Lithios Beverages Drives Excitement in NYC with Successful Sampling Events and Times Square Billboard
NEW YORK, Aug. 08, 2025 (GLOBE NEWSWIRE) — Lithios Beverages, an innovator in functional drinks inspired by the energizing potential of lithium, just wrapped up a slate of in-store sampling events across Manhattan and Brooklyn, including at Fairway Gardens Kips Bay, Brooklyn Fair, and 2131 Broadway Street. Led by Alex and Tina Genzer, Lithios Beverages stands out with its unique fusion of flavor and function.
Recent samplings saw enthusiastic crowds exploring Lithios Beverages' trio of standout flavors: Berry, Electric Lime, and Orange Mango. 'The feedback has been incredible. Everyone connects with different flavors, and the positive energy at our events was contagious,' said Tina Genzer.
The spontaneous excitement around the upcoming launch of Brain Fuel+ Hydration Drink Mix was undeniable, with guests eagerly reserving their spots after learning about its breakthrough formula. Crafted with a mineral-rich base and enhanced by Max Catalyst™ for faster absorption, it delivers 71+ trace minerals from ConcenTrace®, essential electrolytes, Vitamin C, and B12—all in a clean, highly bioavailable format.
Science-backed functional ingredients like GeniusPure® Alpha GPC and SalidroPure® Salidrosides support immunity, focus, mental clarity, and natural energy, while helping the body adapt to stress and combat fatigue. Consumers are invited to sign up online ahead of the official launch to receive 10% off their first order.
Dustin Elliott, chief brand officer at NNB Nutrition, shared: 'Lithios Beverages captures what NNB stands for—real progress in human performance. GeniusPure® is the most concentrated, clinically researched Alpha GPC, shown to improve cognitive function with just one serving. And SalidroPure™ delivers 99% pure, naturally fermented salidrosides, offering a sustainable alternative to Rhodiola without compromising potency.'
The interactive environment saw customers trying creative flavor combinations and brainstorming cocktail ideas, showing buzz building up for Lithios Beverages' next product line. ' The energy was remarkable. People started blending flavors, exchanging recipes, and already envisioning new ways to enjoy our Brain Fuel+ Hydration Drink Mix,' noted co-founder Alexander Genzer. 'Clearly, New Yorkers are looking for hydration that truly supports mind and body.'
Lively testimonials continue to flood the company's Instagram (@drinklithiosbeverages). Lithios Beverages also recently made its Times Square debut with stunning billboard spots. This overwhelming support has prompted Fairway Markets to request more sampling events and secure additional inventory.
Industry recognition is following suit. Lithios Beverages was spotlighted in GI's recent 'Companies to Watch' report, drawing attention to the broader growth of functional drinks inspired by the dynamic properties associated with lithium. The report, which highlights the functional beverage sector through 2033, can be accessed in the Press and Media area of the Lithios Beverages website.
'We're honored by the excitement and curiosity Lithios Beverages is generating,' said Tina Genzer. 'Just as lithium powers modern technology, Lithios Beverages energizes everyday wellness. Our upcoming Brain Fuel+ Hydration will go even further to meet today's needs for clarity, resilience, and refreshment.'
Lithios Beverages is continuing in-store sampling across NYC throughout July, with more events planned for September. It has also opened a round for early-stage investors.
For more information, visit https://www.drinklithios.com or follow @drinklithiosbeverages on Instagram.
