Cell and gene therapy
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BioLife Solutions Signs Multi-Year Supply Agreement with Qkine Limited to Expand its Product Portfolio into the Rapidly Growing Cytokines Market
Prnewswire· 2026-02-12 13:03
BioLife Solutions Signs Multi-Year Supply Agreement with Qkine Limited to Expand its Product Portfolio into the Rapidly Growing Cytokines Market [Accessibility Statement] Skip NavigationBOTHELL, Wash., Feb. 12, 2026 /PRNewswire/ -- [BioLife Solutions, Inc.](NASDAQ: [BLFS]), a leading developer and supplier of bioproduction tools and services for the cell and gene therapy (CGT) market, announces it has entered into a multi-year supply agreement with Qkine Limited under which BioLife will distribute certain c ...
Interim report 2025/26 - Organic growth despite challenges in the North American market
Globenewswire· 2026-02-04 17:10
Core Insights - The company reported a 3% revenue growth in local currencies for the first half of 2025/26, but a 1% decline in Danish kroner to DKK 249.0 million year-on-year, primarily due to a slowdown in US demand caused by a government shutdown [1][6] - Despite the challenges, EBITDA increased by 1% to DKK 136.2 million, resulting in an EBITDA margin of 55%, up from 54% in the previous year [6] Revenue Performance - Revenue in Q2 2025/26 decreased by 8% to DKK 124.4 million compared to DKK 135.9 million in the same period last year [5][6] - Sales of instruments fell by 12% to DKK 77.0 million in the first half, while sales of consumables and services increased by 6% and 3%, respectively, accounting for 45% and 23% of total revenue [6] Product Performance - Sales of the XcytoMatic instruments experienced a significant organic growth of 60% year-on-year, reaching DKK 30.8 million, despite the overall decline in instrument sales [1][6] - Positive customer feedback on new products highlights their precision, user-friendliness, and integration into automated workflows, indicating strong potential for future growth [4] Market Outlook - The US cell and gene therapy market is identified as an area of potential growth, driven by significant investments from major players [2] - The company is focusing on establishing new partnerships, particularly with European firms in the bioprocessing segment, to enhance workflow automation solutions [3] Financial Guidance - The company maintains its full-year revenue guidance for 2025/26 in the range of DKK 565-580 million and EBITDA guidance in the range of DKK 320-335 million [7]
Cell and gene therapy investment strategy pivots as funding dries up
Yahoo Finance· 2025-12-10 12:46
Core Insights - The gene therapy (CGT) sector is experiencing a significant decline in venture capital investment, with deals dropping by approximately 61% from 2021 to 2025, and CGT-specific deals decreasing by 66% in the same timeframe [1][2] Industry Trends - Half of the CGT venture capital activity is concentrated in Series B funding, indicating a shift from platform validation to clinical studies, reflecting a broader trend in the pharmaceutical industry towards less risky targets like obesity drugs and antibody-drug conjugates (ADCs) [2] - The average value of CGT venture capital deals is currently around $60 million in 2025, which is notably lower compared to other modalities, highlighting a decrease in deal frequency and value [3] Market Dynamics - The peak activity for venture capital in the CGT sector occurred in 2021, but commercial challenges have led some companies to withdraw from the space despite the presence of approved CGT therapies in major markets like the US and Europe [4] - Companies such as Galapagos and Takeda have recently exited the cell therapy sector, indicating a shift in focus towards small molecules, biologics, and ADCs [5] Acquisition Strategies - There is ongoing interest from biopharma companies in CGT technologies, primarily through acquisitions rather than in-house development, with a focus on platforms and scalable manufacturing systems [6] - Eli Lilly has been notably active in the CGT space, investing $475 million in a licensing deal for ophthalmology gene therapy and acquiring Adverum Biotechnologies for over $260 million, along with a $1.3 billion investment in Rznomics for RNA-based gene therapies [6]
Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy
Globenewswire· 2025-12-08 12:30
