SAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics (NASDAQ: BNGO) participated in the Association for Molecular Pathology (AMP) Annual Meeting, held November 11-15, 2025 in Boston, MA. Key presentations at the conference highlighted how optical genome mapping (OGM) can enhance the detection of structural variants (SVs) with greater clarity and sensitivity than traditional cytogenetic and molecular techniques. Through platform presentations and poster sessions, multiple researchers emphasized the ...

Core Insights - Bionano Laboratories announced a significant increase of 47% in the clinical lab fee schedule for the CPT code 81195, raising it from $1263.53 to $1853.22, effective January 1, 2026, which pertains to optical genome mapping (OGM) for hematologic malignancies [1][2][4] Summary by Sections Payment Determination - The Centers for Medicare & Medicaid Services (CMS) previously set the payment for CPT code 81195 at $1263.53, effective January 1, 2025, based on a crosswalk to an existing code. A request for reconsideration led to a unanimous vote by the clinical diagnostic laboratory test committee to re-price the code to $1853.22, effective January 1, 2026 [2] Importance of CPT Codes - CPT codes for OGM are essential for reimbursement from third-party payers for Bionano Laboratories' laboratory developed tests (LDTs). Currently, there are two codes: 81195 for hematologic malignancy analysis and 81354 for constitutional genetic disease [3] Impact on OGM Services - The increase in reimbursement for CPT code 81195 is expected to facilitate the offering of OGM-based LDTs for hematologic malignancies, as it provides a more favorable reimbursement environment. The new payment level is deemed appropriate for the additional data collection and reporting required for OGM in blood cancers [4] Company Overview - Bionano Laboratories, a subsidiary of Bionano Genomics, specializes in optical genome mapping (OGM) testing and offers a range of diagnostic services. The company aims to transform genome analysis through advanced technologies and provides OGM solutions for various research applications [5][6]

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Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $7.4 million, reflecting a 21% increase compared to Q3 2024. Adjusting for a $0.5 million write-down in 2024, core revenues increased by 12% year over year [6][7] - Non-GAAP gross margin for Q3 2025 was 46%, significantly higher than the 26% reported for Q3 2024 [7][11] - Non-GAAP operating expenses were $9.7 million in Q3 2025, a 40% reduction compared to $16.1 million in Q3 2024 [7][10] Business Line Data and Key Metrics Changes - A record 8,390 flow cells were sold in Q3 2025, reflecting a 7% increase compared to the same period last year [7] - Revenue contributions from consumables and software grew 15% year over year in Q3 2025, representing 72% of the total product mix [9] Market Data and Key Metrics Changes - In Q3 2025, there were 97 new publications demonstrating the value of optical genome mapping, a 10% growth over the same period the previous year [12] - The cumulative number of clinical research genomes published reached nearly 11,500, supporting the adoption of optical genome mapping [12] Company Strategy and Development Direction - The company is focusing on transforming pathology from analog to digital, with a strategy centered on routine users who have established sample flows [4][5] - Four strategic pillars include supporting the installed base, driving software utilization, building reimbursement support, and improving profitability and scalability [5] Management's Comments on Operating Environment and Future Outlook - The company reiterated its full-year 2025 revenue guidance of $26-30 million, expecting Q4 revenues to be in the range of $7.5-$7.9 million [17][18] - Management expressed confidence in the ongoing growth of utilization among routine users, aiming for an average of low 20s samples per week across all routine users [20] Other Important Information - The company completed a $10 million public offering of common stock, enhancing its balance sheet and extending its cash runway into Q3 2026 [8] - The establishment of a second category one CPT code for optical genome mapping is seen as a significant milestone for the community [16][17] Q&A Session Summary Question: What is the potential peak level of utilization for routine use customers? - Management indicated that labs are not sample-limited and that the average utilization is about four samples per week, with a target of reaching the low 20s on average across routine users [19][20] Question: What is the current install base in Japan and its market potential? - Currently, there is one system installed in Japan, with expectations for the market to evolve similarly to the U.S. market over time, particularly in genetic diseases and cell and gene therapy [21][22] Question: Will operating expenses remain stable going forward? - Management intends to keep operating expenses flat, with some areas identified for potential investment [23]

Financial Performance - Revenue reached $7.4 million, a 21% increase compared to Q3 2024[13] - Core revenue increased by 12% compared to Q3 2024[13] - Non-GAAP gross margin improved to 46%, significantly higher than the 26% in Q3 2024[13] - Non-GAAP operating expenses decreased by 40% compared to Q3 2024, totaling $9.7 million[13] Operational Highlights - Flowcells sold increased by 7% to 8,390 compared to Q3 2024[13] - The OGM installed base grew by 4% compared to Q3 2024, reaching 384 systems[13] - Seven new OGM installations were completed in Q3 2025, bringing the year-to-date total to 23[13] Strategic Focus and Outlook - The company completed a $10 million public offering of common stock in September 2025[13] - Cash, cash equivalents, and available-for-sale securities totaled $31.8 million as of September 30, 2025[13] - The company is reiterating its full-year 2025 revenue guidance of $26 - $30 million[30] - The company expects new OGM installations to surpass 25 systems for FY 2025, exceeding prior expectations of 20-25 systems[30]

