Bionexus Gene Lab (BGLC)
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BioNexus Gene Lab Corp. Completes Strategic Investment in Fidelion Diagnostics; Secures 15% Equity Stake in Global AI-Oncology Platform and Exclusive Southeast Asian Rights for VitaGuard™
Globenewswire· 2025-12-03 13:45
Core Insights - BioNexus Gene Lab Corp. has completed a strategic transaction with Fidelion Diagnostics and Tongshu Biotechnology, enhancing its position in precision diagnostics and gene-based technologies [1][2] Strategic Acquisition - BGLC has acquired a 15% equity stake in Fidelion Diagnostics, which holds exclusive global commercial rights (excluding Greater China) to the VitaGuard™ Tumor-Naïve AI-oncology platform, providing BGLC shareholders with participation in Fidelion's international expansion [3] - The transaction allows BGLC to secure exclusive, perpetual rights to manufacture, market, and distribute the VitaGuard™ platform across all ASEAN markets, establishing it as the sole provider of this technology in a rapidly growing oncology region [4] Market Opportunity - The healthcare landscape in Southeast Asia is modernizing, with increasing demand for precision diagnostics and non-invasive cancer management tools, positioning BGLC to capture early-mover advantage [5] Transaction Structure - The deal was structured to maximize balance-sheet strength and minimize dilution, enabling BGLC to accelerate market entry and expand regional sales functions while preserving shareholder value [6] Value Creation Model - The transaction establishes a dual-asset value creation model, combining a high-margin commercial asset through exclusive ASEAN rights and an investment asset via the equity stake in Fidelion, ensuring benefits from both immediate commercial activity and long-term enterprise value creation [7][8] Financial Arrangement - The equity stake was acquired through a non-cash share exchange, aligning long-term interests between BGLC and Fidelion, while the commercial license fee is payable over 24 months, matching outflows to expected inflows [9] Management Commentary - The CEO of BGLC emphasized that this partnership elevates the company's strategic position, providing two distinct value levers: regional commercial expansion and exposure to Fidelion's international growth [10]
BioNexus Gene Lab Corp. (Nasdaq: BGLC) Secures $500 Million Equity Facility From ARC Group International to Support Expansion of Precision Diagnostics, CDMO Operations, and Therapeutic Commercialization
Globenewswire· 2025-12-02 13:05
Core Insights - BioNexus Gene Lab Corp. (BGLC) has entered into a $500,000,000 Equity Purchase Agreement with ARC Group International Ltd. to enhance its capital position for strategic initiatives [1][4] - The agreement allows BGLC to issue and sell registered shares of its common stock to ARC over a 36-month period, with a one-time fee of 175,000 shares issued at a price of $4.32 [2] - The facility complements BGLC's existing $20 million At-The-Market program, providing financial flexibility while maintaining control over capital deployment [3] Advancing Precision Oncology - BGLC has executed a licensing agreement with Fidelion Diagnostics to commercialize the VitaGuard™ MRD assay, aimed at early cancer detection and monitoring [5] - The new facility will support clinical adoption and infrastructure development for MRD testing across Southeast Asia, including Malaysia, Singapore, Indonesia, and Thailand [5] Supporting CDMO Transformation - BGLC is expanding into contract development and manufacturing organization (CDMO) services, enhancing its capabilities in biologics production and high-performance diagnostics [6] - The facility will enable investments in quality systems, manufacturing capacity, and strategic partnerships aligned with global CDMO standards [6] Advancing Therapeutic Opportunities - BGLC is progressing a strategic partnership with BirchBioMed Inc. for a therapeutic candidate targeting fibrosis and skin regeneration [7] - The facility provides capital optionality to support clinical and regulatory preparations as the partnership moves forward [7] Company Overview - BioNexus Gene Lab Corp. is focused on precision medical diagnostics and expanding into contract development and manufacturing services across Southeast Asia [9] - The company is headquartered in Kuala Lumpur, Malaysia, and aims to enhance its capabilities in oncology diagnostics and biologics development [9]
