CyPath Lung
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BIAF Stock Dips After Q3 Earnings Reflect Lower Sales and Wider Loss
ZACKS· 2025-11-19 17:35
Core Viewpoint - bioAffinity Technologies, Inc. (BIAF) has experienced a significant decline in stock value following its third-quarter 2025 results, with shares dropping 21.8% since the earnings release, compared to a 2.2% loss in the S&P 500 Index during the same period [1] Financial Performance - In Q3 2025, bioAffinity reported total revenues of $1.4 million, a decrease of 38.5% from $2.4 million in the same quarter last year, due to a strategic exit from unprofitable pathology services and a focus on CyPath Lung commercialization [2] - CyPath Lung testing revenue increased by 122% year-over-year, driven by higher case volumes and increased physician adoption, particularly within Veterans Administration (VA) medical centers [2] - Operating expenses fell by 13.5% to $3.7 million from $4.3 million, primarily due to lower laboratory-related costs, but the net loss widened to $5.1 million from $2 million a year ago, largely due to non-cash expenses related to warrant revaluations [3] - Loss per share slightly narrowed to $4.74 from $4.84 [3] Operational Metrics - Direct costs decreased by 34.6% year-over-year to $0.9 million from $1.4 million, reflecting efficiency initiatives [4] - Selling, general, and administrative expenses decreased by 6.6%, while depreciation and amortization expenses dropped by 25.1% [4] - Research and development (R&D) spending rose by 20.4%, and clinical development costs increased by 52.9% due to expanded preclinical and clinical work [4] Growth and Adoption - Test volumes for CyPath Lung increased by 97% in the first nine months of 2025 compared to the prior year, with a record quarterly sales level in Q3 2025, climbing 92% from the previous quarter [5] - Management emphasized the importance of marketing initiatives targeting the VA health system, which have shown positive traction [7] Balance Sheet and Cash Position - Cash and equivalents improved significantly to $7.7 million from $1.1 million at year-end 2024, supported by $10.4 million in gross proceeds from equity transactions during the quarter [6] Strategic Focus and Future Plans - Management outlined strategic objectives for 2025, including expanding the sales team, engaging with major VA medical centers, and increasing marketing efforts [11] - The company is advancing companion diagnostic candidates for asthma and chronic obstructive pulmonary disease (COPD), targeting an estimated $26 billion global market [12] Governance and Intellectual Property - bioAffinity strengthened its governance with new board appointments and regained full Nasdaq Capital Market compliance [13] - The company added another U.S. patent protecting its proprietary algorithm used in CyPath Lung, marking its second consecutive quarter of patent portfolio expansion [13]
Why Merus Shares Are Trading Higher By 38%; Here Are 20 Stocks Moving Premarket - bioAffinity Technologies (NASDAQ:BIAF), Avalo Therapeutics (NASDAQ:AVTX)
Benzinga· 2025-09-29 09:07
Core Insights - Merus NV's shares increased by 38.2% to $95.21 following Genmab's announcement of an $8 billion all-cash acquisition deal, which includes the addition of the breakthrough therapy Petosemtamab to Genmab's late-stage pipeline [1] Gainers - Steakholder Foods Ltd rose 92% to $8.32 after announcing an agreement to acquire Twine Solutions [4] - JFB Construction Holdings surged 77.4% to $12.15 following a $44 million private placement announcement [4] - Plus Therapeutics gained 24.3% to $0.77 after securing a national coverage agreement with UnitedHealthcare for its CNSide assay [4] - Avalo Therapeutics rose 24.1% to $13.40 after a previous decline of 6% [4] - Enanta Pharmaceuticals gained 22.7% to $9.69 ahead of presenting topline results from its Phase 2b study of Zelicapavir for RSV [4] - Canopy Growth Corp jumped 19.4% to $1.60 [4] - Zura Bio Ltd gained 18.3% to $2.85 after a 15% increase on Friday [4] - Tilray Brands surged 17.4% to $1.35, with first-quarter financial results to be announced on October 9 [4] - Larimar Therapeutics jumped 16.4% to $5.93, with an update on the Nomlabofusp program scheduled for September 2 [4] Losers - MoonLake Immunotherapeutics dipped 86.3% to $8.50 despite achieving statistically significant results in its Phase 3 VELA trials [4] - Maris Tech fell 37.3% to $2.62 after reporting a H1 loss of 30 cents per share [4] - Sunrise New Energy Co Ltd shares dipped 28.1% to $0.88 after a previous 10% gain [4] - Cycurion Inc declined 15.5% to $0.28 after a significant drop of over 30% on Friday [4] - bioAffinity Technologies dipped 14.4% to $4.53 after a 55% increase on Friday [4] - Youxin Technology Ltd fell 13.9% to $0.058 following a 1-for-80 reverse split announcement [4] - Top KingWin Ltd declined 12.8% to $4.07 after a previous 48% increase [4] - Cellectis SA fell 10.4% to $3.01 [4] - Quantum-Si Inc decreased 10.1% to $1.34 after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc fell 8.4% to $24.00 [4]
