Executive Summary

Q2 2025 reflected intentional de‑prioritization of consumer healthtech as Tivic pivoted into biopharma: revenue fell to $0.086M while gross margin improved materially; operating expenses rose on increased R&D, widening net loss .
Management announced plans to exit the ClearUP business by year‑end to concentrate resources on late‑stage Entolimod (TLR5 agonist) and the ncVNS program; Type B FDA meeting and GMP manufacturing validation are near‑term milestones .
No formal numerical guidance was provided; funding runway bolstered by preferred equity tranches and a $25M equity line, with ~$7M remaining under the preferred agreement to progress Entolimod GMP validation .
Key stock narratives near term: regulatory path clarity (Type B meeting, EUA possibilities), GMP validation progress, ncVNS optimization study readout, and consumer exit execution—each potential catalysts for sentiment re‑rating .

What Went Well and What Went Wrong

What Went Well

Strategic focus sharpened: “We have established a strong foundation for Tivic’s strategic transformation…expansion into biopharmaceuticals,” with planned ClearUP exit to maximize focus on late‑stage pipeline .
Regulatory and government engagement momentum: Fast Track and Orphan Drug designations for Entolimod, planning a Type B FDA meeting; positive interest from White House and FDA officials on defense applications for ARS .
Operational progress: Entered GMP manufacturing validation with Scorpius; completed ncVNS optimization study visits, with initial findings reinforcing personalization for efficacy .

What Went Wrong

Topline pressure: Q2 revenue declined to $0.086M (vs. $0.140M a year ago) driven by lower ClearUP unit sales amid reduced advertising .
Higher OpEx and wider loss: Operating expenses rose to $2.0M vs. $1.3M YoY; net loss widened to $(1.931)M vs. $(1.266)M in Q2 2024, primarily due to biopharma program investments .
Cash draw pre‑financings: Cash fell to $1.184M at quarter‑end (from $2.002M at year‑end), necessitating equity line and preferred equity utilization post‑quarter to bolster liquidity .

Financial Results

Consolidated Metrics vs. Prior Periods

Metric	Q3 2024	Q1 2025	Q2 2025
Revenue ($USD Millions)	$0.126	$0.070	$0.086
Gross Profit ($USD Millions)	$0.044	$0.050	$0.054
Operating Expenses ($USD Millions)	$1.475	$1.556	$1.988
Net Loss ($USD Millions)	$(1.431)	$(1.502)	$(1.931)
Diluted EPS ($)	$(0.23)	$(2.52)	$(2.19)
Gross Margin (%)	N/A	72%	63%

Notes:

Q2 gross margin improvement driven by reductions in product support and fulfillment costs and prior supply chain restructuring .
Revenue declines reflect reduced advertising spend to reallocate capital to Entolimod and ncVNS programs .

Balance Sheet and Liquidity

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash and Equivalents ($USD Millions)	$2.002	$0.669	$1.184
Total Current Assets ($USD Millions)	$2.639	$1.261	$1.842
Total Stockholders’ Equity ($USD Millions)	$2.535	$3.036	$3.687
Debt	None	None	None

Funding actions:

~$0.9M raised subsequent to Q2 via equity line and Series B Preferred; ~$7M remains under preferred equity purchase agreement .
$25M equity line of credit established March 2025 (95% of lowest VWAP pricing and other terms) .

Segment Breakdown

Company reports consolidated results; no segment revenue disclosure (ClearUP consumer device de‑prioritized, planned exit by YE2025) .

Operating Expense Detail (Q2 2025)

OpEx Category ($USD Millions)	Q2 2024	Q2 2025
R&D	$0.302	$0.655
Sales & Marketing	$0.207	$0.426
G&A	$0.787	$0.907
Total	$1.296	$1.988

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Q2 2025	None provided	None provided	Maintained: No formal guidance
Gross Margin	Q2 2025	None provided	63% reported (actual)	N/A (reported actual)
OpEx	FY/Q2 2025	None provided	Investment rising with biopharma programs	Directional: Higher
Strategic Actions	2025	ClearUP active	Exit ClearUP by YE2025 to focus on biopharma/ncVNS	New directive
Regulatory Milestones	2025	N/A	Plan Type B FDA meeting; EUA exploration; GMP validation underway	New milestones

