Tivic Health Systems, Inc. (TIVC) Bundle
You're looking at Tivic Health Systems, Inc. (TIVC) and trying to understand the real financial picture behind their dramatic strategic pivot-it's a classic high-risk, high-reward scenario, and the Q3 2025 report confirms the shift is complete. The direct takeaway is this: TIVC is no longer a consumer health device stock; it's a pure-play biopharma company, and its near-term financials reflect the cost of that transition, not the potential of its pipeline. The numbers are stark: Revenue for the quarter was a minimal $146,000, which is the result of their intentional wind-down of the ClearUP business, and the net loss widened to $2.6 million as they ramp up investment in their lead drug candidate, Entolimod. To be fair, the balance sheet shows some runway, with cash and equivalents at $3.5 million as of September 30, 2025, plus another $3.5 million in committed funding, but that capital is defintely earmarked for advancing their biologics pipeline. This is a binary bet on their drug pipeline. We need to look past the top line and focus on their progress toward cGMP (Current Good Manufacturing Practice) manufacturing validation, which is the critical next step for Entolimod's commercial readiness.
Revenue Analysis
You need to look past the top-line numbers at Tivic Health Systems, Inc. (TIVC) because they reflect a company in a deep, intentional strategic pivot. The current revenue is minimal and comes almost entirely from a legacy product line being sunsetted, but the future valuation hinges on their new biopharmaceutical pipeline.
The primary source of revenue for Tivic Health Systems, Inc. in the 2025 fiscal year remains the sales of its non-invasive bioelectronic sinus device, ClearUP, through online retailers and commercial distributors. However, this is a rapidly shrinking segment as the company executes a board-approved wind-down of the consumer business to focus capital on its new immunotherapeutics pipeline, which includes the drug candidate Entolimod and its vagus nerve stimulation (VNS) program.
Here's the quick math on the near-term revenue trends, which are highly volatile due to this transition:
- Q3 2025 Revenue: $146,000, up from $126,000 in Q3 2024.
- Q3 Year-over-Year Growth: A modest 15.9% increase, primarily from fulfilling reseller orders as the consumer business exits.
- Nine-Month 2025 Revenue (YTD): $302,000, a sharp decline from $600,000 in the same period of 2024.
The nine-month revenue drop of nearly 50% is the real story here. It shows the company is defintely following through on its plan to cut advertising and sales resources for ClearUP, reallocating those funds to the clinical pipeline. They expect minimal to no revenue from the consumer side going forward until regulatory approvals are obtained for the new drug candidates. This is a high-risk, high-reward move.
The table below summarizes the financial shift, showing how the consumer device business is being intentionally starved of resources:
| Metric | 9 Months Ended Sep 30, 2025 | 9 Months Ended Sep 30, 2024 | Change |
| Total Revenue | $302,000 | $600,000 | -49.67% |
| Q3 Revenue | $146,000 | $126,000 | +15.9% |
The future revenue streams will be entirely different. Tivic Health Systems, Inc. is transforming into a diversified immunotherapeutics company, meaning revenue will eventually come from the commercialization and potential government stockpiling of Entolimod for acute radiation syndrome (ARS), and licensing or sales of their next-generation VNS devices for chronic conditions. This is a complete segment change, moving from a direct-to-consumer model to a biopharma model. You can see how this pivot is attracting new capital in Exploring Tivic Health Systems, Inc. (TIVC) Investor Profile: Who's Buying and Why?
Profitability Metrics
You're looking at the profitability of Tivic Health Systems, Inc. (TIVC) and seeing a lot of red ink, which is defintely a concern. The direct takeaway is that the company's reported margins are deeply negative, but this is an intentional, short-term outcome of a massive strategic pivot from a consumer device company to a clinical-stage biopharma firm. You have to look past the reported numbers to the underlying operational efficiency.
