Tivic Health Systems, Inc. (TIVC): Business Model Canvas [Dec-2025 Updated]

Honestly, when you look at Tivic Health Systems, Inc.'s current state, you see a company executing a full-throttle pivot, and that's where the real analysis begins. They are actively winding down the consumer tech side-which only chipped in $146,000 in revenue in Q3 2025-to chase a massive biopharma payoff with their Entolimod drug candidate for things like Acute Radiation Syndrome. This isn't a side project; it's a complete re-platforming, especially since their cash position was only $3.5 million at the end of September 2025. This Business Model Canvas lays out the high-stakes partnerships and the razor-thin resources supporting this move from gadgets to government countermeasures. See below how they plan to fund this massive shift.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Key Partnerships

You're hiring before product-market fit, so understanding who you rely on for your core assets is defintely critical. Here's the quick math on the relationships driving Tivic Health Systems, Inc.'s biopharma pivot as of late 2025.

Statera Biopharma for Entolimod™ and Entolasta™ licensing and IND transfer

Tivic Health Systems, Inc. acquired worldwide exclusive license rights to the late-stage Toll-like Receptor 5 (TLR5) agonist Entolimod™ from Statera Biopharma, Inc. in February 2025. This agreement covers the Initial Indication of Acute Radiation Syndrome (ARS) and grants an exclusive option for subsequent indications. Select team members from Statera joined Tivic Health to establish biopharmaceutical capabilities. The prior development investment in Entolimod and Entolasta totaled approximately $140 million.

Tivic Health Systems, Inc. also holds an exclusive option to license additional indications, including Lymphocyte exhaustion, Immunosenescence, and chronic radiation syndrome, plus use as a vaccine adjuvant.

Scorpius Biomanufacturing, Inc. for cGMP manufacturing validation

Tivic Health Systems, Inc. entered a definitive agreement with Scorpius BioManufacturing, Inc. to complete the Current Good Manufacturing Practice (cGMP) manufacturing validation for Entolimod in preparation for a Biologics License Application (BLA) filing with the U.S. Food & Drug Administration (FDA). Scorpius BioManufacturing, Inc. is the primary U.S. manufacturer, utilizing its facility in San Antonio, Texas. The company completed the cell line verification, a critical first step for cGMP, during the third quarter of 2025.

• Total estimated investment for the GMP Validation Program: approximately $4.1 million.
• Estimated service fees payable to Scorpius BioManufacturing, Inc.: approximately $2.4 million.
• Pass-through costs are subject to a 15% administrative fee.
• Tivic Health must settle invoices within 30 days.

US Government agencies (BARDA, FDA) for Entolimod stockpiling potential

Entolimod, for Acute Radiation Syndrome (ARS), has secured both Fast Track and Orphan Drug designations from the FDA. Tivic Health Systems, Inc. has been actively engaging with government bodies regarding its potential as a military medical countermeasure and stockpile drug. The company secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA)'s Radiological and Nuclear Medical Countermeasures Program staff on November 18, 2025.

The global ARS market was estimated to be valued at USD 5.2 billion in 2024. Tivic Health Systems, Inc. previously received significant funding for the TLR5 program development from agencies including BARDA, the Defense Threats Reduction Agency (DTRA), the Department of the Army, and the Department of Defense (DoD).

• FDA Designations: Fast Track and Orphan Drug for ARS.
• BARDA Engagement: Exclusive Techwatch meeting secured on November 18, 2025.
• Prior Government Support: Funding received from BARDA, DTRA, and DoD.

Top-tier online retail and distribution partners for ClearUP (winding down)

Tivic Health Systems, Inc. is executing a strategic exit from the ClearUP consumer health tech business by the end of 2025. The company discontinued all advertising and marketing initiatives for ClearUP on October 1, 2025, to focus resources on the biopharma pipeline. The wind-down included a write-off of inventory and equipment.

The financial impact of this shift is visible in the revenue figures. Revenue net of returns for the nine months ended September 30, 2025, totaled $302,000, down from $600,000 for the same period in 2024. The third quarter of 2025 was the final quarter for direct-to-consumer sales, though fulfillment to resellers continues through the fourth quarter to support holiday promotions. The inventory reserve for the ClearUP wind-down recorded in Q3 2025 was $230,000.