Contact information:Tina GenzerLithios Beverages
Website: https://www.drinklithios.com/
[email protected]
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FDA Grants 510(k) Clearance for Sonic Incytes' Velacur ONE™, AI-Guided Point of Care Ultrasound for the Management of Chronic Liver Diseases
VANCOUVER, British Columbia--(BUSINESS WIRE)--Sonic Incytes Medical Corp, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Velacur ONE™, its point-of-care ultrasound elastography device. Building on the success of its original model, Velacur™, Velacur ONE™ introduces an enhanced interface and features for improved portability and user experience. These improvements enable broader scalability to support Sonic Incytes' accelerated US and global expansion strategy. Velacur ONE™ measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE and aids in the management of chronic liver disease including MASH and MASLD. The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy. Share Velacur ONE™ arrives at a critical time for improved non-invasive testing, following the recent FDA clearance of Rezdiffra—the first therapeutic for Metabolic dysfunction–associated steatohepatitis (MASH), a progressive and often underdiagnosed liver disease. In the U.S. alone, an estimated 100 million adults have Metabolic dysfunction–associated Steatotic Liver Disease (MASLD)1, with 15–20 million of those affected by MASH2. Yet, 90% of MASH cases remain undiagnosed3. If left untreated, worsening MASH increases morbidity and may progress to severe complications, including cirrhosis, liver failure, liver cancer, and liver transplant4,5. MASH remains challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care. With the first therapeutic now available and more in the pipeline, clinicians need improved non-invasive tests to diagnose and monitor MASH at point-of-care6. Current treatment guidelines for MASH recommend imaging-based elastography, such as Velacur™, to assess liver scarring (fibrosis) and fat content (steatosis). While ultrasound elastography is widely used, when it comes to treating patients with MASH, liver stiffness alone cannot be relied on to assess treatment response in the short term7. The best predictor of treatment responses was a decrease in steatosis (identified as ≥30% reduction in MRI-PDFF)8. VDFF, Sonic Incytes' proprietary algorithm that received FDA clearance in 2024, demonstrates a strong correlation (r = 0.85) with MRI-PDFF—the gold standard for liver fat measurement—and achieves an outstanding accuracy (AUC) of 95% of patients with more than 5% MRI-PDFF, defining the presence of hepatic steatosis9. Velacur ONE™ combines this technology with a refined user interface, including B-mode imaging—enabling 3–4x higher reimbursement than non-imaging elastography—and an AI-based organ overlay feature to aid in liver localization, making it the only point-of-care device that estimates both liver stiffness and attenuation that correlates to MRI-PDFF10. 'The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy,' said Barry Allen, CEO of Sonic Incytes. 'This next-generation device enhances clinical utility and operational scalability, positioning us to better support the growing demand for accessible, non-invasive liver diagnostics and treatment, particularly in the management of MASLD and MASH at the point-of-care.' About Sonic Incytes Sonic Incytes is committed to enhancing patient care through innovative diagnostic solutions. The company's flagship product, Velacur™, equips physicians with an advanced liver imaging tool to help manage the growing epidemic of fatty liver disease. Velacur™ offers real-time, AI-guided quantification of the key markers for fatty liver disease: liver stiffness, attenuation and VDFF. With real-time results, a low up-front cost and AI guidance, Velacur™ makes liver imaging at the point-of-care affordable and accessible. For more information, visit ________________________________ 1 American Liver Foundation. (2025, June). Nonalcoholic fatty liver disease (NAFLD). American Liver Foundation 2 Le P, Tatar M, Dasarathy S, et al. Estimated Burden of Metabolic Dysfunction–Associated Steatotic Liver Disease in US Adults, 2020 to 2050. JAMA Netw Open. 2025;8(1):e2454707. doi:10.1001/jamanetworkopen.2024.54707 3 Fishman, J., Kim, Y., Charlton, M.R. et al. Estimation of the Eligible Population For Resmetirom Among Adults in the United States for Treatment of Non-Cirrhotic NASH with Moderate-to-Advanced Liver Fibrosis. Adv Ther 41, 4172–4190 (2024). 4 Friedman SL. Fat, fibrosis, and the future: navigating the maze of MASLD/MASH. J Clin Invest. 2025 Apr 1;135(7):e186418. doi: 10.1172/JCI186418. PMID: 40166940; PMCID: PMC11957683. 5 Fishman J, Alexander T, Kim Y, Kindt I, Mendez P. A clinical decision support tool for metabolic dysfunction-associated steatohepatitis in real-world clinical settings: a mixed-method implementation research study protocol. J Comp Eff Res. 2024 Oct;13(10):e240085. doi: 10.57264/cer-2024-0085. Epub 2024 Sep 20. PMID: 39301878; PMCID: PMC11426282. 6 Gbadamosi, S. O., Evans, K. A., Brady, B. L., & Hoovler, A. (2025). Noninvasive tests and diagnostic pathways to MASH diagnosis in the United States: a retrospective observational study. Journal of Medical Economics, 28(1), 314–322. 7 Noureddin, M., Charlton, M. 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Bolt Projects Holdings Reports Q2 2025 Financial Results
