Conference Call to be Hosted on Monday, January 12 at 1:30 PM PT/4:30 PM ET FREMONT, CA / ACCESS Newswire / January 8, 2026 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that Management will host a special conference call to further discuss the company's recent acquisition of certain contract development and manufacturing organization (CDMO) assets as announced on December 11, 2025. The call will cover how the acquisition has accelerated key strategic ...

Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the nine months ended September 30, 2025, highlighting significant progress in both its CDMO and R&D business units [1][13]. Financial Summary - As of September 30, 2025, cash, cash equivalents, and short-term deposits totaled $3,005 thousand, an increase from $1,964 thousand as of September 30, 2024 [3]. - Revenues for the nine months ended September 30, 2025, were $1,049 thousand, compared to $452 thousand for the same period in 2024, reflecting growth in Scinai Bioservices [7]. - R&D expenses decreased to $1,799 thousand from $4,195 thousand year-over-year, primarily due to lower employee and facility cost allocations [7]. - Marketing, general, and administrative expenses increased to $1,929 thousand from $1,767 thousand, mainly due to insurance reimbursements recorded in 2024 [7]. - The net loss for the nine months ended September 30, 2025, was $6,244 thousand, compared to a net profit of $7,026 thousand for the same period in 2024, largely due to financial income from loan conversion recognized in 2024 [7]. Business Update - Scinai Bioservices is expanding its role as a boutique CDMO, serving early-stage biotech companies in Israel, the U.S., and Europe [4]. - The company received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund part of an investment in an advanced sterile fill-and-finish system [8]. - The new system aims to enhance small-batch manufacturing capacity for early-stage biotech clients, with installation expected in Q1 2026 and commercial operations planned for Q2 2026 [8]. R&D Developments - Scinai is advancing its NanoAb pipeline focused on inflammation and immunology, with two STEP grant applications of up to €15 million each, with decisions expected in Q1 2026 [6]. - The lead program, SCN-1, is approaching Phase 1/2a for mild-moderate psoriasis, with a grant application decision expected in Q1 2026 [7]. - The company is evaluating the future of the PC111 program after its €12 million grant application was not approved, considering alternative funding routes or potential termination of the acquisition option for Pincell Srl [10][11]. Partnering Outlook - Scinai is actively seeking partnerships for co-development, licensing, or broader collaborations across all pipeline programs [12]. CEO Statement - The CEO emphasized significant progress in 2025, noting the strengthening of CDMO operations and the ongoing evaluation of strategic paths for R&D programs, particularly in light of recent grant outcomes [13].

Core Insights - BioHarvest Sciences has entered a strategic CDMO partnership with Saffron Tech to enhance the production of saffron-derived botanical compounds using its patented Botanical Synthesis technology [1][3][5] - The partnership aims to address the challenges of saffron cultivation, which is labor-intensive and geographically limited, by utilizing cell-based production methods [8][12] Company Overview - BioHarvest Sciences is a biotechnology company specializing in Botanical Synthesis, allowing for the production of plant-based compounds without the need to grow the plants themselves [13] - Saffron Tech, founded in 2020, has developed advanced cultivation methods that enable year-round production of high-quality saffron, significantly increasing yield compared to traditional methods [2][12] Partnership Details - The agreement stipulates that Saffron Tech will own 75% of the developed saffron compositions, while BioHarvest will retain 25% [4] - The collaboration will involve simultaneous development phases, which could expedite the time to market for saffron-derived products [3][7] Market Potential - Saffron is the world's most expensive spice, retailing for over $10,000 per kilogram, and is primarily sourced from Iran, which accounts for over 80% of global production [2][8] - The partnership aims to create a sustainable and controlled production alternative to meet the growing global demand for saffron-based wellness products [8][12] Financial Performance - BioHarvest's preliminary revenue for Q3 2025 is expected to be approximately $9.1 million, with an adjusted EBITDA range of ($0.7 million) to ($0.4 million) [9][11] - Guidance for Q4 2025 indicates a revenue range of $9 million to $9.5 million, with adjusted EBITDA expected to be between ($0.6 million) and $0.0 million [10][11]

Core Insights - National Resilience has secured long-term debt financing of up to $825 million from Oak Hill Advisors to enhance its balance sheet and support growth initiatives [1] - The new capital will facilitate the acceleration of Resilience's CDMO (Contract Development and Manufacturing Organization) business strategy and investments in manufacturing operations located in Cincinnati and Toronto [1] Financial Strategy - The financing aims to strengthen the company's financial position, allowing for increased operational capabilities and expansion [1] - The investment is expected to play a crucial role in Resilience's plans to broaden access to complex medicines [1]

