Welcome to our dedicated page for Tivic Health Systems SEC filings (Ticker: TIVC), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Valion Bio, formerly Tivic Health Systems, files SEC reports that document its biopharmaceutical transformation, Nasdaq-listed common stock, governance matters, and material corporate events. Recent 8-K filings cover the completed corporate name change and VBIO ticker, executive appointments, annual results disclosure, Nasdaq listing compliance matters, and material agreements involving Velocity Bioworks.
The company’s proxy materials describe annual meeting proposals, director elections, equity incentive plan matters, and stockholder voting mechanics. Registration statements and periodic disclosures address securities offerings, emerging-growth and smaller-reporting-company status, capital structure, risk factors, Entolimod and Entolasta development, and the CDMO operations of Velocity Bioworks.
Valion Bio, Inc. reported a net loss of $6.2 million for the three months ended March 31, 2026, compared with $1.5 million a year earlier, driven by sharply higher research and development and selling, general and administrative expenses. Cash and cash equivalents were $7.2 million at March 31, 2026, after using $5.0 million in operating cash during the quarter, and accumulated deficit reached $59.0 million. The company’s financial statements state that these factors raise “substantial doubt” about its ability to continue as a going concern without additional financing. Valion expanded through the 2025 acquisition of Scorpius’ CDMO assets and entered long-term facility leases, recording operating lease right-of-use assets of $10.1 million. It also carries a senior secured convertible note with $16.3 million principal and a derivative liability. In March 2026, Valion received a Nasdaq notice that its share price fell below the $1.00 minimum bid requirement and has until September 15, 2026 to regain compliance.
Valion Bio, Inc., formerly Tivic Health Systems, reported its first full quarter under its new identity, highlighting progress on its TLR5 immunotherapy platform and integrated manufacturing arm Velocity Bioworks for the three months ended March 31, 2026.
The company advanced Entolimod toward potential approval under the FDA's Animal Rule for acute radiation syndrome and continued developing Entolasta, a next-generation TLR5 agonist aimed at oncology supportive care, longevity, and immunosenescence. Engagement with U.S. agencies including NIAID, BARDA and other federal stakeholders expanded around potential procurement and stockpiling.
Velocity Bioworks' San Antonio facility supported internal Entolimod manufacturing while pursuing third-party CDMO opportunities in what management describes as an underserved Phase I and II biologics market. Operating expenses rose to $5.6 million from $1.4 million a year earlier, driven by the Velocity acquisition, Entolimod development, and rebranding costs. Net loss was $6.2 million ($2.23 per share) versus $1.5 million ($2.52 per share). Cash and cash equivalents were $7.2 million at March 31, 2026, down from $12.6 million at December 31, 2025, and the company is evaluating capital alternatives to fund its pipeline, regulatory, and manufacturing milestones.
Valion Bio, Inc. reporting persons 3i, Tumim Stone Capital LLC, 3i Management LLC and Maier Joshua Tarlow filed Amendment No. 1 to update beneficial ownership. The filing states 2,877,926 shares outstanding as of March 17, 2026 and reports that 3i beneficially owns 307,526 shares (9.99%) and Tumim beneficially owns 200,418 shares (6.51%). The reported ownership combines direct holdings, warrants, a senior secured convertible note (original principal approximately $16.3 million), and convertible Series B and Series C preferred holdings, each exercise or conversion being subject to a 9.99% beneficial ownership limitation (a "Blocker"). Mr. Tarlow is identified as having shared voting and dispositive power via management roles; he does not directly own the shares.
Valion Bio, Inc. granted its General Counsel & SVP of Legal, Melinda Lackey, an employee stock option to purchase 45,000 shares of common stock at an exercise price of $0.96 per share.
The option vests 25% on the first anniversary of the grant date, with the remaining 75% vesting in twelve equal quarterly installments over the following three years, and expires on May 1, 2036. After this grant, she holds options for 45,000 shares directly. This is a compensation-related award rather than an open-market purchase.
Valion Bio, Inc. disclosed that Melinda Lackey, its General Counsel & SVP of Legal, has become a reporting insider by filing an initial statement of beneficial ownership on Form 3. The filing establishes her status as an officer subject to insider reporting rules but does not list any reportable transactions.
Valion Bio, Inc. appointed Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs. She brings more than 18 years of legal and biotech experience, including senior roles at Alaunos Therapeutics and Kuur Therapeutics and prior IP-focused practice at major law firms.
Under her May 1, 2026 employment agreement, Ms. Lackey will receive a base salary of $321,000 per year, be eligible for an annual bonus of up to 35% of base salary, and may receive future equity grants under the 2021 Equity Incentive Plan. She also received an option to purchase 45,000 Valion Bio common shares at fair market value on the grant date.
If she resigns for good reason or is terminated without cause after at least six months, she is entitled to six months of base salary and six months of COBRA premiums. The company issued a press release highlighting her IP, clinical-stage, and Nasdaq public company experience as it advances Entolimod™ and its Velocity Bioworks CDMO operations.
Valion Bio, Inc. is asking stockholders to vote at a fully virtual 2026 annual meeting on May 28, 2026. Holders of common stock as of April 24, 2026, when 3,139,095 shares were outstanding, may vote; holders of Series A, B and C preferred cannot.
Proposals include re-electing one Class II director, expanding the 2021 Equity Incentive Plan by 2,581,608 shares to a total of 3,219,566 authorized shares, and ratifying Rosenberg Rich Baker Berman, P.A. as auditor. Several items seek Nasdaq Listing Rule 5635(d) approval for issuing common stock upon conversion of Series B and Series C preferred, a senior secured convertible note, related warrants, and a common stock Equity Line of Credit with Tumim Stone Capital, LLC.
Tivic Health Systems, Inc. is changing its corporate name to Valion Bio, Inc., effective April 28, 2026, with its Nasdaq ticker symbol expected to switch from TIVC to VBIO. The company states that shareholder approval was not required and that the name change does not alter shareholder rights.
The rebrand highlights a shift from consumer medical devices to a late-stage biopharmaceutical model built around lead candidate Entolimod™, a TLR5 agonist with FDA Fast Track and Orphan Drug designations being advanced under the FDA Animal Rule for Acute Radiation Syndrome, and explored for chemotherapy-induced neutropenia. The company reports more than $140 million in cumulative development investment in Entolimod and over 15 years of development history. It is engaging BARDA and other U.S. agencies regarding potential Strategic National Stockpile procurement, which the company notes could represent a non-dilutive, potentially nine-figure revenue opportunity if a contract is secured.
Valion Bio also highlights its wholly owned CDMO subsidiary Velocity Bioworks, acquired in December 2025 for approximately $16.3 million, which recently completed a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation and is intended both to support internal supply and to serve third-party biotech clients.
Tivic Health Systems, Inc. is soliciting stockholder approval at its 2026 Annual Meeting for director election and multiple capital‑raising and governance actions.
The proposals include: (1) approving an amendment to the 2021 Equity Incentive Plan to add 2,581,608 shares (increasing the plan reserve to 3,219,566 shares); (2) ratifying its auditor; and (3) seeking Nasdaq shareholder approvals to permit future issuances upon conversion or exercise tied to the Series C Preferred financing (up to 75,000 shares of Series C for up to $75.0M, with a $2.2310 fixed conversion/exercise price), the Note Purchase (warrant capacity of 4,553,213 shares and total purchase price $16,253,147.10), and an Equity Line of Credit (up to $50M). The Board recommends voting FOR all proposals.