Tivic Health Acquires Manufacturing Assets to Accelerate Entolimod Development with $90M+ Financing Package
核心洞察
Tivic Health Systems acquired strategic manufacturing and development assets from Scorpius Holdings (搜索) to establish Velocity Bioworks (搜索), a wholly owned CDMO subsidiary focused on biologics production.
The acquisition secures US-based cGMP manufacturing capabilities for Entolimod, Tivic's lead drug candidate for acute radiation syndrome that holds Fast Track and Orphan Drug designations.
The transaction is backed by a $90M+ financing package led by 3i, LP (搜索), including $16M in debt financing for asset acquisition and up to $75M in preferred convertible equity for commercialization efforts.
Tivic Health Systems has acquired the strategic manufacturing and development assets of Scorpius Holdings (搜索), Inc. and launched Velocity Bioworks (搜索), a wholly owned subsidiary providing contract development and manufacturing services. The acquisition is supported by a comprehensive $90M+ financing package led by 3i, LP (搜索), positioning the company to accelerate commercialization of its lead drug candidate Entolimod.
Strategic Manufacturing Capabilities Secured
The acquisition establishes a robust US-based manufacturing site for Entolimod as Tivic moves toward a Biologics License Application (BLA) with the U.S. Food & Drug Administration. In Q3, Tivic successfully validated the Entolimod cell line at the same facility that now operates as Velocity Bioworks (搜索), representing a major manufacturing milestone by advancing the company along the path to cGMP compliance, a prerequisite for commercialization.
"Tivic has entered a new era. With the licensing earlier this year of a Phase III biologic asset and our strategic expansion into biologics, the next logical step is bringing development and manufacturing capabilities in-house," stated Jennifer Ernst, Tivic CEO. "This allows us to lower development costs and eliminate long wait times often associated with outsourcing."
Comprehensive Financing Structure
The financing package led by 3i, LP (搜索) includes $16M in debt financing for the purchase of assets, including equipment and facilities improvements. Additionally, up to $75M in preferred convertible equity is available, with $18M structured in two near-term tranches and the remainder accessible at the company's discretion subject to certain conditions. An affiliate of 3i, LP is expected to provide a $50M equity line of credit to further enhance access to growth capital.
Entolimod Development Pipeline
Tivic's lead drug candidate, Entolimod for acute radiation syndrome, is a novel TLR5 (搜索) agonist that has been granted Fast Track and Orphan Drug designations and is currently in late-stage development. The company's biologics compounds activate an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age.
The acquisition strengthens Tivic's position to increase the speed of development for other Entolimod and Entolasta (搜索) indications in the pipeline, including neutropenia and advanced cancer treatments. Entolasta represents an immunologically optimized variant of Entolimod designed for chronic applications.
CDMO Revenue Opportunities
Velocity Bioworks (搜索) will offer integrated contract development and manufacturing services at its purpose-built, state-of-the-art facility in San Antonio. The subsidiary focuses on rapidly advancing biologic programs to the clinic and offers analytical testing, process development, and manufacturing services. Under Tivic's leadership, Velocity Bioworks will focus on speed, value and high-quality production of cellular and biologic therapies for both internal programs and third-party biotech companies.
Workforce Expansion
As part of the acquisition, Tivic hired 45 new employees and granted them options to purchase an aggregate of 54,000 shares of common stock. The options carry an exercise price of $2.33, expire ten years from the date of grant, and vest over four years with one-fourth vesting on the one-year anniversary and the remainder vesting in 12 equal quarterly installments. These inducement grants were approved under Nasdaq Listing Rule 5635(c)(4) and made outside of the company's existing equity incentive plans.