Tivic Health Systems (TIVC) Conference June 11, 2025 01:30 PM ET Speaker0 Hello and welcome to Virtual Investor Conferences. On behalf of the Life Science Investor Forum and our co host, Zach SmallCap Research, we are very pleased you have joined us for our quarterly conference. Our next presentation is from Tivic. Please note, you may submit questions for the presenter in the box to the left of the slides. You can also view our company's availability for a one on one meeting by clicking book meeting in the ...

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 Company Participants Jennifer Ernst - Co-Founder, CEO & DirectorLisa Wolf - Interim CFOMichael Handley - COO & President of the Biopharma Division Operator 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 t ...

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 ...

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 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]

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]