Nasdaq Gains 100 Points; US Consumer Sentiment Falls
Benzinga· 2025-09-26 18:43
Market Performance - U.S. stocks traded higher, with the Dow up 0.83% to 46,328.48, the NASDAQ rising 0.45% to 22,484.92, and the S&P 500 gaining 0.62% to 6,645.73 [1] - Energy shares increased by 1.4%, while information technology stocks fell by 0.4% [1] Commodity Prices - Oil prices rose by 1.7% to $66.10, gold increased by 0.9% to $3,805.00, silver was up 1.8% to $45.945, and copper fell by 0.4% to $4.7390 [5] European Market Trends - European shares showed positive performance, with the eurozone's STOXX 600 gaining 0.66%, Spain's IBEX 35 Index rising 1.28%, London's FTSE 100 up 0.71%, Germany's DAX 40 gaining 0.66%, and France's CAC 40 climbing 0.78% [6] Asian Market Trends - Asian markets closed lower, with Japan's Nikkei 225 down 0.87%, Hong Kong's Hang Seng declining 1.35%, China's Shanghai Composite falling 0.65%, and India's BSE Sensex down 0.90% [7] Company News - MEDIROM Healthcare Technologies Inc. shares surged 106% to $2.9791 after announcing plans to deploy Orb across 100 Japanese relaxation studios [9] - bioAffinity Technologies, Inc. shares increased by 73% to $5.92 following the release of additional case studies demonstrating the effectiveness of CyPath Lung in detecting Stage 1A lung cancer [9] - Datavault AI Inc. shares rose 55% to $1.2890 after securing a $150 million investment in Bitcoin to build a supercomputer [9] - Pop Culture Group Co., Ltd shares dropped 53% to $0.9718 after entering a registered direct offering to sell 5 million shares at $1.20 per share [9] - Kuke Music Holding Limited shares fell 36% to $0.7507 after acquiring a controlling interest in Naxos Music Group [9] - Lexaria Bioscience Corp. shares decreased by 27% to $1.1187 after pricing a $4 million registered direct offering at $1.50 per share [9] Economic Indicators - U.S. personal spending rose by 0.6% month-over-month to $21.112 trillion in August, while personal income increased by 0.4% to $26.280 trillion [11] - The Personal Consumption Expenditures price index rose 2.7% year-over-year in August, marking the highest reading since February 2025 [11] - The University of Michigan consumer sentiment was revised lower to 55.1 in September from a preliminary reading of 55.4 and down from 58.2 in August [11]
Nasdaq Gains 100 Points; US Consumer Sentiment Falls - bioAffinity Technologies (NASDAQ:BIAF)
Benzinga· 2025-09-26 18:43
Market Performance - U.S. stocks experienced gains, with the Dow up 0.83% to 46,328.48, the NASDAQ rising 0.45% to 22,484.92, and the S&P 500 increasing 0.62% to 6,645.73 [1] - Energy shares saw a notable increase of 1.4%, while information technology stocks fell by 0.4% [1] Commodity Prices - Oil prices rose by 1.7% to $66.10, gold increased by 0.9% to $3,805.00, silver was up 1.8% to $45.945, while copper fell by 0.4% to $4.7390 [5] European Market Trends - European shares showed positive movement, with the eurozone's STOXX 600 gaining 0.66%, Spain's IBEX 35 Index rising 1.28%, London's FTSE 100 up 0.71%, Germany's DAX 40 increasing by 0.66%, and France's CAC 40 climbing 0.78% [6] Asian Market Trends - Asian markets closed lower, with Japan's Nikkei 225 down 0.87%, Hong Kong's Hang Seng declining 1.35%, China's Shanghai Composite falling 0.65%, and India's BSE Sensex decreasing by 0.90% [7] Company News - MEDIROM Healthcare Technologies Inc. shares surged 106% to $2.9791 following plans to deploy Orb across 100 Japanese relaxation studios and expand to 200 locations [9] - bioAffinity Technologies, Inc. saw a 73% increase in shares to $5.92 after releasing additional case studies demonstrating the effectiveness of CyPath Lung in detecting Stage 1A lung cancer [9] - Datavault AI Inc. shares rose 55% to $1.2890 after securing a $150 million investment in Bitcoin to build a supercomputer [9] - Pop Culture Group Co., Ltd shares dropped 53% to $0.9718 after entering a registered direct offering to sell 5 million shares at $1.20 each [9] - Kuke Music Holding Limited shares fell 36% to $0.7507 following its acquisition of a controlling interest in Naxos Music Group [9] - Lexaria Bioscience Corp. shares decreased by 27% to $1.1187 after pricing a $4 million registered direct offering at $1.50 per share with $1.34 warrants in a concurrent private placement [9]
Dow Jumps Over 250 Points; Fed's Key Inflation Gauge Remains Hot - bioAffinity Technologies (NASDAQ:BIAF)
