Tivic Receives Formal Request for Information from Ukrainian Ministry of Health Regarding Strategic Stockpiling of Entolimod

Rhea-AI Summary

Tivic Health Systems (Nasdaq:TIVC) received a formal Request for Information from the Ukrainian Ministry of Health on March 31, 2026, to evaluate Entolimod for potential inclusion in Ukraine's national strategic reserves against Acute Radiation Syndrome (ARS).

The ministry also requested a pre-submission meeting. Tivic highlighted Entolimod's selective TLR5 mechanism that protects bone marrow and GI tissues, its potential in oncology supportive care, planned physician-sponsored trials later in 2026, and recent U.S. TechWatch meetings with BARDA on Jan 26 and Mar 10, 2026.

Positive

• Formal RFI received from Ukrainian Ministry of Health (March 31, 2026)
• Pre-submission meeting requested by Ukrainian Ministry of Health
• Completed BARD A TechWatch engagements on Jan 26 and Mar 10, 2026
• Preparing physician-sponsored clinical trials later in 2026

Negative

• Clinical-stage asset with no regulatory approvals yet
• RFI is an initial evaluation; no stockpiling agreement or contract finalized

Key Figures

Operating expenses: $7.9M Cash balance: $12.6M Financing package: > $90M +5 more

8 metrics

Operating expenses $7.9M 2025 operating expenses from full-year results

Cash balance $12.6M Year-end 2025 cash position

Financing package > $90M Financing supporting Velocity Bioworks CDMO

Shares outstanding 2,877,926 shares As of March 17, 2026 per 10-K

Employee count 52 employees Headcount disclosed in 10-K

Nasdaq bid minimum $1.00 per share Minimum bid price rule threshold in Nasdaq notice

Compliance window 180 days Initial period to regain Nasdaq bid price compliance

S-3 registered shares 1,580,437 shares Common stock covered by resale registration

Market Reality Check

Price: $0.8500 Vol: Volume 20,300 is far belo...

low vol

$0.8500 Last Close

Volume Volume 20,300 is far below 20-day average 542,464 (relative volume 0.04x), suggesting limited positioning ahead of this RFI headline. low

Technical Shares at $0.85 are trading below the $2.37 200-day moving average and remain 93.58% under the 52-week high.

Peers on Argus

TIVC was down 8.58% with 3 scanner peers (e.g., HSDT, AMIX, MOVE) also moving do...

1 Up 3 Down

TIVC was down 8.58% with 3 scanner peers (e.g., HSDT, AMIX, MOVE) also moving down (median about -4.7%), while only NUWE was up. This points to broader weakness across related medical-device names rather than a purely idiosyncratic move.

Historical Context

5 past events · Latest: Mar 27 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 27	Conference presentation	Positive	-2.9%	CEO scheduled to present milestones and NIAID GI-ARS study at virtual conference.
Mar 26	Preclinical agreement	Positive	-13.3%	NIAID agreed to fund preclinical Entolimod studies for GI-ARS under Animal Rule path.
Mar 25	Full-year results	Neutral	-13.3%	Reported 2025 results and strategic shift to Entolimod and Velocity Bioworks CDMO.
Mar 24	Strategy pivot letter	Positive	+3.0%	Shareholder letter detailing pivot to TLR5 biopharma and ARS/oncology focus.
Mar 20	Earnings call notice	Neutral	-0.8%	Announcement of scheduled webcast and call for 2025 year-end results.

Pattern Detected

Recent Entolimod- and strategy-focused news skewed positive in tone but often saw negative next-day moves, indicating a pattern of weak price follow-through on favorable announcements.

Recent Company History

Over the last two weeks, Tivic has repeatedly highlighted its pivot from consumer devices to a TLR5-focused biopharma strategy centered on Entolimod and Entolasta. Updates included BARDA-focused manufacturing progress, a GI-ARS preclinical agreement with NIAID, and 2025 results showing higher operating expenses of $7.9M with $12.6M in cash. Despite these milestones, several news days saw negative price reactions, so today’s Ukrainian RFI for Entolimod fits into an ongoing narrative of strategic repositioning and government-focused biodefense engagement.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-17

An effective S-3 resale registration filed on 2025-10-17 covers up to 1,580,437 shares of common stock tied to preferred share conversions and related warrants. The company itself is not selling shares under this registration and would only receive cash upon warrant exercises, as specified in the filing.

Market Pulse Summary

This announcement underscores growing international interest in Entolimod, with Ukraine’s Ministry o...

