Financial Data and Key Metrics Changes - Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago, a decline primarily due to a 41% decrease in unit sales associated with reductions in overall marketing spend [59] - Gross profit was $2,000 compared with $287,000 for the prior year, primarily due to $354,000 in inventory reserves recorded in 2024 compared to $32,000 in 2023 [62] - Net loss for the year decreased to $5.7 million from $8.2 million for 2023 [63] - Cash and cash equivalents at December 31, 2024, totaled $2 million compared with $3.4 million at December 31, 2023 [64] Business Line Data and Key Metrics Changes - Cost of sales decreased 12% to $0.8 million from $0.9 million in the prior year, primarily due to a 41% decrease in unit sales [60] - Total operating expenses were $5.7 million compared to $8.5 million for 2023, with plans to increase research and development investments in the Vagus nerve platform and clinical applications [63] Company Strategy and Development Direction - The company has acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate, Intellimod, which is positioned to fill a critical gap in treatments for acute radiation syndrome [7][15] - The strategic transformation aims to build a biopharmaceutical capacity within the company, combining biologic and bioelectronic medicine to focus on immune dysrhythmias [9][11] - The company is developing a noninvasive cervical vagus nerve stimulation device to treat conditions related to overactive immune systems, aiming to replace surgical approaches with noninvasive methods [36][40] Management's Comments on Operating Environment and Future Outlook - Management views 2025 as a year of growth and progress, focusing on achieving key milestones associated with the Intellimod commercialization and advancing VNS programs [68] - The company has reshaped itself into a diversified therapeutics organization, with a robust immunotherapy pipeline and a focus on cost-effectiveness compared to traditional therapies [50][51] Other Important Information - The company received approval for a compliance plan from NASDAQ and has traded above a dollar for ten consecutive days, expecting to be in compliance with continued listing requirements [54] - An equity line of credit in the amount of $25 million has been closed, providing flexible funding for development stages [55] Q&A Session Summary Question: What are the key milestones for Intellimod commercialization? - Management highlighted the importance of moving into manufacturing validation and filing a biologics license application with the FDA, with potential marketing opportunities within about two years [26][27] Question: How does the company plan to address the challenges of drug development? - The company emphasized the lower capital intensity of advancing the Intellimod program compared to developing a drug from scratch, leveraging prior investments and existing clinical data [24][52]

f UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 001-41052 Tivic Health Systems, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdicti ...

Exhibit 10.1 EQUITY PURCHASE AGREEMENT This equity purchase agreement is entered into as of March 18, 2025 (this " Agreement"), by and between Tivic Health Systems, Inc., a Delaware corporation (the "Company"), and Mast Hill Fund, L.P., a Delaware limited partnership (the "Investor", and collectively with the Company, the "Parties"). WHEREAS, the Parties desire that, upon the terms and subject to the conditions contained herein, the Company shall issue and sell to the Investor, from time to time as provided ...

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q3 2024 Earnings Conference Call November 14, 2024 4:30 PM ET Company Participants Jennifer Ernst - Chief Executive Officer Operator Welcome to Tivic Health Systems' Third Quarter 2024 Financial Results and Operational Update Conference Call. This call has been pre-recorded and questions you have submitted in advance will be answered following the prepared remarks. This call is being webcast and the replay will be available on the IR section of the company's website ...

