Tivic Health Systems(TIVC)

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Tivic Health Systems(TIVC) - 2025 Q2 - Earnings Call Transcript
2025-08-14 21:30
Financial Data and Key Metrics Changes - Revenue net of returns totaled $86,000 for Q2 2025 compared to $140,000 in Q2 2024, and $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024, reflecting a significant decline due to decreased unit sales of ClearUp [16][17] - Cost of sales decreased to $32,000 from $110,000 in the year-ago quarter, and gross margins increased to 63% for Q2 2025 compared to 21% a year ago, driven by reductions in product support and fulfillment costs [17][18] - Net loss was $1,900,000 for Q2 2025 compared with $1,300,000 for Q2 2024, and $3,400,000 for the first half of 2025 compared with $2,700,000 for the first half of 2024 [18][19] Business Line Data and Key Metrics Changes - The decline in revenue was primarily due to reduced unit sales of ClearUp, as the company intentionally decreased marketing expenditures to focus on advancing its TLR5 program [17] - Operating expenses increased to $2,000,000 for Q2 2025 compared with $1,300,000 for Q2 2024, mainly due to increased research and development investments in the biologics program [18] Market Data and Key Metrics Changes - The market for neutropenia drugs is projected to be between $19 billion to $24 billion over the next few years, with entolimod potentially addressing a significant portion of this market [10] Company Strategy and Development Direction - The company is transitioning towards the biopharmaceutical market and away from the consumer device market, planning to exit the consumer health tech business by year-end [14] - The exclusive licensing of Sotero Biopharma's TLR5 portfolio is expected to provide a late-stage, highly derisked drug candidate, with significant sales potential from government contracts for acute radiation syndrome (ARS) treatments [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of entolimod and its derivatives to treat radiation and chemotherapy side effects, emphasizing the importance of their strategic pipeline [11][12] - The company is focused on advancing its clinical and commercial opportunities, with key milestones including the transfer of existing INDs and validation of GMP materials [22][23] Other Important Information - The company raised gross proceeds of $900,000 through equity financing, which will support progress towards GMP manufacturing validation for entolimod [19] - Management highlighted the importance of talent acquisition to support clinical work and government relations, indicating a strategic alignment with their new focus [21] Q&A Session Summary - No specific questions and answers were provided in the content, thus this section is not applicable.
Tivic Health (TIVC) Q2 2025 Earnings Transcript
The Motley Fool· 2025-08-14 21:02
Image source: The Motley Fool.Aug. 14, 2025 at 4:30 p.m. ETCall participantsChief Executive Officer — Jennifer ErnstChief Financial Officer — Lisa WolfNeed a quote from a Motley Fool analyst? Email [email protected]TakeawaysRevenue-- Revenue net of returns was $86,000, reflecting intentional reductions in ClearUp marketing and unit sales. Gross margin-- Gross margin increased to 63%, up from 21% a year ago, due to decreased product support and fulfillment costs.Operating expenses-- Operating expenses were $ ...
Tivic Health Systems(TIVC) - 2025 Q2 - Quarterly Report
2025-08-14 20:32
Table of Contents ppju5 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Tivic Health Systems, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 47685 Lakeview Blvd. Fremont, CA 94538 (Address of principal executive offices including zip code) SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for t ...
Tivic Health Systems(TIVC) - 2025 Q2 - Quarterly Results
2025-08-14 20:02
"We have established a strong foundation for Tivic's strategic transformation with our expansion into biopharmaceuticals, making us unique in treating disease by addressing both the body's biochemical and bioelectronic systems," stated Tivic CEO Jennifer Ernst. "To maximize our focus on the compelling, late-stage clinical pipeline, we have increasingly shifted resources away from consumer healthtech and are now planning to exit the ClearUP business by the end of this year," continued Ernst. "I look forward ...
