Tivic Health Selected to Present Entolimod™ as a Radiation Countermeasure and its Plans for an Oral Transmucosal Program to the Department of War Tech Watch Program on May 7th

Rhea-AI Summary

Tivic Health (Nasdaq: TIVC) announced it was selected to present Entolimod™ and an oral transmucosal delivery program to the U.S. Department of War Tech Watch on May 7, 2026. The company is engaging a formulation partner to pursue a needle-free, fast-administered countermeasure for radiation casualties and is advancing toward a BLA under the FDA Animal Rule. The presentation aims to highlight Entolimod™’s dual GI and bone marrow radioprotective mechanism and its potential for warfighter and mass casualty use.

Positive

• Selected to present at Department of War Tech Watch on May 7, 2026
• Entolimod targets both gastrointestinal and hematopoietic radiation injury
• Pursuing an oral transmucosal formulation to enable needle-free, rapid administration
• Advancing regulatory pathway toward a BLA under the FDA Animal Rule

Negative

• Oral transmucosal program is in early-stage exploration with no formulation finalized
• No new clinical efficacy or human trial data were announced
• Regulatory approval is not secured; BLA remains a future milestone

News Market Reaction – TIVC

+12.90% 2.9x vol

9 alerts

+12.90% Session close to close

+29.7% Peak in 28 hr 17 min

$3.25M Market Cap

2.9x Rel. Volume

In the Apr 15 session, TIVC gained 12.90%, reflecting a significant positive market reaction. Argus tracked a peak move of +29.7% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.9x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock surged +12.9% in the session following this news. A strong positive reaction aligns with T...

Analysis

The stock surged +12.9% in the session following this news. A strong positive reaction aligns with Tivic’s growing government engagement around Entolimod, including Tech Watch visibility and prior interest from Ukraine and NIAID. However, past news produced both rallies and sharp selloffs, with moves of -13.26% following seemingly positive updates. Investors monitoring such a surge would weigh durability against factors like active resale registrations, rising $7.9M operating expenses, going-concern language, and reliance on external funding such as the $50.0M equity line.

Key Figures

Registered resale shares: 956,222 shares Equity line capacity: $50.0 million Registered stake proportion: 24.94% +5 more

8 metrics

Registered resale shares 956,222 shares S-1 registration for Tumim Stone Capital resale

Equity line capacity $50.0 million Common stock purchase agreement over 24 months

Registered stake proportion 24.94% If all 956,222 shares issued vs 3,834,148 assumed outstanding

Operating expenses $7.9M Full year 2025 operating expenses

Year-end cash $12.6M Cash balance at 2025 year-end

Financing package >$90 million Financing supporting Velocity Bioworks and biopharma pivot

Shares outstanding 2,877,926 shares Common shares outstanding as of Mar 17, 2026

Microbial facility rent $5.34 million Aggregate base rent over eight-year lease term

Historical Context

5 past events · Latest: Mar 31 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 31	Government RFI	Positive	+4.2%	Ukrainian Ministry of Health requested information on Entolimod for ARS stockpiling.
Mar 27	Conference presentation	Positive	-2.9%	CEO scheduled to present milestones including NIAID agreement at investor conference.
Mar 26	NIAID study support	Positive	-13.3%	NIAID agreed to sponsor preclinical Entolimod studies for GI-ARS under Animal Rule path.
Mar 25	Full-year results	Negative	-13.3%	2025 results with higher $7.9M operating expenses and strategic transformation costs.
Mar 24	Strategic pivot	Positive	+3.0%	CEO letter detailing pivot to TLR5 biopharma platform and ARS preparedness focus.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

News tied to Entolimod and strategic repositioning has produced mixed reactions, with both strong selloffs and rallies, and several instances where positive developments coincided with negative price moves.

Recent Company History

Over the past month, Tivic has pivoted fully to its TLR5 biopharma strategy around Entolimod, discontinuing legacy consumer devices and scaling manufacturing via Velocity Bioworks. Key steps included NIAID-sponsored non-clinical GI-ARS studies, interest from Ukraine’s Ministry of Health in ARS stockpiling, and outreach via investor conferences. Financially, 2025 results showed higher operating expenses of $7.9M and year-end cash of $12.6M. Today’s Tech Watch presentation news fits a pattern of defense- and ARS-focused milestones building governmental engagement around Entolimod.

