Earnings Labs

Tivic Health Systems, Inc. (TIVC)

Q3 2025 Earnings Call· Fri, Nov 14, 2025

$1.38

+3.76%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-21.47%

1 Week

-13.61%

1 Month

-0.52%

vs S&P

-0.44%

Transcript

Operator

Operator

Welcome to Tivic Health Systems third quarter 2025 financial results and operational update conference call. This call has been prerecorded. This call is being webcast, and the replay will be available on the IR of the company's website for three months. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated in our forward-looking statement. Please read the safe harbor statement contained in the press release that Tivic Health issued today as well as the risk factors contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K of the year ended 12/31/2024 and the Form 10-Q to be filed with the SEC today as well as other companies' SEC filings. Hosting today's call is Jennifer Ernst, Tivic CEO, and Lisa Wolf, Tivic CFO. Now let me turn the call over to Jennifer Ernst. Thank you, and welcome to everyone listening today.

Jennifer Ernst

Management

I'm pleased to be reporting on the progress we have made during the third quarter in building a new Tivic. As many of you know, at the start of the year, we undertook a significant strategic transformation of Tivic Health Systems, Inc. Beginning in February, with the licensing of entolimod and related assets, we expanded from bioelectronics to biologic pharmaceuticals with a common focus on the immune system and the ways we can harness the immune system to improve clinical outcomes and save lives. We've accomplished a great deal in a very short time. In Q2, we built out the team and secured the first meetings with potential customers for Entelimod's use as a military countermeasure. We continue to deepen those connections and expect to be meeting with BARDA in the coming months to discuss stockpiling opportunities. While our commercial focus is squarely on moving Intaloupe through our first BLA with the FDA for acute radiation syndrome, we've also continued to enrich our pipeline. We licensed Entelimod and Entelasta for neutropenia and have begun discussions with leading institutions about conducting investigator-led studies in this area. We have filed new intellectual property, IP that supports the potential use of our TLR5 agonist as adjunctive therapies for immuno-oncology cancer therapeutics. We have completed the optimization study for our VNS device design, uncovering the key parameters that have the strongest influence on the autonomic nervous system activity. And we are completing the exit from the consumer health market, increasing focus on prescription therapeutics. Today, let me focus more on our fully licensed entolimod portfolio and report to you where this drug candidate stands from a clinical development perspective. Entalimod itself is a first-in-class late-stage, highly derisked drug candidate. And the first commercial opportunity for Tivic Health Systems, Inc. with entolimod is for acute…

Lisa Wolf

Management

For ease of listening, all of the financial metrics I will be comparing the third quarter ended 09/30/2025, to the prior year quarter ended 09/30/2024. And the nine months ended 09/30/2025, to the nine months ended 09/30/2024 unless otherwise stated. Financial results for the third quarter and first nine months of the year reflect our transition as a company with our focus towards the biopharmaceutical market and away from the consumer device market. As mentioned in our last quarterly call, we plan to exit the consumer device market by the end of the year. Toward that end, during the third quarter, we recorded reserves for excess and obsolete inventory of $230,000, which is included in the cost of goods sold. We also wrote off certain assets related to clear up, with a net book value of $117,000, which is included in other expenses. We do not expect to incur additional significant costs associated with our exit from the consumer device business. Additionally, we have now discontinued the allocation of any significant resources toward clear up sales. As part of this progression, the company launched a new corporate website that puts the emphasis on our transformed mission and expanded clinical pipeline. Revenue net of returns totaled $140,000 for the quarter, compared to $126,000 in the year-ago quarter. Revenue net of returns totaled $302,000 for the nine-month period compared to $600,000 in 2024. The increase in the quarter was a result of increased unit sales, driven by reduced selling prices as we push to reduce prior to exiting the business. The decrease for the nine-month period was primarily due to decreased unit sales resulting from reductions in our advertising spend as we focused our resources on the advancement of our TLR5 program. Cost of sales increased to $291,000 from $82,000 in the…

Jennifer Ernst

Management

Thank you, Lisa. So to recap, we started a process in February to transform the business. And today, this transformation is well underway. In the third quarter and subsequent weeks, we've transferred two INDs to Tivic Health Systems, Inc., completed the cell line verification required to enable a future BLA with the FDA, wound down the consumer health tech business, advanced discussions of potential pathways to deploying entolimod as a military countermeasure and stockpile drug, and last but not least, we closed additional tranches of the company's $8,400,000 financing for a total of $3,800,000 in net proceeds during the third quarter. So yes, the transformation progress is well underway. And I want to thank you for listening and for your continued interest in Tivic Health Systems, Inc. We look forward to continuing our progress in the coming weeks and months as we focus on advancing value creation activities on behalf of our shareholders, while at the same time working to bring life-saving and life-enhancing treatments to patients in need. And with that, I'll turn the call back to the operator. Thank you.

Operator

Operator

This will conclude today's conference. You may disconnect your lines at this time, and have a great day. Thank you for your participation.