For the third quarter of 2025, the company's reported profitability metrics were severely depressed by one-time restructuring costs related to winding down the ClearUP consumer business. The reported revenue was a mere $146,000. Here's the quick math on the reported margins, which highlights the transition's impact:
- Reported Gross Profit Margin: Approximately -99.3%.
- Operating Profit Margin: Approximately -1,675%.
- Net Profit Margin: Approximately -1,781%.
A net loss of $2.6 million on only $146,000 in revenue for the quarter is a clear signal: Tivic Health Systems, Inc. is operating purely as a research and development (R&D) entity right now, not a commercial one.
Operational Efficiency and Margin Trends
To be fair, the reported gross loss of $145,000 in Q3 2025 was primarily driven by a $230,000 inventory reserve tied to the consumer business exit. What this estimate hides is the underlying product efficiency before those charges. Stripping out that one-time reserve, the adjusted gross margin for the quarter was actually 42%, up from 35% a year ago. That improvement is now largely irrelevant, though, because the consumer business is being discontinued.
The real operational story is the surge in operating expenses (OpEx), which totaled $2.3 million in Q3 2025, up significantly from the prior year. This increase is directly due to the addition of the biopharma business in February 2025, specifically the investment in the Entolimod program. So, the trend is a sharp, intentional decline in revenue and a sharp, intentional increase in R&D-heavy OpEx. The company is trading near-term profitability for a shot at high-value biopharma success.
Industry Comparison: A Clinical-Stage Reality
Comparing Tivic Health Systems, Inc.'s profitability to a fully commercialized company in the life sciences sector is like comparing a seed-stage startup to a mature public tech company. It's not an apples-to-apples comparison. Large, diversified life sciences companies often report positive operating margins, like Azenta's adjusted operating margin of 2.6% for fiscal 2025, or even higher for large pharma. Tivic Health Systems, Inc.'s massive negative operating margin of roughly -1,675% is a stark contrast, but it is typical for a clinical-stage biopharma company with minimal revenue and high R&D costs.
The key for investors isn't the current negative margin, but the burn rate-how fast they are using cash-and the runway. The company's Q3 2025 net loss of $2.6 million is the true measure of their current cash burn, which is necessary to advance their biologics pipeline. The focus shifts entirely to the clinical milestones and regulatory progress of their lead candidate, Entolimod, which is the whole point of the pivot. For a deeper dive into the risks and opportunities of this transformation, you can read our full analysis: Breaking Down Tivic Health Systems, Inc. (TIVC) Financial Health: Key Insights for Investors.
| Profitability Metric | Q3 2025 Value (Reported) | Q3 2025 Margin | Context/Trend |
| Revenue | $146,000 | N/A | Down due to planned exit of consumer business. |
| Gross Profit (Loss) | ($145,000) | -99.3% | Depressed by $230,000 inventory reserve. Adjusted margin was 42%. |
| Operating Expenses | $2.3 million | N/A | Up significantly due to biopharma program build-out. |
| Net Loss | $2.6 million | -1,781% | Reflects high R&D burn rate of a clinical-stage company. |
Finance: Monitor the quarterly operating expense run-rate against the cash runway to ensure the biopharma milestones can be met.
Debt vs. Equity Structure
You're looking at Tivic Health Systems, Inc. (TIVC) and wondering how they fund their major strategic pivot-that shift from consumer health tech to a diversified immunotherapeutics company. The short answer is: they are running a zero-leverage model.
As of the third quarter of 2025, Tivic Health Systems, Inc. has no debt on its balance sheet. This is a critical point. It means their total long-term and short-term debt stands at $0.0 million. This is defintely a clean slate for a company in the middle of a major transformation, but it also means their funding strategy is entirely reliant on equity, which has its own trade-offs.
Here's the quick math: with $0.0 million in total debt and approximately $5.6 million in total shareholder equity, the company's Debt-to-Equity (D/E) ratio is 0%. This is significantly lower than the industry standard for Biotechnology companies, which, as of November 2025, averages around 0.17. A 0% D/E ratio means zero financial leverage (i.e., no interest payments), but it also signals a reliance on shareholder dilution for capital.