Key Terms

toll-like receptor 5 (tlr5), nf-κb, hematopoietic, g-csf, +4 more

8 terms

toll-like receptor 5 (tlr5) medical

"Entolimod™ is a selective Toll-like receptor 5 (TLR5) agonist that activates..."

Toll-like receptor 5 (TLR5) is a protein found on certain immune cells that acts like a security sensor, detecting a specific component of bacterial tails and triggering an immune response. It matters to investors because therapies or vaccines that target or exploit TLR5 can change how the immune system reacts, influencing clinical trial results, regulatory scrutiny and the commercial potential of biotech programs, so TLR5-related data can affect risk and valuation.

nf-κb medical

"agonist lead drug candidate and its plans... that activates NF-κB signaling pathways..."

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.

hematopoietic medical

"currently stockpiled ARS countermeasures... designed to stimulate hematopoietic recovery..."

Hematopoietic describes the biological process and the cells that produce blood—the stem cells in bone marrow that make red blood cells, white blood cells and platelets. It matters to investors because therapies, diagnostics or procedures targeting these cells can drive patient outcomes and market demand; think of hematopoietic function as a factory keeping the body’s delivery and defense systems running, so improvements or failures can affect commercial value and regulatory risk.

g-csf medical

"over currently stockpiled G-CSF therapies, which address only hematopoietic recovery..."

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.

oral transmucosal medical

"plans for an oral transmucosal delivery program for Entolimod™ — a delivery concept..."

Oral transmucosal describes a way drugs are given by placing them against the inner lining of the mouth so the medicine soaks through the tissue and enters the bloodstream directly, bypassing the stomach and first pass through the liver. For investors, this matters because such formulations can work faster, be easier to use, lower dose requirements, and create product differentiation or regulatory pathway differences that affect market size, pricing power, and patent value—think of it as a direct shortcut compared with swallowing a pill.

acute radiation syndrome medical

"reserves 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.

bla submission regulatory

"Regulatory pathway: Advancing toward BLA submission under the FDA's Animal Rule"

A BLA submission is a company’s formal application to the U.S. Food and Drug Administration asking for permission to market a biologic drug or therapy. Think of it like applying for a permit to sell a complex medical product: the agency reviews safety, effectiveness, and manufacturing quality before deciding. For investors, a BLA filing signals a late-stage regulatory milestone that can reduce uncertainty and, if approved, unlock revenue and change a company’s valuation, while also carrying regulatory and timing risk.

animal rule regulatory

"Regulatory pathway: Advancing toward BLA submission under the FDA's Animal Rule"

A regulatory pathway that allows safety and effectiveness of drugs or vaccines to be judged primarily from well-controlled animal studies when human trials would be unethical or impossible, such as for treatments against rare, lethal exposures. It matters to investors because approval via this route can speed a product to market for urgent or niche needs but carries extra scientific and regulatory risk—think of it as accepting a high-quality dress rehearsal instead of a live show, with requirements for strong animal models and often additional post-approval obligations.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN ANTONIO, April 15, 2026 /PRNewswire/ -- Tivic Health Systems, Inc. (Nasdaq: TIVC), a clinical-stage immunotherapeutics company, today announced it has been selected to present at the U.S. Department of War's Tech Watch program on May 7, 2026. The Tech Watch initiative identifies emerging technologies with high-value defense and dual-use applications.

Tivic Health will present its Entolimod^™ TLR5 agonist lead drug candidate and its plans for an oral transmucosal delivery program for Entolimod^™ — a delivery concept the Company believes has compelling and immediate relevance for both individual warfighter care and large-scale mass casualty response. The Company is currently in the process of engaging a specialized formulation development partner to advance this program.

"The geopolitical environment has fundamentally changed the calculus around medical countermeasure preparedness," said Michael K. Handley, chief executive officer of Tivic Health Systems. "The threats are no longer theoretical — governments around the world are actively reassessing their readiness, and the window to establish Entolimod™ as a cornerstone of national and allied defense stockpiles has never been more open. We believe this is the right technology, at exactly the right time."