Tivic Health Systems (TIVC) Conference Transcript
2025-06-11 18:32
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 Transcript
2025-05-22 18:00
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) - 2025 Q1 - Earnings Call Transcript
2025-05-15 21:32
Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [11][12] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [12] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 for both quarters [12][13] - Cash and cash equivalents were $669,000 as of March 31, 2025, down from $2,000,000 at the end of 2024 [13] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing biopharmaceutical assets and supporting clinical research in non-invasive vagus nerve stimulation [9] Market Data and Key Metrics Changes - The treatment market for neutropenia is expected to reach $20 billion by 2029, indicating a substantial growth opportunity for the company [36] Company Strategy and Development Direction - The company is focused on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the licensing agreement for entelimod [9][10] - A strategic shift towards immunotherapeutics is underway, with plans to advance both late and early-stage treatments in the pipeline [42] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the high economic uncertainty and the impact of reduced advertising on revenue, but emphasized the importance of capital management for future returns [10] - The company views 2025 as a year of tremendous opportunity with several key milestones expected in the second half of the year [44] Other Important Information - The FDA granted Fast Track status and orphan drug status for entelimod, with potential for accelerated pathways and emergency use designations [37] - The company has secured an $8.4 million tranche funding agreement to support its transformation [8] Q&A Session Summary - No specific questions and answers were provided in the content, as the call was pre-recorded and questions were submitted in advance.
Tivic Health Systems(TIVC) - 2025 Q1 - Earnings Call Transcript
2025-05-15 21:30
Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [10][11] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [11] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 remaining unchanged year-over-year [11][12] - Cash and cash equivalents were $669,000 at the end of Q1 2025, down from $2,000,000 at the end of 2024, with working capital at $520,000 [12] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing and operationalizing biopharmaceutical assets, particularly in the licensing agreement with Staterra for entelimod and its derivative [8][14] Market Data and Key Metrics Changes - The market for neutropenia treatment is projected to reach $20 billion by 2029, indicating a significant opportunity for the company’s new drug candidates [33] - The company is positioned to address diseases caused by both underactive and overactive immune systems, which is a unique market opportunity [40] Company Strategy and Development Direction - The strategic focus is on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the advancement of entelimod and the vagus nerve stimulation program [8][9] - The company aims to transition into high-value markets while managing capital to minimize dilution for investors [7][8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of the licensing agreement with Staterra as a significant strategic shift, providing a foundation for growth and value creation [16][18] - The FDA granted Fast Track and orphan drug status to entelimod, with potential for accelerated pathways and emergency use designations [35] Other Important Information - The company has entered into an $8,400,000 tranche funding agreement to support its transformation and has secured a $25,000,000 equity line of credit [7][12] - The company is committed to advancing its non-invasive vagus nerve stimulation program, with ongoing clinical studies expected to yield results in the near future [39][40] Q&A Session Summary Question: What is the company's strategy regarding the new licensing agreement? - The licensing agreement with Staterra is seen as a major opportunity to accelerate value creation and leverage the company’s commercial infrastructure for long-term growth [14][16] Question: How does the company plan to address the decline in revenue? - The company intentionally reduced advertising spend to focus on capital resources for biopharmaceutical assets, which impacted revenue but is expected to lead to greater long-term value [10][11] Question: What are the expected milestones for entelimod? - The company is focused on validating the manufacturing process for entelimod and preparing for the biological licensing application with the FDA, with significant confidence in the collaboration for successful outcomes [36][40]
Tivic Health Systems(TIVC) - 2025 Q1 - Quarterly Report
2025-05-15 20:31
