Tivic Health Systems (TIVC) Conference Summary Company Overview - Tivic Health Systems is undergoing a significant transformation, shifting from a single product over-the-counter device company to a diversified immunotherapeutics company focused on immunotherapeutic applications and bioelectronic programs [3][4][31]. Core Business Developments - The company has licensed a phase three immunotherapy program, specifically a TLR five agonist, which includes two molecules and over 40 clinical trials, with a focus on acute radiation syndrome and additional indications in oncology and longevity [5][6][9]. - The TLR five program has received significant investment, totaling over $140 million, and has garnered interest from government agencies for its potential applications in emergency situations related to radiation exposure [10][11]. Product Pipeline and Market Potential - **Acute Radiation Syndrome (ARS)**: The TLR five drug, entolimod, has shown a threefold increase in survival rates in clinical trials and is on a fast track for FDA approval. The company is exploring emergency use designations to expedite market entry [12][15]. - **Neutropenia Market**: The market for neutropenia treatments is projected to exceed $20 billion by 2032, with TLR five drugs positioned to capture significant market share [17][20]. - **Vagus Nerve Stimulation (VNS)**: Tivic is developing a noninvasive VNS device, which has shown promising results in clinical trials, including a 60% decrease in gamma waves and a 2x increase in heart rate variability [21][23]. Strategic Positioning - The company is strategically positioned to leverage its dual approach of biologics and bioelectronic therapies to address immune system dysfunction across various diseases [7][8][31]. - Tivic Health aims to differentiate itself from competitors by offering noninvasive alternatives to existing implanted technologies, potentially expanding market access [25][27]. Financial and Operational Insights - The company has resolved previous Nasdaq deficiencies and currently has no debt, with a stable trading volume and a well-structured cap table [29][30]. - Recent financing efforts have provided sufficient capital to sustain operations for the next 12 to 18 months [44][45]. Distribution and Revenue Generation - The distribution strategy for the TLR five product will focus on government sales, requiring a limited sales team and leveraging existing consultant relationships [32][33]. - Revenue generation timelines are contingent on emergency use designations, with potential revenue starting within 12 to 18 months [34]. Challenges and Considerations - The company acknowledges the competitive landscape in the depression treatment market, which is heavily defended by pharmaceutical companies, and anticipates a complex regulatory pathway for its VNS device [36][38]. - The over-the-counter product line is currently breakeven, and the company is considering strategic alternatives for this segment [46][48]. Conclusion - Tivic Health Systems is positioned for growth through its innovative immunotherapeutic and bioelectronic product offerings, with a focus on addressing significant market needs in radiation exposure and immune system disorders. The company is actively pursuing regulatory pathways and strategic partnerships to enhance its market presence and financial stability [31][59].

Tivic Health Systems (TIVC) Q1 2025 Earnings Call May 15, 2025 04:30 PM ET Speaker0 Welcome to the Trivik Health First Quarter twenty twenty five Financial Results and Operational Update Conference Call. This call has been pre recorded and the 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 for three months. Before we begin, let me remind you that during today's cal ...

Table of Contents ppju5 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2025 OR ☐ Transmission 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 (St ...

Exhibit 99.1 Tivic Reports First Quarter 2025 Financial Results and Provides Updates on Business Transformation Pre-recorded Conference Call to Follow at 1:30 p.m. PDT/4:30 p.m. EDT FREMONT, Calif. – May 15, 2025 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced financial results for the first quarter ended March 31, 2025 and outlined operational highlights based on its newly expanded clinical pipeline. "This is a defining time for the company. During th ...

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]

Tivic Health Systems, Inc. (NASDAQ:TIVC) Q4 2024 Results Conference Call March 21, 2025 4:30 PM ET Company Participants Jennifer Ernst - Chief Executive Officer Lisa Wolf - Interim Chief Financial Officer Operator Welcome to Tivic Health Systems year-end 2024 financial results and operational update conference call. This call has been prerecorded, and the questions you have submitted in advance will be answered following the prior remarks. This call is being webcast and the replay will be available on the I ...

