Every 8-K that Tivic Health Systems, Inc. (TIVC) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TIVC and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TIVC filings page.
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. 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.
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 reported its full-year 2025 results and highlighted a major strategic shift into immunotherapy centered on its Entolimod™ platform and next-generation molecule Entolasta™. Management described 2025 as a defining year, securing global rights to Entolimod and advancing regulatory and development readiness.
The company is prioritizing Entolimod for acute radiation syndrome while planning to extend into oncology supportive care, initially targeting neutropenia via physician-sponsored trials expected later in the year. Through its Velocity Bioworks subsidiary, Tivic is vertically integrating manufacturing, positioning it as a standalone CDMO to both lower internal costs and pursue third-party revenue opportunities.
Tivic Health Systems, Inc. reported that Nasdaq has notified the company it is not in compliance with the Nasdaq Capital Market’s minimum bid price rule because its common stock closed below $1.00 per share for at least 30 consecutive business days. The stock remains listed for now, and Tivic has 180 days from March 19, 2026, through September 15, 2026, to regain compliance by having its closing bid at or above $1.00 for at least 10 consecutive business days. If it fails to do so, Nasdaq may grant an additional 180‑day grace period if other listing standards are met and Tivic indicates an intent to cure the deficiency; otherwise the shares could be subject to delisting, with a right of appeal.
Tivic Health Systems, Inc., through its wholly owned subsidiary Velocity Bioworks, Inc. (VBI), has committed to new facilities in San Antonio, Texas via three long-term agreements. VBI entered an eight-year lease for an approximately 8,024 sq ft microbial building with aggregate base rent of about $5.34 million and a one-time option to extend for five years, plus an exclusive option to purchase the building and property for $12.5 million during the first 24 months. VBI also signed a 102‑month lease for an approximately 20,144 sq ft mammalian facility with aggregate base rent of about $6.29 million. In addition, VBI agreed to a 110‑month sublease for about 8,122 sq ft of office space at the same property, with starting monthly base rent of $31,044.94; this office will serve as the company’s new principal executive office. For all three agreements, VBI will also pay its share of operating expenses, taxes and utilities.
Tivic Health Systems, Inc. canceled its previously adjourned special meeting of stockholders that had been scheduled to reconvene on March 12, 2026. The meeting was originally held and then adjourned on February 19, 2026 because too few shares were represented to form a quorum.
As of the December 29, 2025 record date, 2,525,778 shares of common stock were entitled to vote, but stockholders holding less than one-third of this capital stock were present or represented by proxy. On March 11, 2026, the Board adopted a resolution to cancel the adjourned meeting and withdraw all proposals described in the related proxy materials.
Tivic Health Systems, Inc. announced a leadership transition, appointing Michael K. Handley as Chief Executive Officer and a member of the board of directors, effective immediately. Handley, a life sciences executive with more than two decades of commercialization and regulatory experience, has been the company’s Chief Operating Officer and President of Tivic Biopharma since February 2025.
Jennifer Ernst resigned as Chief Executive Officer effective March 2, 2026 and will step down from the board on March 5, 2026. Under a Separation Agreement, she will receive an aggregate cash payment of $325,000 over a 12‑month severance period, continued COBRA coverage during that period, continued vesting of her unvested equity awards over the severance period, and $50,000 in restricted common stock, subject to shareholder approval. The company emphasized that her resignation was not due to any dispute or disagreement regarding operations, policies or practices.
Tivic Health Systems filed an amended Form 8-K to add audited financial statements for Scorpius Holdings and unaudited pro forma results related to its December 2025 asset acquisition through subsidiary Velocity Bioworks. Scorpius generated $6.24 million of 2024 revenue but reported a net loss attributable to Scorpius of $32.8 million and an accumulated deficit of $287.2 million.
Scorpius ended 2024 with cash and cash equivalents of $1.03 million and total assets of $39.2 million against total liabilities of $37.5 million, including $16.0 million of related-party convertible promissory notes and a warrant liability of $2.10 million. Its auditors highlighted recurring losses and limited cash as raising substantial doubt about Scorpius’s ability to continue as a going concern.
Tivic Health Systems, Inc. entered a common stock purchase agreement that allows it, at its discretion, to sell up to $50,000,000 of newly issued common stock to Tumim Stone Capital over a period tied to the effectiveness of a resale registration statement.
Sales are priced at 97% of the daily VWAP for a one-day valuation or 95% of the lowest VWAP over a three-day period, subject to volume limits. Issuances are capped at 506,848 shares, representing 19.99% of shares outstanding before the agreement, unless stockholders approve a waiver or a minimum price condition is met.
As a commitment fee, Tumim received pre-funded warrants to acquire 437,012 shares at an exercise price of $0.0001 per share, exercisable immediately with beneficial ownership capped at 4.99% or, at Tumim’s election, 9.99% of outstanding common stock.
Tivic Health Systems, Inc. filed a current report to note that it has made a corporate presentation available to investors on its website as of January 20, 2026. The presentation, dated January 2026, is included as Exhibit 99.1 and is provided under Regulation FD, which is intended to ensure fair public disclosure of material information.
The company explains that this investor presentation and the related disclosure are being "furnished" rather than "filed," meaning they are not subject to certain legal liabilities under the Securities Exchange Act and will not be automatically incorporated into other securities filings unless specifically referenced. The report also includes standard cautionary language about forward-looking statements, emphasizing that actual results may differ materially due to various risks and uncertainties described in Tivic Health’s filings with the SEC.
