Tivic Health Systems(TIVC)
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Tivic to Showcase Strategic Pivot and Forward Outlook on Advancing Entolimod(TM) to Commercialization at DealFlow Discovery Conference
Accessnewswire· 2026-01-26 15:10
CEO Presentation to Include Updates and Further Information on the Following Topics: rd FREMONT, CA / ACCESS Newswire / January 26, 2026 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that the company's CEO will present at the 3 Annual DealFlow Discovery Conference, set to take place on January 28-29, 2026 in Atlantic City, New Jersey. Event Details Investors interested in scheduling a meeting with the Tivic's management team should request an investor ...
Tivic Health Systems (NasdaqCM:TIVC) Conference Transcript
2026-01-22 22:12
Summary of Tivic Health Conference Call Company Overview - **Company**: Tivic Health - **Ticker Symbol**: TIVC (Nasdaq) - **Focus**: Transitioning into a biopharmaceutical company with late-stage assets, particularly in radiation treatment and oncology [1][2] Core Points and Arguments - **Transformation**: Tivic Health has completed a major overhaul, focusing on harnessing the immune system to improve clinical outcomes, particularly in radiation treatment [2] - **Intolamod**: - Licensed drug with significant prior investment ($140 million) and government support ($36 million) aimed at treating acute radiation syndrome [3] - Potential applications in oncology, with a well-characterized mechanism of action supported by over 40 studies [4] - **Market Opportunity**: - Current standard of care in the acute radiation syndrome market is valued at $9.4 billion, primarily addressing blood disorders from radiation exposure [5] - Intolamod could replace existing G-CSF drugs and provide protective benefits while supporting regeneration of fast-growing cells [6] - **Commercialization Milestones**: - Successful scaling of manufacturing from small batch to 200x, maintaining or exceeding purity and potency levels [8] - Plans to file a Biologics License Application (BLA) with the FDA, with Fast Track and Orphan Drug Designation already secured [8] - **Government Interest**: Significant interest from the U.S. government as a medical countermeasure for nuclear disasters, alongside oncology applications [9] - **Strategic Moves**: - Acquisition of manufacturing assets to bring production in-house, ensuring cGMP manufacturing access and reducing time to market [10] - Establishment of a contract development and manufacturing organization (CDMO) for phase one and two biologics, creating an additional revenue stream [11] - **Financial Position**: Recently closed a financing package allowing access to up to $75 million, targeting multiple high-value therapeutic inflection points within the next 18 to 24 months [12] Additional Important Content - **Regulatory Pathway**: The company is drafting its BLA and anticipates starting investigator-led trials in oncology applications this year [9] - **Partnership Opportunities**: Intolamod's unique position in both acute radiation syndrome and oncology creates real partnering opportunities as the company progresses [10] - **Location Advantage**: The San Antonio facility is strategically positioned to serve U.S. government requirements, with proximity to military bases and airports for emergency product transport [11]
Tivic CEO To Present at the Upcoming Emerging Growth's January 2026 Virtual Conference
Accessnewswire· 2026-01-20 22:50
Presentation will Cover Recent Corporate Milestones Including Acceleration of Manufacturing Readiness for Entolimodâ"¢ FREMONT, CA / ACCESS Newswire / January 20, 2026 / Tivic Health® Systems, Inc. (NASDAQ:TIVC), a late-stage immunotherapeutics company, today announced that its CEO will provide a corporate update focused on recent developments in its advancement of Entolimod â"¢ during the Emerging Growth Virtual Conference on January 21 and 22, 2026 WHO: Jennifer Ernst, Chief Executive Officer WHERE: Janua ...
Tivic Health Systems, Inc. (TIVC) Discusses Acquisition of Biomanufacturing Assets and Strategic Transformation Transcript
Seeking Alpha· 2026-01-12 23:15
PresentationOperator Welcome to Tivic Health Systems January 7th Special Conference Call. This call has been prerecorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, I would like to remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties th ...