Potential pharmaceutical partners for Entolimod co-development/licensing

The licensing agreement with Statera Biopharma, Inc. provides Tivic Health Systems, Inc. with options for co-development or licensing of Entolimod and Entolasta across multiple indications. The company exercised its option to license the Neutropenia indication, a market estimated to exceed $20 billion by 2029. Furthermore, an IND transfer was completed in August 2025 to allow clinical trials for Entolimod in the treatment of advanced cancers.

Tivic Health Systems, Inc. has the option to license three additional indications:

• Lymphocyte exhaustion
• Immunosenescence
• Chronic radiation syndrome

The company also discussed potential expedited pathways and export opportunities for Entolimod and Entolasta with the FDA in April 2025.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Key Activities

You're shifting the entire focus of Tivic Health Systems, Inc. from consumer devices to biopharmaceuticals, so the key activities reflect a massive internal pivot. Here's the quick math on what that transition looks like operationally as of late 2025.

Advancing Entolimod™ (TLR5 agonist) toward Biologics License Application (BLA)

The primary activity centers on moving Entolimod, the TLR5 agonist, toward regulatory submission, particularly for Acute Radiation Syndrome (ARS).

• Entolimod holds Fast Track and Orphan Drug designations for ARS.
• The company secured a Techwatch meeting with BARDA on November 18, 2025, to discuss BLA preparations.
• Discussions with government agencies regarding stockpile potential occurred at the 2025 Military Health System Research Symposium (MHSRS) in August 2025.

Initiating Phase 2 clinical studies for Entolimod in neutropenia

Resource allocation is now directed at expanding the Entolimod indications using existing safety data.

• Tivic Health Systems, Inc. completed the transfer of two INDs from Statera Biopharma.
• These IND transfers enable the pursuit of clinical trials in neutropenia and lymphocyte exhaustion.
• Management expects the ability to move directly into Phase 2 studies for neutropenia.

Executing cGMP manufacturing process for Entolimod scalability

Manufacturing readiness is a critical path item supporting the BLA goal.

• The company reported successful cell line verification, which is a critical first step for establishing reproducibility and scalability for future BLA submission.
• This verification advances the program toward cGMP readiness.
• A prior agreement for GMP manufacturing validation was entered into with Scorpius Biomanufacturing, Inc.
• A risk noted is that the contract manufacturer experienced financial stress, causing schedule delays.

Developing and patenting non-invasive cervical Vagus Nerve Stimulation (ncVNS) device

While biologics are the focus, the bioelectronic platform continues development and intellectual property capture.

• Tivic Health Systems, Inc. completed all study visits in the Optimization Study for the ncVNS device in the second quarter of 2025.
• Findings from the VNS Optimization Trial led to additional patent filings subsequent to the third quarter's end.

Winding down the consumer ClearUP business by late 2025

The wind-down is an active, resource-shifting activity that has significant financial reporting impacts for the period.

The financial and operational metrics related to the ClearUP exit are detailed below:

The shift is also reflected in operating expenses, where R&D investment increased to support the biologics program.

• Operating Expenses Q3 2025: $2.3 million.
• Operating Expenses Q3 2024: $1.5 million.
• Operating Expenses Nine Months 2025: $5.9 million.
• Operating Expenses Nine Months 2024: $4.4 million.

Cash position at September 30, 2025, was $3.5 million, up from $2.0 million at December 31, 2024, supported by $3.8 million in net proceeds from financing tranches closed in Q3. Tivic Health Systems, Inc. maintained zero debt on its balance sheet.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Key Resources

The Key Resources for Tivic Health Systems, Inc. (TIVC) as of late 2025 are heavily weighted toward its intellectual property and the financial runway supporting its biopharma pivot.

The company's financial foundation, as reported for the end of the third quarter, shows a focused liquidity position:

The core value resides in the proprietary assets driving the therapeutics pipeline. You'll want to track the progress on these tangible and intangible assets closely.