The company is balancing its growth entirely through equity funding, which is typical for early-stage or transforming biotech firms that are pre-revenue or pre-profit and lack the cash flow for traditional debt service.
- No debt: Eliminates interest expense and default risk.
- Equity-heavy: Funds strategic pivot via share sales and agreements.
- Industry D/E: Tivic's 0% is well below the 0.17 biotech average.
Their recent financing activity confirms this strategy. In the third quarter of 2025 alone, Tivic Health Systems, Inc. closed tranches of a preferred equity purchase agreement, pulling in $3.8 million in net proceeds. They also have a substantial $25 million equity line of credit (ELOC) in place, plus about $3.5 million remaining available under the preferred equity agreement as of September 30, 2025. This is how they are funding the Entolimod program and the shift away from the consumer business.
What this estimate hides is the potential for shareholder dilution. Every dollar raised through equity, whether a preferred purchase agreement or an ELOC, increases the share count, which can depress the Earnings Per Share (EPS) for existing common shareholders. Still, for a company focused on a high-risk, high-reward biologics transformation, equity is the only practical funding source. They simply cannot get a favorable credit rating or traditional bank loan without predictable cash flow.
For more on the implications of this shift, you should read the full analysis: Breaking Down Tivic Health Systems, Inc. (TIVC) Financial Health: Key Insights for Investors.
Liquidity and Solvency
You need to know if Tivic Health Systems, Inc. (TIVC) can cover its near-term obligations, especially as it shifts from a consumer device business to a biologics pipeline. The short answer is yes, the company's liquidity position is strong, primarily due to recent financing, but its cash burn from operations is significant.
The company's ability to meet its short-term debts is excellent. As of the most recent reporting period, the Current Ratio stands at a robust 5.86, with the Quick Ratio (Acid-Test Ratio) close behind at 5.44. A ratio above 1.0 is generally considered healthy, so these figures show a substantial cushion. Here's the quick math: with current assets of approximately $3.74 million and current liabilities of about $638,000, the company has roughly $5.86 in liquid assets for every dollar of short-term debt. That's defintely a strong liquidity position.
Working Capital Trends and Analysis
The positive liquidity ratios translate directly into a healthy working capital position. Tivic Health Systems, Inc.'s working capital-current assets minus current liabilities-is approximately $3.102 million. This indicates that the company has ample capital to manage its daily operations and fund its strategic pivot. The trend in working capital is heavily influenced by two factors: the wind-down of the consumer business and new financing.
- The Q3 2025 results showed a $230,000 inventory reserve, a direct consequence of discontinuing the ClearUP™ consumer sales, which will reduce future inventory and streamline the balance sheet.
- The company carries no debt on its balance sheet, which is a major strength in its solvency profile.
This is a biotech-style balance sheet-high cash, low operational liabilities, but relying on external funding for runway. You can dig deeper into the capital structure by Exploring Tivic Health Systems, Inc. (TIVC) Investor Profile: Who's Buying and Why?
Cash Flow Statement Overview
While the balance sheet looks strong, the cash flow statement shows the real cost of Tivic Health Systems, Inc.'s transformation. The company is in a cash-intensive development phase, which is typical for a biopharma-focused entity. For the Trailing Twelve Months (TTM) leading up to Q3 2025, the company used approximately $6.08 million in cash from operating activities. This operating cash flow burn is the primary risk.
The cash flow trends break down like this:
| Cash Flow Activity (TTM/9 Months Ended Sept 30, 2025) | Amount (in millions USD) | Trend/Implication |
|---|---|---|
| Operating Cash Flow (TTM) | ($6.08) | High cash burn from R&D and net loss. |
| Investing Cash Flow (TTM Capital Expenditures) | ($0.013) | Minimal capital expenditures, focused on core R&D. |
| Financing Cash Flow (Q3 Net Proceeds) | $3.8 | Crucial inflow from preferred equity financing. |
The net loss for the nine months ended September 30, 2025, was $6.029 million, which drives the negative operating cash flow. The good news is that financing activities have been effective, bringing in $3.8 million in net proceeds during Q3 2025 alone, which is vital for funding the Entolimod biologics program. The cash balance at September 30, 2025, was $3.5 million, up from $2.0 million at the end of 2024, showing the financing is successfully offsetting the burn.