Tivic Health Systems (NasdaqCM:TIVC) Update / briefing Transcript
2026-01-12 22:32
Tivic Health Systems Conference Call Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Industry**: Biopharmaceuticals, specifically focusing on immunotherapeutics and contract development and manufacturing organization (CDMO) services Key Points Strategic Transition - In 2025, Tivic transitioned from a consumer health tech company to a late-stage vertically integrated immunotherapeutics company through a licensing agreement and acquisition of manufacturing assets [3][4] - The acquisition of Scorpius Holdings Inc.'s biomanufacturing assets enhances operational capabilities and supports the commercialization of drug candidates [4][6] Acquisition Details - The acquisition cost approximately $16 million, significantly lower than the estimated $30-$32 million for outsourcing cGMP production [6][20] - Tivic can now produce tens of millions of doses of Entolimod annually, enhancing its capacity for various indications [7][8] Velocity BioWorks - A new subsidiary, Velocity BioWorks, was established to manage in-house manufacturing and development, reducing costs and wait times associated with outsourcing [9][11] - Velocity BioWorks aims to serve both Tivic and third-party biotech companies, with potential annual revenue of up to $70 million at full capacity [10][14] Market Opportunity - The biologics CDMO market is projected to reach approximately $145 billion by 2037, with a compound growth rate of over 15% [13] - The phase I and II segment is growing even faster at 17%-19% annually, driven by the demand for monoclonal antibodies and biosimilars [13][14] Financial Implications - The acquisition and financing package includes $60 million in debt, with expectations that revenue from Entolimod and Velocity BioWorks will cover debt obligations [18][23] - The potential revenue from Entolimod is estimated at $1.6-$2 billion, with production capacity for over 20 million doses [23][24] Regulatory and Government Engagement - Upcoming meetings with BARDA are critical for securing government interest and funding for Entolimod as a radiation countermeasure [25] - The ability to control manufacturing and supply chain enhances Tivic's position with government agencies, particularly in light of national security concerns [12][23] Future Outlook - 2026 is focused on execution, with plans to accelerate clinical and product development timelines across Tivic's oncology portfolio [27] - The transformation positions Tivic to create significant shareholder value through its proprietary TLR5 platform and secured manufacturing capabilities [28] Additional Insights - The aging population and increasing prevalence of chronic diseases are driving pharmaceutical demand, presenting further opportunities for Tivic [15] - Velocity BioWorks is designed to address the capacity gap faced by small to mid-sized biotech companies, which often encounter long wait times for manufacturing slots [14][22] This summary encapsulates the strategic direction, operational enhancements, market opportunities, and financial implications for Tivic Health Systems as discussed in the conference call.
Tivic Delivers 200x Scale-up in Manufacturing for Lead Drug Candidate Entolimod(TM) And Achieves Reproducible Yields, Potency and Purity
Accessnewswire· 2026-01-12 14:00
Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS) and Neutropenia through wholly owned contract development manufacturing organization (CDMO). Velocity Bioworks Company's next step is to initiate production under current Good Manufacturing Practice (cGMP), a critical milestone moving towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) Milestone achieved in advance of January 26 Tech ...
Tivic Announces Special Webcast To Discuss Its Recent Acquisition of CDMO Assets - Highlighting Near-Term Strategic Potential and Immediate Contributions to Accelerated Drug Development Timelines
Accessnewswire· 2026-01-08 13:30
Core Viewpoint - Tivic Health® Systems, Inc. has announced a conference call to discuss the recent acquisition of CDMO assets, highlighting its strategic importance and potential benefits for the company [1] Group 1: Acquisition Details - The acquisition of certain CDMO assets was announced on December 11, 2025, and is expected to accelerate key strategic priorities for the company [1] - The conference call will address how this acquisition impacts development and commercialization timelines [1] Group 2: Future Prospects - The management will discuss near-term potential benefits resulting from the acquisition during the conference call [1]
MSP Recovery (NASDAQ:MSPR) versus Tivic Health Systems (NASDAQ:TIVC) Head-To-Head Comparison
Defense World· 2025-12-14 08:03
Core Viewpoint - The comparison between MSP Recovery and Tivic Health Systems highlights the strengths and weaknesses of both small-cap medical companies, focusing on profitability, valuation, risk, analyst recommendations, institutional ownership, earnings, and dividends. Analyst Recommendations - Both MSP Recovery and Tivic Health Systems have a rating score of 1.00, with one sell rating each and no buy or strong buy ratings [2]. Earnings and Valuation - MSP Recovery reported gross revenue of $18.25 million, a price-to-sales ratio of 0.22, and a net income of -$360.50 million, resulting in an earnings per share of -$572.83 [4]. - Tivic Health Systems had gross revenue of $780,000, a price-to-sales ratio of 4.74, and a net income of -$5.66 million, leading to an earnings per share of -$6.68 [4]. - Despite lower revenue, Tivic Health Systems has higher earnings compared to MSP Recovery and is trading at a lower price-to-earnings ratio, indicating it is currently more affordable [4]. Institutional and Insider Ownership - Institutional ownership for MSP Recovery stands at 3.8%, while Tivic Health Systems has 4.3% [5]. - Insider ownership is significantly higher for MSP Recovery at 50.5%, compared to just 0.5% for Tivic Health Systems [5]. Volatility and Risk - MSP Recovery has a beta of -2.96, indicating its stock price is 396% less volatile than the S&P 500 [6]. - In contrast, Tivic Health Systems has a beta of 1.97, suggesting its stock price is 97% more volatile than the S&P 500 [6]. Profitability - MSP Recovery's net margins are at -7,328.48%, with a return on equity of -326.80% and a return on assets of -81.27% [8]. - Tivic Health Systems shows net margins of -1,557.26%, a return on equity of -202.20%, and a return on assets of -173.34% [8]. Summary - Tivic Health Systems outperforms MSP Recovery in 7 out of 11 factors compared between the two stocks [9].