Core Insights - Abeona Therapeutics Inc. has announced the first commercial patient treatment with its FDA-approved gene therapy ZEVASKYN, aimed at treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][2] - ZEVASKYN is the first and only autologous cell sheet-based gene therapy for RDEB, which is characterized by severe skin wounds due to a defect in the COL7A1 gene [4][5] - The treatment has shown clinically meaningful wound healing and pain reduction with a single surgical application [4] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being a key product in its portfolio [8] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [8] Treatment Details - ZEVASKYN incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, essential for skin integrity [4] - The therapy is indicated for both adult and pediatric patients suffering from RDEB [5] - Abeona Assist® is a comprehensive patient support program that helps patients understand insurance benefits and provides logistical assistance [2]
Bio-Techne (NasdaqGS:TECH) FY Conference Transcript
2025-12-02 14:22
Bio-Techne FY Conference Summary Company Overview - **Company**: Bio-Techne (NasdaqGS: TECH) - **Date of Conference**: December 02, 2025 Key Industry Insights 1. Performance in Large Pharma - Large pharma accounts for approximately 30% of Bio-Techne's revenue and has shown double-digit growth for three consecutive quarters [3][6] - The company is optimistic about continued strength in this segment, particularly in China, which has seen organic growth for two consecutive quarters [3][4] 2. Biotech Market Dynamics - Smaller biotech represents roughly 20% of Bio-Techne's revenue, but funding in this sector has decreased by 30% year-over-year [7][8] - Despite a high single-digit decline in biotech revenue in the most recent quarter, there is a belief that the market is stabilizing, with increased funding observed in recent months [11][12] 3. Academic and Government Market - Academic and government sectors contribute about 20% of global revenues, with stable growth in Europe but uncertainty in the U.S. due to NIH funding concerns [12][13] - Recent signals from Congress suggest flat budgets, alleviating some anxiety among academic customers [13][14] Financial Performance 1. Revenue and Growth - The company reported an organic decline of 1% in the latest quarter, attributed to headwinds from two major cell therapy customers who received Fast Track designation from the FDA [3][6] - Despite this, Bio-Techne managed to achieve a 90 basis points margin expansion [6] 2. Future Guidance - The company maintains a soft guidance for low single-digit growth in fiscal 2026, with expectations for Q2 results to mirror Q1 [19][20] - The underlying strength of the business is improving, with projections for better performance in the second half of the fiscal year [20][24] Product and Market Highlights 1. Product Portfolio - The ProteinSimple franchise continues to perform well, with double-digit growth in consumables [4][20] - The spatial product line has stabilized and is expected to improve, with positive growth in reagents [5][20] 2. Cell Therapy Dynamics - The Fast Track designation for two major customers has led to a temporary reduction in orders, as these customers are combining phases in their clinical trials [32][36] - The potential revenue from these therapies could reach $40-$50 million each upon commercialization, with a base case for commercial ramp starting in fiscal year 2028 [51][55] Market Risks and Uncertainties 1. Academic Funding Concerns - The primary uncertainty affecting the biotech market is the outcome of academic funding, which could impact spending in the biotech sector [25][26] - There is a belief that even in a flat academic market, Bio-Techne can outperform due to its positioning and product offerings [26][29] 2. Pharma Market Stability - While the pharma market has shown double-digit growth, uncertainties regarding pricing and tariffs have largely subsided, leading to a more stable outlook [30][31] Conclusion - Bio-Techne is navigating a complex market landscape with a focus on innovation and strategic positioning in key growth areas such as large pharma, biotech, and cell therapy - The company is optimistic about future growth, particularly in fiscal year 2027, driven by its diverse product portfolio and improving market conditions [15][19][78]
MaxCyte (NasdaqGS:MXCT) FY Conference Transcript
2025-11-19 15:02
MaxCyte FY Conference Summary Company Overview - **Company**: MaxCyte (NasdaqGS:MXCT) - **Industry**: Cell and Gene Therapy Key Points and Arguments Strategic Focus and Changes - MaxCyte has undergone significant changes, including a CFO transition, acquisition of SecureDx, and operational restructuring to enhance focus on scientific, engineering, and commercial teams [3][4][6] - The company has grown from approximately 50 employees pre-COVID to around 90 employees, reflecting its expansion in the cell and gene therapy space [4][6] Acquisition of SecureDx - The acquisition of SecureDx is seen as a strategic move to enhance MaxCyte's capabilities in early-stage customer engagement and safety profiling in gene therapy [4][5][12] - SecureDx's offerings align with FDA's focus on safety assessments, particularly in gene editing therapies [14][15][43] Market Dynamics and Demand - The cell