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 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].

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]

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.

Product Development and Regulatory Approvals - Tivic Health's lead product candidate, Entolimod™, is in late-stage development for treating acute radiation syndrome (ARS) and has received Fast Track and Orphan Drug designations from the FDA[183]. - Tivic Health has invested over $140 million in Entolimod and Entolasta, including $35.6 million from various government agencies, and plans to initiate Phase 2 clinical studies for oncology-related indications[188]. - The company plans to validate the manufacturing process for Entolimod to submit a biologics license application (BLA) to the FDA, which is crucial for marketing the product in the U.S.[189]. - The FDA has granted Entolimod designations to mitigate the likelihood of death following a potential lethal dose of total body ionization during radiation disasters[188]. - The company plans to increase investments in manufacturing and regulatory processes for product candidates Entolimod and Entolasta as it prepares to seek a Biologics License Application (BLA) from the FDA[229]. Financial Performance and Revenue - For the three months ended September 30, 2025, revenue increased by $20 thousand, or 16%, compared to the same period in 2024, primarily due to a 40% increase in the number of units sold[206]. - For the nine months ended September 30, 2025, revenue decreased by $298 thousand, or 50%, compared to the same period in 2024, primarily due to a 45% decrease in the number of units sold[207]. - The company expects revenues to decrease significantly as it plans to exit the consumer business by the end of the year[208]. - Cash used in operating activities for the nine months ended September 30, 2025, was $4.7 million, primarily due to a net loss of $6.0 million, offset by non-cash charges of $857 thousand[244]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $6.7 million, including proceeds from the sale of common stock and Series B Preferred Stock[247]. Expenses and Financial Challenges - Cost of sales for the three months ended September 30, 2025, increased by $209 thousand, or 255%, compared to the same period in 2024, primarily due to a $230 thousand inventory reserve for excess and obsolete inventory[210]. - Research and development expenses increased by $436 thousand for the three months ended September 30, 2025, and by $868 thousand for the nine months ended September 30, 2025, primarily due to the addition of the biopharma program[215]. - General and administrative expenses increased by $246 thousand for the three months ended September 30, 2025, and by $521 thousand for the nine months ended September 30, 2025, driven by increased employee-related costs and legal fees[220][221]. - The company incurred an accumulated deficit of $49.6 million through September 30, 2025, and expects to continue incurring losses in the future as it expands research and development activities[236]. - The company anticipates that its cash and financial resources may be insufficient to meet anticipated needs for the next twelve months, raising substantial doubt about its ability to continue as a going concern[236]. Strategic Changes and Business Focus - The company has shifted focus from its consumer health business to advancing its biologic pipeline, leading to the discontinuation of the ClearUP device by year-end[184][186]. - The company plans to wind down its consumer health business, which is expected to lead to a decline in revenue until regulatory approval is obtained for new product candidates[230]. - The company may consider strategic acquisitions or licensing opportunities that align with its growth plan, which could require a substantial portion of its cash reserves[235]. Operational and Market Conditions - The ongoing geopolitical conflicts, including those in Ukraine and Israel, have led to increased economic uncertainty and volatility in capital markets, potentially impacting the company's operations[249][255][256]. - Supply chain disruptions in 2022 resulted in increased inventory balances, with material reserves expected in 2024 and 2025 due to ongoing shortages and financial stress of contract manufacturers[250][251]. - Inflation has significantly increased in 2024, affecting costs related to products, interest rates, and transportation, which may impact future operating results[259]. - The recent prolonged shutdown of the U.S. federal government has created challenges in forecasting future revenues and financial results due to increased economic volatility[257]. - The company is considering alternative contract manufacturers due to the financial instability of its current contract manufacturer, which may affect production timelines[268]. Agreements and Funding - The company has entered into an Equity Purchase Agreement allowing it to sell up to $25 million in common stock over 24 months, with gross proceeds of $783 thousand from 235,792 shares sold as of September 30, 2025[195]. - A Preferred Purchase Agreement has been established for the sale of up to 8,400 shares of Series B Non-Voting Convertible Preferred Stock, generating gross proceeds of $4.9 million from four tranche closings[196]. - The company closed multiple tranches of funding under the Preferred Purchase Agreement, raising a total of $8.4 million, with net proceeds from various tranches totaling approximately $4.8 million[226]. Miscellaneous - The company has not entered into any off-balance sheet arrangements, maintaining a straightforward financial structure[260]. - Significant accounting policies and estimates are detailed in Note 2 of the condensed financial statements[271]. - Recent accounting pronouncements are also described in Note 2 of the condensed financial statements[272]. - There are no applicable quantitative and qualitative disclosures about market risk[273].