PART I - FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for the three months ended March 31, 2025 and 2024, including balance sheets, statements of operations, stockholders' equity, and cash flows, with accompanying notes on accounting policies, key transactions, and the going concern assessment Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $669 | $2,002 | | Total current assets | $1,261 | $2,639 | | Licensed technology | $2,226 | $0 | | Total assets | $3,777 | $2,807 | | Total current liabilities | $741 | $272 | | Total stockholders' equity | $3,036 | $2,535 | Condensed Statement of Operations Data (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $70 | $334 | | Gross profit | $50 | $167 | | Total operating expenses | $1,556 | $1,648 | | Loss from operations | $(1,506) | $(1,481) | | Net loss | $(1,502) | $(1,481) | | Net loss per share | $(2.52) | $(17.15) | Condensed Statement of Cash Flows Data (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(889) | $(1,666) | | Net cash used in investing activities | $(526) | $0 | | Net cash provided by (used in) financing activities | $82 | $(61) | | Net decrease in cash and cash equivalents | $(1,333) | $(1,727) | - The company has incurred recurring net losses and negative cash flows, with cash and cash equivalents at **$0.7 million** as of March 31, 2025, raising substantial doubt about its ability to continue as a going concern within one year[22](index=22&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide detailed explanations of the financial statements, covering key events such as the Statera license acquisition, a reverse stock split, equity line of credit, preferred stock designations, and significant subsequent financing and manufacturing agreements - In February 2025, the Company acquired an exclusive worldwide license from Statera Biopharma for the late-stage TLR5 agonist Entolimod™ for treating Acute Radiation Syndrome (ARS) and an option for additional indications[20](index=20&type=chunk) - Effective March 7, 2025, the Company implemented a **1-for-17 reverse stock split** of its common stock, with all share and per-share amounts retroactively restated[25](index=25&type=chunk) - The acquisition of the Statera license was accounted for as an asset acquisition, with a total consideration of **$1.7 million** (**$1.2 million** in stock, **$0.5 million** in cash and capitalized costs), and the company also exercised an option for the neutropenia indication for an additional **$500 thousand** in stock[68](index=68&type=chunk)[74](index=74&type=chunk)[77](index=77&type=chunk) - Subsequent to the quarter end, on April 29, 2025, the company entered into a Securities Purchase Agreement to sell up to **$8.4 million** of new Series B Preferred Stock and warrants in several tranches[129](index=129&type=chunk) - On May 9, 2025, the Company entered into a Statement of Work with Scorpius BioManufacturing to serve as the primary U.S. manufacturer for Entolimod, with an estimated total investment of approximately **$4.1 million**[143](index=143&type=chunk)[145](index=145&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's transformation into a diversified therapeutics company, analyzing the Q1 2025 revenue decrease, operating expenses, liquidity issues, and future funding requirements, while reiterating substantial doubt about its going concern ability and outlining recent strategic financing and manufacturing partnerships [Business Overview and Updates](index=39&type=section&id=Business%20Overview%20and%20Updates) The company has diversified into a therapeutics company with bioelectronic and biopharma programs, with recent updates including regaining Nasdaq compliance via a reverse stock split and establishing a $25 million equity line of credit - The company is now a diversified therapeutics company with a bioelectronic program (ClearUP, VNS) and a biopharma program focused on the late-stage TLR5 agonist, Entolimod™, for acute radiation syndrome (ARS)[149](index=149&type=chunk)[150](index=150&type=chunk) - The company regained compliance with Nasdaq's minimum bid price requirement in April 2025 after implementing a **1-for-17 reverse stock split** on March 7, 2025[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) - On March 18, 2025, the company entered into a **$25 million** Equity Line of Credit with Mast Hill Fund, L.P., allowing it to sell shares at its discretion over 24 months[168](index=168&type=chunk) - On March 28, 2025, the company exercised its option to license Entolimod for the neutropenia indication, paying the first **$500,000** milestone in company stock[185](index=185&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) For Q1 2025, revenue decreased by 79% to **$70 thousand** due to reduced advertising, while gross profit was **$50 thousand**, operating expenses slightly decreased, and net loss remained stable at approximately **$1.5 million** Comparison of Operations (in thousands) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70 | $334 | $(264) | | Gross Profit | $50 | $167 | $(117) | | Research and development | $335 | $256 | $79 | | Sales and marketing | $179 | $505 | $(326) | | General and administrative | $1,042 | $887 | $155 | | Net loss | $(1,502) | $(1,481) | $(21) | - The **79% decrease in revenue** was primarily due to an **81% decrease in units sold**, associated with a **92% decrease in advertising spend** as capital was reallocated to the Statera Licensing Agreement[220](index=220&type=chunk) - Gross margin increased by **21%** compared to the same period in 2024, attributed to the restructuring of the supply chain and a move to a lower-cost logistics provider[225](index=225&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces substantial