and gene therapy market has faced rationalization, with developers reducing the number of programs they are pursuing, impacting the number of licenses used in clinics [17][18] - Despite headwinds, MaxCyte is experiencing larger placements of instruments and continues to sign strategic platform licenses (SPLs), with four signed in the current year [19][20] Product Offerings and Differentiation - MaxCyte specializes in non-viral cell engineering, providing scalable solutions for ex vivo cell therapy, including the introduction of gene editing tools like CRISPR [9][10][11] - The company is expanding its offerings with a new product set to launch early next year, aimed at early-stage research and development [47][48] Financial Performance and Projections - MaxCyte anticipates a cash burn of $10 million to $15 million for the next year, significantly reduced from previous years, with a focus on achieving profitability [54][55] - The company expects to return to historical gross margins of 84%-85% as revenue grows, despite recent fluctuations due to changes in product mix [49][51][53] Future Outlook - MaxCyte is optimistic about growth in the second half of 2026, driven by new product launches, expansion in Asia, and a focus on core business development [60][61] - The company believes in the long-term potential of cell and gene therapies to address diseases in ways that traditional therapies cannot [62] Regulatory Environment - The FDA's increasing scrutiny on safety in gene editing therapies is creating opportunities for MaxCyte to position itself as a leader in non-viral solutions [22][24][25] Customer Engagement - MaxCyte is seeing increased interest from customers in non-viral therapies due to safety concerns associated with viral delivery methods [22][24] - The company aims to engage with customers earlier in the development process to help mitigate risks associated with off-target effects [25][26] Additional Important Insights - The company has developed over 1,000 protocols for various cell types and gene editing tools, positioning itself well for the growing allogeneic therapy market [30][29] - MaxCyte's focus on scientific engagement and customer relationships is expected to drive future growth and innovation in the cell and gene therapy space [41][42] This summary encapsulates the key insights from the MaxCyte FY Conference, highlighting the company's strategic direction, market dynamics, product offerings, and future outlook in the cell and gene therapy industry.
BioLife Solutions to Report Third Quarter 2025 Financial Results and Business Update on November 6, 2025
Prnewswire· 2025-10-23 20:03
Core Insights - BioLife Solutions, Inc. will release its third quarter 2025 financial results on November 6, 2025, after market close [1] - A conference call and live webcast will be held on the same day at 4:30 PM ET to discuss the financial results and provide a business update [1] Company Overview - BioLife Solutions is a leading developer and supplier of bioproduction products and services for the cell and gene therapy (CGT) market [3] - The company specializes in solutions that maintain the health and function of biologic materials during collection, development, storage, and distribution [3]
Avantor Partners With BlueWhale Bio to Advance CAR-T Manufacturing
ZACKS· 2025-10-17 17:26
Core Insights - Avantor (AVTR) has entered a strategic partnership with BlueWhale Bio to enhance CAR-T cell therapy manufacturing, combining Avantor's bioprocessing expertise with BlueWhale's Synecta cell-derived nanoparticle technology [1][8] - The collaboration aims to improve scalability, reduce variability, and shorten time-to-patient in CAR-T production, thereby expanding patient access and strengthening Avantor's position in the cell therapy market [2][10] Company Summary - The partnership is expected to deepen Avantor's role in the cell therapy manufacturing landscape by leveraging its bioprocessing capabilities to scale BlueWhale's CDNP platform, which has shown promising results in preclinical and clinical programs [9] - Avantor's market capitalization currently stands at $9.46 billion [6] - Following the announcement, Avantor's shares remained flat, with a year-to-date decline of 30.8%, contrasting with the industry's 0.5% growth and the S&P 500's 14.5% gain [3] Industry Summary - The global cell and gene therapy manufacturing market was valued at $7.28 billion in 2022 and is projected to grow at a CAGR of 26.6% from 2023 to 2030, indicating favorable industry prospects for companies like Avantor [11]
Autolus(AUTL) - 2025 Q2 - Earnings Call Transcript
2025-08-12 13:30