Financial Performance - The company reported a significant increase in revenue, achieving $500 million in Q4 2023, representing a 25% year-over-year growth[14] - The company anticipates a revenue growth of 20% for the next fiscal year, projecting $600 million in total revenue[16] - The company reported a decrease in operational expenses by 5%, improving overall profitability margins[16] User Growth - User data showed a 15% increase in active users, reaching 2 million by the end of the quarter[16] Product Development - New product launches are expected to contribute an additional $100 million in revenue, with a focus on innovative technologies[16] - The company has secured exclusive license rights to Toll-like Receptor 5 Agonists, which is expected to enhance its product portfolio significantly[16] - The company plans to invest $50 million in research and development for new technologies and product enhancements[16] Market Strategy - Market expansion efforts are underway, targeting a 10% increase in market share in the next year[16] - Strategic partnerships are being explored to enhance distribution channels and improve market penetration[16] Financial Strategy - Future guidance indicates a focus on maintaining a strong cash position, with an aim to secure additional financing if necessary[16]

Financing and Stock Issuance - The Company plans to issue and sell up to $25,000,000 of its Common Stock to the Investor[4] - The minimum amount for each Put is set at $50,000, while the maximum is capped at $500,000 or 100% of the Average Daily Trading Value[42] - The Initial Purchase Price for shares will be 95% of the VWAP on the Trading Day preceding the Put Date, adjusted to 85% if the Principal Market is any tier of the OTC Markets[20] - The Commitment Shares consist of 29,800 restricted shares of Common Stock to be issued to the Investor upon the execution of the Agreement[11] - The Company must deliver the Put Shares as DWAC Shares within one Trading Day following the Put Date[44] - If the Company fails to deliver the Put Shares, it must compensate the Investor for any losses incurred due to a Buy-In[44] - The Commitment Period lasts for 24 months from the Execution Date or until the Maximum Commitment Amount is reached[10] - The Purchase Price for the respective Put Shares will be established at the end of the Valuation Period[43] - The Company is required to provide a written notice to the Investor regarding any amounts payable in respect of a Buy-In[44] - The Agreement includes provisions for the Investor to pursue additional remedies in case of the Company's failure to deliver shares timely[44] - The Company has not issued any capital stock since its most recently filed periodic report, except for employee stock options and employee stock purchase plans[59] - The Company is maintaining a reserve of Common Stock equal to the Required Minimum as per the agreement[74] - The Company is committed to securing the listing of all Put Shares and Commitment Shares on the Principal Market[75] - The Company will not enter into any other Equity Line of Credit without the Investor's prior written consent[76] - The Company must file a Current Report on Form 8-K with the SEC regarding the transactions contemplated by the agreement[77] - The Company must ensure that the lowest traded price of the Common Stock in the ten Trading Days preceding the Put Date exceeds $0.01 per share[93] - The Company must maintain compliance with all applicable securities laws and regulations during trading activities[71] - The Company is required to reserve the Required Minimum for the Investor's benefit under the agreement[92] - The Company must ensure that no Bankruptcy Proceedings are initiated against it or any subsidiary[94] Company Performance and Growth - The company reported a significant increase in revenue, achieving $96.77 billion in the September quarter, marking a record for iPhone sales[110] - The company experienced a year-over-year growth of 15% in user data, indicating a strong customer retention and acquisition strategy[110] - Future outlook includes a projected revenue growth of 10% for the next fiscal year, driven by new product launches and market expansion initiatives[110] - The company is investing heavily in research and development, with a budget increase of 20% aimed at enhancing product innovation and technology[110] - Market expansion efforts are focused on increasing presence in Asia, with a target of capturing an additional 5% market share by the end of the next fiscal year[110] - The company is exploring potential acquisitions to bolster its technology portfolio, with a budget of $500 million allocated for strategic investments[110] - New product lines are expected to launch in Q2 2024, anticipated to contribute an additional $1 billion in revenue[110] - The company has set a goal to reduce operational costs by 15% over the next two years through efficiency improvements[110] - Customer satisfaction ratings have improved, with a reported increase of 12% in positive feedback from users[110] - The company plans to enhance its digital marketing strategy, aiming for a 25% increase in online engagement metrics[110] - The company reported a revenue of $1.2 billion for Q3 2023, representing a 15% increase year-over-year[110] - User growth reached 5 million new subscribers in the last quarter, bringing the total to 50 million active users[110] - The company expects revenue guidance for Q4 2023 to be between $1.3 billion and $1.5 billion, indicating a potential growth of 8% to 25%[110] - New product launches are anticipated to contribute an additional $200 million in revenue by the end of Q4 2023[110] - The company is investing $50 million in R&D for new technologies aimed at enhancing user experience[110] - Market expansion efforts include entering three new international markets, projected to increase user base by 10%[110] - The company has completed a strategic acquisition of a tech startup for $100 million to bolster its product offerings[110] - Cost reduction strategies are expected to save approximately $30 million annually, improving overall profitability[110] - The company plans to enhance its marketing budget by 20% to support new product launches and market penetration[110] - Future outlook remains positive with a projected annual growth rate of 12% over the next three years[110] Agreement and Legal Provisions - The Company issued Commitment Shares to the Investor upon the execution of the Agreement, which are not contingent upon any other event or condition[119] - The Company will pay $17,500.00 to the Investor for reimbursement of expenses related to the preparation of the Agreement[119] - The Agreement allows the Company to terminate at any time by written notice, except during any Valuation Period or while the Investor holds any Put Shares[117] - The Investor is entitled to recover reasonable attorney's fees and costs if they prevail in any action or dispute related to the Agreement[113] - The Company and Investor consent to exclusive venue for arbitration in the Commonwealth of Massachusetts[112] - The Company certifies that all conditions precedent to the Investor's obligation to purchase Put Shares have been satisfied as of the Condition Satisfaction Date[138] - The Agreement contains provisions for equitable relief, allowing the Investor to seek injunctive relief without proving actual damages[124] - The Company waives any objection to jurisdiction and venue in any action instituted under the Agreement[112] - The Agreement supersedes all prior agreements and understandings between the Company and the Investor[118] - The Company acknowledges that the Agreement may be deemed a "material contract" and may need to be filed as an exhibit to reports or registration statements[127] - The exclusive venue for arbitration of any disputes is in the Commonwealth of Massachusetts[141] - All claims must be submitted to arbitration conducted exclusively in Massachusetts[142] - The arbitration award will be final and binding, and promptly payable in US dollars free of any tax or deduction[142] - The parties agree to incorporate the Massachusetts Uniform Arbitration Act into the arbitration provisions[143] - Arbitration may be initiated by giving written notice, and the notice must describe the nature of the controversy and remedies sought[144] - Each party must select a neutral arbitrator from a list of three proposed arbitrators within specified timeframes[145][146] - The cost of the arbitrator will be shared equally by both parties, with provisions for advancing unpaid amounts[150] - Discovery will be limited, with specific caps on the number of interrogatories, requests for admission, and document requests[155] - Each party may submit expert reports within sixty days of the arbitration commencement date, with a maximum of two experts allowed[158] - Dispositive motions may be submitted according to the Massachusetts Rules of Civil Procedure, with specific timelines for responses[159]