doubt about its going concern ability due to limited cash and a significant accumulated deficit, necessitating reliance on recently secured financing arrangements to fund future operations - As of March 31, 2025, the company had cash of **$0.7 million**, working capital of **$0.5 million**, and an accumulated deficit of **$45.0 million**[233](index=233&type=chunk) - Management believes its cash and financial resources are insufficient to meet anticipated needs for the next twelve months, which raises substantial doubt about the Company's ability to continue as a going concern[239](index=239&type=chunk)[245](index=245&type=chunk) - The company has established several financing facilities to raise capital, including an Equity Distribution Agreement with Maxim, a **$25 million** Equity Purchase Agreement with Mast Hill, and an **$8.4 million** Preferred Purchase Agreement with an investor[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) - Subsequent to quarter end, the company raised **$1.7 million** in net proceeds from its Equity Distribution Agreement with Maxim[236](index=236&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=68&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is noted as not applicable, indicating the company does not have significant exposure to market risks - The company has indicated that this item is not applicable[277](index=277&type=chunk) [Controls and Procedures](index=68&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective, but identified a material weakness in internal control over financial reporting due to limited team size, with no material changes during the quarter - Management concluded that disclosure controls and procedures were effective as of the evaluation date[279](index=279&type=chunk)[281](index=281&type=chunk) - A material weakness in internal controls over financial reporting was identified, stemming from the small size of the accounting and financial reporting team, leading to the conclusion that internal control was not effective as of December 31, 2024[283](index=283&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[285](index=285&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=71&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings, litigation, or claims that would have a material adverse effect on its business or financial condition - The company is not currently a party to any legal proceedings which would have a material adverse effect on its business[288](index=288&type=chunk) [Risk Factors](index=71&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material updates or changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material updates or changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[290](index=290&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=71&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the first quarter of 2025, the company did not have any unregistered sales of its equity securities that were not already reported on a Form 8-K, nor did it repurchase any outstanding equity securities - There were no unregistered sales of securities during the quarter ended March 31, 2025, that were not previously reported[291](index=291&type=chunk) - The Company did not repurchase any of its equity securities during the three months ended March 31, 2025[292](index=292&type=chunk) [Defaults upon Senior Securities](index=71&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) The company reports that there were no defaults upon senior securities during the period - None reported[293](index=293&type=chunk) [Mine Safety Disclosures](index=71&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[294](index=294&type=chunk) [Other Information](index=71&type=section&id=Item%205.%20Other%20Information) The company discloses that none of its directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the first quarter of 2025 - During the three months ended March 31, 2025, no directors or officers entered into, modified, or terminated a Rule 10b5-1 trading arrangement[295](index=295&type=chunk) [Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including Certificates of Designation for Series A and B Preferred Stock, various securities purchase and registration rights agreements, an exclusive license agreement with Statera, and a statement of work with Scorpius BioManufacturing - Lists key agreements filed as exhibits, including the Exclusive License Agreement with Statera, the Equity Purchase Agreement with Mast Hill, and the Securities Purchase Agreement for Series B Preferred Stock[297](index=297&type=chunk)
Tivic Health Systems(TIVC) - 2025 Q1 - Quarterly Results
2025-05-15 20:06