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New filings, especially in beauty and personal care, bolster Bolt's focus on innovation and market leadership. 'Bolt's Vegan Silk Platform is already delivering commercial success stories like the 'Goddess Molecule,'' said David Breslauer, Chief Product and Technology Officer. 'Our biotech expertise and growing IP portfolio has allowed us to create novel molecules that we believe improve performance and enable proprietary claims — giving partners a competitive edge in a crowded, claims-driven market. While many brands reference science, few go beyond basic chemistry. Bolt offers exclusive biotech innovation that drives both differentiation and sustainability.' Corporate Milestones Beyond product progress, Bolt achieved several key corporate developments since Q1 2025. 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On August 1, 2025, Bolt reached an agreement with Southern Point Capital to convert $1.7 million in vendor payables to equity, subject to court approval and shareholder approval at the annual meeting. Financial Results for the second Quarter Ended June 30, 2025 Revenues. Revenues for Q2 2025 were approximately $1.3 million, up from $56 thousand in Q2 2024. Revenue growth was driven by ongoing shipments to Goddess Maintenance Company and reorders from prior launches. Cost of Revenues. Cost of revenues was approximately $1.2 million in Q2 2025, compared to $85 thousand in Q2 2024. The Company achieved a positive gross margin in Q2 2025, reflecting continued success in reducing material costs and on-going pricing discipline. Based on this progress, Bolt is introducing gross profit targets for 2025 and 2026. Operating Expenses. Operating expenses were approximately $4.9 million in Q2 2025, down from $9.6 million in Q2 2024. Excluding 2024 bridge note issuance costs and stock-based compensation, spending increased to support business growth. Research & Development. Decreases were driven by lower consulting costs partially offset by higher personnel costs to support the delivery of a new material (xl-silk™) and new substantiated cosmetic active claims for b-silk™. Sales & Marketing. Increases were driven by personnel and expanded brand activity, including trade shows and digital platforms. General & Administration. Higher costs, excluding bridge note issuance costs and stock-based compensation, reflect Bolt's ongoing public company obligations. Bolt continues to manage operating expenses to reduce cash burn and to achieve positive free cash flow. Loss from Operations and Net Loss. Loss from operations was approximately $4.8 million; net loss was $4.6 million in Q2 2025, compared to $9.6 million and $58.9 million, respectively, in Q2 2024. Loss from operations decreased primarily due to the absence of the bridge note issuance costs in 2025, partially offset by higher stock-based compensation expense in 2025. Net loss decreased significantly year-over-year due to loss on extinguishment of convertible notes in the second quarter of 2024 and decreased remeasurement losses on Bolt's shared-based liabilities in the second quarter of 2025 compared to the same quarter last year. Adjusted EBITDA. Adjusted EBITDA was approximately ($3.3) million in the second quarter of 2025, compared to ($2.6) million for the second quarter of 2024. Net Loss per Share. Basic and diluted net loss per share was ($2.20) for the second quarter of 2025 compared to ($252.21) for the second quarter of 2024. Cash and Cash Equivalents. As of June 30,2025, the Company had $1.0 million in cash and cash equivalents, which was roughly flat with the prior quarter, compared to $3.5 million as of December 31, 2024. Based on our current operating plan and forecasted cash requirements, management believes Bolt's existing cash resources will be sufficient to fund planned operations until the anticipated financing activities are completed in the third quarter of 2025. There is no assurance that these financing activities will be consummated. Financial Outlook Bolt projects: Revenues of at least $4.5 million in 2025 and at least $9.0 million in 2026 Gross profit of $0.5 million in 2025 and $1.0 million in 2026 Nasdaq Listing Status On August 12, 2025, the Company received a notice of determination of delisting from the Nasdaq. The Company intends to submit a hearing request to appeal the delisting determination and request a stay of the suspension to remain trading pending the hearing. The appeal process will allow the Company's common stock to remain listed on the Nasdaq Global Select Market during the pendency of the hearing process and during any extension period granted by the Nasdaq Hearings Panel. At the hearing, the Company intends to present a compliance plan. There can be no assurance that our request for continued listing will be granted or that we will ultimately regain compliance with the applicable Nasdaq listing requirements. Forward-Looking Statements This press release contains forward-looking statements within the meaning of This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). All statements other than statements of historical facts contained in this communication, including, without limitation, statements regarding: the Company's financial outlook and financial guidance; expected cash runway; growth objectives; planned operational efficiencies and cost reductions; expected product launches; market potential and market adoption; business strategy; and plans and objectives of management for future operations; stockholder approval, or court approval, as applicable for, or consummation of the transactions with Southern Point Capital or Ascent Partners LLC; and access to funding from Ascent Partners LLC. In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'budget,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'will' or the negatives of these terms or variations of them or similar terminology although not all forward-looking statements contain these words. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: substantial doubt as to the Company's ability to continue as a going concern; the Company's history of net losses and negative cash flows; the Company's ability to generate sufficient cash to service its debt; the Company's ability to meet the continued listing requirements of Nasdaq and remain listed on a national stock exchange; the Company's ability to execute its business plan and adequately control its expenses or raise additional capital on favorable terms, if at all; the Company's dependence on sales of b-silk™ and xl-silk™ products from its Vegan Silk Technology Platform; the Company's reliance on a single or limited manufacturing partners and manufacturing facilities; reliance on manufacturing partners in regions that could be impacted by U.S. trade policy, including renegotiating or terminating existing trade agreements and leveraging tariffs; costs of and availability for its Vegan technology Platform products that are out of the Company's control; the Company's reliance on a single manufacturing partner and manufacturing facility for the production of its Vegan Silk Technology Platform product; pricing and availability for the Company's Vegan Silk Technology Platform products; market acceptance of from consumer product companies; the Company's ability to protect adequately its patents and other intellectual property assets; government regulations and private party actions relating to the marketing and advertising of cosmetic products that include the Company's Vegan Silk Technology Platform products or other products the Company develops; and the other risks and uncertainties discussed under the caption 'Risk Factors' included in the Company's Annual Report on Form 10-K for the fiscal year ended, December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, and accessible on the SEC's website at and the Investors section of the Company's website at The Company cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. The Company undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law. Non-GAAP Financial Measures In addition to the financial measures presented in this release in accordance with U.S. Generally Accepted Accounting Principles ('GAAP'), the Company has included certain non-GAAP financial measures in this release, including EBITDA, Adjusted EBITDA, and free cash flow. The Company uses such non-GAAP financial measures as internal measures of business operating performance and as performance measures for benchmarking against the Company's peers and competitors. The Company believes its presentation of EBITDA and Adjusted EBITDA provide a meaningful perspective of the underlying operating performance of the Company's current business and enables investors to better understand and evaluate its historical and prospective operating performance. The Company uses