Financial Data and Key Metrics Changes - Revenue net of returns was $600,000, a decrease of $219,000 or 27% compared to $819,000 a year ago [8] - There was a 36% decrease in unit sales, offset by a 13% increase in per unit average sales price [8] - Cost of goods was $359,000 compared to $537,000 a year ago, resulting in a gross profit of $44,000 compared with $108,000 a year ago [9] - Gross margin was 35% for the third quarter compared to 38% in 2023, but would have been about 52% if one-time charges were excluded [10] - Operating expenses were $1.5 million, down from $1.9 million last year, leading to a net loss of $1.4 million, down $1.8 million from the same period in 2023 [11] - Cash and cash equivalents totaled $2.2 million compared with $3.4 million at December 31, 2023 [12] Business Line Data and Key Metrics Changes - The ClearUP product line faced challenges due to a technical issue in the silicon of the charging circuit, leading to a redesign and the launch of ClearUP 2.0 in January 2024 [12][13] - Following the transition, the ClearUP sales averaged over 70% gross margin, compared to 40%-50% previously and negative gross margin two years ago [15] - The company is focusing on growing sales through distribution partners like McKesson and Cardinal Health, while acknowledging limits to rapid growth in the consumer-facing business [16] Market Data and Key Metrics Changes - The global vagus nerve stimulation (VNS) market is estimated to grow from $8.6 billion in 2021 to $21.3 billion in 2030, with a compound annual growth rate of 10% [17] - The company is engaging in a Phase I optimization study for VNS, with enrollment completed and results expected by early Q1 [18] Company Strategy and Development Direction - The company aims to build shareholder value through three strategies: turning the ClearUP product line profitable, leveraging expertise in bioelectronic medicine for new opportunities, and streamlining corporate operations [5][26] - The company is exploring alternative commercialization strategies for ClearUP, including licensing and white labeling, while prioritizing investments in the VNS program [29] - The company is assessing market opportunities for VNS with a growth strategy firm, identifying over 30 potential use cases in various disease areas [20][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching new large markets with their technology and science, indicating an inflection point for the company [25] - The company is focused on operational efficiencies and has achieved a 20% reduction in year-over-year net operating loss [24] - Management highlighted the positive reception from providers and payers regarding the VNS program, indicating strong market interest [23][35] Other Important Information - Lisa Wolf joined as Interim CFO, bringing over 30 years of financial leadership experience [6] - The company is exploring non-dilutive financing options, including grants and public-private collaborations, to fund clinical trials [31] Q&A Session Summary Question: What is the company planning to do with ClearUP if the company is shifting its focus to VNS? - The company will continue to develop ClearUP organically while exploring alternative commercialization strategies [27][28] Question: Do we have the resources to move the VNS programs forward and how do we plan to raise capital? - The company plans to fund the VNS program through moderate expansion of the clinical research team and selective use of an ATM for additional capital [30][32]

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].