[CEO's Statement on Business Transformation](index=1&type=section&id=CEO%27s%20Statement%20on%20Business%20Transformation) The CEO highlighted a significant strategic shift towards immunotherapeutics, driven by the exclusive licensing of the Phase III drug Entolimod and its derivative, Entolasta. The company has received positive interest from the White House and FDA for defense applications, is advancing its non-invasive vagus nerve stimulation (VNS) program with new IP, and has secured financing to support these key initiatives - The company initiated a significant strategic shift to expand its clinical pipeline for restoring immune system health[3](index=3&type=chunk) - Executed a worldwide exclusive licensing agreement for the Phase III TLR5 agonist, Entolimod, and its derivative, Entolasta. Phase III validation for Entolimod for acute radiation syndrome (ARS) is complete, and manufacturing validation has been initiated[4](index=4&type=chunk) - Briefed senior leadership at the White House and FDA, receiving positive interest for potential military and defense applications of Entolimod for ARS and the non-invasive vagus nerve stimulation (VNS) program[5](index=5&type=chunk) - Created new intellectual property through patent filings covering breakthroughs in personalizing and optimizing the clinical effects of vagus nerve stimulation[6](index=6&type=chunk) - Entered into financing agreements expected to fund the company through Entolimod's manufacturing validation and upcoming VNS data readouts[7](index=7&type=chunk) [Business and Operational Updates](index=1&type=section&id=First%20Quarter%20and%20Subsequent%20Weeks%20Business%20and%20Operational%20Updates) During and after Q1 2025, Tivic engaged with senior U.S. government leadership, secured significant financing through an equity line and purchase agreement, licensed a second indication for Entolimod, advanced its ncVNS technology, regained Nasdaq compliance through a reverse stock split, and initiated GMP manufacturing validation for Entolimod - Secured a **$25 million** equity line of credit and a separate purchase agreement for up to **$8.4 million** of company securities[11](index=11&type=chunk) - Licensed the Phase II drug candidate Entolimod for a second indication, the treatment of neutropenia, with Phase II trials expected to start later in the year[11](index=11&type=chunk) - Regained compliance with the Nasdaq Minimum Bid Price Listing rule following a **1-for-17** reverse stock split effective March 7[11](index=11&type=chunk) - Post-quarter, entered an agreement for GMP manufacturing process validation for Entolimod in preparation for a Biologics License Application (BLA) filing with the FDA[11](index=11&type=chunk) [Q1 2025 Financial Performance](index=2&type=section&id=Financial%20Performance%20for%20the%20first%20quarter%20of%202025) In Q1 2025, revenue significantly decreased to $70,000 from $334,000 year-over-year, a result of a 92% reduction in advertising for the ClearUP™ device as the company pivoted resources to R&D. Despite the revenue drop, the net loss remained flat at $1.5 million, and gross margin improved to 72%. The company's cash position was $669,000 at quarter-end Q1 2025 vs. Q1 2024 Financial Comparison | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70,000 | $334,000 | -79.0% | | Gross Profit | $50,000 | $167,000 | -70.1% | | Gross Margin | 72% | 50% | +22 p.p. | | Operating Expenses | $1.6 million | $1.6 million | Flat | | Net Loss | $1.5 million | $1.5 million | Flat | - The decrease in revenue was attributed to lower unit sales of the ClearUP™ device, resulting from a **92%** decrease in advertising expenses as the company reallocated resources to R&D programs[11](index=11&type=chunk) Cash Position | Date | Cash and Cash Equivalents | | :--- | :--- | | March 31, 2025 | $669,000 | | December 31, 2024 | $2.0 million | | Subsequent to Q1 | Raised net proceeds of $1.7 million under ATM | - The company has no debt on its balance sheet as of March 31, 2025[11](index=11&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The financial statements for Q1 2025 show total assets increased to **$3.8 million**, while cash decreased to **$0.7 million**, and the net loss remained flat at **$1.5 million** despite a significant revenue decline [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, Tivic's total assets were **$3.8 million**, up from **$2.8 million** at year-end 2024, primarily due to an increase in noncurrent assets. Cash and cash equivalents decreased to **$0.7 million** from **$2.0 million**. The company reported no long-term debt, and total stockholders' equity increased to **$3.0 million** Condensed Balance Sheet (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | **ASSETS** | | | | Cash and cash equivalents | $669 | $2,002 | | TOTAL CURRENT ASSETS | $1,261 | $2,639 | | TOTAL ASSETS | $3,777 | $2,807 | | **LIABILITIES & EQUITY** | | | | TOTAL CURRENT LIABILITIES | $741 | $272 | | TOTAL LONG-TERM LIABILITIES | $— | $— | | TOTAL STOCKHOLDERS' EQUITY | $3,036 | $2,535 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $3,777 | $2,807 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended March 31, 2025, Tivic reported revenues of **$70,000**, a sharp decline from **$334,000** in the prior-year period. The net loss was stable at **$1.5 million**, or (**$2.52**) per share, compared to a net loss of **$1.5 million**, or (**$17.15**) per share, in Q1 2024. The significant change in EPS reflects a different number of weighted-average shares outstanding following a reverse stock split Condensed Statement of Operations (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | REVENUES | $70 | $334 | | GROSS PROFIT | $50 | $167 | | TOTAL OPERATING EXPENSES | $1,556 | $1,648 | | NET OPERATING LOSS | $(1,506) | $(1,481) | | NET LOSS | $(1,502) | $(1,481) | | NET LOSS PER SHARE - BASIC AND DILUTED | $(2.52) | $(17.15) | | WEIGHTED-AVERAGE NUMBER OF SHARES | 596,368 | 86,338 |