No formal numerical guidance on revenue, margins, OpEx, tax, or segment metrics was issued in Q2 2025; management emphasized milestones and strategic transformation .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2: Q3 2024)	Previous Mentions (Q-1: Q1 2025)	Current Period (Q2 2025)	Trend
Biopharma pivot (TLR5/Entolimod)	Focus on device portfolio; biopharma not yet central	Licensed Entolimod/Entolasta; initiated GMP validation; defense/FDA briefings	Biopharma central; Type B FDA planning; defense interest; neutropenia license extension	Accelerating
ncVNS program	Phase 1a optimization study started; clinical prioritization	Optimization study expanded; personalization IP; poster presented	Completed study visits; initial findings reinforce personalization; Feinstein report forthcoming	Advancing
Consumer ClearUP	Supply chain redesign; margin improvements	Lower ad spend; sales decline; device remains in portfolio	Plan to exit ClearUP by YE2025	Strategic exit
Regulatory path	N/A	Fast Track/Orphan; expedited pathways explored with FDA	Type B meeting planning; EUA possibilities for ARS; IND transfers	Clarifying
Government/Defense	N/A	White House and FDA briefings, strong interest	Positive interest reinforced; Military Health System Symposium meetings	Strengthening
Financing runway	Equity raises post Q3’24; ATM proceeds	$25M ELOC; up to $8.4M preferred agreement	$1.4M preferred tranches, $547k ELOC proceeds, ~$7M remaining preferred	Sustained
Leadership	Interim CFO appointed	Active management transition and compliance regained	Lisa Wolf named permanent CFO; CSO transition to consultant	Stabilizing

Management Commentary

“We have established a strong foundation for Tivic’s strategic transformation with our expansion into biopharmaceuticals…unique in treating disease by addressing both the body’s biochemical and bioelectronic systems.” — CEO Jennifer Ernst .
“To maximize our focus on the compelling, late‑stage clinical pipeline…planning to exit the ClearUP business by the end of this year.” — CEO Jennifer Ernst .
“Fast Track and Orphan Drug designation…planning a Type B meeting this year to confirm the final clinical, manufacturing, and validation requirements for our planned BLA.” — CEO Jennifer Ernst .
“Gross margins have increased to 63% for the second quarter…due to reductions of our product support and fulfillment costs.” — CFO Lisa Wolf .
“We believe these funds, along with the $7,000,000 in remaining planned tranches…will allow us to make meaningful progress toward GMP manufacturing validation for entolimod.” — CFO Lisa Wolf .

Q&A Highlights

The call was pre‑recorded and did not include a live Q&A session; only prepared remarks were provided .
Management emphasized milestone timing (Type B meeting, GMP validation batch completion, ncVNS study results) and strategic exit from consumer device operations .

Estimates Context

Wall Street consensus (S&P Global) for Q2 2025 EPS and revenue was unavailable; microcap coverage appears limited. Values retrieved from S&P Global.*
Most recent quarter with “actual” values recorded in SPGI data was Q3 2025 (post‑period): Revenue $0.146M*; EBITDA $(2.483)M*.

Metric	Q2 2025	Q3 2025
Revenue Consensus Mean ($USD Millions)	N/A*	$0.146 (actual)*
Primary EPS Consensus Mean ($)	N/A*	N/A*
EBITDA Consensus Mean ($USD Millions)	N/A*	$(2.483) (actual)*

Disclaimer: Values retrieved from S&P Global.*

Implications:

With no published consensus for Q2 2025, estimate‑based beat/miss analysis is not feasible; publishable revisions will likely key off regulatory and pipeline milestones rather than near‑term consumer revenue.

Key Takeaways for Investors

The narrative has decisively shifted to biopharma and bioelectronic therapeutics; watch for Type B FDA meeting scheduling, EUA discussions for ARS, and GMP validation progress as potential catalysts .
Exit of ClearUP by YE2025 should reduce commercial distraction and align OpEx with R&D priorities; near‑term topline will remain light until biopharma milestones translate into contracts (e.g., national stockpile) .
Liquidity improved post‑quarter via equity line and preferred tranches; ~$7M remaining preferred capacity supports manufacturing validation, but continued capital discipline is critical given rising R&D .
ncVNS optimization study completed with encouraging personalization signals; data readout later this year could expand optionality in neuromodulation markets .
Gross margin improvements reflect operational fixes; however, operating losses will persist short term as biopharma investments ramp .
Trading lens: headline risk and event‑driven catalysts dominate—FDA interactions, military/defense engagement outcomes, and study readouts likely to move shares; consensus coverage thin, increasing volatility potential .
Medium‑term thesis hinges on converting late‑stage Entolimod into commercial orders (stockpile/defense) and demonstrating ncVNS clinical efficacy; strategic focus and funding alignment are positives, execution risk remains .

Tivic Health Systems, Inc. (TIVC)·Q2 2025 Earnings Summary