8-K: Tivic Health Enters Manufacturing Agreement with Scorpius BioManufacturing for Acute Radiation Syndrome Treatment

Tivic Health Systems partners with Scorpius BioManufacturing to validate the manufacturing process for Entolimod, a treatment for Acute Radiation Syndrome, in preparation for FDA submission.

Summary

• Tivic Health Systems has entered into an agreement with Scorpius BioManufacturing for the GMP manufacturing validation of Entolimod, a TLR5 agonist, for the treatment of Acute Radiation Syndrome (ARS).
• Scorpius will serve as the primary U.S. manufacturer for Entolimod.
• The agreement includes cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and upstream and downstream optimization.
• Tivic Health will pay Scorpius an estimated $2.4 million in service fees, with a total estimated investment of approximately $4.1 million, including pass-through costs and expenses.
• The fees and costs are payable on a milestone-based invoicing schedule.
• Scorpius will manage pass-through costs for raw materials, consumables, reagents, shipping, and subcontracted services at cost plus a 15% administrative fee.
• Tivic Health will own all deliverables and intellectual property generated specifically for Entolimod, excluding improvements to Scorpius' background IP.
• Either party can terminate the agreement with 60 days' written notice or upon breach of a material provision with 30 days' notice to cure.
• Tivic Health issued a press release on May 14, 2025, announcing the agreement.

Sentiment

Score: 7

Explanation: The announcement is positive, highlighting a key partnership for manufacturing validation. However, it also includes standard risk disclosures, resulting in a moderately positive sentiment.

Positives

• The agreement with Scorpius BioManufacturing aims to accelerate the development and manufacturing of Entolimod.
• Scorpius' expertise in manufacturing biologicals and experience with Department of Defense programs is considered a strong asset.
• The use of a domestic facility in San Antonio, Texas, offers a leaner supply chain and ensures U.S. manufacturing.
• Entolimod is potentially the only therapy that can prevent and treat radiation-related damage to both human hematopoietic and gastrointestinal cells.
• The FDA has granted Fast Track and Orphan Drug designation to Entolimod.

Risks

• The agreement is subject to termination by either party with written notice or upon breach of a material provision.
• Tivic Health is required to pay open invoices and expenses if the agreement is terminated, plus liquidated damages.
• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.
• The company's ability to secure additional working capital is a risk factor.
• The company's ability to maintain its Nasdaq listing is a risk factor.

Future Outlook

Tivic Health anticipates that the agreement with Scorpius will facilitate the GMP manufacturing validation of Entolimod and support the submission of a BLA to the FDA, with the goal of commercializing the treatment for Acute Radiation Syndrome.

Management Comments

• Jennifer Ernst, CEO of Tivic, believes Scorpius' specialized focus on manufacturing of biologicals and its experience with Department of Defense programs makes them the perfect partner for completing the GMP manufacturing validation for the FDA BLA filing and commercial production.
• Jeff Wolf, CEO of Scorpius, welcomes the opportunity to contribute scientific and technical expertise to delivering the successful manufacture of this important therapy.

Industry Context

This announcement reflects a trend in the biopharmaceutical industry towards outsourcing manufacturing to specialized CDMOs like Scorpius to streamline development and production processes, particularly for complex biologics. The focus on domestic manufacturing also aligns with broader efforts to strengthen supply chains and ensure access to critical therapies.

Comparison to Industry Standards

• The $4.1 million investment for GMP validation is within the typical range for early-stage biopharmaceutical manufacturing agreements.
• Comparable companies such as Emergent BioSolutions and Catalent also engage in contract manufacturing for government-related programs and biodefense applications.
• The milestone-based payment structure is a standard practice in the CDMO industry to align incentives and manage risk.

Stakeholder Impact

• Shareholders may view the agreement positively as it advances the development of Entolimod.
• The partnership could create jobs at Scorpius' facility in San Antonio, Texas.
• Successful development of Entolimod could provide a valuable treatment option for patients exposed to radiation.

Next Steps

• Scorpius will begin the GMP manufacturing validation process for Entolimod.
• Tivic Health will continue to work with Scorpius to meet milestones and prepare for the FDA BLA submission.
• Tivic Health will file the full text of the Agreement as an exhibit to the Company's next periodic report.

Key Dates

Keywords

Entolimod, Scorpius BioManufacturing, Acute Radiation Syndrome, GMP manufacturing validation, FDA, BLA, Tivic Health, Manufacturing Agreement, TLR5 agonist, Pharmaceuticals