Product Development and Research - Tivic Health's ClearUP product is the first FDA-approved bioelectronic treatment for sinus pain and congestion, with U.S. FDA clearance granted in January 2019 and expanded in March 2021[112][113]. - Tivic Health entered into a Collaboration and Research Support Agreement with The Feinstein Institutes for Medical Research to optimize responses in Autonomic Nervous System function, with a project length of one year[120]. - The company has identified approximately 30 potential medical use cases for its non-invasive vagus nerve stimulation (ncVNS) technology in various disease areas[122]. - Tivic Health's non-invasive cervical vagus nerve stimulation approach showed a 97% increase in heart rate variability and significant changes in brain activity during clinical research[118][119]. - The company launched ClearUP 2.0, which includes new power management circuitry for faster charging and longer battery life[136]. - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024[153]. Financial Performance - Revenue for the three months ended September 30, 2024, decreased by $156 thousand, or 56%, compared to the same period in 2023, primarily due to a 55% decrease in the number of units sold[140]. - For the nine months ended September 30, 2024, revenue decreased by $219 thousand, or 27%, compared to the same period in 2023, primarily due to a 36% decrease in unit sales, offset by a 13% increase in the per unit average sales price[140]. - Cost of sales for the three months ended September 30, 2024, decreased by $92 thousand, or 53%, compared to the same period in 2023, primarily driven by the decrease in unit sales[143]. - Gross profit for the three months ended September 30, 2024, was $44 thousand, a decrease of $64 thousand compared to the same period in 2023[138]. - Research and development expenses for the three months ended September 30, 2024, increased by $85 thousand compared to the same period in 2023, while for the nine months, they decreased by $315 thousand[147]. - Sales and marketing expenses for the three months ended September 30, 2024, decreased by $246 thousand compared to the same period in 2023, and for the nine months, they decreased by $444 thousand[149]. - General and administrative expenses for the three months ended September 30, 2024, decreased by $232 thousand compared to the same period in 2023, and for the nine months, they decreased by $1.2 million[150]. - As of September 30, 2024, the company had cash and cash equivalents of $2.2 million and an accumulated deficit of $42.1 million[151]. - The company has incurred an accumulated deficit of $42.1 million through September 30, 2024, and expects to incur additional losses in the future as it expands research and development activities[157]. - Cash used in operating activities for the nine months ended September 30, 2024, was $4.4 million, compared to $6.7 million for the same period in 2023[162][163]. - The company generated $3.2 million from financing activities during the nine months ended September 30, 2024, primarily from the sale of 4,710,000 shares of common stock[165]. Operational Changes and Agreements - The company expects a reduction of approximately $200,000 in lease expenses over the next year and a half following the termination of a sublease agreement[126]. - The company has transitioned to third-party logistics and in-house assembly capabilities after terminating its Fulfillment Services Agreement with ALOM Technologies Corporation[128]. - The Amended and Restated 2021 Equity Incentive Plan increased the number of shares authorized for issuance from 92,376 to 1,000,000 shares, approved by stockholders on August 9, 2024[135]. - The company entered into an Equity Distribution Agreement allowing for the sale of up to $10 million in shares of common stock, with only $18 thousand in gross proceeds utilized to date[151]. - The company has remaining commitments to pay a total of $231 thousand for milestones related to the development of Tivic's ncVNS technology, expected to be incurred over the next six months[179]. - The company has entered into a Co-Working Space Agreement for $1 thousand a month, with an initial term of six months[178]. Market and Economic Conditions - A 2023 study indicated that approximately 85 million U.S. adults experience inflammation-related symptoms, with 58% of sufferers trying to avoid medication[114]. - Global supply chain shortages and inflation may increase the cost of components, potentially decreasing gross margins or necessitating price increases[168]. - Global issues and macroeconomic factors have made it difficult to accurately forecast revenues and financial results, with potential for significant market disruptions[172]. - Inflation has increased recently, with potential adverse effects on operating results due to rising costs of products and services[174]. - The company continues to monitor geopolitical tensions and their potential impacts on operations and supply chains[173]. - The company has not been materially impacted by ongoing military conflicts, but the extent of future impacts remains unpredictable[171]. Compliance and Future Outlook - The company is actively monitoring its stock price to regain compliance with Nasdaq's minimum bid price requirement by December 26, 2024[132][134]. - The company anticipates that operating expenses will increase significantly as it seeks regulatory approval and commercializes new products[152][153]. - The company expects 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[152][157]. - The company has faced significant costs associated with operating as a public company and expects to continue incurring losses for the foreseeable future[154]. - The company has not generated significant revenue from product sales and plans to finance operations through equity or debt financings until substantial revenue is achieved[160]. - There were no changes in internal control over financial reporting that materially affected the company's reporting[185]. - The company is not currently a party to any legal proceedings that would materially affect its business[187]. - The company may consider strategic acquisitions or transactions that align with its growth plan, which could require a substantial portion of its cash reserves[155][156].