• Entolimod™ drug candidate, which holds both FDA Fast Track and Orphan Drug designations for acute radiation syndrome (ARS).
• Exclusive worldwide license for Entolimod and Entolasta.
• Patented bioelectronic and Vagus Nerve Stimulation (VNS) device technology and intellectual property, bolstered by additional patent filings subsequent to the VNS Optimization Trial findings.
• Two INDs (Investigational New Drug applications) transferred from Statera Biopharma, enabling clinical trials for neutropenia and cancer-related conditions.
• Initiation of the cGMP manufacturing process with successful cell line verification for Entolimod.
• Experienced biopharma leadership team guiding drug commercialization and regulatory strategy, including securing an exclusive BARDA Techwatch meeting on November 18, 2025.

The company is definitely using its capital to validate the Entolimod manufacturing, which management sees as a key value inflection point.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Value Propositions

You're looking at the core value Tivic Health Systems, Inc. (TIVC) is trying to deliver right now, which is heavily weighted toward its biopharma pipeline as of late 2025. The company has made a decisive pivot, which means the value proposition for its legacy product is shrinking while the potential for its drug candidates is scaling up.

Life-saving medical countermeasure for Acute Radiation Syndrome (ARS) (Entolimod)

The primary value proposition here is providing a novel, life-saving medical countermeasure for Acute Radiation Syndrome (ARS). Entolimod, the lead candidate, is a Toll-like Receptor 5 (TLR5) agonist that activates antiapoptotic and cell protective mechanisms. This drug has secured both Fast Track Designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for ARS. The development pathway has relied on extensive trials under the FDA's Animal Rule, showing robust survival and improved hematopoiesis in animal models. Furthermore, Tivic Health Systems, Inc. is actively engaging key government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), to deploy Entolimod as a military countermeasure and stockpile drug. To be fair, a single contract for ARS has the potential to total several hundred million dollars, which is a significant value driver.

Non-invasive, drug-free alternative for sinus pain relief (ClearUP, legacy)

The value proposition from the legacy ClearUP device is diminishing as Tivic Health Systems, Inc. executes its exit from the consumer health tech business. The company discontinued all advertising and marketing initiatives for ClearUP on October 1, 2025, to focus capital on the biologics pipeline. The financial results reflect this strategic choice, with Q3 2025 revenue coming in at $146,000, which was an increase of 15.9% compared to the $126,000 reported in Q3 2024. However, the move to exit meant a $230,000 inventory reserve was recorded in Q3 2025, resulting in a gross loss of $(145,000) for the quarter. Still, the underlying product margin showed improvement, with an adjusted gross margin of 42% in Q3 2025, up from 35% in Q3 2024.

Potential to regulate specific biologic responses via non-invasive VNS

Tivic Health Systems, Inc. offers a bioelectronic value proposition through its non-invasive cervical vagus nerve stimulation (ncVNS) device, which aims to regulate autonomic nervous system activity. The company completed all study visits in the Optimization Study for this patent-pending device. The compelling findings from this trial uncovered new insights into personalizing the effects of vagus nerve stimulation, which has led to additional patent filings intended to protect future prescription device development and licensing. The feedback from regulatory bodies, including the FDA, was positive regarding expedited pathways like breakthrough device designations following this clinical work.

Treatment for neutropenia and potential adjunctive cancer therapy (Entolimod)

Entolimod provides value by targeting conditions resulting from immune system dysregulation, specifically neutropenia and cancer-related conditions. Tivic Health Systems, Inc. exercised its option to license Entolimod for the treatment of neutropenia on March 28, 2025. The market potential is substantial; the global Neutropenia market is estimated to exceed $20 billion by 2029, and management notes that neutropenia drugs represent anywhere from $19 billion to $24 billion over the next few years. The transfer of two Investigational New Drug (IND) applications allows Tivic to initiate clinical trials for neutropenia and explore Entolimod's anti-tumor activity. A key manufacturing value step was completed with the finalization of cell line verification, a prerequisite for Current Good Manufacturing Practices (cGMP) needed before filing a Biologics License Application (BLA).

