Tivic Health (now Valion Bio) ends quarter with $669,000 cash, lines up financing

Tivic Health Systems, Inc., based in Fremont, California, reported its first-quarter 2025 results on May 15, 2025. At the time it traded on Nasdaq as TIVC. The company is now called Valion Bio, but the May release was issued under the Tivic name. The company describes itself in the release as a diversified immunotherapeutics company, after what it calls a significant strategic shift in the quarter.

Revenue fell and the cost base did not

Revenue for the quarter was $70,000, against $334,000 a year earlier. The company attributes the drop to lower unit sales of its ClearUP device, which treats sinus pain and pressure, and to a 92% fall in advertising spending as it focused resources on research and development. Gross profit fell to $50,000 from $167,000. Gross margin rose to 72% from 50%, but on a much smaller sales base.

Operating expenses were $1.6 million, flat with the prior year. The net loss was $1.5 million, also flat. The statements show a net loss per share of $2.52, against $17.15 a year earlier, on a weighted-average share count of 596,368 against 86,338.

Cash and the financing lines

Cash and cash equivalents were $669,000 at March 31, 2025, down from $2.0 million at the end of 2024. Noncurrent assets rose to $2,398 thousand from $49 thousand, and the release does not say what they are. After the quarter, the company raised net proceeds of $1.7 million under its at-the-market program. The release says the company has no debt on its balance sheet.

The company also says it secured a $25 million equity line of credit and signed a purchase agreement for the sale of up to $8.4 million of company securities. An equity line lets a company sell shares to an investor in stages. The release names neither the investor on either line nor any placement agent, sales agent, underwriter or counsel, and it gives no share count for either deal.

CEO Jennifer Ernst said the company has entered into financing agreements that it expects to fund the Entolimod manufacturing validation and the upcoming VNS data readouts. The release gives no cash runway in months, and the cash balance at quarter end was small against a quarterly net loss of $1.5 million. Future sales of stock under these lines would add dilution, although the release does not say how many shares those sales would involve.

Entolimod and the regulatory path

The company's main story is Entolimod, a TLR5 agonist that it licensed worldwide in February 2025 along with its derivative, Entolasta, under an agreement covering several indications. The release calls Entolimod a Phase III candidate for acute radiation syndrome, and says Phase III validation for that indication has been completed through the FDA's animal rule pathway. It adds that manufacturing validation must be done before any regulatory filing.

The release presents no human efficacy data for Entolimod in that indication. After the quarter, the company signed an agreement for GMP manufacturing process validation for Entolimod ahead of a planned Biologics License Application. The company has not filed that application, and the release gives no date for it.

Tivic also exercised an option to license Entolimod for neutropenia, a second indication it obtained from Statera. The release calls that a Phase II drug candidate and says Phase II trials are expected to start later in 2025. The ncVNS device, which the release links to vagus nerve stimulation, is in a separate optimization study, and a poster at a bioelectronic medicine meeting showed optimized effects on autonomic function.

The listing and the reverse split

The company said it regained compliance with the Nasdaq minimum bid price rule, after a 1-for-17 reverse stock split that took effect on March 7, 2025. The release does not say where the share price has traded since the split.

The release does not give a total share count after the reverse split, the terms of the equity line or the amount drawn on it to date. It also does not state how many months the company's cash will last, which is the question the financing is meant to answer.

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