Benzinga· 2025-09-26 14:07
Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 250 points, closing at 46,213.26, a rise of 0.58% [1] - The NASDAQ rose by 0.31% to 22,455.17, and the S&P 500 gained 0.47% to 6,636.07 [1] - Energy shares saw a notable increase of 1%, while consumer staples stocks fell by 0.3% [1] Inflation and Economic Indicators - The Personal Consumption Expenditures (PCE) price index, the Federal Reserve's preferred inflation gauge, rose by 2.7% year-over-year in August, slightly above July's 2.6% [2][3] - Monthly PCE inflation accelerated to 0.3% in August, up from 0.2% in July [3] - Personal spending in the U.S. increased by 0.6% month-over-month to $21.112 trillion in August, exceeding market estimates [13] - U.S. personal income rose by 0.4% month-over-month to $26.280 trillion in August, also above market expectations [13] Commodity Market - Oil prices increased by 0.7% to $65.44, while gold rose by 0.5% to $3,789.00 [6] - Silver saw a rise of 1.4% to $45.725, whereas copper fell by 0.7% to $4.7240 [6] European Market Performance - European shares showed positive performance, with the eurozone's STOXX 600 gaining 0.8% [7] - Spain's IBEX 35 Index rose by 1.1%, London's FTSE 100 increased by 0.8%, Germany's DAX 40 gained 0.8%, and France's CAC 40 climbed 0.9% [7] Company-Specific Movements - MEDIROM Healthcare Technologies Inc. saw a significant share price increase of 155% to $3.74 following its expansion plans [9] - BioAffinity Technologies, Inc. shares surged by 92% to $6.57 after releasing additional case studies related to lung cancer detection [9] - Datavault AI Inc. shares rose by 50% to $1.2510 after securing a $150 million investment in Bitcoin [9] - Pop Culture Group Co., Ltd experienced a drop of 52% to $0.9802 due to a registered direct offering [9] - Kuke Music Holding Limited shares fell by 31% to $0.8111 after acquiring a controlling interest in Naxos Music Group [9] - Lexaria Bioscience Corp. shares decreased by 27% to $1.11 following a registered direct offering announcement [9] Asian Market Performance - Asian markets closed lower, with Japan's Nikkei 225 falling by 0.87%, Hong Kong's Hang Seng declining by 1.35%, China's Shanghai Composite down by 0.65%, and India's BSE Sensex falling by 0.90% [10]
Dow Jumps Over 250 Points; Fed's Key Inflation Gauge Remains Hot
Benzinga· 2025-09-26 14:07
Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 250 points, closing at 46,213.26, a rise of 0.58% [1] - The NASDAQ rose by 0.31% to 22,455.17, and the S&P 500 gained 0.47% to 6,636.07 [1] - Energy shares saw a notable increase of 1%, while consumer staples stocks fell by 0.3% [1] Inflation and Economic Indicators - The Personal Consumption Expenditures (PCE) price index, the Federal Reserve's preferred inflation gauge, rose by 2.7% year-over-year in August, slightly above July's 2.6% [2][3] - Monthly PCE inflation accelerated to 0.3% in August, up from 0.2% in July [3] - Personal spending in the U.S. increased by 0.6% month-over-month to $21.112 trillion in August, surpassing market estimates [13] - U.S. personal income rose by 0.4% month-over-month to $26.280 trillion in August, also above market expectations [13] Commodity Market - Oil prices increased by 0.7% to $65.44, while gold rose by 0.5% to $3,789.00 [6] - Silver saw a rise of 1.4% to $45.725, whereas copper fell by 0.7% to $4.7240 [6] European Market Performance - European shares showed positive performance, with the eurozone's STOXX 600 gaining 0.8% [7] - Spain's IBEX 35 Index rose by 1.1%, London's FTSE 100 increased by 0.8%, Germany's DAX 40 gained 0.8%, and France's CAC 40 climbed by 0.9% [7] Company-Specific Movements - MEDIROM Healthcare Technologies Inc. shares surged by 155% to $3.74 following the announcement of expansion plans [9] - bioAffinity Technologies, Inc. saw a 92% increase in shares to $6.57 after releasing additional case studies [9] - Datavault AI Inc. shares rose by 50% to $1.2510 after securing a $150 million investment in Bitcoin [9] - Pop Culture Group Co., Ltd shares dropped by 52% to $0.9802 due to a registered direct offering [9] - Kuke Music Holding Limited shares fell by 31% to $0.8111 after acquiring a controlling interest in Naxos Music Group [9] - Lexaria Bioscience Corp. shares decreased by 27% to $1.11 following a registered direct offering announcement [9] Asian Market Performance - Asian markets closed lower, with Japan's Nikkei 225 falling by 0.87%, Hong Kong's Hang Seng declining by 1.35%, China's Shanghai Composite down by 0.65%, and India's BSE Sensex falling by 0.90% [10]
BIAF Stock Down Following Q2 Earnings Despite CyPath Lung Growth
ZACKS· 2025-08-21 20:00