free cash flow as an indication of the strength of the Company and its ability to generate cash. The Company believes free cash flow is meaningful to investors as a useful measure of liquidity. The Company believes that these non-GAAP financial measures are important supplemental measures of operating performance because they exclude items that vary from period to period without correlation to the Company's core operating performance and highlight trends in its business that may not otherwise be apparent when relying solely on GAAP financial measures. Due to the nature of the items being excluded, such items do not reflect future gains, losses, expenses or benefits and are not indicative of the Company's future operating performance. The Company believes investors, analysts and other interested parties use EBITDA, Adjusted EBITDA, and free cash flow in evaluating issuers, and the presentation of these measures facilitates a comparative assessment of the Company's operating performance in addition to the Company's performance based on GAAP results. The Company's non-GAAP financial measures should not be considered as an alternative to net income (loss) as a measure of financial performance or any other performance measure derived in accordance with GAAP and should not be construed as an inference that the Company's future results will be unaffected by unusual or non-recurring items. In addition, free cash flow should not be understood to mean that the entire free cash flow amount is available for discretionary expenditures. EBITDA is defined as net income (loss) adjusted for interest expense and depreciation. Adjusted EBITDA is defined as net income (loss) adjusted for interest expense and depreciation and amortization, loss on extinguishment on convertible notes, non-cash fair value remeasurements of convertible notes, warrant and share-based liabilities, bridge note issuance costs, restructuring costs, and stock-based compensation. The Company defines free cash flow as net cash provided by (used in) operating activities less payments for capital expenditures. EBITDA, Adjusted EBITDA, and free cash flow are not recognized terms under GAAP, and the Company's presentation of these non-GAAP measures does not replace the presentation of the Company's financial results in accordance with GAAP. Because all companies do not use EBITDA, Adjusted EBITDA, and free cash flow (and similarly titled financial measures) in the same way, those measures as used by other companies may not be consistent with the way the Company calculates such measures. The non-GAAP financial measures included in this release should not be construed as substitutes for or better indicators of the Company's performance than the most directly comparable GAAP financial measures. See the reconciliation tables that accompany this release for additional information regarding certain of the non-GAAP financial measures included herein. Bolt Projects develops and produces innovative biomaterials for the beauty and personal care industry. The Company is built on biomaterials platforms that aim to disrupt and transform high-volume consumer goods industries. Bolt Projects is a pioneer in the consumer biomaterials space. The Company's Vegan Silk Technology Platform produces b-silk and other offerings for the beauty and personal care industry that are fully vegan and biodegradable. These versatile ingredients have been on the market since 2019. Its intellectual property portfolio is anchored by 77 granted patents and 118 pending patent applications. BOLT PROJECTS HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In Thousands, Except Per Share Data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revised (1) (unaudited) (unaudited) Revenue $ 1,302 $ 56 $ 1,473 $ 75 Cost of revenue 1,240 85 1,412 150 Gross income (loss) 62 (29 ) 61 (75 ) Operating expenses: Research and development 690 971 1,615 1,384 Sales and marketing 183 62 303 123 General and administrative 4,006 8,546 8,360 13,298 Total operating expenses 4,879 9,579 10,278 14,805 Loss from operations (4,817 ) (9,608 ) (10,217 ) (14,880 ) Total other income (expense), net 234 (49,324 ) (325 ) (50,646 ) Loss before income taxes (4,583 ) (58,932 ) (10,542 ) (65,526 ) Income tax provision — — — — Net loss $ (4,583 ) $ (58,932 ) $ (10,542 ) $ (65,526 ) Other comprehensive loss: Reporting currency translation 5 4 7 27 Comprehensive loss $ (4,578 ) $ (58,928 ) $ (10,535 ) $ (65,499 ) Weighted-average common shares outstanding, basic and diluted 2,079,609 233,660 1,905,837 233,660 Net loss per share, basic and diluted $ (2.20 ) $ (252.21 ) $ (5.53 ) $ (280.43 ) Expand (1) Certain expenses previously recorded as research and development were related to activities that should be recorded as