Tivic Acquires Ready-to-Scale cGMP Manufacturing and Development Assets to Accelerate Commercialization of Entolimod; Tivic Growth Backed By $90M+ Financing Package
Accessnewswire· 2025-12-11 14:45
Core Insights - Tivic Health® Systems, Inc. has acquired the strategic manufacturing and development assets of Scorpius Holdings, Inc. and is launching a new subsidiary, Velocity Bioworks™, to provide contract development and manufacturing services [1] Group 1: Acquisition Details - The acquisition is financed by 3i, LP, which includes $16 million in debt financing for asset purchase and up to $75 million in preferred convertible equity for therapeutics commercialization and corporate growth initiatives [1] - The formation of Velocity Bioworks™ secures a robust US-based manufacturing site for Tivic's lead drug candidate, Entolimod™, as the company prepares for a Biologics License Application (BLA) with the U.S. Food & Drug Administration [1]
Tivic Health Systems(TIVC) - 2025 Q3 - Earnings Call Transcript
2025-11-14 22:30
Financial Data and Key Metrics Changes - Revenue net of returns for Q3 2025 totaled $146,000, an increase from $126,000 in Q3 2024, while for the nine-month period, it decreased to $302,000 from $600,000 in 2024 [12][13] - Cost of sales increased to $291,000 from $82,000 in the year-ago quarter, primarily due to a $230,000 inventory reserve recorded in Q3 2025 [13] - Gross margins, excluding the inventory reserve, were 42% for Q3 2025 compared to 35% for Q3 2024 [13] - Net loss for Q3 2025 was $2.6 million, compared to $1.4 million for Q3 2024, while the nine-month net loss was $6 million compared to $4.2 million in 2024 [14][15] - Cash and cash equivalents at September 30, 2025, totaled $3.5 million, up from $2 million at December 31, 2024 [15] Business Line Data and Key Metrics Changes - The company is transitioning from the consumer device market to biopharmaceuticals, with a focus on Entolimod and related assets [3][11] - The company recorded reserves for excess and obsolete inventory of $230,000 as part of its exit from the consumer device market [11] - The company has discontinued significant resources toward ClearUP sales, reflecting its strategic shift [12] Market Data and Key Metrics Changes - The company is focusing on building relationships with U.S. and allied governments for Entolimod as a military countermeasure [5][6] - Discussions with BARDA are anticipated to explore stockpiling opportunities for Entolimod [5] Company Strategy and Development Direction - The company has undergone a significant strategic transformation, expanding from bioelectronics to biologic pharmaceuticals with a focus on the immune system [3][4] - The primary commercial opportunity for Entolimod is as a countermeasure for acute radiation syndrome, with plans to advance clinical programs in neutropenia and lymphocyte exhaustion [6][7] - The company is also exploring alternative commercial opportunities for its non-invasive vagus nerve stimulation (VNS) program [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of the transformation and the potential of Entolimod to deliver clinical benefits across multiple organ systems [7][16] - The company aims to advance value creation activities for shareholders while bringing life-saving treatments to patients [17] Other Important Information - The company has completed the transfer of two INDs for Entolimod, enabling further clinical development [6][16] - A new corporate website has been launched to emphasize the transformed mission and expanded clinical pipeline [12] Q&A Session Summary - No specific Q&A session content was provided in the transcript, thus this section is not applicable.