Revenue and Sales Performance - The installed base of OGM systems grew to 384 as of September 30, 2025, representing a 4% increase from 368 as of September 30, 2024[136] - A total of 8,390 flowcells were sold in the three-month period ended September 30, 2025, a 7% increase from 7,835 flowcells sold in the same period of 2024[136] - Product revenue for the three months ended September 30, 2025, was $6,934,000, compared to $6,021,000 for the same period in 2024, reflecting a year-over-year increase[142] - Total revenue for the three months ended September 30, 2025, was $7.37 million, a 21% increase from $6.07 million in 2024[150] - Product revenue increased by $0.9 million, or 15%, to $6.9 million for the three months ended September 30, 2025, compared to $6.0 million for the same period in 2024[151] - Service and other revenue increased by $0.4 million, or 733%, to $0.4 million for the three months ended September 30, 2025, compared to the same period in 2024[152] - Product revenue decreased by $0.1 million, or 1%, to $19.2 million for the nine months ended September 30, 2025, compared to $19.4 million for the same period in 2024, driven by a 30% decrease in instrument sales[165] - Service and other revenue decreased by $1.9 million, or 60%, for the nine months ended September 30, 2025, due to the discontinuation of certain clinical service offerings, contributing no revenue in 2025 compared to $1.7 million in 2024[166] Financial Performance and Losses - The net loss for the three months ended September 30, 2025, was $8.5 million, with an accumulated deficit of $711.7 million as of the same date[147] - The company incurred net losses of $18.5 million for the nine months ended September 30, 2025, compared to $91.9 million in 2024, with cash and cash equivalents of $3.1 million as of September 30, 2025[178] - Net loss for the three months ended September 30, 2025, was $8.5 million, an improvement of $35.7 million, or 81%, from a net loss of $44.2 million in 2024[150] Operating Expenses and Cost Management - Total operating expenses decreased by $23.5 million, or 66%, to $11.9 million for the three months ended September 30, 2025, compared to $35.5 million in 2024[150] - Cost of product revenue decreased by $10.4 million, or 73%, to $3.8 million for the three months ended September 30, 2025, compared to $14.3 million in 2024[153] - Research and development expenses decreased by $1.9 million, or 40%, to $2.8 million for the three months ended September 30, 2025, compared to $4.7 million in 2024[157] - Selling, general and administrative expenses decreased by $0.4 million, or 4%, to $9.1 million for the three months ended September 30, 2025, compared to $9.5 million in 2024[158] - Research and Development (R&D) expenses decreased by $13.2 million, or 62%, to $8.1 million for the nine months ended September 30, 2025, due to headcount reductions and decreased consulting fees[172] - Selling, General and Administrative (SG&A) expenses decreased by $13.7 million, or 34%, to $26.4 million for the nine months ended September 30, 2025, driven by reductions in salaries and professional fees[173] Cash Flow and Liquidity - As of September 30, 2025, the company had $3.1 million in cash and cash equivalents, $18.5 million in short-term investments, and $10.3 million in restricted short-term investments[194] - Net cash used in operating activities was $12.2 million for the nine months ended September 30, 2025, a decrease of $50.2 million compared to $62.4 million in the same period in 2024[198] - Net cash provided by financing activities was $22.4 million during the nine months ended September 30, 2025, compared to net cash used of $17.6 million in the same period in 2024, an increase of $40.0 million[200] - The company expects to require additional capital to fund operating expenses and capital expenditures into the third quarter of 2026[192] - The company anticipates that its available cash balance will not be sufficient to operate its business for the next twelve months, indicating substantial doubt about its ability to continue as a going concern[194] Market and Operational Challenges - The company has experienced a slowdown in its Asia Pacific business, negatively impacting its manufacturing partners reliant on government funding[137] - The company is closely monitoring the potential impact of the U.S. government shutdown on its manufacturing partners and customers[141] - The company expects to continue incurring significant expenses and operating losses, raising substantial doubt about its ability to continue as a going concern within the next 12 months[147] Stock and Securities - The combined purchase price for each share of common stock and accompanying January Purchase Warrant was $15.120, with gross proceeds from the January 2025 offering approximately $10.0 million[187] - The September 2025 Offering included 4.9 million shares of common stock and generated approximately $10.0 million in gross proceeds[189] - The company sold approximately 2.0 million shares of common stock under the ATM Agreement at an average price of $3.68 per share, generating gross proceeds of approximately $7.4 million[203] - The company has a universal shelf registration statement allowing for aggregate offerings of up to $400.0 million of various securities[202] Accounting and Reporting - The management's discussion and analysis is based on unaudited condensed consolidated financial statements prepared in accordance with generally accepted accounting principles[206] - There have been no changes to critical accounting policies and estimates during the nine months ended September 30, 2025[207] - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[210]

