American Marconi Wireless News - Tivic Health CEO Letter to Shareholders

Dear Valued Shareholders,

As I assume the role of Chief Executive Officer at Tivic, my immediate priority is to establish a transparent dialogue with you regarding our current standing, our strategic pivot, and the long-term vision we are executing.

First, I want to thank the Board of Directors for their confidence and support. Some of you recognize me from my time as Chief Executive Officer of Statera Biopharma, where I led the advancement of Entolimod™, our Toll-like Receptor 5 (TLR5) agonist. Over the past year, as Tivic's Chief Operating Officer and President of Biopharma, I have continued to advance the program strategically and operationally.

A Strategic Pivot to Biopharma

Tivic is now a biopharmaceutical company solely focused on the Entolimod™ and our TLR5 platform with our second-generation TLR5 molecule, Entolasta. To maximize our impact and resources, we have made the deliberate decision to discontinue commercial sales of the ClearUP sinus device and suspend development of the non-invasive vagus nerve stimulation platform. While those assets remain the property of the company, we have made the deliberate decision to concentrate our resources on the significant opportunity represented by our biotherapeutic programs.

Expanding into Oncology Supportive Care

With our pivot into biopharmaceuticals, we are aggressively pursuing the multi-billion-dollar oncology market. Entolimod's mechanism of action shows significant potential in preventing cell death in bone marrow and gastrointestinal epithelial tissues thereby addressing conditions like neutropenia, which affects up to half of all cancer patients, and radiation-induced mucosal necrosis. While we are currently developing the injectable form, we are also exploring oral formulations to significantly broaden our clinical applications.

Strengthening Government Partnerships

A primary pillar of our corporate strategy is our collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following our second meeting with the agency two weeks ago, we are encouraged by our progress. Our objective is to secure BARDA funding to advance Entolimod™ as a medical countermeasure for Acute Radiation

Syndrome (ARS). We believe Entolimod's highly differentiated profile makes it a superior candidate for the Strategic National Stockpile compared to existing treatments. In parallel, we are engaging with allied governments interested in independent stockpiling for their own national preparedness programs.

Operational Excellence and Manufacturing Control

Our speed is driven by our vertical integration. Through Velocity Bioworks, our wholly owned Contract Development & Manufacturing Organization or CDMO, we successfully demonstrated a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation. This milestone was achieved on time and within budget, meeting all purity and potency specifications. Controlling our domestic supply chain is not only an operational advantage but a critical requirement for U.S. government procurement.

Looking Ahead

Tivic is uniquely positioned at the intersection of critical macro trends: the urgent need for national preparedness, the demand for domestic biomanufacturing, and an investor preference for scalable, high value assets. By combining late-stage therapeutics with in-house manufacturing, we are building a profit center designed to serve both our internal pipeline and the broader biotech industry.

We will provide a comprehensive update during our year-end call tomorrow, March 25, held in conjunction with our Form 10-K filing. I look forward to speaking with you then.

In the meantime, please do not hesitate to reach out.

Sincerely,

Michael K. Handley
Chief Executive Officer
Tivic Health Systems, Inc.

About Tivic

Tivic Health's biologics platform focuses on therapies that activate innate immune pathways to protect and restore cellular function in tissues affected by radiation, disease, and aging. Tivic's lead candidate, Entolimod™ for acute radiation syndrome (ARS), has been extensively studied having demonstrated survival benefits and improved tissue recovery in animal models under the FDA's Animal Rule.

Entolimod™ is a novel Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from damage and stimulate immune responses. Entolimod™ has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration.

Tivic's clinical pipeline also includes Entolimod™ to treat neutropenia, which is most commonly caused by infections and chemotherapy, and lymphocyte exhaustion. The company holds exclusive rights to license Entolasta™, a next-generation TLR5 agonist molecule that may enable additional therapeutic applications requiring long term use.

Velocity Bioworks, Inc. is a wholly owned subsidiary of Tivic Health, established in December 2025 following the acquisition of the strategic manufacturing and development assets of Scorpius Holdings, Inc. Headquartered in a purpose-built, state-of-the-art facility in San Antonio, Texas, Velocity Bioworks operates as a full-service contract development and manufacturing organization (CDMO) dedicated to accelerating the advancement of biologic programs into clinical development. The company provides a comprehensive suite of services, including analytical testing, process development, and the manufacturing of cellular and biologic therapies.

Velocity Bioworks supports Tivic Health Systems' strategic objectives by securing a robust, U.S.-based manufacturing platform for its lead drug candidate, Entolimod™, as it progresses toward a Biologics License Application (BLA) with the U.S. Food and Drug Administration, while also generating incremental revenue through the provision of CDMO services to third-party biopharmaceutical and biotechnology companies.

For more information, visit https://ir.tivichealth.com or Velocity Bioworks.

Forward-Looking Statements

This press release may contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim, "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company's interactions with and guidance from the FDA and other regulatory authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod; the ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company's relationship with its partners; expectations regarding the potential benefits of the leadership transition; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of Entolimod, Entolasta or its previously developed bioelectronic platform; changes to the company's business strategy; timing and success of clinical trials and study results; regulatory requirements and pathways for approval; the company's ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company's need for, and ability to secure when needed, additional working capital; the company's ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading "Risk Factors", as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.

Investor Contact:
Hanover International, Inc.
[email protected]

Media Contact:
DJ Freyman
[email protected]

SOURCE: Tivic Health Systems

View the original press release on ACCESS Newswire

Y.Kobayashi--AMWN