FREMONT, Calif. - Tivic Health Systems Inc. (NASDAQ:TIVC), a company specializing in diversified therapeutics, has announced a definitive agreement with Scorpius BioManufacturing for the final GMP manufacturing validation of Entolimod™, its leading drug candidate for treating Acute Radiation Syndrome (ARS). This step is crucial for the subsequent Biological Licensing Application (BLA) to the U.S. Food & Drug Administration (FDA).
Scorpius BioManufacturing, a subsidiary of Scorpius Holdings Inc. (OTC:SCPX), will be the primary manufacturer for Entolimod™ in the United States. The contract development and manufacturing organization (CDMO) is set to leverage its expertise to validate Tivic’s commercial manufacturing process, with a program valued at approximately $4.1 million. Despite challenging market conditions that have led to a significant stock price decline over the past year, InvestingPro analysts anticipate sales growth for Scorpius in the current year, with revenue growth forecast at 156%.
The comprehensive GMP Validation Program includes cell line verification, legacy process verification, scale-up production, and analytical development among other activities, all aimed at ensuring a complete CMC package for the FDA.
Jennifer Ernst, CEO of Tivic, expressed confidence in Scorpius’s ability to support the BLA filing and potential commercial production, citing the company’s specialized focus and experience with biological manufacturing and Department of Defense programs.
Jeff Wolf, CEO of Scorpius, welcomed the partnership and the chance to reinforce Scorpius’s reputation as a reliable biomanufacturing partner. The manufacturing validation will take place at Scorpius’s facility in San Antonio, Texas, which is expected to streamline the supply chain and support the domestic production of the therapy.
Entolimod has received Fast Track and Orphan Drug designation from the FDA, positioning it as a potentially unique therapy for ARS that could prevent and treat radiation-related damage to both hematopoietic and gastrointestinal cells.
Tivic Health is known for its focus on the immune and autonomic nervous systems, with its first FDA-approved product, ClearUP™, available for treating sinus pain and pressure. The company’s bioelectronic program is developing non-invasive medical devices that stimulate the vagus nerve. Discover more detailed financial insights and 15+ additional ProTips about Scorpius’s market position with an InvestingPro subscription, including exclusive analysis of its debt structure and growth potential.
This development is based on a press release statement and does not include any forward-looking statements or predictions. The information provided is subject to the inherent uncertainties of the biopharmaceutical development process.
In other recent news, Scorpius Holdings, Inc. has been notified of non-compliance with the NYSE American’s listing standards due to the late filing of its 2024 annual report. This situation has led to a suspension of trading and the initiation of delisting procedures, although the company plans to appeal this decision. Additionally, Scorpius Holdings has made strategic moves to reduce costs by transferring its lease obligations for former office spaces in Morrisville, North Carolina, to a third party, which is expected to save over $4 million. Furthermore, the company amended its agreement with Elusys Holdings Inc., removing a $2.5 million payment obligation in exchange for an immediate payment of $500,000. In executive news, Scorpius Holdings has updated the employment agreements for two key executives, allowing for remote work and extending employment terms. The company has also expanded its Board of Directors, appointing Tan Sze Thuan, a logistics expert, as a new director to enhance its international strategies. These developments reflect Scorpius Holdings’ ongoing efforts to address financial and operational challenges while strengthening its leadership and strategic direction.
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