BioNexus Gene Lab Corp. (Nasdaq: BGLC) and Fidelion Diagnostics Execute Exclusive Southeast Asia License for VitaGuard™ MRD Platform as Part of Strategic Alliance with Tongshu Gene
Globenewswire· 2025-12-01 13:00
Core Insights - BioNexus Gene Lab Corp. (BGLC) has entered into an Exclusive Intellectual Property License Agreement with Fidelion Diagnostics for the VitaGuard™ minimal residual disease (MRD) liquid biopsy platform in Southeast Asia [1][2][3] License Agreement Details - The license grants BGLC exclusive, irrevocable, royalty-free rights to use, develop, manufacture, market, distribute, and sell VitaGuard-based products and services in Southeast Asia [3] - BGLC will pay Fidelion a US$2 million license fee in 24 equal monthly installments and commit to at least US$500,000 in VitaGuard reagent and system purchases within the first 24 months [4] - The agreement is structured as a perpetual license, ensuring rights remain even if ownership of the underlying patents changes [5] Strategic Framework - The license agreement is part of a broader Share Subscription and Shareholders' Agreement, which positions BGLC as a strategic shareholder in Fidelion [2][6] - Management believes this agreement transforms a strategic framework into an operational business, enhancing BGLC's position in the MRD testing market [7] Market Potential - The global liquid biopsy market is projected to grow from approximately US$13.3 billion in 2025 to over US$22.88 billion by 2030, indicating a significant compound annual growth rate [9] - The MRD market is expected to increase from about US$1.4 billion in 2024 to roughly US$2.5 billion by 2029, representing a CAGR of over 12% [10] Regional Insights - Southeast Asia faces a rising cancer burden, with WHO estimating around 2.3–2.4 million new cancer cases and 1.5 million cancer deaths in 2022, with projections of an 80–85% increase in new cases by 2050 [13] - The region remains underpenetrated in advanced molecular diagnostics, with limited access to MRD testing outside a few top centers [14] - BGLC aims to establish itself as a first mover in the MRD market in Southeast Asia, focusing on building a recurring-revenue platform and a top-tier lab network [15]
Bionexus Gene Lab (BGLC) - 2025 Q3 - Quarterly Report
2025-11-14 22:21
Financial Performance - As of September 30, 2025, the Company recorded a net loss of $1,948,490 and negative cash flows from operating activities of $2,799,444, with an accumulated deficit of $5,391,110[38]. - For the nine months ended September 30, 2025, net revenue was $6,941,151, a slight decrease from $6,986,791 in the same period of 2024, representing a decline of approximately 0.65%[109]. - The net loss attributable to common shareholders for the nine months ended September 30, 2025, was $708,991, compared to a net loss of $1,345,370 for the same period in 2024, indicating an improvement of approximately 47%[135]. - The net loss attributable to common shareholders for the nine months ended September 30, 2025, was $1,948,490, compared to a net loss of $1,250,023 in 2024, representing an increase in loss of approximately 55.9%[140]. - For the three months ended September 30, 2025, the Company reported revenue of $2,543,823, a decrease of 3.3% compared to $2,630,376 for the same period in 2024[212]. - The gross profit for the three months ended September 30, 2025, was $377,685, representing an increase of 15.6% from $326,536 in the prior year[212]. - The Company experienced total other income of $107,760 for the three months ended September 30, 2025, significantly lower than $465,527 in the same period of 2024[212]. - Total operating expenses for the nine months ended September 30, 2025, were $1,187,954, compared to $2,129,685 in the same period of 2024, reflecting a decrease of approximately 44%[135]. Revenue and Segments - Revenue from the trading of industrial chemicals was $6,929,849 for the nine months ended September 30, 2025, compared to $6,975,567 in 2024, indicating a decrease of about 0.66%[109]. - The genomic screening services segment generated revenue of $4,768, while the trading of industrial chemicals segment contributed $2,539,055 for the three months ended September 30, 2025[135]. - Chemrex accounted for $2,539,055 (99.8%) of total revenue, a decrease of 3.4% from $2,627,813 (99.9%) in the previous year, primarily due to lower sales volume[218]. Assets and Liabilities - As of September 30, 2025, the Company's trade receivables amounted to $2,193,935, an increase from $1,894,448 as of December 31, 2024, representing a growth of approximately 15.9%[84]. - The total net trade receivables stood at $1,522,158 as of September 30, 2025, up from $1,376,571 as of December 31, 2024, indicating an increase of 10.6%[84]. - The Company has operating lease right-of-use assets of $186,082 as of September 30, 2025, down from $215,243 as of December 31, 2024, a decrease of 13.5%[95]. - Operating lease liabilities decreased to $183,746 as of September 30, 2025, from $210,557 as of December 31, 2024, representing a decline of 12.7%[96]. - As of September 30, 2025, total segment assets amounted to $7,621,228, down from $10,433,848 as of December 31, 2024, indicating a decrease of approximately 26.9%[142]. Cash and Liquidity - The Company maintains cash balances with multiple financial institutions in Malaysia, with deposits insured up to RM250,000 (approximately USD 55,000) per depositor[39]. - As of September 30, 2025, the Company had cash and cash equivalents of $1.36 million and total liquidity exceeding $5 million, providing a solid foundation for operational continuity and strategic investments[173]. - The Company is actively exploring additional capital-raising mechanisms, including at-the-market offerings and private placements, subject to Nasdaq and SEC compliance[174]. Credit and Allowances - The allowance for expected credit losses increased to $671,777 as of September 30, 2025, compared to $517,877 as of December 31, 2024, reflecting a rise of 29.6%[84]. - The Company applies a historical loss rate matrix for trade receivables, adjusted for forward-looking information and macroeconomic trends relevant to the industries in which customers operate[40]. - The allowance for credit losses is based on historical collection experience, aging of receivables, and current economic conditions, with specific allowances for customers with known financial difficulties[40]. Strategic Initiatives - The Company announced a strategic partnership with ML Tech to optimize Ethereum-based growth strategies, enhancing its position in digital asset management[146]. - A non-binding term sheet was entered into with Fidelion Diagnostics for exclusive commercialization rights of the VitaGuard™ MRD platform in Southeast Asia, with regulatory submissions planned for 2026[150]. - The Company plans to lead regulatory submissions for the VitaGuard™ MRD platform, capable of detecting cancer recurrence at variant allele frequencies as low as 0.02%, with a cost per test expected to be under $300[190]. - The Board of Directors authorized the strategic repositioning of Chemrex Corporation into a biotechnology-focused contract development and manufacturing organization, reallocating up to MYR 10 million for operational development[151]. Accounting and Compliance - The Company is evaluating the impact of ASU 2023-09 on its consolidated financial statements, which expands income tax disclosure requirements and is effective for annual reporting periods beginning after December 15, 2024[74]. - The Company does not expect any other recently issued accounting pronouncements to have a significant effect on its consolidated financial statements[75]. - The Company successfully achieved full Nasdaq compliance in April 2025, reinforcing market stability and investor confidence[187]. Stock and Shareholder Information - The company executed a one-for-ten reverse stock split on April 1, 2025, reducing the number of outstanding shares from 17,967,663 to 1,796,597[125]. - The Series Z Preferred Stock was created to facilitate a reverse stock split proposal, which was approved by shareholders on March 19, 2025[123]. - The Company filed a registration statement to register up to $100 million of securities and entered into an Equity Distribution Agreement for an aggregate offering price of up to $20 million[159].