Here's a quick look at the financial context surrounding the legacy and pipeline assets as of the latest reported quarter:

The company is definitely shifting its value creation engine away from the consumer device. If onboarding takes 14+ days, churn risk rises-though for ClearUP, the decision was to exit, not optimize sales velocity.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Customer Relationships

You're looking at a company in a major pivot, moving resources away from the consumer side to focus on high-stakes biopharma partnerships. The customer relationship strategy reflects this shift, prioritizing government engagement over direct-to-consumer support.

High-touch, strategic engagement with US government/military for Entolimod

Tivic Health Systems, Inc. is heavily engaged in high-touch, strategic relationship building with US government agencies for its lead candidate, Entolimod, for Acute Radiation Syndrome (ARS). This relationship management is crucial given the potential for federal funding and stockpile procurement.

Key engagement milestones and data points include:

• Secured an exclusive BARDA Techwatch meeting on November 18, 2025, to present clinical and manufacturing data for Entolimod ARS development.
• Advanced discussions with key US Government agencies via participation in the 2025 Military Health System Research Symposium (MHSRS), held August 4-7, 2025.
• Met with representatives from the Biomedical Advanced Research and Development Authority (BARDA), the Armed Forces Radiobiology Research Institute (AFRRI), and the Medical CBRN Defense Consortium (MCDC) at MHSRS.
• Provided briefings to senior leadership at the White House and the FDA in April 2025, securing positive interest in military/defense applications for both Entolimod and ncVNS technology.
• Entolimod for ARS holds FDA Fast Track and Orphan Drug designations.
• The GMP manufacturing validation agreement with Scorpius BioManufacturing, Inc. for the Entolimod Biologics License Application (BLA) preparation is valued at approximately $4.1 million.

The balance sheet supports this focus, as Tivic Health Systems reports no debt on its balance sheet as of September 30, 2025.

B2B relationship management for potential licensing of ncVNS technology

For the bioelectronic platform, the relationship focus is shifting toward B2B partnerships, leveraging new intellectual property and the dual-platform strategy. The company is seeking partners whose products could benefit from enhanced immune activation via TLR5 agonists, such as in immuno-oncology cell-based therapies.

The ncVNS technology is also a point of B2B interest, particularly with defense organizations interested in treating neurologic disorders like post-traumatic stress disorder (PTSD).

Direct-to-Consumer (D2C) sales and support for ClearUP (decreasing focus)

Tivic Health Systems is actively winding down its D2C relationship channel for ClearUP, reallocating resources to the biopharma pipeline. This is a deliberate exit from the consumer health tech segment.

The timeline and financial impact of this relationship shift are clear:

• Discontinued all advertising and marketing initiatives on October 1, 2025.
• The third quarter of 2025 was the final quarter for direct consumer sales.
• Fulfilling orders from resellers continues through the fourth quarter to support holiday promotions.
• Q3 2025 revenue net of returns was $146,000.
• Nine-month revenue for 2025 totaled $302,000, compared to $600,000 for the same period in 2024.
• The wind down included a $230,000 inventory write-down recorded as Cost of Goods Sold in Q3 2025.
• Q1 2025 revenue was $70,000, following a 92% decrease in advertising expenses year-over-year.

Professional outreach to physicians for future prescription device adoption

While the immediate focus is on drug development, the professional outreach for the bioelectronic platform is centered on advancing clinical validation and regulatory readiness, which sets the stage for future physician adoption as a prescription device.

The company is preparing for formal engagement with the FDA regarding its bioelectronic program:

• The Feinstein Institute is working with Tivic Health Systems to prepare a report on the ncVNS optimization trial findings.
• The company is in the process of transferring 2 existing Investigational New Drug (IND) applications to Tivic from Statera, enabling formal engagement with the FDA on those fronts.
• New intellectual property has been created, including patent filings covering personalization and optimization of vagus nerve stimulation clinical effects.

Cash on hand as of September 30, 2025, was $3.5 million. Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Channels

You're looking at the channels Tivic Health Systems, Inc. (TIVC) is using, or planning to use, as they pivot hard into biopharma. Honestly, the channel strategy is split between winding down the legacy consumer tech and aggressively pursuing government and pharma partnerships for their drug candidates. It's a tale of two businesses right now, so let's break down the pathways for each.