Liquidity Concerns and Strengths
The primary strength is the capital structure: a high current ratio of 5.86 and zero debt. The main concern is the cash runway (how long the current cash lasts). Management believes the current cash of $3.5 million plus an additional committed $3.5 million from a preferred equity purchase agreement is sufficient to reach key manufacturing validation milestones for Entolimod. What this estimate hides is the potential for delays in clinical development or regulatory approvals, which could quickly consume the $7.0 million in total available and committed funds. The action item for you is to watch for updates on the cGMP manufacturing validation and any non-dilutive government funding for Entolimod as a military countermeasure.
Valuation Analysis
You're looking at Tivic Health Systems, Inc. (TIVC) and wondering if the market has it right. As of November 2025, the short answer is that the stock appears to be trading at a deep discount on a book value basis, but its valuation ratios are screaming a warning sign due to a lack of profitability. This is a classic case of a high-risk, micro-cap healthtech stock where traditional metrics break down.
The core issue is that Tivic Health Systems, Inc. is not profitable, which immediately complicates standard valuation. The trailing twelve-month (TTM) Earnings Per Share (EPS) is negative, so the Price-to-Earnings (P/E) ratio is Not Applicable (N/A). You can't use a P/E ratio to gauge value when a company is losing money; it's a non-starter. Similarly, the Enterprise Value-to-EBITDA (EV/EBITDA) ratio is also N/A because the company has a negative Enterprise Value (EV) of approximately -$736,829, meaning its cash exceeds its debt and market capitalization, plus it has negative EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization).
The one metric that offers a glimpse of potential undervaluation is the Price-to-Book (P/B) ratio, which is sitting at about 0.48.
- P/E Ratio: N/A (Due to negative earnings).
- P/B Ratio: 0.48 (Suggests the stock is trading below its net asset value).
- EV/EBITDA: N/A (Negative EV and negative EBITDA).
Here's the quick math: a P/B of 0.48 means you are paying just 48 cents for every dollar of the company's net assets on the balance sheet. That's defintely cheap, but cheap doesn't mean a good investment if the business model can't generate a profit. You need to look closely at the Mission Statement, Vision, & Core Values of Tivic Health Systems, Inc. (TIVC). to see if you believe in their long-term turnaround strategy.
Stock Price Volatility and Analyst View
The stock price trend over the last year paints a picture of extreme volatility and significant capital destruction. The stock price as of November 21, 2025, was around $1.65, but it has been on a brutal slide, decreasing by -63.52% over the last 52 weeks. The 52-week trading range is massive, swinging from a low of $1.47 to a high of $15.64. This kind of price action is common for micro-caps that have undergone a reverse stock split, which Tivic Health Systems, Inc. did in March 2025 with a 1:17 ratio.
On the income side, the company does not pay a dividend, so the dividend yield is 0.00%, and the payout ratio is N/A. This is expected for a growth-focused healthtech firm that needs to retain all capital for operations and product development.
The analyst community is not bullish. The consensus among Wall Street analysts is a clear Sell rating. Only one analyst has issued a rating in the last 12 months, and it is a Sell. The stated predicted downside is an alarming -100.00%. What this estimate hides is the potential for further dilution or operational failure, which would justify such a dire forecast. The market is pricing in significant risk.
| Metric | Value (2025 Fiscal Data) | Implication |
|---|---|---|
| 52-Week Price Change | -63.52% | Significant capital loss and bearish momentum. |
| 52-Week High/Low | $15.64 / $1.47 | Extreme volatility; high risk. |
| Analyst Consensus | Sell | Expectation of underperformance. |
| Dividend Yield | 0.00% | No current return to shareholders via dividends. |
Your action here is simple: treat this as a highly speculative bet, not a value investment. The P/B of 0.48 is tempting, but the Sell rating and the negative cash flow profile mean the risk of the stock price continuing toward the $0.00 target is very real.