general and administrative. As a result, management has corrected this error by reducing research and development expense by $1.1 million for the six months ended June 30, 2024, respectively, and increasing general and administrative expense by $1.1 million for the six months ended June 30, 2024, respectively. This classification adjustment was made to better reflect the nature of the expenses in accordance with U.S. GAAP. The misclassification had no impact on the Company's total operating expenses, net loss, or earnings per share. Expand BOLT PROJECTS HOLDINGS, INC. Selected Cash Flow Information (In Thousands) Six Months Ended June 30, 2025 2024 (unaudited) Net cash used in operating activities $ (2,856 ) $ (7,362 ) Net cash used in investing activities (12 ) (13 ) Net cash provided by financing activities 330 16,300 Effect of exchange rates on cash and cash equivalents — (47 ) Net change in cash and cash equivalents (2,538 ) 8,878 Cash and cash equivalents at beginning of period 3,512 934 Cash and cash equivalents at end of the period $ 974 $ 9,812 Expand (1) Certain expenses previously recorded as research and development were related to activities that should be recorded as general and administrative. As a result, management has corrected this error by reducing research and development expense by $1.1 million for the six months ended June 30, 2024 and increasing general and administrative expense by $1.1 million for the six months ended June 30, 2024. This classification adjustment was made to better reflect the nature of the expenses in accordance with U.S. GAAP. The misclassification had no impact on the Company's total operating expenses, net loss, or earnings per share. (2) Includes the following: •Remeasurement of share-based termination liability of zero and $1.5 million for the three months ended June 30, 2025 and June 30, 2024, respectively, and zero and $1.3 million for the six months ended June 30, 2025 and June 30, 2024, respectively. •Remeasurement of related party convertible notes of zero and $5.3 million for the three months ended June 30, 2024 and June 30, 2025, respectively, and zero and $5.5 million for the six months ended June 30, 2025 and June 30, 2024, respectively. •Remeasurement of convertible notes of zero and $15.9 million for the three months ended June 30, 2024 and June 30, 2025, respectively, and zero and $17.1 million for the six months ended June 30, 2025 and June 30, 2024, respectively. •Remeasurement of public placement warrant liability of ($0.1) million and zero for the three months ended June 30, 2025 and June, 2024, respectively, and ($0.3) million and zero for the six months ended June 30, 2025 and June 30, 2024, respectively. •Remeasurement of related party private placement warrant liability of $(0.5) million and zero for the three months ended June 30, 2025 and June 30, 2024, respectively, and $0.1 million and zero for the six months ended June 30, 2025 and June 30, 2024, respectively. (3) Includes Bridge Convertible Notes issuance costs of zero and $6.9 million included in operating expenses within general and administrative expenses for the three months ended June 30, 2025 and June 30, 2024, respectively, and zero and $9.4 million for the six months ended June 30, 2025 and June 30, 2024, respectively. Expand
Business Wire
3 hours ago
- Business Wire
FDA Grants 510(k) Clearance for Sonic Incytes' Velacur ONE
VANCOUVER, British Columbia--(BUSINESS WIRE)--Sonic Incytes Medical Corp, proudly announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Velacur ONE™, its point-of-care ultrasound elastography device. Building on the success of its original model, Velacur™, Velacur ONE™ introduces an enhanced interface and features for improved portability and user experience. These improvements enable broader scalability to support Sonic Incytes' accelerated US and global expansion strategy. Velacur ONE™ measures attenuation, VDFF (Velacur Determined-Fat Fraction), and liver stiffness using 3D S-WAVE and aids in the management of chronic liver disease including MASH and MASLD. The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy. Velacur ONE™ arrives at a critical time for improved non-invasive testing, following the recent FDA clearance of Rezdiffra—the first therapeutic for Metabolic dysfunction–associated steatohepatitis (MASH), a progressive and often underdiagnosed liver disease. In the U.S. alone, an estimated 100 million adults have Metabolic dysfunction–associated Steatotic Liver Disease (MASLD) 1, with 15–20 million of those affected by MASH 2. Yet, 90% of MASH cases remain undiagnosed 3. If left untreated, worsening MASH increases morbidity and may progress to severe complications, including cirrhosis, liver failure, liver cancer, and liver