BioNexus Gene Lab Corp. (Nasdaq: BGLC) Announces Strategic Agreements with Fidelion Diagnostics for Southeast Asia MRD Commercialization
Globenewswire· 2025-11-12 13:00
Core Insights - BioNexus Gene Lab Corp. has entered into definitive agreements with Fidelion Diagnostics and Tongshu Biotechnology to commercialize the VitaGuard™ liquid-biopsy platform for minimal residual disease (MRD) testing [1][2][3] Strategic Highlights - The collaboration aims to support the development and commercialization of MRD testing in Southeast Asia, leveraging aligned ownership and operational support [2][3] - The goal is to replicate the cost reduction seen with the sub-$1,000 genome for MRD testing, making it more accessible [2][5] Transaction Details - BGLC will receive new shares from Fidelion equal to at least 15% of Fidelion's fully diluted share capital, while Fidelion will receive restricted BGLC shares equal to 19.9% of BGLC's pre-money outstanding shares [14] - The completion of the agreements is contingent upon an IP License Agreement granting BGLC exclusive commercialization rights across ASEAN [14] Clinical and Economic Impact - VitaGuard™ can detect circulating tumor DNA (ctDNA) down to 0.02% variant allele frequency at approximately 20,000× depth, recovering around 95% cfDNA [15] - The collaboration intends to broaden access to MRD testing in Southeast Asia, with an initial focus on Singapore and Malaysia [15] Next Steps - The parties expect to complete the agreements following the satisfaction of remaining conditions precedent within the specified period [6]
BioNexus Gene Lab Corp. Files $100 Million Shelf Registration and Establishes $20 Million At-the-Market Program to Advance Strategic Growth Opportunities
Globenewswire· 2025-11-10 13:00
Core Viewpoint - BioNexus Gene Lab Corp. has filed a registration statement with the SEC to register up to $100 million of securities, aiming to enhance financial flexibility and support growth initiatives in precision diagnostics and gene-based technologies [1][3][4] Group 1: Financial Strategy - The company has entered into an Equity Distribution Agreement with Maxim Group LLC, allowing it to offer and sell up to $20 million of its common stock through an at-the-market (ATM) program [2] - The shelf registration and ATM facility are expected to provide structural capital readiness to support the execution of growth and operating initiatives [4] Group 2: Growth Initiatives - BioNexus is focusing on expanding its footprint in precision oncology, regenerative medicine, and contract biologics manufacturing through its subsidiaries MRNA Scientific Sdn. Bhd. and Chemrex Corporation Sdn. Bhd. [3][6] - Recent partnerships with Fidelion Diagnostics Pte Ltd. and BirchBioMed Inc. are part of the company's strategy to drive growth [3] Group 3: Market Positioning - The company aims to transform into a next-generation biotechnology platform serving both Asian and U.S. markets [4] - BioNexus is building a platform that spans precision medicine, biologics manufacturing, and AI-integrated healthcare solutions [6]
BioNexus Gene Lab Corp Signs Strategic Partnership Term Sheet with BirchBioMed Inc.
Globenewswire· 2025-10-20 12:00
Core Insights - BioNexus Gene Lab Corp (BGLC) has entered into a non-binding Strategic Partnership Term Sheet with BirchBioMed Inc. to advance the FS2 topical platform and enhance BGLC's biotech presence in Asia [1][2] Group 1: Partnership Details - BGLC will lead Birch's upcoming USD 10 million financing round through a strategic equity investment, aiming to accelerate the commercialization of Birch's FS2 topical platform in Southeast Asia [2] - The partnership combines BGLC's regional market access and infrastructure with Birch's innovative science in dermal regeneration and fibrosis control [2][5] Group 2: Proposed Terms - The Term Sheet is non-binding except for exclusivity and confidentiality provisions, which are binding for 60 days from execution [4] - BGLC will issue common shares representing 4.99 percent of its outstanding shares to Birch as part of the investment, while Birch will issue 1.5 million common shares to BGLC [9] Group 3: Strategic Support and Next Steps - BGLC will provide Birch with market intelligence, regulatory and clinical-trial strategy guidance, and assistance in securing licensees and commercialization partners for the FS2 topical cream in Malaysia and Singapore [9] - Both parties plan to negotiate a definitive agreement that includes customary representations, warranties, and closing conditions [9]