Financial Data and Key Metrics Changes - ClearUP revenues for Q2 2024 were $140,000, a decrease of $63,000 or 12% compared to the first half of 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in the per-unit average sale price [6][9] - Gross profits for the first half of 2024 were $197,000, showing margin improvement to 42% compared to 32% in 2023 [7] - The company incurred a net loss of $1.3 million for Q2 2024, which is an improvement from a net loss of $2.1 million in 2023 [9] - Cash and cash equivalents totaled $3.7 million as of June 30, 2024, compared to $3.4 million at the end of 2023 [9] Business Line Data and Key Metrics Changes - Cost of sales for Q2 2024 was $110,000, a decrease of $86,000 or 24% compared to the first half of 2023, driven by reduced sales volume and cost improvements [7] - Total operating expenses for Q2 2024 were $1.2 million, down from $2.2 million in 2023, reflecting a year-over-year cost reduction of $1.5 million [8] Company Strategy and Development Direction - The company is focusing on developing a novel vagus nerve stimulation (VNS) system, which is a critical part of its strategy to build shareholder value [5][6] - The company aims to broaden its footprint in bioelectronic medicine, leveraging learnings from its first product to target high-value medical applications [13][35] - The company is prioritizing noninvasive VNS, which is expected to have lower costs and risks compared to implanted devices, allowing for quicker market entry [22][26] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the macro environment, including increased supply chain costs and tighter marketing restrictions, which may limit short-term profitability of the ClearUP product [12] - The company is optimistic about the potential of its VNS program, with plans to validate market opportunities and optimize applications for strong commercial results [34][35] - Management emphasized the importance of transparency with investors regarding future plans and the potential for significant shareholder returns from the VNS program [13][35] Other Important Information - The company received a notification from NASDAQ regarding non-compliance with the minimum bid price requirement, with a 180-day period to regain compliance [10] - The company has a robust patent portfolio with nine issued patents and ten pending patents, which are crucial for protecting its innovations in VNS [41][42] Q&A Session Summary Question: What is the company planning to do with ClearUP as it turns towards VNS? - Management indicated that while ClearUP is a valuable product, the focus will shift towards exploring alternative monetization strategies, including licensing and international distribution agreements [39][40] Question: Does the company have resources to move forward with the VNS program? - Management confirmed that while operational cutbacks have been made, the research pipeline is crucial for building shareholder value, and there will be a need to expand the clinical research team as the program progresses [40] Question: What diseases is the company considering targeting based on the VNS study? - Management stated that there is a prioritized list of potential targets, but specific indications are not ready to be communicated publicly yet [41] Question: Are there any patents pending, and what is the risk of expiration? - Management confirmed the existence of a robust patent portfolio with no immediate risk of expiration, as the patents are newly issued and the company expects to bring products to market quickly [42]