Core Insights - Scinai Bioservices has received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund 66% of a NIS 1.23 million ($373,000) project aimed at enhancing its fill-and-finish capabilities, addressing a significant gap for early-stage biotech companies [1][2][5] Group 1: Company Developments - The grant will enable Scinai to acquire and install an advanced fill-and-finish system for sterile manufacturing, which is crucial for local biotech firms that currently face high costs and long lead times when outsourcing overseas [1][4] - Scinai's CDMO operations, initiated in 2023, have already provided high-quality manufacturing support to various biotech companies, emphasizing close collaboration and rapid project initiation [4][6] - The planned expansion supported by the grant will enhance Scinai's ability to deliver agile, small-batch, end-to-end CDMO services compliant with EMA and FDA cGMP standards [4][5] Group 2: Industry Context - Israel's biopharma sector, comprising over 300 companies, is underserved by full-service CDMOs, a challenge that is also prevalent globally among early-stage biotech innovators [3] - Scinai aims to fill this gap by offering flexible CDMO solutions that support drug development from early clone selection through to GMP drug substance and product manufacturing [3][6] - The company focuses on providing personalized, agile, and cost-effective solutions to early-stage biotech clients in Israel, the U.S., and Europe, which is often not prioritized by larger CDMOs [6] Group 3: Future Plans - The installation and qualification of the new filling system are expected to be completed by Q1 2026, with commercial operations planned for Q2 2026 [7] - Scinai's R&D unit is also advancing novel biological drug candidates for inflammatory and immunological diseases, indicating a dual focus on both manufacturing and drug development [8][9]

Core Insights - Dr. Park CDMO has selected Thermo Fisher Scientific to equip its new viral vector manufacturing facility, aiming to enhance large-scale production and global access to cell and gene therapies [1][4] Group 1: Company Overview - Dr. Park specializes in Adeno-associated virus-based (AAV-based) viral vector production, currently operating at a capacity of 5,000 L per batch and producing up to 40 clinical-grade batches annually [2] - The new Phase 1 facility was inaugurated on August 5, 2025, with plans to achieve cGMP certification in 2026 and to expand capacity to 10,000 L per batch in the future [2] Group 2: Technological Integration - The facility will utilize several advanced solutions from Thermo Fisher, including the HyPerforma™ 1,000 L Single-Use Bioreactor and DynaSpin™ Single-Use Centrifuge, aimed at streamlining production processes and enhancing efficiency [3] - These technologies are designed to improve process control and automation, thereby supporting rapid scale-up from clinical to commercial production while maintaining high standards of quality and regulatory compliance [3] Group 3: Strategic Collaboration - The collaboration between Dr. Park CDMO and Thermo Fisher is seen as crucial for advancing viral vector manufacturing in South Korea, reflecting the growing importance of robust manufacturing infrastructure for cell and gene therapies [4][5] - Both companies emphasize the need for collaboration to accelerate the development and delivery of therapies to patients, addressing the rising global demand for gene therapy [5]

Core Insights - WuXi Biologics has been awarded "CDMO of the Year – Asia Pacific", "Best Biologics CDMO Award: Bioprocessing", and "Best Biologics CDMO in Greater China Region" at the APBCEA 2025 [1][2] - The company has received multiple awards since 2017, highlighting its consistent excellence in the biomanufacturing sector [1][2] Company Achievements - WuXi Biologics has a portfolio of 864 integrated projects, including 168 bispecific and multispecific antibodies and 225 antibody-drug conjugates (ADCs) [3] - The development cycle for monoclonal antibody projects has been reduced to 6 months from DNA to Investigational New Drug (IND) application [3] - The company has achieved a 100% success rate in Pre-License Inspections (PLI) and has passed 44 inspections by global regulatory authorities, including 22 by the FDA and EMA [3] Leadership and Vision - Dr. Chris Chen, CEO of WuXi Biologics, emphasized the recognition received from clients and the industry, attributing it to the company's commitment to excellence and world-class quality standards [4] - The company aims to empower partners to accelerate the delivery of groundbreaking therapies to patients globally [4] Workforce and Global Presence - WuXi Biologics employs over 12,000 skilled professionals across China, the United States, Ireland, Germany, and Singapore [6] - The company supports 864 integrated client projects, with 24 currently in commercial manufacturing as of June 30, 2025 [6] Sustainability Commitment - WuXi Biologics prioritizes sustainability as a cornerstone for long-term growth, focusing on green technology innovations and responsible practices [7] - The company collaborates with stakeholders to create positive social and environmental impacts while promoting excellence in Environment, Social, and Governance (ESG) [7]

Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the first half of 2025, showing significant growth in revenues and a reduction in R&D expenses compared to the same period in 2024 [1][5]. Financial Summary - Revenues for the six months ended June 30, 2025, totaled $773 thousand, up from $284 thousand in the same period of 2024, indicating growth in the CDMO business [5]. - R&D expenses decreased to $1,237 thousand from $2,788 thousand year-over-year, primarily due to lower wage and facility allocations [5]. - Marketing, general, and administrative expenses increased to $1,256 thousand from $1,003 thousand, attributed to share-based payments and an insurance reimbursement recorded in 2024 [5]. - The net loss narrowed to $4,134 thousand from $4,481 thousand, reflecting higher revenues and lower R&D expenses [5]. - As of June 30, 2025, cash and cash equivalents were $989 thousand, with an additional $4.2 million raised in July and August 2025, enhancing the cash position [5]. Business Update - Scinai Bioservices, the CDMO unit, generated $421 thousand in revenues in the first half of 2025, with total service orders reaching $1.0 million [5]. - The company is advancing its anti-IL-17 NanoAb program, focusing on treatments for psoriasis with two product profiles in development [5]. - Scinai plans to apply for up to €15 million in grant financing under the EU STEP program to fund Phase 1/2a clinical trials, with a decision expected in Q1 2026 [5]. - In 2025, the company filed patents for four additional NanoAbs and is exercising its exclusive option to license them [5]. - The company signed an option agreement to acquire PinCell srl, with a related €12 million FENG grant application under review [5].

Core Insights - The company reported strong interim results for the first half of 2025, with revenue reaching RMB831.9 million and a gross profit margin of 40.8%, reflecting a significant improvement in operational efficiency and business structure optimization [1] - The CRO business experienced a positive growth trajectory, with revenue increasing by approximately 9.6% year-over-year, driven by a recovery in global biopharmaceutical investments and a surge in domestic innovative drug transactions [2] - The company has successfully expanded its client base, serving 1,669 CRO clients, including all top 10 global pharmaceutical companies, with overseas revenue contributing approximately 85% [3] Financial Performance - Revenue for the first half of 2025 was RMB831.9 million, with a gross profit of RMB339.4 million, leading to a gross profit margin increase of 6.3 percentage points [1] - Net profit amounted to RMB148.6 million, a 3.1% increase year-over-year, while adjusted non-IFRS net profit rose by 9.1% to RMB183.5 million [1] - Langhua Pharmaceutical's revenue reached RMB409.0 million, with an adjusted gross profit margin of 37.9%, reflecting a year-on-year increase of 7.9 percentage points [8] CRO Business Development - The CRO business saw a revenue increase to RMB422.8 million, with adjusted gross profit rising to RMB194.6 million, attributed to improved operational efficiency and a robust order backlog [2] - New modalities accounted for approximately 15% of CRO revenue, growing nearly 19% year-on-year, indicating a shift towards innovative drug development [4] - The company has integrated AI technology into its drug discovery platform, contributing to nearly 10% of total CRO revenue [5][6] CDMO and CMC Business - The company is enhancing its CDMO capabilities through the acquisition of Langhua Pharmaceutical, which has initiated new commercialization projects [7] - Langhua Pharmaceutical's adjusted gross profit margin improved significantly due to structural optimization in its CDMO business [8] - The CMC business has shown significant profitability improvements, with a focus on synthesis and analysis operations [10] Investment and Portfolio Management - The company successfully exited investments from various portfolio companies, generating total proceeds of nearly RMB76.5 million [12] - As of June 30, 2025, the company had invested in 93 portfolio companies, with a significant portion located in North America [12][13] - The company is actively participating in establishing an RMB-denominated fund to support biopharmaceutical ventures [15] Infrastructure and Workforce - As of June 30, 2025, the company employed 2,085 staff, with a significant number dedicated to CRO R&D [16] - The company has expanded its facilities, including a new headquarters in Shanghai and multiple parks for R&D and production [17][18] - The Shanghai Supercomputing Center has been operational, supporting advanced drug discovery computations [19] Strategic Vision - The company aims to strengthen the synergy between its CRO and CDMO businesses, enhancing its one-stop innovative drug R&D platform [20] - Future plans include boosting revenue growth and profitability through strategic partnerships and improved operational efficiencies [11][22]

Core Insights - EUROAPI has appointed Frédéric Robert as Chief Commercial Officer to enhance its API Solutions and CDMO activities, aligning with the FOCUS-27 transformation plan [1][3] - The new role will focus on creating synergies between API and CDMO operations, delivering the FOCUS-27 sales plan, and redefining the global sales strategy [2][3] Company Overview - EUROAPI is a leading producer of active pharmaceutical ingredients (API) and operates as a contract development and manufacturing organization (CDMO) [1][5] - The company offers approximately 200 products and has strong R&D capabilities with six manufacturing sites in Europe, serving customers in over 80 countries [5][6] Leadership Background - Frédéric Robert brings over 25 years of experience in the pharmaceutical industry, having held senior roles at companies like Aptar, Fareva, and NAOS Bioderma [3][4] - His expertise includes overseeing commercial operations across Europe and North America, providing a comprehensive understanding of the API and CDMO value chain [3][4]