Tivic Health Systems agreed through its subsidiary Velocity Bioworks to buy substantially all assets of Scorpius Holdings’ CDMO business in an Article 9 auction for $16,253,147.10 in cash, assuming no pre‑closing liabilities. The deal closed on December 10, 2025 and moves manufacturing of Tivic’s Entolimod program in‑house while positioning the company to offer contract development and manufacturing services to other clients.
To fund the purchase, Tivic issued to 3i, LP a senior secured convertible note with a principal amount of $16,253,147.10 and a warrant for up to 4,553,213 common shares at a $2.2310 exercise price, together subject to a 19.99% exchange cap equal to 353,013 shares. Tivic also arranged a Series C Non‑Voting Convertible Preferred Stock program of up to 75,000 shares at $1,000 each, for potential gross proceeds of $75,000,000 in multiple tranches, with 6% cumulative dividends, a $2.2310 fixed conversion price and a variable formula with a $0.39 floor, plus additional warrants. The company terminated a prior $25,000,000 equity purchase agreement with Mast Hill and granted new investors participation rights, financing restrictions and, under certain cash burn conditions, board appointment rights.
Tivic Health Systems, Inc. reported that it secured a Techwatch meeting with the Biomedical Advanced Research and Development Authority’s Radiological and Nuclear Medical Countermeasures Program staff to present clinical data on Entolimod’s effects on radiation-induced injury and acute radiation syndrome.
The company also plans to discuss its progress on manufacturing readiness and preparations for a biologics license application, as described in a press release furnished as an exhibit. The report emphasizes that these plans and expectations are forward-looking and subject to significant risks and uncertainties that could cause actual results to differ materially.
Tivic Health Systems (TIVC) filed an 8-K announcing it issued a press release reporting findings from its Clinical Optimization Study for its non-invasive vagus nerve stimulation device. The press release is furnished as Exhibit 99.1 and incorporated by reference.
The filing includes customary forward-looking statements language, noting risks and uncertainties that could cause actual results to differ from expectations.
Tivic Health Systems entered into a new executive employment agreement with CEO Jennifer Ernst, replacing her 2021 offer letter. The agreement sets a base salary of 325,000 per annum, with an annual end-of-year incentive bonus of up to 50% of base salary at the Board’s discretion, and eligibility for annual focal equity grants under the Amended and Restated 2021 Equity Incentive Plan.
Employment is at will. If she resigns without good reason, is terminated for cause, or upon death or disability, no separation benefits apply and no bonus is payable if not employed through December 31. If she terminates for good reason or is terminated without cause, she is entitled to severance equal to 1/12 of base salary for twelve months, Company-paid COBRA coverage for twelve months, and continued vesting of unvested equity awards for twelve months.
Tivic Health Systems, Inc. has appointed Odyssey Transfer and Trust Company as its new transfer agent and registrar, effective as of August 30, 2025. All registered shares of common stock and related records will move from the prior transfer agent, Equiniti Trust Company, LLC, to Odyssey by that date. As of the same effective date, Odyssey will also replace Equiniti as successor warrant agent under the May 13, 2024 Warrant Agency Agreement covering the Company’s Series B Warrants issued to certain investors.
Tivic Health Systems, Inc. reported that two investigational new drug applications (INDs) for its lead candidate, Entolimod, have been transferred to the company from Statera Biopharma, Inc.
The transferred INDs cover Entolimod for treating acute radiation syndrome, including hematopoietic and gastrointestinal sub-syndromes, and for treating advanced cancers both as an anti-tumor agent and for addressing effects of cancer treatments. This step gives Tivic formal regulatory control of these development programs, which is important for planning future clinical work and potential collaborations.
Tivic Health Systems, Inc. (TIVC) filed an 8-K to disclose that it has entered into an Amended & Restated Exclusive License Agreement (A&R License) with Statera Biopharma covering the TLR5 agonist programs Entolimod and Entolasta. The new agreement fully supersedes the original license executed on 11 Feb 2025.
Key changes versus the February 2025 agreement:
- Royalty flexibility – future royalties may be paid in cash or in Tivic common stock, solely at Tivic’s discretion. This could conserve cash but may cause shareholder dilution if equity is used.
- Directed payments – aside from the original license fee already paid, up to an additional $5.6 million in milestone or other payments owed to Statera will be remitted directly to Avenue Capital on Statera’s behalf.
All other material terms, including Tivic’s worldwide exclusivity for the Acute Radiation Syndrome indication and its option on additional indications (Lymphocyte Exhaustion, Immunosenescence, Neutropenia, Vaccine Adjuvant), remain unchanged.
Strategic implications: The amended structure preserves Tivic’s strategic control of a potentially high-value immunomodulatory asset while improving liquidity management through optional equity settlement. However, the commitment to fund up to $5.6 million—whether in cash or shares—represents a meaningful obligation for a micro-cap issuer and may introduce dilution or leverage pressure depending on financing choices.
Tivic Health Systems (NASDAQ:TIVC), an emerging growth company, filed an 8-K announcing the completion of their Optimization Study for a non-invasive vagus nerve stimulation device. The announcement was made via press release on June 25, 2025. The filing is being furnished under Regulation FD disclosure rules and includes standard forward-looking statements disclaimers. The company's interim CFO, Lisa Wolf, signed the filing.