Financial Data and Key Metrics Changes - In Q2 2025, net product revenue was $20.9 million, up from $9 million in Q1 2025, indicating strong momentum in the product launch [14][6] - The net loss for Q2 2025 was $47.9 million, reduced from a loss of $58.3 million in Q2 2024 [17] - Cash, cash equivalents, and marketable securities totaled $454.3 million at the end of Q2 2025, down from $588 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - Product sales for the first six months of the launch reached $29.9 million, with a total of 46 centers authorized for the use of Ocatsol [6][7] - Cost of sales in Q2 2025 was $24.4 million, which includes costs for products delivered but not yet administered [15] - Research and development expenses decreased to $27.4 million in Q2 2025 from $36.6 million in the same period in 2024 [16] Market Data and Key Metrics Changes - The company has achieved 90% total US medical lives covered and aims to reach over 60 authorized centers by year-end [7] - The company does not expect EU sales in 2025 and 2026 due to limited resources and the need for economically viable market access [9] Company Strategy and Development Direction - The company is focused on expanding the use of Ovicell beyond adult patients with relapsed-refractory ALL and is making progress in autoimmune diseases [12][20] - The company is taking a disciplined approach to market access in Europe, evaluating country by country for economically viable launches [9][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the product's reception and the potential for increased patient enrollment as administrative adjustments are resolved by Q4 [8][30] - The company plans to release updated data from its Phase I study at the ACR meeting in October and expects to dose the first patients in several upcoming studies [20][98] Other Important Information - The company received conditional marketing authorization in the UK and from the European Commission, with ongoing market access discussions [8][9] - The company is broadening real-world experience in the US to support market access conversations elsewhere [9] Q&A Session Summary Question: What is the status of the Germany launch? - Management indicated that market access methodologies in Europe are challenging, particularly for CAR T programs, and emphasized a methodical approach to launching in different countries [24][26] Question: How will revenue recognition change with the split reimbursement? - The CFO clarified that revenue recognition has shifted to a 50/50 split between the first and second administration, with expectations for enrollment and sales to accelerate post-implementation [28][29] Question: What is the feedback from the US community regarding the product? - Management reported very positive feedback, with early reorder activity from treatment centers indicating strong acceptance [38] Question: What is the timeline for the UK and Germany launches? - Management expects potential launches in the UK by early next year, contingent on favorable negotiations, while Germany's timeline remains uncertain [65][66] Question: How many patients were treated in Q2? - Management did not provide specific numbers but indicated that the revenue can be backtracked based on therapy costs [90] Question: What is the expected data release for the lupus Phase II trial? - Management stated that it is premature to provide a timeline for data from the lupus nephritis study, as patient enrollment is just beginning [99]
AscellaHealth HUB Partnership with Abeona Therapeutics® Supports Launch Success of Novel Cell-Based Gene Therapy and Access to Treatment for Rare Disease Patients
GlobeNewswire News Room· 2025-07-29 14:00
Core Insights - AscellaHealth has partnered with Abeona Therapeutics to support the commercialization of ZEVASKYN™, an FDA-approved cell-based gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) [1][2][10] - The partnership focuses on creating patient-centric solutions that address clinical, operational, and reimbursement needs, enhancing patient access and clinical outcomes [1][2][9] Company Overview - AscellaHealth provides customizable solutions for the specialty pharmaceutical industry, emphasizing patient support and efficient healthcare delivery [1][9] - Abeona Therapeutics is a biopharmaceutical company developing innovative cell and gene therapies, with ZEVASKYN™ being its flagship product for RDEB [10] Product Details - ZEVASKYN™ is the first autologous cell sheet-based gene therapy for RDEB, utilizing the COL7A1 gene to produce functional type VII collagen in patients' skin cells [3][5][6] - The therapy has shown clinically meaningful results in wound healing and pain reduction with a single application [5][6] Partnership Dynamics - The collaboration between AscellaHealth and Abeona Therapeutics is characterized by shared goals, open communication, and a commitment to patient-centric care [2][9] - AscellaHealth's HUB model has proven effective in enhancing compliance, retention, and satisfaction rates for specialty pharmaceuticals and gene therapies [2]