.5 million because of a write-down of aged receivables tied to discontinued clinical service products. Q3 2024 revenue represents a 35% decrease from Q3 2023Total installed base of 368 optical genome mapping (OGM) systems as of Q3 2024, which represents a 22% increase over Q3 2023Sold 7,835 nanochannel array flowcells in Q3 2024, which represents a 27% increase from the number of flowcells ...

SAN DIEGO, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that it adjourned its reconvened Special Meeting of Stockholders originally held on October 2, 2024 and subsequently adjourned to October 30, 2024 (the “Special Meeting”) because a quorum was not present at the time of the reconvened meeting. Based on preliminary reports as of October 30, 2024, approximately 30.7% of total shares outstanding as of the record date have submitted their votes, whereas 33.3% of to ...