Risk Factors
You need to know that Tivic Health Systems, Inc. (TIVC) is in a high-stakes transition right now, moving from a consumer device company to a biopharmaceutical and bioelectronic therapeutics firm. This pivot introduces significant, near-term execution and financial risks that you must factor into your analysis. The core takeaway is simple: the company is burning cash to chase a high-reward drug and device pipeline, so the timeline for regulatory milestones is everything.
Operational and Financial Headwinds
The company's strategic shift from its consumer product, ClearUP, to its biologics pipeline-specifically Entolimod-is the primary driver of both risk and opportunity. The financial picture for the first nine months of 2025 shows the strain of this transition. For the nine-month period ending September 30, 2025, the net loss widened to $6 million, up substantially from $4.2 million in the same period a year prior. That's a clear sign of the increased operating expenses, which totaled $5.9 million for the first nine months of 2025, largely due to the biopharma build-out.
Near-term revenue is defintely a major headwind. With the wind-down of the consumer business, management expects minimal to no revenue until their new drug candidates receive approval and are commercialized. The Q3 2025 results already reflect this, with a $230,000 inventory reserve recorded as part of the consumer exit, contributing to a gross loss of $145,000 for the quarter.
Here's the quick math on liquidity as of September 30, 2025:
- Cash and Cash Equivalents: $3.5 million
- Committed Funding Remaining: Approximately $3.5 million (from preferred equity purchase agreement)
- Total Available Near-Term Capital: Roughly $7.0 million
Management believes this capital is sufficient to reach the key value inflection point of cGMP manufacturing validation for Entolimod, but that runway is tight for a biopharma company. You can read more about the capital structure, including the $25 million equity line of credit, in Exploring Tivic Health Systems, Inc. (TIVC) Investor Profile: Who's Buying and Why?
Execution and Regulatory Hurdles
The biggest risks are tied directly to execution on the biopharma side. The timeline for Entolimod, their lead drug candidate for Acute Radiation Syndrome (ARS), has faced delays because a contract manufacturing partner experienced financial stress. This forces Tivic Health Systems, Inc. (TIVC) to work with the manufacturer's investors or find alternative partners to stabilize the supply chain and meet their cGMP (Current Good Manufacturing Practice) deadlines. That's a classic biotech operational risk.
On the regulatory side, the path to market is long and costly. Even with Fast Track and Orphan Drug designations for Entolimod, the company still needs to secure bioequivalency data and a full year of stability data before they can file the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA). Any delay in these steps pushes back the potential for commercial revenue and increases the need for further funding rounds.
The external risks are formidable, too:
- Biopharma Competition: Entolimod will face competitive pressures from established players in the ARS treatment space.
- Bioelectronics Competition: The non-invasive vagus nerve stimulation (ncVNS) device is entering a crowded market with big names already in the space.
- Market Volatility: The stock's high volatility (Beta of 2.09, as noted in earlier analysis) means the price is prone to significant swings on news, and the company must maintain compliance to avoid a NASDAQ delisting.
Mitigation Strategies and Key Milestones
Tivic Health Systems, Inc. (TIVC) is actively mitigating these risks by focusing on government contracts and securing alternative financing. The company is engaging with agencies like the Biomedical Advanced Research and Development Authority (BARDA) to position Entolimod as a military medical countermeasure and stockpile drug, which could provide a large, non-dilutive revenue stream. They are also expanding the Entolimod license to include neutropenia and cancer-related conditions, diversifying the potential market. The core action is to hit the manufacturing milestones; they are working with new partners to stabilize the cGMP process. That's the one thing that matters most right now. The clock is ticking on their cash position and the Entolimod BLA timeline.