Bionexus Gene Lab (BGLC) - 2025 Q2 - Quarterly Report
2025-08-18 20:48
PART I – FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements for the six months ended June 30, 2025, reporting a **net loss of $1.24 million** and a decrease in total assets to **$9.42 million** Condensed Consolidated Balance Sheet Summary | Account | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | **Total Current Assets** | $6,379,326 | $7,430,449 | | **Total Assets** | $9,421,205 | $10,433,848 | | **Total Current Liabilities** | $1,757,821 | $1,951,303 | | **Total Liabilities** | $1,899,168 | $2,111,044 | | **Total Stockholders' Equity** | $7,522,037 | $8,322,804 | Condensed Consolidated Statements of Operations Summary | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Revenue** | $4,397,328 | $4,356,415 | | **Gross Profit** | $711,515 | $653,751 | | **(Loss)/Profit from Operations** | $(1,229,711) | $180,140 | | **Net (Loss)/Profit** | $(1,239,499) | $95,347 | | **EPS (Basic and Diluted)** | $(0.690) | $0.054 | Condensed Consolidated Statements of Cash Flows Summary | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net Cash Used in Operating Activities** | $(1,561,979) | $(709,428) | | **Net Cash (Used in)/Generated from Investing Activities** | $(44,178) | $66,960 | | **Net Cash (Used in)/Generated from Financing Activities** | $(1,890) | $202,344 | | **Net Change in Cash and Cash Equivalents** | $(1,349,777) | $(555,503) | | **Cash and Cash Equivalents, End of Period** | $1,537,189 | $3,962,207 | [Note 2: Summary of Significant Accounting Policies](index=8&type=section&id=NOTE%202%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Management concluded prior substantial doubt about going concern is alleviated, with key policies including point-in-time revenue recognition and FIFO inventory - Management has concluded that the conditions that previously raised **substantial doubt** about the Company's ability to continue as a going concern are **alleviated** based on its evaluation of liquidity, capital actions, and planned operating initiatives[39](index=39&type=chunk) - Revenue is recognized at a **point in time** when control of promised goods or services is transferred to the customer[56](index=56&type=chunk)[57](index=57&type=chunk) [Note 9: Revenue](index=18&type=section&id=NOTE%209%20%E2%80%93%20REVENUE) Total revenue for the six months ended June 30, 2025, was **$4.40 million**, primarily from industrial chemicals trading, with Malaysia as the largest market Revenue by Product Line (Six Months Ended June 30) | Product/Service Line | 2025 | 2024 | | :--- | :--- | :--- | | Trading of industrial chemicals | $4,390,794 | $4,347,754 | | Screening services and related sales | $6,534 | $8,661 | | **Net revenue** | **$4,397,328** | **$4,356,415** | - Revenue is recognized at a **point in time** when control of goods is transferred or when a final report for services is delivered to the customer[110](index=110&type=chunk)[111](index=111&type=chunk) [Note 12: Stockholders' Equity](index=20&type=section&id=NOTE%2012%20%E2%80%93%20STOCKHOLDERS%27%20EQUITY) A **1-for-10 reverse stock split** effective April 7, 2025, reduced outstanding shares to **1,796,597** to regain Nasdaq compliance - On April 1, 2025, the company filed to effect a **1-for-10 reverse stock split** of its common stock, which became effective on April 7, 2025[133](index=133&type=chunk)[200](index=200&type=chunk) - Post-split, the number of issued and outstanding shares was reduced to **1,796,597** from 17,967,663[133](index=133&type=chunk) [Note 13: Segment Information](index=22&type=section&id=NOTE%2013%20%E2%80%93%20SEGMENT%20INFORMATION) The company operates three segments, with industrial chemicals generating most revenue but reporting an operating loss of **$(557,349)** for the six months ended June 30, 2025 Segment Performance (Six Months Ended June 30, 2025) | Segment | Revenue | (Loss)/Profit from Operations | | :--- | :--- | :--- | | Trading of industrial chemicals | $4,390,794 | $(557,349) | | Provision for genomic screening services | $6,534 | $(231,063) | | Investment holding | $ - | $(441,299) | | **Total** | **$4,397,328** | **$(1,229,711)** | - The company expects the **MRNA Scientific (genomic screening)** segment to