Financial Performance - Revenue for Q3 2025 totaled $146,000, a 15.9% increase from $126,000 in Q3 2024[6] - Gross loss for Q3 2025 was $145,000, compared to a gross profit of $44,000 in Q3 2024, primarily due to $230,000 in inventory reserves[6] - Operating expenses increased to $2.3 million in Q3 2025 from $1.5 million in Q3 2024, attributed to the addition of the biopharma business and increased corporate costs[6] - Net loss for Q3 2025 was $2.6 million, compared to a net loss of $1.4 million in Q3 2024[9] - Tivic's gross margin, excluding inventory reserves, was 42% in Q3 2025, compared to 35% in Q3 2024[6] Cash Position - Cash and cash equivalents as of September 30, 2025, were $3.5 million, up from $2.0 million at December 31, 2024[9] Business Development - Tivic completed the transfer of two INDs from Statera Biopharma, enabling clinical trials for Entolimod in neutropenia and cancer-related conditions[6] - The company successfully completed cell line verification, a key step for cGMP manufacturing, necessary for filing a biologics license application with the FDA[6] - The company executed the write-down of ClearUP inventory, resulting in $230,000 of cost of goods sold and $117,000 of other expenses[9] - The company is advancing discussions for deploying Entolimod as a military countermeasure and stockpile drug[6]

Core Insights - Tivic Health® Systems, Inc. is advancing its strategic transformation and biologics pipeline, focusing on its lead product candidate, Entolimod, for acute radiation syndrome (ARS) [1] Financial Results - The company announced financial results for the third quarter and nine months ended September 30, 2025 [1] Business Update - Engagement with key government agencies has generated interest in Entolimod as a military medical countermeasure and stockpile drug [1]

Core Insights - Tivic Health Systems, Inc. has optimized key device and treatment parameters for ncVNS, enhancing its effectiveness through personalization [1] Company Developments - The company collaborated with The Feinstein Institutes for Medical Research at Northwell Health to conduct a study on ncVNS treatment [1] - Key parameters optimized include frequency, amplitude, electrode positioning, and duration of stimulation [1] Study Findings - Personalizing the frequency of ncVNS stimulation led to a 46% increase in heart rate variability, which was 8.9 times more effective than using a uniform frequency across all subjects [1] - The optimal ncVNS frequency varied between subjects and visits, highlighting the need for personalized stimulation parameters before each treatment [1] - Certain electrode placements and configurations were found to significantly impact heart rate variability, with some placements increasing it while others decreased it [1] - A duration of four minutes of ncVNS stimulation was sufficient to achieve a substantial increase in heart rate variability, proving more effective than twenty minutes of stimulation [1]

Core Viewpoint - Tivic Health Systems, Inc. will report its third quarter financial results for 2025 on November 14, 2025, via a pre-recorded conference call and webcast [1]. Company Overview - Tivic Health is a diversified immunotherapeutics company that utilizes both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [2][3]. - The company's lead drug candidate, Entolimod™, is a novel TLR5 agonist aimed at treating acute radiation syndrome and has received Fast Track and Orphan Drug designations, currently in late-stage development [3]. Product Development - Tivic's biologics compounds are designed to activate an innate immune pathway to prevent cell death in bone marrow and epithelial tissues affected by radiation and aging [3]. - The bioelectronic program is focused on developing a non-invasive medical device targeting neural pathways associated with various prevalent diseases, showing promising early trial results [4]. Upcoming Events - CEO Jennifer Ernst will participate in the 8th Annual Northwell Health Innovation Constellation Forum on October 23, discussing advancements in bioelectronic medicine [8]. - Jennifer Ernst will also present at the Emerging Growth virtual conference on September 25, 2025, detailing the company's strategic transformation [9]. Manufacturing Progress - Tivic has completed the verification of its Entolimod™ cell line, marking the first step towards establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application (BLA) [10][11].

Core Insights - Tivic Health Systems, Inc. is participating in the eighth annual Northwell Health Innovation Constellation Forum, focusing on bioelectronic medicine and its potential to transform healthcare delivery [1][4] - CEO Jennifer Ernst will join a panel to discuss collaboration across the healthcare ecosystem to drive the adoption of bioelectronic medicine [2][3] Company Overview - Tivic Health is a diversified immunotherapeutics company utilizing both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [5] - The company's lead drug candidate, Entolimod™, is in late-stage development for acute radiation syndrome and has received Fast Track and Orphan Drug designations [6] Industry Context - Bioelectronic medicine is positioned as a transformative frontier that integrates science, technology, and patient care, with the potential to disrupt traditional disease management [2][4] - The upcoming program at the Constellation Forum will highlight breakthroughs, commercialization strategies, and challenges in scaling bioelectronic medicine into everyday healthcare [4]