Tivic Health Systems (TIVC) Company Report

Tivic Health has completed a major overhaul, transforming into a biopharmaceutical company focused on late-stage assets, particularly Intolamod, which is intended to harness the immune system to save lives and improve clinical outcomes.
The company has significantly advanced Intolamod's manufacturing readiness, including cell line verification and a 200x scale-up of protein production, and has acquired its manufacturing partner to bring production in-house, accelerating time to market and establishing a contract development and manufacturing organization (CDMO).
Intolamod, which has Fast Track and Orphan Drug Designation, is being developed for acute radiation syndrome (ARS) with significant government interest and for oncology applications, with investigator-led trials anticipated to start this year.
The drug addresses a $9.4 billion to $9.5 billion market for ARS, with substantial opportunities in oncology, and the company has secured access to up to $75 million in capital to support its goals and target multiple high-value therapeutic inflection points within the next 18 to 24 months.

Jan 22, 2026, 9:10 PM

Transcript

Tivic Health Transforms into Biopharmaceutical Company, Accelerates Intolamod Manufacturing and Development

TIVC

New Projects/Investments

Revenue Acceleration/Inflection

M&A

Tivic Health has completed a major overhaul, transforming into a biopharmaceutical company focused on late-stage assets, particularly the drug Intolamod.
The company is accelerating manufacturing readiness for Intolamod, including a 200x scale-up of proteins, and recently acquired its manufacturing partner's assets to bring production in-house, ensuring cGMP access and creating a new CDMO revenue stream.
Intolamod, which has Fast Track and Orphan Drug Designation, is being developed for acute radiation syndrome with significant government interest (including an invited BARDA/DoD presentation on January 26) and has lucrative oncology opportunities in a $9.5 billion market, with trials anticipated to start this year.
Tivic Health has secured access to up to $75 million of capital and is targeting multiple high-value therapeutic inflection points within the next 18 to 24 months.

Jan 22, 2026, 9:10 PM

Transcript

Tivic Health provides update on biopharmaceutical transformation and Entolimod progress

TIVC

New Projects/Investments

M&A

Product Launch

Tivic Health (TIVC) has completed a major business overhaul, transforming into a biopharmaceutical company focused on harnessing the immune system, and has in-licensed Entolimod, a drug for acute radiation syndrome with significant prior investment and government support.
The company has achieved a 200x scale-up in Entolimod manufacturing, maintaining high purity and potency, and has acquired its manufacturing partner's assets to bring production in-house, accelerating time to market and creating a new contract development and manufacturing organization (CDMO) revenue stream.
Entolimod, which has Fast Track and Orphan Drug Designation, is targeting a $9.4 billion acute radiation syndrome market and anticipates starting investigator-led trials in oncology applications this year, with multiple high-value therapeutic inflection points targeted within the next 18 to 24 months.
Tivic Health has secured access to up to $75 million in capital to support its initiatives.

Jan 22, 2026, 9:10 PM

Transcript

Tivic Health Systems, Inc. Releases Corporate Presentation Detailing Late-Stage Pipeline and New Subsidiary

TIVC

New Projects/Investments

Revenue Acceleration/Inflection

Tivic Health Systems, Inc. made a corporate presentation available on January 20, 2026, highlighting its focus on harnessing the immune system to improve clinical outcomes.
The company's TLR5 Agonist Portfolio includes Entolimod, which is in Late Phase III for Acute Radiation Syndrome (ARS) and has potential applications in oncology, and Entolasta, which is pre-clinical for chronic syndromes.
Entolimod targets the market for G-CSF drugs, which was valued at $9.46 billion in 2024 and is projected to grow to $21.3 billion by 2032.
Tivic Health has established Velocity Bioworks, a new CDMO subsidiary, to ensure access to manufacturing, accelerate time-to-market, and create new revenue opportunities.
The company has a BARDA TechWatch Meeting scheduled for January 26 regarding its TLR5 Agonist Portfolio.

Jan 20, 2026, 2:00 PM

8-K

Tivic Health Systems Completes Strategic Acquisition and Launches New Subsidiary

TIVC

M&A

New Projects/Investments

Convertible Preferred Issuance

Tivic Health Systems completed a strategic acquisition of manufacturing and development assets from Scorpius Holdings Inc. for approximately $16 million in December 2025, transitioning into a vertically integrated immunotherapeutics company.
The acquisition established Velocity BioWorks, a new subsidiary capable of producing tens of millions of Entolimod doses annually for Tivic and serving as a third-party Contract Development and Manufacturing Organization (CDMO).
Velocity BioWorks is anticipated to generate meaningful third-party revenue starting in 2026, with a potential annual top-line revenue of up to $70 million at full capacity.
A financing package from Third Eye provided $18 million in upfront new capital and access to a total of $75 million in preferred convertible equity, supporting the acquisition and future growth.
This vertical integration is expected to yield cost savings of approximately $10 million and significantly accelerate the commercialization of Entolimod.