benefit from new technology integration, while the **Chemrex (industrial chemicals)** segment's relative contribution is expected to decrease as it transitions to a **CDMO model**[136](index=136&type=chunk) [Note 15: Subsequent Events](index=27&type=section&id=NOTE%2015%20%E2%80%93%20SUBSEQUENT%20EVENTS) Post-quarter, the company entered a non-binding term sheet with Fidelion Diagnostics and approved Chemrex's strategic repositioning into a biotechnology-focused CDMO - On July 30, 2025, the company entered a **non-binding term sheet** with **Fidelion Diagnostics** for a proposed cross-equity investment and exclusive commercialization rights for Fidelion's **VitaGuard™ MRD platform** in Southeast Asia[158](index=158&type=chunk) - On July 31, 2025, the Board approved the **strategic repositioning of Chemrex Corporation into a biotechnology-focused CDMO** and authorized up to **MYR 10 million** for its development[159](index=159&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Q2 2025 saw **14.5% YoY revenue growth** but an operating loss of **$(611,293)** due to higher expenses, alongside strategic shifts to biotech and a new Ethereum treasury strategy Q2 2025 vs Q2 2024 Performance | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Revenue** | $2,260,253 | $1,974,564 | | **Gross Profit** | $368,022 | $288,720 | | **(Loss)/Profit from Operations** | $(611,293) | $259,168 | | **Net (Loss)/Profit** | $(616,172) | $199,104 | - The increase in operating loss was primarily driven by a **345.8% surge** in Sales and Marketing expenses to **$608,427** in Q2 2025, mainly due to higher compensation at the Chemrex subsidiary[220](index=220&type=chunk) - The company **regained full Nasdaq compliance** in April 2025 after implementing a **1-for-10 reverse stock split** to address the minimum bid price requirement[182](index=182&type=chunk)[188](index=188&type=chunk) - Key strategic initiatives include a potential alliance with **Fidelion Diagnostics**, the transition of **Chemrex into a biotech CDMO**, and a new **Ethereum-focused treasury strategy**, although no digital assets were held as of June 30, 2025[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is exempt from providing quantitative and qualitative disclosures about market risk - The Company is **not required** to provide information for this item as it qualifies as a "**smaller reporting company**" under Regulation S-K[266](index=266&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were **not effective** as of June 30, 2025, due to significant deficiencies at Chemrex, prompting a remediation plan - The CEO and CFO concluded that the Company's disclosure controls and procedures were **not effective** as of June 30, 2025[268](index=268&type=chunk) - A **significant deficiency** was identified in the internal financial controls at the **Chemrex subsidiary**, concerning documentation, transaction approval, and reporting[274](index=274&type=chunk)[275](index=275&type=chunk) - A **remediation plan is underway**, including appointing the company's CFO to the Chemrex board, updating policies, and enhancing reporting from the subsidiary to the parent company[276](index=276&type=chunk)[281](index=281&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending or threatened material legal proceedings against it, its property, or its directors and officers - There are presently **no pending material legal proceedings** to which the Company or its property is subject[279](index=279&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) New material risks include execution risk for the Fidelion Diagnostics transaction, market volatility from the Ethereum treasury strategy, and operational risks in Chemrex's CDMO transition - **Fidelion Transaction Risk:** There is **no guarantee** that the **non-binding term sheet** with **Fidelion Diagnostics** will lead to a definitive agreement or that the transaction will close, and integration presents further challenges[282](index=282&type=chunk) - **Ethereum Treasury Risk:** The company's Ethereum-focused treasury strategy exposes it to **high price volatility**, **evolving regulations**, and **cybersecurity risks**, which could materially impact financial results[283](index=283&type=chunk) - **Chemrex CDMO Transition Risk:** The transition of Chemrex to a CDMO model involves **significant execution risk**, including potential **revenue shortfalls**, delays in obtaining **GMP certification**, and uncertainty regarding market demand[284](index=284&type=chunk) [Other Required Disclosures](index=41&type=section&id=Item%202.