Product Development and Market Opportunity - Tivic Health's ClearUP product is the first FDA-approved bioelectronic treatment for sinus pain and congestion, with a market opportunity identified for approximately 85 million U.S. adults experiencing related symptoms[98] - A pilot study confirmed a 97% increase in heart rate variability (RMSSD) due to the company's non-invasive cervical vagus nerve stimulation (ncVNS) approach, indicating potential clinical utility in major disease areas[102] - The market for peripheral nerve stimulation in bioelectronic medicine is forecasted to grow at a 35% CAGR from 2019 through 2029, indicating strong growth potential in the sector[96] - The company has entered into a collaboration agreement with Feinstein to advance research on autonomic nervous system function in response to neuromodulation[104] Financial Performance - Revenue for the three months ended June 30, 2024, decreased by $21 thousand, or 13%, compared to the same period in 2023, primarily due to a 12% decrease in the per unit average sales price[119] - For the six months ended June 30, 2024, revenue decreased by $63 thousand, or 12%, compared to the same period in 2023, primarily due to a 27% decrease in unit sales, offset by a 20% increase in the per unit average sales price[119] - Cost of sales for the three months ended June 30, 2024, increased by $10 thousand, or 10%, compared to the same period in 2023, driven by a $20 thousand increase in the inventory reserve for obsolescence[121] - Gross profit for the three months ended June 30, 2024, was $30 thousand, a decrease of $31 thousand compared to $61 thousand for the same period in 2023[117] Expense Management - Research and development expenses for the three months ended June 30, 2024, decreased by $166 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $400 thousand[126] - Sales and marketing expenses for the three months ended June 30, 2024, decreased by $245 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $198 thousand[127] - General and administrative expenses for the three months ended June 30, 2024, decreased by $539 thousand compared to the same period in 2023, and for the six months ended June 30, 2024, decreased by $933 thousand[128] Cash Flow and Capital Needs - As of June 30, 2024, the company had cash and cash equivalents of $3.7 million and an accumulated deficit of $40.6 million[130] - Net cash used in operating activities for the six months ended June 30, 2024, was $3.0 million, compared to $4.9 million for the same period in 2023[141][142] - The company generated $3.3 million from financing activities during the six months ended June 30, 2024, primarily from the sale of 4,710,000 shares of common stock[144] - The company anticipates needing to raise additional capital to fund operations, including research and development and clinical trials, due to insufficient cash resources[135][138] Operational Changes - The company terminated its Fulfillment Services Agreement with ALOM Technologies to reduce costs and has transitioned to third-party logistics and in-house assembly capabilities[112] - The company expects a reduction of approximately $200,000 in lease expenses over the next year and a half following the termination of a sublease agreement[107] - The company has not entered into any off-balance sheet arrangements and terminated its previous office lease, now renting co-working space for $1,000 a month[154] Challenges and Risks - The Nasdaq notified the company of non-compliance with the minimum bid price requirement due to the closing bid price being below $1.00 for 33 consecutive business days, with a compliance period until December 26, 2024[109] - The company faces challenges from global supply chain shortages and inflation, which could increase component costs and affect gross margins[147][153] - The ongoing geopolitical tensions and economic uncertainties may negatively impact the company's ability to forecast revenues and secure additional funding[145][151] Research Outcomes - A study on postoperative pain following sinus surgeries showed no statistically significant differences between the active microcurrent device and a sham device, leading the company to halt further research in this area[114] - The company plans to increase research and development investments in its vagus nerve platform and clinical applications in 2024[132] - The company has incurred an accumulated deficit of $40.6 million through June 30, 2024, and expects to incur additional losses as it expands research and development activities[135] Accounting and Compliance - Recent accounting pronouncements are detailed in Note 2 of the condensed financial statements[158] - There are no applicable quantitative and qualitative disclosures about market risk[158]

Exhibit 99.1 Tivic Reports Second Quarter 2024 Financial Results SAN FRANCISCO – (Business Wire) – August 14, 2024 – Tivic Health® Systems, Inc. ("Tivic", Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, today announced its second quarter 2024 financial results and discussed growth strategies based on its investments in vagus nerve stimulation ("VNS"). "This quarter is the start of a potentially transformational period for Tivic. We announced the results of our s ...

Core Viewpoint - Tivic Health Systems' stock has experienced significant volatility, with a recent rally attributed to a patent update, leading to a notable increase in trading volume and share price [4][6]. Group 1: Stock Performance - Tivic Health Systems' stock (TIVC) rose by 38.9% as of Monday morning, although it remains down 64.8% year-to-date and 87% over the past 12 months [7]. - The trading volume for TIVC reached approximately 68 million shares on Monday, compared to the daily average of about 2.9 million shares [1]. Group 2: Recent Developments - The recent rally in TIVC stock was initially driven by a patent update, which significantly boosted the stock during normal trading hours on Thursday [4]. - Best Growth Stocks, an equity research firm utilizing artificial intelligence, provided an analysis regarding the implications of the latest patent news for Tivic Health Systems [2].

Core Insights - Tivic Health Systems has updated its intellectual property portfolio, which has positively impacted its stock performance [2][6] - The company received two new patents, enhancing protection for its devices and methods related to treatment [6] - TIVC stock experienced a significant increase of 44% on Thursday, although it remains down 83.1% year-to-date [4] Intellectual Property Developments - The newly granted US Patent 12,011,592 and European Patent EP3615133 cover methods to identify preferred treatment points and trigger treatment modes [6] - The company emphasizes the unique features of its adaptive design and personalization of treatment parameters, which contribute to the effectiveness and comfort of its products [6] - The company is committed to building a robust intellectual property portfolio to support current and future products, including non-invasive vagus nerve stimulation [6] Stock Performance - TIVC stock saw heavy trading activity with over 33 million shares traded on Thursday, compared to a daily average of approximately 816,000 shares [6] - The stock's recent rise follows a significant decline earlier in the year, highlighting volatility in its market performance [4]