Direct sales and distribution to US government stockpiling entities (future Entolimod)

This channel is all about Entolimod for Acute Radiation Syndrome (ARS), positioning it as a medical countermeasure. Tivic Health Systems, Inc. is actively pushing this through direct engagement with federal agencies. You saw them advance discussions with key US Government agencies at the 2025 Military Health System Research Symposium (MHSRS), which took place from August 4-7, 2025. The biggest step here is the formal technical exchange with the Biomedical Advanced Research and Development Authority (BARDA); Tivic secured an exclusive BARDA Techwatch meeting on November 18, 2025, to present clinical and manufacturing readiness data for Entolimod. This meeting signals a potential pathway to federal funding and stockpile consideration, aligning the program with defined federal acquisition processes. To support this, the company entered an agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation for Entolimod, a program valued at approximately $4.1 million, which is crucial for any potential procurement. On the balance sheet side, Tivic Health Systems, Inc. reported having no debt on its balance sheet as of September 30, 2025, which is important when negotiating large, long-term government contracts.

Licensing and co-development agreements with pharmaceutical companies

For the biopharma pipeline, the channel isn't about selling a finished product yet; it's about securing rights and hitting development milestones that trigger payments or future revenue sharing. Tivic Health Systems, Inc. extended its worldwide license for Entolimod to include the treatment of neutropenia. This specific indication targets a market projected to reach nearly $21 billion worldwide by 2032. The initial license agreement from February 11, 2025, with Statera Biopharma included a license fee of $1,500,000, which was comprised of $300,000 in cash plus equity considerations. Furthermore, on March 28, 2025, Tivic exercised its option for the Neutropenia indication and accelerated the first milestone payment of $500,000 related to the IND filing and initiation of a Phase 2 clinical study for that indication. Shareholders approved the necessary equity issuance for these licensing arrangements during their meeting on June 30, 2025.

Online retail and e-commerce platforms for ClearUP device (legacy channel)

The ClearUP device channel is actively being shut down as part of the strategic transformation, but it still contributed revenue in 2025. Tivic Health Systems, Inc. discontinued all advertising and marketing initiatives on October 1, 2025, and the third quarter (Q3 2025) was the final quarter they sold ClearUP directly to consumers. They are, however, fulfilling reseller orders through the fourth quarter to support holiday promotions. The financial impact of this wind-down is clear in the recent results. For instance, Q1 2025 net revenue was only $70,000, an 81% decrease from Q1 2024's $334,000, directly tied to a 92% reduction in advertising spend. The company also recorded a $230,000 inventory reserve in Q3 2025 specifically for the ClearUP wind-down. Here's a quick look at the revenue trend as the channel was intentionally de-prioritized:

The gross margin for the ClearUP business, excluding the inventory reserve, was 42% in Q3 2025, up from 35% in Q3 2024, showing better margin control even as sales dropped.

Direct-to-physician marketing for future prescription ncVNS device

The channel for the non-invasive cervical Vagus Nerve Stimulation (ncVNS) device is currently focused on clinical validation rather than broad commercial sales. Tivic Health Systems, Inc. completed all study visits for its patent-pending ncVNS Optimization Study. The findings from this trial uncovered new insights that led to additional patent filings specifically intended to protect the prescription device development for future commercialization and licensing. The strategy here is to move from clinical proof to a licensing/co-development model, similar to the Entolimod path, rather than building out a large direct-to-physician sales force immediately. The company is exploring alternative commercial opportunities for this VNS program.

• Completed all study visits for the ncVNS Optimization Study.
• Generated new patent filings to protect prescription device development.
• Exploring commercialization via licensing or co-development agreements.

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Customer Segments

You're looking at Tivic Health Systems, Inc. right at a major inflection point, so the customer segments reflect a company actively pivoting its focus. The legacy consumer base is being intentionally downsized to prioritize high-value biopharma partnerships and government contracts. Here's the breakdown of who Tivic Health Systems, Inc. is targeting as of late 2025.