%20Unregistered%20Sale%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities, no defaults on senior securities, and confirmed mine safety disclosures are not applicable - The company reported **no unregistered sales of equity securities**, **no defaults upon senior securities**, and that mine safety disclosures are **not applicable**[286](index=286&type=chunk)[287](index=287&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information) On August 15, 2025, the Board approved new equity compensation, including non-qualified stock options for executives and directors, with CEO awards tied to stock price targets - On August 15, 2025, the Board approved **new stock option awards** for executives, directors, and key employees[288](index=288&type=chunk) - The CEO's award includes **four tranches of 300,000 options** each, with vesting tied to service and achieving **20-day VWAP hurdles of $8.00, $12.00, $20.00, and $30.00 per share**[289](index=289&type=chunk) - The CFO, independent directors, and key employees will receive **annual grants of options** with vesting based on continued service[290](index=290&type=chunk)[291](index=291&type=chunk)[292](index=292&type=chunk) [Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists filed exhibits, including officer certifications, a Non-Qualified Stock Option Agreement, and Inline XBRL data files - Filed exhibits include **officer certifications** (31.1, 31.2, 32.1, 32.2), a **Form of Non-Qualified Stock Option Agreement** (10.8), and various **Inline XBRL documents**[294](index=294&type=chunk)
BioNexus Gene Lab Corp. and Fidelion Diagnostics Announce Landmark Alliance—Touted as a new “DeepSeek Moment” in Precision Oncology
Globenewswire· 2025-07-30 12:00
Core Insights - BioNexus Gene Lab Corp. (BGLC) and Fidelion Diagnostics have entered a strategic partnership aimed at enhancing liquid biopsy cancer monitoring and AI-driven biotechnology, marking a significant advancement in the field [1][2] Company Overview - BGLC will acquire a strategic equity stake in Fidelion and gain exclusive commercial rights to the VitaGuard™ platform for minimal-residual-disease (MRD) testing across Southeast Asia [2] - Fidelion will receive an equity investment and a licensing fee from BGLC, fostering long-term value creation for both companies [2] - The partnership is expected to leverage BGLC's commercial network to deliver next-generation cancer care to approximately 680 million people in Southeast Asia [7] Technology and Innovation - VitaGuard™ is a liquid biopsy technology that detects circulating tumor DNA (ctDNA) through a simple blood draw, offering earlier cancer recurrence detection compared to traditional methods [3][4] - The technology is tumor-naïve, meaning it can identify cancer without prior tumor sequencing, akin to facial recognition software [5] - VitaGuard™ significantly reduces the cost of MRD monitoring from over USD 3,000 to under USD 300, making it accessible to a broader market [6][4] Market Potential - Southeast Asia is projected to see over 2.4 million new cancer cases annually by 2030, indicating a substantial market opportunity for affordable cancer monitoring solutions [6] - The partnership aims to capitalize on the growing demand for cost-effective cancer diagnostics in the region [6] Strategic Highlights - VitaGuard™ technology achieves 0.02% variant-allele-frequency sensitivity and 95% cfDNA recovery, while maintaining sample stability for 14 days at room temperature [8] - BGLC will lead regulatory submissions and a phased rollout of the technology, starting in Singapore and Malaysia [8] - The partnership includes cross-shareholdings to ensure long-term strategic alignment between BGLC and Fidelion [8] Future Developments - The alliance plans to develop companion-diagnostic programs and an AI-powered Cancer Interception System utilizing longitudinal MRD datasets from VitaGuard™ [9]
Bionexus Gene Lab (BGLC) - 2025 Q1 - Quarterly Report
2025-05-15 20:30
