Tivic Health Systems, Inc.
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About the company
Tivic Health Systems, Inc. operates as a late-stage immunotherapeutics company. Its lead drug candidate is Entolimod, a TLR5 agonist that is in late-stage development to treat acute radiation syndrome.
- CEO
- Michael Kevin Handley
- IPO
- 2021
- Employees
- 52
- HQ
- San Antonio, TX, US
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- Market Cap
- $279.15K
- P/E
- -2.44
- PEG
- -0.02
- P/S
- 0.27
- P/B
- 0.65
- EV/EBITDA
- -0.16
- Div Yield
- 0.00%
- Gross Margin
- 48.61%
- Op Margin
- -425.35%
- Net Margin
- -229.23%
- ROE
- -27.04%
- ROIC
- -6.89%
Latest fiscal year · YoY change
- Revenue
- $382.00K-51.0%
- Gross Profit
- $-5,000-350.0%
- Op Income
- $-7,898,000
- Net Income
- $-8,878,000-57.0%
- EPS
- $-7.84+60.1%
- OCF Growth
- -22.3%
- FCF Growth
- -32.4%
- 52W High
- $5.60
- 52W Low
- $0.26
- 50D MA
- $0.96
- 200D MA
- $2.09
- Beta
- 1.83
- RSI (14)
- 29
- Avg Volume
- 382.26K
Earnings call summaries
Pick a quarter — each call distilled into takeaways, results, and a bull vs bear read.
Tivic Health said its third quarter marked further progress in transforming into a biopharma company, with early manufacturing milestones for entolimod, new IND transfers, and continued exit from consumer health, but losses widened as R&D spending rose.· November 14, 2025
- Revenue was $140,000, up from $126,000 a year ago, while nine-month revenue fell to $302,000 from $600,000.
- Gross margin excluding a $230,000 inventory reserve was 42% in Q3 versus 35% last year; nine-month gross margin excluding the reserve was 37% versus 40%.
- Net loss widened to $2.6 million from $1.4 million in Q3; nine-month net loss widened to $6.0 million from $4.2 million.
- The company completed transfer of two entolimod INDs and verified the entolimod cell line, a step management said advances future GMP manufacturing and a BLA path.
- Management said it is exiting the consumer device market by year-end and focusing resources on entolimod, including potential ARS stockpiling and oncology-related indications.
Third-quarter revenue net of returns was $140,000, compared with $126,000 in the year-ago quarter; nine-month revenue was $302,000 versus $600,000 in 2024. Cost of sales was $291,000 versus $82,000 in the prior-year quarter, driven mainly by a $230,000 inventory reserve; gross margin excluding that reserve was 42% versus 35% a year ago. Operating expenses were $2.3 million versus $1.5 million, and net loss was $2.6 million versus $1.4 million. For the first nine months, operating expenses were $5.9 million versus $4.4 million and net loss was $6.0 million versus $4.2 million. Cash and cash equivalents were $3.5 million at 9/30/2025 versus $2.0 million at 12/31/2024, with no debt. Management did not give formal quarterly or full-year revenue/EPS guidance; instead, it said existing cash plus remaining tranches of the preferred purchase agreement should support meaningful progress toward GMP manufacturing validation for entolimod, and noted the company closed additional tranches of its $8.4 million financing for $3.8 million in net proceeds during Q3.
Jennifer Ernst framed the quarter as part of a broader company transformation that began in February, from bioelectronics toward biologic pharmaceuticals focused on the immune system. She emphasized progress on entolimod for acute radiation syndrome, talks with BARDA and government stakeholders, and expansion into neutropenia, lymphocyte exhaustion, and oncology-related applications. Her tone was constructive and forward-looking, but she also acknowledged manufacturing delays tied to financial stress at a contract manufacturer and said the VNS program may need a reassessment of its initial commercial focus.
Lisa Wolf highlighted that Q3 results reflect the shift away from consumer devices and toward the biopharma pipeline. She pointed to a $230,000 reserve for excess and obsolete inventory in cost of goods sold, a $117,000 asset write-off tied to clear up, and said the company does not expect significant additional exit costs and has discontinued meaningful resource allocation to clear up sales. She also noted $3.5 million in cash at quarter-end, no debt, and said cash plus remaining preferred purchase agreement tranches should help fund GMP manufacturing validation for entolimod.
