• ClearUP: A medical device designed to relieve sinus and nasal inflammation.

Major Customers of Tivic Health Systems Inc. (VBIO)

Based on the provided company description, Tivic Health Systems Inc. (trading as VBIO) sells its products through a combination of channels, including direct-to-consumer sales and sales to other companies (online retailers and platforms). Its major customers include:

• Amazon.com (Symbol: AMZN)
• Walmart.com (Symbol: WMT)
• BestBuy.com (Symbol: BBY)
• FSAStore.com

Additionally, the company serves individual consumers directly through its own websites, representing a significant direct-to-consumer customer category.

Michael K. Handley, Chief Executive Officer
Michael K. Handley became the CEO of Tivic Health Systems Inc. (now Valion Bio Inc.) on March 4, 2026. He joined the company in 2025 as Chief Operating Officer and President of Tivic Health's Biopharma division. Previously, he served as Chief Executive Officer, President & Chairman of the public company Statera Biopharma. Handley has held senior management roles at various life science companies, including Armis Biopharma, Vessix Vascular, Inc. (acquired by Boston Scientific), and Acclarent (acquired by Johnson & Johnson). He began his career as a research scientist at Amgen, where he developed patents and was published, later transitioning to a management consultant role in the healthcare industry. He has been instrumental in the US approval and commercialization of seventeen products, generating billions of dollars in revenue.

Lisa Wolf, Chief Financial Officer
Lisa Wolf was appointed permanent Chief Financial Officer of Tivic Health Systems Inc. (now Valion Bio Inc.) on July 7, 2025, after serving as Interim CFO since October 1, 2024. She brings over 30 years of financial leadership experience from both public and private companies across various industries, including life sciences and technology. Most recently, Wolf served as Vice President at Murdock Martell, a consulting firm. She previously held the position of Chief Accounting Officer at Nasdaq-listed Resonant, Inc., where she played a key role in the company's growth and eventual sale to Murata Electronics North America. Wolf earned her CPA while working at Arthur Andersen.

Key Risks to Valion Bio (VBIO):

1. Dependence on Government Procurement and Regulatory Approval for Entolimod (Acute Radiation Syndrome): Valion Bio's flagship drug candidate, Entolimod, a TLR5 agonist for Acute Radiation Syndrome (ARS), is being developed under the FDA's Animal Rule pathway, which permits approval based on animal efficacy data when human trials are not feasible. A significant portion of the company's future revenue hinges on securing a substantial procurement contract for Entolimod with the U.S. Strategic National Stockpile, a potential nine-figure revenue event. Consequently, the failure to obtain timely regulatory approvals or to finalize the anticipated government procurement agreement represents a critical business risk.
2. Clinical Development and Commercialization Risks for Oncology Pipeline: Beyond ARS, Valion Bio is advancing Entolimod for oncology supportive care, specifically chemotherapy-induced neutropenia, with physician-sponsored clinical trials targeted for 2026. The company is also developing Entolasta, a next-generation TLR5 agonist. These programs are subject to the inherent uncertainties of the biopharmaceutical industry, including the risk of clinical trial failures, regulatory hurdles for market approval, and challenges in effectively commercializing new products in a competitive therapeutic landscape.
3. Need for Additional Capital and Maintaining Nasdaq Listing: As a biopharmaceutical company with late-stage development programs, Valion Bio has an ongoing requirement for additional working capital to fund its research, development, and operational expenses. The ability to secure this necessary capital is crucial for the company's continued progress. Furthermore, there is an inherent risk related to the company's capacity to maintain its listing on the Nasdaq exchange, which is vital for liquidity, investor confidence, and access to capital markets.

1. Government Procurement of Entolimod for Acute Radiation Syndrome (ARS): Valion Bio's lead drug candidate, Entolimod, a novel Toll-like receptor 5 (TLR5) agonist, is being advanced as a medical countermeasure for Acute Radiation Syndrome (ARS) under the FDA's Animal Rule pathway. The company is actively engaging with government agencies, including BARDA, DTRA, and NIAID, for Entolimod's potential inclusion in the U.S. Strategic National Stockpile. A successful procurement contract could result in a significant, potentially nine-figure, non-dilutive revenue event.
2. Expansion of Entolimod into Oncology Supportive Care: Beyond its application in ARS, Entolimod's mechanism of action, which involves cytoprotection of bone marrow and gastrointestinal epithelial tissue, positions it for parallel development in oncology supportive care. Valion Bio plans to initiate physician-sponsored clinical trials in 2026 for chemotherapy-induced neutropenia, with the goal of achieving Phase IIb readiness. This represents a potential entry into a large commercial market.
3. Growth of CDMO Services through Velocity Bioworks: The company's wholly-owned subsidiary, Velocity Bioworks, acquired in December 2025, is a full-service contract development and manufacturing organization (CDMO). Velocity Bioworks is expected to build an independent revenue base by providing biomanufacturing services to third-party biotech companies. This diversified revenue stream also provides crucial domestic manufacturing capabilities and supply chain security for Entolimod.
4. Development of Next-Generation TLR5 Agonist, Entolasta: Valion Bio's pipeline includes Entolasta, a next-generation TLR5 agonist designed for broader therapeutic applications. Entolasta offers additional pipeline depth and intellectual property extension across both ARS and oncology supportive care indications, suggesting future revenue potential as it progresses through development.

Inbound Investments

• Valion Bio's lead drug candidate, Entolimod, has received over $140 million in cumulative development investment over 15 years, anchoring the company's biopharmaceutical platform.
• The company is actively pursuing a non-dilutive, potentially nine-figure procurement contract with U.S. government agencies for Entolimod's inclusion in the U.S. Strategic National Stockpile.

Outbound Investments

• In December 2025, Valion Bio acquired Velocity Bioworks, a wholly-owned CDMO (Contract Development and Manufacturing Organization) subsidiary, for approximately $16.3 million.

Capital Expenditures

• The acquisition of Velocity Bioworks for $16.3 million in December 2025 represents a significant investment in establishing domestic biomanufacturing capabilities for its drug pipeline.
• Valion Bio plans physician-sponsored clinical trials in chemotherapy-induced neutropenia in 2026, indicating ongoing substantial investment in research and development.
• The company leverages Velocity Bioworks' manufacturing capabilities to enhance its drug pipeline, aiming for lower costs, accelerated manufacturing outcomes, and secure supply chains.