Financial Position - As of March 31, 2025, the company had cash and cash equivalents of $3.6 million and total liquidity exceeding $6 million, providing a solid foundation for operational continuity and strategic investments [173]. - The company maintains a clean capital structure, free of preferred stock and convertible debt, positioning it favorably for growth initiatives [173]. - As of March 31, 2025, working capital decreased to $4,982,026 from $6,415,877 as of December 31, 2024, primarily due to operational losses and strategic investments [223]. - Net cash used in operating activities for Q1 2025 was $(824,072), compared to $(37,153) in Q1 2024 [225]. - Net cash used in investing activities for Q1 2025 was $(15,646), primarily due to the purchase of plant and equipment totaling $(9,052) [228]. - Net cash used in financing activities for Q1 2025 was $(860) due to a loan repayment, compared to a net cash generation of $26,930 in Q1 2024 [230]. - The company believes cash flow from operations will be sufficient to sustain its current level of operations for at least the next 12 months [224]. Revenue and Expenses - For the quarter ended March 31, 2025, total revenue was $2,137,075, a decrease of 10.3% from $2,381,851 in the same quarter of 2024 [200]. - Chemrex contributed $2,134,007 (99.9%) of total revenue, reflecting a decline of 10.29% due to a slowdown in market demand and disruptions from Malaysian e-Invoicing requirements [201]. - MRNA Scientific's revenue was $3,068 (0.1%), down approximately 3.1% from $3,165, primarily due to fewer client referrals and a key RNA machine being under repair [202]. - Total cost of revenue for the quarter was $1,793,582, a decrease of 11.1% from $2,016,820 in the prior year [203]. - Gross profit for the quarter was $343,493, down approximately 5.9% from $365,031 in the same quarter of 2024 [206]. - Total other income decreased by approximately 54.7% to $91,420 from $201,847 in the prior year [209]. - Total operating expenses increased by approximately 63.3% to $1,053,331 from $645,906 in the same quarter of 2024 [212]. - Sales and marketing expenses surged by 251.4% to $540,695, primarily due to increased spending at Chemrex [212]. - General and administrative expenses rose to $391,876, an increase of 24.09% from $315,794 in the prior year [217]. - MRNA Scientific's research and development expenses slightly increased by 5.8% to $12,139 from $11,475 in the same quarter of 2024 [216]. - MRNA incurred $56,006 (14.29%) of total general and administrative expenses of $391,876 for Q1 2025, up from $38,275 (12.12%) in Q1 2024, representing a 46.3% increase [218]. - BGLC's general and administrative expenses were $210,737 (53.78%) of total expenses for Q1 2025, compared to $147,098 (46.58%) in Q1 2024, an increase of approximately 43.3% [219]. Operational Performance - Chemrex reported a loss from operations of $618,418 for Q1 2025, a significant increase of approximately 682.5% from a loss of $79,028 in Q1 2024 [219]. - Chemrex experienced a foreign currency gain of $72,159 in Q1 2025, compared to a loss of $209,908 in Q1 2024 [221]. Strategic Initiatives - The company is actively exploring additional capital-raising mechanisms, including at-the-market offerings and private placements, to support growth initiatives in digital health and decentralized financial infrastructure [174]. - The company reported a strategic investment in Ascension Innovation Sdn Bhd, enhancing its portfolio in the healthcare diagnostics sector [179]. - The company’s strategic focus includes expansion into digital healthcare, sustainable materials, and blockchain-based treasury solutions [175]. - The company’s leadership team is committed to maintaining robust compliance with Nasdaq listing standards as part of its growth strategy [177]. - The company has implemented additional protocols to strengthen compliance with corporate policies and regulatory requirements, particularly concerning related-party transactions at its Chemrex subsidiary [193]. - The company is focused on enhancing its internal control environment and improving governance procedures within its Chemrex subsidiary following recent transactions [194]. - The company successfully completed a reverse stock split at a ratio of 1-for-10, effective April 7, 2025, to regain compliance with Nasdaq Listing Rule 5550(a)(2) [195]. - The company achieved full compliance with Nasdaq Listing Rule 5550(a)(2) on April 30, 2025, after successfully maintaining a minimum bid price of $1.00 per share [187]. - The company plans to add administrative and marketing personnel and increase advertising to generate more revenues [231].