Core Viewpoint - bioAffinity Technologies, Inc. (BIAF) has experienced a significant decline in stock value following its second-quarter 2025 earnings release, with an 11% drop since the report and a 27.4% decline over the past month, contrasting with the S&P 500's performance [1][2]. Financial Performance - For Q2 2025, bioAffinity reported revenues of $1.3 million, a 47.1% decrease from $2.4 million in the same quarter last year, primarily due to the discontinuation of unprofitable pathology services [2]. - Testing revenue from the CyPath Lung diagnostic test increased by 62.3% year-over-year in the first half of 2025, reaching $323,000 from $199,000, indicating growing physician adoption [2]. - Operating expenses decreased by 15.6% to $3.8 million from $4.5 million a year earlier, but the net loss widened to $4.1 million, or $0.17 per share, compared to a loss of $2.1 million, or $0.19 per share, in Q2 2024 [3]. - The accumulated deficit increased to $60.4 million, with total stockholders' deficit at $2.1 million as of June 30, 2025 [5]. Cost Management - Direct costs fell by 27.8% year-over-year, and research and development spending decreased by 22.6% to $0.3 million [4]. - Clinical development expenses surged by 151.2% to $129,279, reflecting increased professional fees for advancing CyPath Lung toward pivotal trials [4]. - Selling, general, and administrative expenses were reduced by 10.4% to $2.2 million, aided by efficiencies from integrating Precision Pathology Laboratory Services [4]. Strategic Initiatives - CEO Maria Zannes highlighted the acceleration of the CyPath Lung commercialization strategy, supported by real-world case studies demonstrating its effectiveness in detecting early-stage lung cancers [6]. - A price increase for CyPath Lung to $2,900 was implemented to align with private payer reimbursement, and a logistics partnership with Cardinal Health OptiFreight was established to enhance sample delivery reliability [7]. - The company has expanded its intellectual property portfolio with new patents in the U.S., China, Canada, and Australia [7][10]. Market Positioning - The decline in revenue was attributed to a strategic exit from lower-margin pathology services, allowing a focus on high-margin diagnostics [8]. - CyPath Lung achieved record sales in June and July, indicating strong market traction [8]. - Management aims to broaden distribution into new regions and health systems while advancing next-generation diagnostic and therapeutic platforms [9].
BIAF Stock Rises Post Q1 Earnings Despite Revenue Decline
ZACKS· 2025-05-20 17:15
Core Insights - bioAffinity Technologies, Inc. (BIAF) reported a revenue decline of 22.9% year-over-year for Q1 2025, totaling $1.9 million, primarily due to changes in revenue contributions from various services [2] - Despite the revenue drop, the net loss per share improved to $0.16 from $0.20 in the previous year, although the absolute loss increased to $2.7 million from $1.9 million due to a higher share count [2] - The company's flagship diagnostic, CyPath Lung, experienced a significant sales increase of 276% year-over-year, indicating strong market acceptance and operational scaling [3] - Management is implementing strategic changes, including discontinuing low-margin services and cutting costs, expected to save approximately $3.8 million annually [4] - The company ended the quarter with $0.4 million in cash but has since raised $1.4 million through warrant exercises and $3.3 million via a public offering to support commercialization and clinical development [7] - bioAffinity received acceptance of a patent application for CyPath Lung from the Australian Patent Office, enhancing its international commercialization potential [9] Financial Performance - Revenues for Q1 2025 were $1.9 million, down from $2.4 million in Q1 2024 [2] - Operating expenses increased by 2.9% to $4.5 million, while direct costs declined by 13.1% to $1.4 million [2] - R&D expenses fell by 6.7% to $367,386, but clinical development expenses rose sharply from $48,960 to $138,353 [2] Strategic Initiatives - The company is focusing on commercial execution and operational changes to support CyPath Lung's growth [5] - Recent enhancements in test processing increased data acquisition throughput by 50% and reduced per-test costs by over 25% [6] - Management's strategic pivot aims to concentrate resources on high-margin diagnostics while improving overall profitability [4] Market Position and Future Outlook - The company did not provide forward-looking financial guidance but indicated a continued focus on expanding CyPath Lung's market presence [8] - The strong demand for CyPath Lung is supported by over 600 tests delivered in 2024, with continued momentum into 2025 [3]