US Government and Military for ARS medical countermeasure stockpiling

This segment is now a primary focus for the lead drug candidate, Entolimod, for Acute Radiation Syndrome (ARS). Discussions are advanced, evidenced by participation in the 2025 Military Health System Research Symposium (MHSRS) held August 4-7, 2025. Tivic Health Systems, Inc. secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) staff to discuss deployment pathways for mass-casualty and stockpile situations. This group represents potential large-volume, non-recurring revenue through government procurement contracts, which is a significant shift from the previous consumer focus.

Pharmaceutical and large medical device companies (for licensing deals)

This segment is crucial for leveraging the existing investment in the biologics pipeline beyond the initial ARS indication. Tivic Health Systems, Inc. has the exclusive option to license additional indications for Entolimod, including Lymphocyte exhaustion and Immunosenescence, plus the indication for Entolasta. Prior investment in Entolimod and Entolasta totaled approximately $140 million across more than 40 trials. The company is preparing for a Biologics License Application (BLA) filing, which is a key value driver for potential future licensing or partnership deals. The company has no debt on its balance sheet as of September 30, 2025, giving it leverage in partnership negotiations.

Patients with neutropenia and certain cancer-related conditions (future Entolimod)

This represents the expansion of the Entolimod program into therapeutic indications with broad patient populations. Tivic Health Systems, Inc. exercised its option for the exclusive, worldwide rights to Entolimod for Neutropenia on March 28, 2025, following a $500,000 milestone payment. The company completed the transfer of two Investigational New Drug (IND) applications to initiate clinical trials for neutropenia and lymphocyte exhaustion (a potential cancer-related indication). The global Neutropenia market is estimated to exceed $20 billion by 2029, according to Data Bridge Market Research. This segment is a long-term value driver, contingent on successful clinical progression.

Consumers seeking drug-free sinus relief (ClearUP, legacy segment)

This is the legacy customer segment for the ClearUP device, which is now being actively exited. Tivic Health Systems, Inc. discontinued all advertising and marketing initiatives for ClearUP on October 1, 2025, and the third quarter of 2025 was the final quarter of direct consumer sales. The financial impact is clear: nine-month revenue for 2025 totaled only $302,000, down from $600,000 in the same period of 2024. The company recorded a $230,000 inventory reserve in Q3 2025 connected to this wind-down. The focus is now on fulfilling orders through existing resellers through the fourth quarter of 2025 only.

The shift in focus is reflected in the Q3 2025 financials:

The increase in operating expenses is tied directly to R&D investments in the biologics program. The company is relying on $3.5 million in cash and committed funding from a preferred purchase agreement to reach the next key milestone: manufacturing validation for Entolimod.

The customer base is now defined by these potential relationships:

• Government agencies interested in ARS stockpile procurement.
• Pharmaceutical partners for licensing Entolimod/Entolasta indications.
• Patients with neutropenia and cancer-related conditions (future market).
• Resellers of the legacy ClearUP device (winding down).

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Cost Structure

You're looking at the cost side of Tivic Health Systems, Inc. (TIVC) as they push hard on their biopharma transformation. The costs are heavily weighted toward advancing the Entolimod pipeline, which means significant upfront spending before any potential revenue from that stream hits.

The overall spending profile shows a clear shift away from the consumer business, though some wind-down costs are still present. For the third quarter of 2025, the total operating expenses were reported at $2.3 million. This was up from $1.5 million for the same period in 2024.

Heavy investment in Research & Development (R&D) for biologics program is a primary driver of this cost structure. The increases in operating expenses for Q3 2025 were explicitly attributed to increased research and development investments in the biologics program, alongside increased corporate costs and advertising spend related to the ClearUP consumer exit. For the first nine months of 2025, total operating expenses reached $5.9 million, up from $4.4 million in the first nine months of 2024.

Clinical trial expenses for Entolimod and ncVNS optimization studies are embedded within the R&D spend. The company completed all study visits in the Optimization Study for its non-invasive cervical vagus nerve stimulation (ncVNS) device during Q2 2025. Furthermore, the transfer of two Investigational New Drug (IND) applications allows Tivic Health Systems, Inc. to initiate clinical trials for Entolimod in neutropenia and cancer-related conditions.

cGMP manufacturing and supply chain costs for Entolimod are a critical, near-term expenditure. The company achieved a key milestone with the successful cell line verification, which is a critical first step toward establishing reproducibility and scalability for drug manufacturing. Tivic Health Systems, Inc. entered into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the Biologics License Application (BLA) process. The company believes its current and committed funding is sufficient to make meaningful progress toward this manufacturing validation.