transplant 4,5. MASH remains challenging to diagnose effectively due to the limitations of existing non-invasive methods, especially those available at the point-of-care. With the first therapeutic now available and more in the pipeline, clinicians need improved non-invasive tests to diagnose and monitor MASH at point-of-care 6. Current treatment guidelines for MASH recommend imaging-based elastography, such as Velacur™, to assess liver scarring (fibrosis) and fat content (steatosis). While ultrasound elastography is widely used, when it comes to treating patients with MASH, liver stiffness alone cannot be relied on to assess treatment response in the short term 7. The best predictor of treatment responses was a decrease in steatosis (identified as ≥30% reduction in MRI-PDFF) 8. VDFF, Sonic Incytes' proprietary algorithm that received FDA clearance in 2024, demonstrates a strong correlation (r = 0.85) with MRI-PDFF—the gold standard for liver fat measurement—and achieves an outstanding accuracy (AUC) of 95% of patients with more than 5% MRI-PDFF, defining the presence of hepatic steatosis 9. Velacur ONE™ combines this technology with a refined user interface, including B-mode imaging—enabling 3–4x higher reimbursement than non-imaging elastography—and an AI-based organ overlay feature to aid in liver localization, making it the only point-of-care device that estimates both liver stiffness and attenuation that correlates to MRI-PDFF 10. 'The launch of Velacur ONE™ marks a pivotal milestone for Sonic Incytes as we accelerate our US and global commercial expansion strategy,' said Barry Allen, CEO of Sonic Incytes. 'This next-generation device enhances clinical utility and operational scalability, positioning us to better support the growing demand for accessible, non-invasive liver diagnostics and treatment, particularly in the management of MASLD and MASH at the point-of-care. ' About Sonic Incytes Sonic Incytes is committed to enhancing patient care through innovative diagnostic solutions. The company's flagship product, Velacur™, equips physicians with an advanced liver imaging tool to help manage the growing epidemic of fatty liver disease. Velacur™ offers real-time, AI-guided quantification of the key markers for fatty liver disease: liver stiffness, attenuation and VDFF. With real-time results, a low up-front cost and AI guidance, Velacur™ makes liver imaging at the point-of-care affordable and accessible. For more information, visit ________________________________ 1 American Liver Foundation. (2025, June). Nonalcoholic fatty liver disease (NAFLD). American Liver Foundation 2 Le P, Tatar M, Dasarathy S, et al. Estimated Burden of Metabolic Dysfunction–Associated Steatotic Liver Disease in US Adults, 2020 to 2050. JAMA Netw Open. 2025;8(1):e2454707. doi:10.1001/jamanetworkopen.2024.54707 3 Fishman, J., Kim, Y., Charlton, M.R. et al. Estimation of the Eligible Population For Resmetirom Among Adults in the United States for Treatment of Non-Cirrhotic NASH with Moderate-to-Advanced Liver Fibrosis. Adv Ther 41, 4172–4190 (2024). 4 Friedman SL. Fat, fibrosis, and the future: navigating the maze of MASLD/MASH. J Clin Invest. 2025 Apr 1;135(7):e186418. doi: 10.1172/JCI186418. PMID: 40166940; PMCID: PMC11957683. 5 Fishman J, Alexander T, Kim Y, Kindt I, Mendez P. A clinical decision support tool for metabolic dysfunction-associated steatohepatitis in real-world clinical settings: a mixed-method implementation research study protocol. J Comp Eff Res. 2024 Oct;13(10):e240085. doi: 10.57264/cer-2024-0085. Epub 2024 Sep 20. PMID: 39301878; PMCID: PMC11426282. 6 Gbadamosi, S. O., Evans, K. A., Brady, B. L., & Hoovler, A. (2025). Noninvasive tests and diagnostic pathways to MASH diagnosis in the United States: a retrospective observational study. Journal of Medical Economics, 28 (1), 314–322. 7 Noureddin, M., Charlton, M. R., Harrison, S. A., Bansal, M. B., Alkhouri, N., Loomba, R., Sanyal, A. J., & Rinella, M. E. (2024). Expert panel recommendations: Practical clinical applications for initiating and monitoring resmetirom in patients with MASH/NASH and moderate to noncirrhotic advanced fibrosis. Clinical Gastroenterology and Hepatology, 22(12), 2367–2377. 8 Chen VL, Morgan TR, Rotman Y, Patton HM, Cusi K, Kanwal F, Kim WR. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology. 2025 Jan 1;81(1):312-320. doi: 10.1097/HEP.0000000000001112. Epub 2024 Oct 18. Erratum in: Hepatology. 2025 Apr 1;81(4):E133. 9 Honarvar, M., Lobo, J., Schneider, C., Klein, S., Smith, G. I., Loomba, R., Ramji, A., Hassanein, T., Yoshida, E. M., Pang, E., Curry, M. P., & Afdhal, N. H. (2024). Methods and validation of Velacur determined fat fraction in patients with MASLD. WFUMB Ultrasound Open, 2(2), Article 100061. Expand