Entolimod™ is a selective Toll-like receptor 5 (TLR5) agonist that activates NF-κB signaling pathways to protect cells from radiation-induced damage across both bone marrow and gastrointestinal tissues simultaneously. This dual-system mechanism represents a meaningful advance over currently stockpiled ARS countermeasures, including Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Leukine® (sargramostim), which are designed to stimulate hematopoietic recovery but do not address the lethal damage caused to the gastrointestinal tract at higher radiation doses — a key determinant of survival that remains a significant unmet need.

The Company is in early-stage exploration of an oral transmucosal delivery formulation intended to extend this radioprotection advantage by making Entolimod™ faster to administer, more stable, and accessible in scenarios where intravenous or injectable delivery is not practical. If successfully developed, an oral transmucosal formulation could be administered rapidly, without needles, and without the need for trained medical personnel — a critical advantage in combat environments and mass casualty events where speed of treatment and ease of administration can determine survival outcomes. The Company believes this delivery approach, if realized, could meaningfully expand access to life-saving countermeasures in scenarios where conventional medical infrastructure is unavailable, overwhelmed, or destroyed.

"Our Entolimod™ platform was built to address the most urgent unmet needs in radiation medicine, and we believe an oral transmucosal approach, if successfully developed, would take that mission to the next level," Mr. Handley continued. "For the warfighter in the field and for first responders managing a mass casualty event, the ability to administer an effective radiation countermeasure quickly, simply, and without specialized equipment would be transformative. We look forward to presenting this vision to the Department of War on May 7th and to advancing what we believe is a critical component of national preparedness."

The Department of War has expressed encouraging interest in advancing discussions with Tivic Health regarding Entolimod™ and its potential applications for national defense preparedness.

Strategic and Competitive Positioning

• Warfighter relevance: Addresses a critical unmet need in military radiation casualty care with a mechanism that protects both GI and hematopoietic tissues
• Mass casualty potential: Early-stage oral transmucosal delivery concept, if developed, could enable rapid treatment of large numbers of casualties without trained personnel or medical infrastructure
• Differentiated mechanism: Dual GI and bone marrow protection versus currently stockpiled G-CSF therapies, which address only hematopoietic recovery
• Administration simplicity (target profile): No needle, no IV, no specialized equipment required — subject to successful formulation development
• Regulatory pathway: Advancing toward BLA submission under the FDA's Animal Rule

About Tivic Health Systems

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; the ability to successfully engage a formulation development partner and develop an oral transmucosal delivery formulation; 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, 2025, filed with the SEC, 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:
Tivic Investor Relations
ir@tivichealth.com

Media Contact:
DJ Freyman
DJ@FastrackPR.com

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SOURCE Tivic Health Systems, Inc.

FAQ

What will Tivic Health (TIVC) present to the Department of War on May 7, 2026?

Tivic Health will present Entolimod™ and its oral transmucosal delivery program to the Department of War. According to the company, the presentation will focus on Entolimod™’s dual GI and bone marrow radioprotection and plans to pursue a needle-free formulation for rapid mass-casualty use.

How does Entolimod™ protect against radiation compared to current stockpiled therapies for TIVC?

Entolimod™ activates TLR5 to protect both gastrointestinal and hematopoietic tissues, unlike G-CSF therapies. According to the company, this dual-system mechanism addresses lethal GI damage that current stockpiled agents do not target, potentially improving survival at higher radiation doses.

What is Tivic Health’s (TIVC) oral transmucosal program and why is it important?

The oral transmucosal program aims to create a fast, needle-free Entolimod™ formulation for field and mass-casualty use. According to the company, this approach could allow rapid administration without trained personnel or IV equipment, improving access where conventional infrastructure is unavailable.

Has Tivic Health (TIVC) reached regulatory milestones for Entolimod™?

Tivic Health is advancing toward a Biologics License Application under the FDA Animal Rule but has not announced approval. According to the company, the program is proceeding toward a BLA pathway that relies on animal efficacy data where human trials are not feasible.

What is the Department of War’s interest in Tivic Health’s (TIVC) Entolimod™ program?

The Department of War expressed encouraging interest in discussing Entolimod™ for national defense preparedness. According to the company, Tech Watch selected the program to evaluate its dual-use relevance for warfighter care and large-scale mass casualty response.