Tivic Health Shifts Focus to Biopharmaceuticals, Advances Immunotherapy Pipeline

Tivic Health Systems (TIVC) is undergoing a strategic transformation, expanding into the biopharmaceutical sector and advancing its next-generation vagus nerve stimulation devices. CEO Jennifer Ernst highlighted the company's progress in the $19B+ immunotherapy market pipeline. The company's consumer health tech focus is being phased out.

Tivic Health Systems (TIVC) is undergoing a significant strategic transformation, expanding its operations into the biopharmaceutical sector and advancing its next-generation vagus nerve stimulation (VNS) devices. CEO Jennifer Ernst outlined the company's strategic pivot during the Q2 2025 earnings call, stating that Tivic is "reshaping the company by expanding into the biopharmaceutical sector."

Ernst emphasized the company's progress in the $19 billion+ immunotherapy market, noting that Tivic has secured an exclusive licensing agreement for Statera Biopharma's portfolio. This includes a late-stage, highly derisked Phase III drug candidate, Entolimod, which is being developed for acute radiation syndrome (ARS) and neutropenia. The company has made significant strides in government engagement, with additional progress in validating the U.S. government's interest in Entolimod for ARS. Tivic is also exploring an emergency use authorization for Entolimod and has secured Fast Track and orphan drug designations from the FDA.

The company is planning a Type B meeting with the FDA to confirm the final clinical manufacturing and validation requirements for Entolimod. Tivic has begun work with Scorpius BioManufacturing on GMP manufacturing validation for Entolimod, which will lead to bioequivalence and biostability testing. Ernst identified oncology as a key growth area, positioning Entolimod as potentially differentiated due to its upstream immune engagement.

In addition to its biopharma focus, Tivic has completed study visits for its noninvasive cervical vagus nerve stimulation (NcVNS) device, with results expected later this year. The company is more confident than ever that its NcVNS device has the potential to deliver clinical outcomes similar to or better than those of surgically implanted vagus nerve devices.

However, Tivic is also phasing out its consumer health tech business. The company has determined that it is in the best interest of shareholders to exit the consumer health tech business by year-end, citing underperformance of ClearUP sales. CFO Lisa Wolf reported that revenue net of returns totaled $86,000 for the quarter compared to $140,000 in the year ago quarter. Gross margins have improved to 63% for the second quarter compared to 21% a year ago. Wolf confirmed the company's capital position, with cash and cash equivalents totaling $1.2 million at June 30, 2025, compared to $2 million at December 31, 2024. The company has no debt on its balance sheet.

Ernst and Wolf acknowledged that ClearUP sales have not met expectations, prompting the consumer business exit. The company faces risks in the form of successful clinical, regulatory, and manufacturing milestones for Entolimod and the VNS device. Wolf stated that the company believes the funds, along with the $7 million in remaining planned tranches of its preferred purchase agreement, will allow it to make meaningful progress toward GMP manufacturing validation for Entolimod, but no guidance was given on cash runway beyond these events.

Tivic's strategic refocus and pipeline progress are priorities for value creation, with no specific forward-looking revenue or EPS guidance issued. The company's strategy now centers on regulatory and manufacturing milestones for its key drug asset, with new leadership and expanded biopharma expertise supporting the transition. Investors are advised to monitor progress on these milestones as indicators of future value creation.

References:
[1] https://seekingalpha.com/news/4485831-tivic-health-signals-exit-from-consumer-health-tech-while-advancing-19b-immunotherapy-market