Growth Opportunities
You're looking at Tivic Health Systems, Inc. (TIVC) and seeing a company in the middle of a radical, high-stakes pivot. The direct takeaway is this: the legacy consumer business is being sunset, but the new focus on immunotherapeutics and bioelectronic medicine represents a massive, albeit high-risk, opportunity that is driving all near-term strategy.
The company is intentionally shifting away from its initial product, ClearUP, and is planning to exit that consumer healthtech business by the end of 2025. This strategic transformation is why the 2025 financial results show steep declines in revenue, but it's also the key to future growth. For the first half of 2025, the company reported total revenue of only $156,000, compared to $474,000 in the first half of 2024, because they cut advertising by 92% to conserve capital for the new pipeline. The focus is now entirely on two major growth drivers.
Key Growth Drivers: Biopharma and Bioelectronics
Tivic Health Systems, Inc.'s future is tied to its dual approach of biochemical and bioelectric therapies. The company is betting on two distinct, high-value markets, which is a defintely bold move for a company of its size.
- Entolimod (Biopharma): This is a late-stage Toll-like Receptor 5 (TLR5) agonist drug candidate, licensed exclusively worldwide, for treating Acute Radiation Syndrome (ARS) and neutropenia. The FDA has granted Entolimod Fast Track and Orphan Drug designations for ARS, which expedites the approval process. The neutropenia market alone is projected to reach nearly $21 billion worldwide by 2032.
- Non-Invasive Vagus Nerve Stimulation (ncVNS): This is the next-generation bioelectronic device, which is a major product innovation. Recent research with The Feinstein Institutes for Medical Research at Northwell Health showed that customizing the stimulation frequency for each person led to a 46% increase in heart rate variability, a significant improvement over a uniform frequency. This personalization is a key competitive advantage in the VNS market, which is estimated to grow to $21.3 billion by 2030.
Financial Reality and Forward Projections
The current financial picture reflects a company in a capital-intensive transition, not a profitable operation. The net loss for the first nine months of 2025 totaled approximately $6.0 million. However, the strategic initiatives are designed to bridge this gap and fund the clinical pipeline.
Here's the quick math on the current financial state and runway:
| Metric (2025) | Value (USD) | Context |
| Q1-Q3 2025 Total Revenue | $302,000 | Steep decline due to ClearUP advertising cuts. |
| Q1-Q3 2025 Total Net Loss | $6.0 million | Driven by increased R&D for biopharma programs. |
| Cash & Equivalents (Sept 30, 2025) | $3.5 million | Improved from Q1 due to new financing. |
| Committed Financing Available | Approximately $3.5 million | Remaining tranche of preferred equity purchase agreement. |
What this estimate hides is the potential for a massive revenue inflection point if Entolimod secures a major government contract for ARS treatment, a possibility management has been exploring through briefings with the White House and the FDA. The company has also secured a manufacturing validation agreement with Scorpius Biomanufacturing, Inc. to prepare for the FDA biologics license application, which is a critical step toward commercialization.
Competitive Edge and Strategic Partnerships
Tivic Health Systems, Inc. maintains a strong balance sheet for a micro-cap biotech, reporting no long-term debt and a healthy current ratio of 1.7 as of July 2025. This financial flexibility is crucial for funding the clinical trials and regulatory filings ahead. Their competitive advantage is rooted in their non-invasive approach and intellectual property, which includes 16 issued patents and 10 pending patents.
The company's strategy is clear: use the non-invasive bioelectronic platform to develop personalized treatments, while simultaneously fast-tracking the late-stage Entolimod drug candidate. You can read more about their core philosophy here: Mission Statement, Vision, & Core Values of Tivic Health Systems, Inc. (TIVC).
Next Step: Finance: Monitor the Q4 2025 earnings release for an update on the ClearUP exit timeline and any new milestones from the Entolimod manufacturing validation by the end of the year.

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