Jan 12, 2026, 9:30 PM

Transcript

Tivic Health Systems Announces Strategic Acquisition and Formation of Velocity BioWorks

TIVC

M&A

New Projects/Investments

Debt Issuance

Tivic Health Systems completed a significant transition in 2025 to become a vertically integrated immunotherapeutics company, culminating in the December 2025 acquisition of cGMP manufacturing and development assets from Scorpius Holdings Inc. for approximately $16 million.
This acquisition enables Tivic to produce tens of millions of Entolimod doses per year internally, significantly lowering costs (expected savings of about $10 million before BLA filing) and eliminating long external manufacturing wait times.
A new subsidiary, Velocity BioWorks, was formed to utilize the acquired assets for Tivic's needs and to serve as a third-party Contract Development and Manufacturing Organization (CDMO), with the potential to generate up to $70 million in annual top-line revenue at 100% capacity utilization.
The transaction was financed by 3i, including $18 million in upfront new capital and access to a total of $75 million in preferred convertible equity, alongside $60 million in debt.

Jan 12, 2026, 9:30 PM

Transcript

Tivic Health Acquires Manufacturing Assets and Secures Financing

TIVC

M&A

Debt Issuance

Convertible Preferred Issuance

Tivic Health Systems, Inc. (TIVC) announced on December 11, 2025, the acquisition of cGMP manufacturing and development assets from Scorpius Holdings, Inc., leading to the launch of Velocity Bioworks™, a wholly owned subsidiary.
The company secured a financing package exceeding $90 million, led by 3i, LP, which includes $16 million in debt financing for the asset purchase and up to $75 million in preferred convertible equity. An affiliate of 3i, LP is also expected to provide a $50 million equity line of credit.
This strategic move aims to secure a US-based manufacturing site for Tivic's lead drug candidate Entolimod™, accelerate its commercialization, and create new revenue opportunities through Velocity Bioworks™' contract development and manufacturing services.

Dec 11, 2025, 10:09 PM

8-K

Tivic Health Systems Secures BARDA Meeting for Entolimod for ARS

TIVC

New Projects/Investments

Product Launch

Tivic Health Systems, Inc. announced on November 18, 2025, that it has secured a Techwatch meeting with the Biomedical Advanced Research and Development Authority’s (BARDA) Radiological and Nuclear Medical Countermeasures Program staff.
During the meeting, Tivic will present clinical data on Entolimod’s effects on radiation-induced injury and acute radiation syndrome (ARS), its manufacturing readiness, and preparations for a biologics license application (BLA).
Entolimod, Tivic's lead drug candidate, is a novel TLR5 agonist that has demonstrated robust survival and improved recovery in animal models for ARS and has been granted Fast Track and Orphan Drug designations by the FDA.
This interaction supports Tivic's strategy to develop high-value therapeutic assets with potential government partnership or acquisition pathways.

Nov 18, 2025, 1:32 PM

8-K

Tivic Health Systems, Inc. Reports Q3 2025 Financial Results and Announces Strategic Shift to Biopharma Focus

TIVC

Earnings

New Projects/Investments

Tivic Health Systems, Inc. reported a net loss of $2.6 million for the third quarter of 2025, compared to a net loss of $1.4 million in the prior year period, with revenue totaling $146,000.
The company is winding down its ClearUP consumer health tech business to focus primarily on its biopharma program, incurring approximately $347 thousand in charges during Q3 2025 related to this exit.
As part of its biopharma advancement, Tivic completed the transfer of two Investigational New Drug (IND) applications for Entolimod and initiated the cGMP manufacturing process for its lead product candidate.
Cash and cash equivalents stood at $3.5 million as of September 30, 2025, supported by $3.8 million in net proceeds from financing tranches closed during the third quarter.

Nov 14, 2025, 9:31 PM

8-K

Tivic Health Systems Reports Q3 2025 Results and Strategic Transformation Update

TIVC

Earnings

New Projects/Investments

Convertible Preferred Issuance

Tivic Health Systems is undergoing a significant strategic transformation, shifting its focus from bioelectronics/consumer health to biologic pharmaceuticals, specifically the Entolimod portfolio, and plans to exit the consumer device market by the end of 2025.
The company reported a net loss of $2.6 million for Q3 2025, compared to $1.4 million in Q3 2024, on revenue of $146,000, up from $126,000 in the prior year quarter.
Key progress in Q3 2025 included the transfer of two Entolimod INDs and successful verification of the Entolimod cell line for manufacturing, although manufacturing experienced delays due to a contract manufacturer's financial stress.
Tivic closed additional tranches of an $8.4 million financing, securing $3.8 million in net proceeds during Q3 2025, and held $3.5 million in cash and cash equivalents as of September 30, 2025.