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Financial Performance - Total revenue for Q3 2025 was $7.4 million, a 21% increase from $6.1 million in Q3 2024[5] - Total revenue for Q3 2025 was $7,367,000, a 21.3% increase from $6,073,000 in Q3 2024[20] - Product revenue increased to $6,934,000 in Q3 2025 from $6,021,000 in Q3 2024, representing a 15.2% growth[20] - Net loss for Q3 2025 was $8,503,000, compared to a net loss of $44,246,000 in Q3 2024, indicating a significant reduction in losses[20] Revenue Guidance - Full year 2025 revenue guidance is reiterated in the range of $26.0 to $30.0 million[7] - Q4 2025 revenue is expected to be between $7.5 and $7.9 million[7] Cost Management - Operating expenses were reduced by 66% to $11.9 million, with non-GAAP operating expenses down 40% to $9.7 million[5] - Research and development expenses for Q3 2025 were $2,844,000, down from $4,717,000 in Q3 2024, reflecting a 39.7% decrease[20] - Selling, general and administrative expenses were $9,064,000 in Q3 2025, slightly lower than $9,464,000 in Q3 2024[20] Profitability Metrics - Gross margin improved to 46%, up from (139)% in Q3 2024, with non-GAAP gross margin also at 46% compared to 26% in the prior year[5] - GAAP gross margin for Q3 2025 improved to 46% from a negative 139% in Q3 2024[22] - Non-GAAP gross profit for Q3 2025 was $3,401,000, compared to $1,597,000 in Q3 2024, showing a substantial improvement[22] Cash and Assets - The company ended Q3 2025 with cash and equivalents totaling $31.8 million[5] - Total current assets increased to $48,800,000 as of September 30, 2025, up from $39,489,000 as of December 31, 2024[18] - Total stockholders' equity increased to $49,799,000 as of September 30, 2025, up from $35,375,000 as of December 31, 2024[18] Product and Installation Metrics - Consumables and software revenues increased by 15% compared to the prior year[5] - The company sold 8,390 nanochannel array flowcells in Q3 2025, a 7% increase from 7,835 in Q3 2024[5] - Installed base of OGM systems reached 384, representing a 4% increase from 368 systems at the end of Q3 2024[5] - New OGM system installations are anticipated to exceed 25 for the full year 2025, up from previous expectations of 20 to 25[7] Liabilities - Total liabilities decreased to $29,263,000 as of September 30, 2025, down from $41,295,000 as of December 31, 2024[18]

Core Insights - Bionano Genomics reported a total revenue of $7.4 million for Q3 2025, marking a 21% increase from $6.1 million in Q3 2024, despite a prior year write-down of $0.5 million in clinical services revenue [5][20] - The company has shifted its business model to focus on consumables and software utilization, which has led to improved margins and reduced operating expenses [2][5] - Bionano's gross margin for Q3 2025 was 46%, a significant recovery from (139)% in Q3 2024, indicating a positive trend in financial performance [5][20] Financial Performance - Total revenue for Q3 2025 was $7.4 million, up 21% from $6.1 million in Q3 2024 [5] - Consumables and software revenues increased by 15% year-over-year [5] - Operating expenses were reduced by 66% to $11.9 million, and non-GAAP operating expenses decreased by 40% to $9.7 million [5][20] - The company ended Q3 2025 with cash and equivalents totaling $31.8 million [5] Business Highlights - Bionano sold 8,390 nanochannel array flowcells in Q3 2025, a 7% increase from 7,835 flowcells sold in Q3 2024 [5] - The installed base of optical genome mapping (OGM) systems reached 384, a 4% increase from 368 systems at the end of Q3 2024 [5] - The company completed a public offering in September 2025, raising $10 million in gross proceeds [6] Market Outlook - Bionano anticipates Q4 2025 revenue in the range of $7.5 to $7.9 million and full-year revenue between $26.0 to $30.0 million [11] - The company expects to install over 25 new OGM systems in 2025, exceeding previous expectations of 20 to 25 installations [11]

Core Insights - Bionano Genomics announced a study demonstrating that optical genome mapping (OGM) can effectively address limitations of targeted RNA-sequencing (RNA-seq) in detecting gene rearrangements in acute leukemias [1][4][5] Summary of Findings - The study published by The University of Texas MD Anderson Cancer Center indicates that OGM can identify a higher proportion of clinically significant structural variants (SVs) compared to a 108-gene targeted RNA-seq panel [4][5] - A total of 234 gene rearrangements or fusions were detected by OGM and/or RNA-seq across 206 subjects, representing 43.6% of a cohort of 467 acute leukemia research subjects [8] - OGM uniquely identified 37 events (15.8%), while RNA-seq uniquely identified 22 events (9.4%), highlighting the complementary nature of both technologies [8] - RNA-seq detected only 20.6% of the enhancer-hijacking events identified by OGM, emphasizing the importance of OGM in detecting critical gene rearrangements [8] Company Overview - Bionano Genomics provides genome analysis solutions aimed at transforming the understanding of the genome through OGM, diagnostic services, and software [6] - The company offers OGM solutions applicable across various research domains, along with a platform-agnostic genome analysis software and nucleic acid extraction solutions [6]