Corporate and General & Administrative (G&A) overhead contributes to the operating expenses. The increase in Q3 2025 operating expenses included higher corporate costs. The company also incurred specific, non-recurring costs related to exiting the consumer business, which impacted the gross profit line but are part of the overall operational restructuring costs. These included a $230,000 inventory reserve and a $117,000 write-off of certain ClearUP assets. The company has no debt on its balance sheet.

Here's a quick look at the key financial metrics that frame these costs:

The capital structure supporting these costs includes:

• Financing tranches closed in Q3 totaled $3.8 million in net proceeds.
• Approximately $7.0 million remained available under a preferred equity purchase agreement as of June 30, 2025.
• The company maintains a $25 million equity line of credit.
• The company has zero debt on the balance sheet.

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Tivic Health Systems, Inc. (TIVC) as the company executes a sharp pivot away from consumer health tech toward biopharma. This means the revenue streams are in transition, moving from device sales to future, potentially much larger, drug-related income. Here's the quick math on what's coming in and what's on the horizon.

Sales of ClearUP Consumer Bioelectronic Device

The ClearUP device revenue stream is effectively being shut down, but it contributed a final figure for the period. Tivic Health Systems, Inc. reported revenue of $146,000 for the third quarter of 2025 from ClearUP sales. This was the final quarter that Tivic Health Systems, Inc. sold ClearUP directly to consumers, as all advertising and marketing initiatives for the device were discontinued as of October 1, 2025. To be fair, the company did continue to fulfill orders from existing resellers through the fourth quarter to support their holiday promotions, but the focus is clearly elsewhere.

Revenue from Selling Through Remaining ClearUP Inventory

The wind-down of the consumer health tech business involved clearing out existing stock. This process was significant enough to require a financial adjustment; a $230,000 inventory reserve was recorded in the third quarter of 2025 specifically in connection with this exit. Management has guided that they expect minimal to no revenue from this segment going forward until regulatory approvals are obtained for the biologics pipeline. The operating expenses for the third quarter included increases in advertising costs as they pushed to sell through this remaining inventory prior to the exit.

Future Sales of Entolimod to Government for Strategic Stockpiling

This is the near-term, high-priority revenue driver now. Entolimod, the lead product candidate for acute radiation syndrome (ARS), is being positioned as a military medical countermeasure and stockpile drug. Tivic Health Systems, Inc. advanced discussions with key U.S. Government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), the Armed Forces Radiobiology Research Institute (AFRRI), and the Medical CBRN Defense Consortium (MCDC) during the 2025 Military Health System Research Symposium. CEO Jennifer Ernst estimates the global market for ARS treatment at $1.5-2 billion. If Entolimod gains approval, initial annual sales could potentially exceed $200 million annually, which would definitely change the company's financial profile.

Potential Milestone Payments and Royalties from Licensing Agreements (Entolimod/ncVNS)

The biopharma platform revenue is structured around the licensing agreement for Entolimod. Tivic Health Systems, Inc. initially paid Statera Biopharma $1,200,000 in equity consideration and $300,000 cash for the ARS indication. Furthermore, the company exercised its option for the Neutropenia indication, which triggered an accelerated milestone payment of $500,000. Future revenue from this asset will be royalty and milestone-driven, tied directly to the clinical and commercial success of Entolimod and its derivative, Entalasta. The non-invasive cervical vagus nerve stimulation (ncVNS) development also has potential for commercialization and licensing, which could generate additional, though less defined, future revenue streams.

Here's a look at the current and potential revenue components:

The shift in focus means that the revenue base is expected to be minimal until the biologics program hits a major regulatory or commercial milestone. The company's current cash position, totaling $3.5 million at September 30, 2025, plus committed funding, is intended to support manufacturing validation for Entolimod.

You should track the progress of the Biologics License Application (BLA) submission, which is targeted for late 2026, as that will be the key event unlocking the high-value stockpile and royalty streams. Finance: draft 13-week cash view by Friday.