Analysis

This announcement underscores growing international interest in Entolimod, with Ukraine’s Ministry of Health initiating an RFI and pre-submission meeting discussions for ARS stockpiling. It complements recent U.S. engagement with BARDA and Tivic’s pivot toward TLR5-based immunotherapeutics targeting ARS and chemotherapy-related neutropenia. Investors may track progress on Ukrainian and U.S. government procurement paths, manufacturing readiness milestones, and any subsequent clinical data or regulatory submissions tied to Entolimod’s dual biodefense and oncology roles.

Key Terms

toll-like receptor 5, acute radiation syndrome, neutropenia, myelosuppression, +3 more

7 terms

toll-like receptor 5 medical

"late-stage Toll-like Receptor 5 (TLR5) agonist for potential inclusion"

Toll-like receptor 5 (TLR5) is a protein on certain immune cells that acts like a security sensor, detecting a specific component of bacterial tails and triggering an inflammation and immune response. Investors care because drugs or vaccines that activate or block TLR5 can change how the body fights infections or cancer, serving as therapeutic targets or vaccine ingredients; progress or setbacks in TLR5-focused research can materially affect the value and prospects of biotech firms.

acute radiation syndrome medical

"strategic reserves as a countermeasure against Acute Radiation Syndrome (ARS)"

Acute radiation syndrome is the sudden illness that happens after a person absorbs a large dose of ionizing radiation in a short time, damaging blood cells, the gut, skin, and other organs. Think of it like a severe, internal burn that can impair a person’s ability to heal and fight infection. Investors watch it because outbreaks, accidents, or tests can trigger urgent regulatory action, reshape demand for medical treatments and protective equipment, create liability risks, and affect the operations and stock prices of companies in healthcare, energy, insurance, and related supply chains.

neutropenia medical

"Myelosuppression and neutropenia (a severe depletion of white blood cells)"

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

myelosuppression medical

"The same mechanism that protects the body from high-dose radiation holds transformative potential ... Myelosuppression and neutropenia"

A condition where the bone marrow slows or stops making blood cells, causing low white cells (higher infection risk), red cells (fatigue, oxygen problems), or platelets (bleeding risk). Think of the marrow as a factory that supplies vital workers; when it falters, patients become vulnerable. For investors, myelosuppression matters because it can limit a drug’s safety, change dosing or monitoring needs, affect regulatory approval and label warnings, and influence commercial potential and costs.

nf-κb medical

"As a selective TLR5 agonist, Entolimod™ activates the NF-κB signaling pathway"

NF-κB is a protein complex inside cells that acts like a master switch for inflammation, immune responses and cell survival; when turned on it tells many genes to produce signals that promote immune activity, cell growth or protection from stress. Investors care because drugs or diagnostics that affect NF-κB can influence treatments for cancers, autoimmune disorders and inflammatory diseases, so changes in NF-κB activity can meaningfully alter a therapy’s potential market and risk profile.

apoptosis medical

"signaling pathways, actively prevents programmed cell death (apoptosis) in both bone marrow"

Apoptosis is a controlled, built‑in process where cells deliberately shut down and are safely removed, like a person retiring and clearing out their belongings so the house stays orderly. Investors care because many drugs and diagnostics target or measure this process: how well a therapy triggers or avoids apoptosis can determine clinical trial success, safety profiles, regulatory approval, and ultimately a company’s valuation.

g-csf medical

"benefit that currently approved G-CSF therapies cannot provide"

G‑CSF (granulocyte colony-stimulating factor) is a manufactured protein that prompts the bone marrow to produce neutrophils, a type of white blood cell that protects patients from infection after chemotherapy, bone marrow transplant, or severe illness. For investors, G‑CSF products matter because they fulfill a steady, clinical need—like safety gear hospitals must replenish—so changes in approvals, patents, manufacturing capacity, or competing biosimilars can meaningfully affect sales and company valuations.

AI-generated analysis. Not financial advice.

SAN ANTONIO, TX / ACCESS Newswire / March 31, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a clinical-stage immunotherapeutics company, today announced it has received a formal Request for Information (RFI) from the Ukrainian Ministry of Health. The RFI initiates the formal evaluation of Entolimod™ Tivic's late-stage Toll-like Receptor 5 (TLR5) agonist for potential inclusion in Ukraine's national strategic reserves as a countermeasure against Acute Radiation Syndrome (ARS). Additionally, the Ukrainian Ministry of Health has requested to schedule a pre-submission meeting for Entolimod™.

"Tivic's Entolimod, from our TLR5 platform, has catalyzed significant interest from international governments that recognize its potential as a cornerstone of national preparedness," said Michael K. Handley, chief executive officer of Tivic. "We are working closely with the Ukrainian Ministry of Health to establish a pathway toward potential accelerated approval and a formal stockpiling agreement. Our goal is to provide a superior therapeutic solution that addresses the complex requirements of regional security and patient survival."