There was no live analyst Q&A in the prerecorded call, so no questions or follow-ups were raised on the record. The main management disclosures instead addressed likely investor concerns directly: manufacturing delays from the contract manufacturer’s financial stress, the lack of formal guidance, and the need to reassess the VNS commercial strategy after surprising optimization-trial findings. Management also said it is evaluating alternative commercialization opportunities for VNS while focusing limited resources on entolimod and follow-on oncology applications.
The bull case from this call is that Tivic now has multiple concrete milestones behind the entolimod program: two INDs transferred, a verified cell line, and a clearer path toward GMP manufacturing and a future BLA. Management also described potential opportunities in ARS stockpiling, neutropenia, lymphocyte exhaustion, and oncology, which broadens the market narrative beyond a single indication.
The bear case is that the company is still pre-commercial, still losing money, and still dependent on financing and manufacturing execution. Q3 losses widened as R&D spending increased, consumer revenue is being wound down, and management acknowledged delays caused by the contract manufacturer’s financial stress. The VNS program also produced unexpected findings that may force a reassessment of its original commercial plan.
AI summary of the company's earnings call · Paraphrased · Not investment advice
- Free Float
- 95.0%
- Shares Outstanding
- 1.08M
- Float Shares
- 1.03M
of shares held by institutions
7 13F filers
Buy/sell ratio 0.00. Sells can include pre-scheduled 10b5-1 plan sales, not just discretionary selling.
Top institutional holders
Largest 13F positions, with quarter-over-quarter change.
| Holder | Shares | Δ Quarter |
|---|---|---|
| Lasry Marc | 101.64K | ▲ 101.64K |
Recent insider transactions
Who's buying, who's selling, and how much.
| Date | Insider | Type | Shares |
|---|---|---|---|
| Apr 15, 26 | Bolton Sheryle | buy | 10,000 |
| Apr 1, 26 | Valauri Christina Rizopoulos | buy | 19,000 |
| Mar 18, 26 | Wolf Lisa G | other | 92 |
| Mar 18, 26 | Wolf Lisa G | other | 92 |
| Feb 18, 26 | Handley Michael K | other | 8,824 |
| Feb 18, 26 | Handley Michael K | other | 8,824 |
| Dec 18, 25 | Wolf Lisa G | other | 736 |
| Dec 18, 25 | Wolf Lisa G | other | 736 |
| Dec 18, 25 | Wolf Lisa G | other | 302 |
| Dec 18, 25 | Ernst Jennifer | other | 14,706 |
A “Sell” may be a pre-scheduled 10b5-1 plan sale rather than a discretionary decision — read insider selling with that in mind.
Our TIVC coverage
Recent articles, reports, and earnings notes.
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Generate TIVC report →Tivic Health Systems Rebrands as Valion Bio, Reflecting Completed Transformation into a Late-Stage Biopharmaceutical Company with Government-Backed Asset and Potential Multiple Revenue Stream Model
prnewswire.com · Apr 23
Tivic Health Systems (NASDAQ:TIVC) Director Sheryle Bolton Purchases 10,000 Shares of Stock
defenseworld.net · Apr 21
Tivic Health Selected to Present Entolimod™ as a Radiation Countermeasure and its Plans for an Oral Transmucosal Program to the Department of War Tech Watch Program on May 7th
prnewswire.com · Apr 15
Reviewing Omnicell (NASDAQ:OMCL) & Tivic Health Systems (NASDAQ:TIVC)
defenseworld.net · Apr 6
Tivic Health Systems Touts Entolimod Phase 3 ARS Path, Eyes BLA in 2027-2028 at Conference
defenseworld.net · Apr 3
Financial Comparison: Tivic Health Systems (NASDAQ:TIVC) versus Rennova Health (OTCMKTS:RNVA)
defenseworld.net · Apr 3
Tivic Receives Formal Request for Information from Ukrainian Ministry of Health Regarding Strategic Stockpiling of Entolimod
accessnewswire.com · Mar 31
Head to Head Analysis: Tivic Health Systems (NASDAQ:TIVC) versus American Well (NYSE:AMWL)
defenseworld.net · Mar 29
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