A Differentiated Mechanism: Beyond Hematopoietic Recovery

Entolimod™ represents a paradigm shift in the treatment of Acute Radiation Syndrome. While currently stockpiled treatments, such as Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), are effective at stimulating the recovery of white blood cells after depletion, they do not address the lethal damage caused to the gastrointestinal (GI) tract at higher radiation doses.

As a selective TLR5 agonist, Entolimod™ activates the NF-κB signaling pathway, through a cascade of cell signaling pathways, actively prevents programmed cell death (apoptosis) in both bone marrow and GI epithelial tissues. This dual-system protection offers a comprehensive survival benefit that currently approved G-CSF therapies cannot provide, positioning Entolimod™ as a unique and essential candidate for national defense and emergency response.

Bridging Biodefense and Oncology: The Neutropenia Opportunity

The same mechanism that protects the body from high-dose radiation holds transformative potential for the multi-billion-dollar oncology supportive care market. Myelosuppression and neutropenia (a severe depletion of white blood cells) are the primary dose-limiting side effects for the 60 percent of cancer patients undergoing chemotherapy and radiation.

Unlike existing standard-of-care treatments that reactively stimulate cell production after the damage has occurred, Entolimod™ is being developed as a protective agent to prevent cell death in the bone marrow. By mitigating the underlying tissue damage, Entolimod™ has the potential to reduce the incidence of life-threatening infections, minimize treatment delays, and improve overall clinical outcomes for cancer patients. The Company is currently preparing to advance this program into physician-sponsored clinical trials later this year.

Advancing U.S. Strategic Engagement and Manufacturing Readiness

The engagement in Ukraine follows substantial progress in the United States. Tivic recently completed focused TechWatch meetings with the Biomedical Advanced Research and Development Authority (BARDA) and adjacent departments on January 26, 2026, followed by an expedited follow-up session on March 10, 2026. These discussions focused on Entolimod's clinical data and the Company's domestic manufacturing readiness.

About Tivic

Tivic Health is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven by radiation, disease, and immune dysregulation. The company'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™ for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration.

Tivic is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. Tivic's clinical pipeline includes potential treatments for neutropenia, which is most commonly caused by chemotherapy, and a state of T-cell dysfunction known as lymphocyte exhaustion.

Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization, (CDMO) offering biomanufacturing services to third-party biotech companies. Tivic also leverages Velocity Bioworks' manufacturing capabilities to advance its own drug pipeline with the expected benefits of lower costs, accelerated manufacturing outcomes and supply chain security. For more information, visit https://ir.tivichealth.com.

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, including related to the Animal Rule; the company's future development of Entolimod or Entolasta; changes to the company's business strategy; timing and success of pre-clinical and 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.
ir@tivichealth.com

Media Contact
DJ Freyman
DJ@FastrackPR.com

SOURCE: Tivic Health Systems

View the original press release on ACCESS Newswire

FAQ

What did Tivic (TIVC) announce on March 31, 2026 about Entolimod and Ukraine?

Tivic said it received a formal Request for Information from the Ukrainian Ministry of Health. According to Tivic, the RFI opens a formal evaluation for Entolimod's inclusion in Ukraine's national strategic reserves against Acute Radiation Syndrome.

Does the March 2026 RFI mean Entolimod is approved for stockpiling in Ukraine (TIVC)?

No, the RFI is an initial formal evaluation and not an approval or contract. According to Tivic, the ministry also requested a pre-submission meeting to discuss potential pathways toward accelerated approval and stockpiling.

How does Entolimod differ from existing ARS treatments mentioned by Tivic (TIVC)?

Entolimod is a selective TLR5 agonist that protects both bone marrow and GI tissues. According to Tivic, this dual protection addresses GI damage that current G-CSF therapies do not prevent at higher radiation doses.

What U.S. engagements did Tivic (TIVC) report related to Entolimod in early 2026?

Tivic completed focused TechWatch meetings with BARDA on Jan 26, 2026 and had an expedited follow-up on Mar 10, 2026. According to Tivic, these sessions covered clinical data and domestic manufacturing readiness.

Will Entolimod (TIVC) be studied for oncology supportive care in 2026?

Yes, Tivic is preparing to advance an oncology supportive-care program into physician-sponsored clinical trials later in 2026. According to Tivic, the mechanism may protect bone marrow and reduce neutropenia risk during chemo and radiation.

What is the immediate investor impact of the Ukrainian RFI for Tivic (TIVC)?

The RFI signals government interest but does not guarantee revenue or procurement. According to Tivic, the RFI initiates evaluation and a pre-submission meeting, with no stockpiling agreement yet announced.