US Market News
1月前
Valion Bio's Velocity Bioworks Secures Exclusive Commercial License to LarmorBio's BioScan-NMR™ PlatformMay 14, 2026 4:31 PM
PR Newswire (US) First Commercial Installation Targeted for July 2026 in San Antonio; Strategic Reference Site Positions Velocity Bioworks at the Forefront of Next-Generation NMR-Based DiagnosticsSAN ANTONIO, May 14, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company, today announced that its wholly owned subsidiary, Velocity Bioworks, has entered into an exclusive commercial development and license agreement with LarmorBio, Inc. ("LarmorBio") for LarmorBio's BioScan-NMR™ platform, a next-generation nuclear magnetic resonance (NMR) system. Under the agreement, Velocity Bioworks will host the first commercial deployment of the BioScan-NMR platform, with installation and commissioning at the Company's San Antonio facility targeted for July 2026. Valion Bio secured the exclusive license and reference site arrangement at pre-institutional pricing, ahead of LarmorBio's pending Series A financing. The structure aligns the two companies as co-dependent strategic partners — rather than in a conventional vendor-customer relationship — with both parties commercially and operationally aligned on the validation, optimization, and scaled deployment of the BioScan-NMR platform."Securing exclusive commercial rights to BioScan-NMR ahead of LarmorBio's Series A reflects how we are building Velocity Bioworks — early access to differentiated technologies, structural alignment with the developer, and a position that strengthens as the platform scales," said Michael K. Handley, Chief Executive Officer of Valion Bio. "Hosting the first commercial installation gives Velocity Bioworks a defined role in the validation and commercialization of a next-generation NMR platform, and supports an advanced diagnostics service offering that we believe will benefit the biomanufacturing of programs both our internal pipeline and our third-party CDMO clients."The San Antonio installation, targeted for commissioning in July 2026, is expected to anchor Velocity Bioworks' advanced diagnostics service offering and to serve as the demonstration and validation site for LarmorBio's broader commercial pipeline. The reference site role provides Velocity Bioworks with first-mover access to the platform, while giving LarmorBio a high-visibility commercial proof point as it engages institutional capital and prospective customers.About Valion Bio, Inc.Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO) is a clinical-stage immunotherapeutics company developing Entolimod, a TLR5 agonist, for Acute Radiation Syndrome (ARS), oncology supportive care, and longevity indications. Entolimod for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio is also advancing Entolasta, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. The Company'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. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development manufacturing organization (CDMO) offering biomanufacturing services to third-party biotech companies. Valion Bio 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 www.valionbio.com.About Velocity BioworksVelocity Bioworks, a wholly owned subsidiary of Valion Bio, Inc., is a full-service contract development and manufacturing organization (CDMO) headquartered in San Antonio,Texas. Velocity Bioworks provides biomanufacturing, process development, and advanced analytics services to biotechnology and biopharmaceutical clients, while also serving as the manufacturing engine for Valion Bio's internal drug development pipeline.About LarmorBio, Inc.LarmorBio, Inc. is a life sciences and clinical diagnostics company developing the BioScan-NMR™ platform, a next-generation microscale nuclear magnetic resonance (NMR) system for rapid, label-free phenotyping of live cells and micro-sized biological samples. Founded as a Massachusetts Institute of Technology (MIT) spin-off, LarmorBio's technology is designed to deliver molecular-level diagnostic information from small sample volumes in minutes, without the cryogenics, dedicated infrastructure, or specialized personnel required by conventional NMR instrumentation. The Company's platform supports applications across bioprocessing, cell and gene therapy development, and clinical diagnostics. For more information, visit www.larmorbio.com.Forward-Looking StatementsThis 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 Valion Bio, 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, including the integration of the BioScan-NMR™ platform within Velocity Bioworks, within expected time frames or at all; the timing and completion of installation and commissioning of the BioScan-NMR™ platform at Velocity Bioworks' San Antonio facility; the timing and completion of LarmorBio's pending Series A financing and the impact of such financing on the Company's arrangement with LarmorBio; changes to the company's relationship with its partners; 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 Valion Bio's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, 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 + Media Contact:
Rich Cockrell
CG Capital
vbio@cg.capital View original content to download multimedia:https://www.prnewswire.com/news-releases/valion-bios-velocity-bioworks-secures-exclusive-commercial-license-to-larmorbios-bioscan-nmr-platform-302772886.htmlSOURCE Valion Bio, Inc. Original: Valion Bio's Velocity Bioworks Secures Exclusive Commercial License to LarmorBio's BioScan-NMR™ Platform
US Market News
1月前
Valion Bio to Report First Quarter 2026 Financial Results on May 14, 2026May 11, 2026 8:01 AM
PR Newswire (US) SAN ANTONIO, Texas, May 11, 2026 /PRNewswire/ -- Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced that it will report financial results for the first quarter ended March 31, 2026, after market close on Thursday, May 14, 2026. Management will host a conference call and webcast to discuss the Company's financial results and provide a business update.Conference Call and Webcast DetailsWebcast: https://www.webcaster5.com/Webcast/Page/2865/54024
Dial-In: 888-506-0062
International: 973-528-0011
Participant Access Code: 118764A replay of the webcast will be available on the Investors section of the Company's website following the conclusion of the event.About Valion Bio, Inc.Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO) is a clinical-stage immunotherapeutics company developing Entolimod™, a TLR5 agonist, for Acute Radiation Syndrome (ARS), oncology supportive care, and longevity indications. Entolimod™ for ARS has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Valion Bio is also advancing Entolasta™, a next-generation TLR5 agonist designed for potential broader therapeutic applications, including oncology supportive care. The Company'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. Valion Bio's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development and manufacturing organization (CDMO) offering biomanufacturing services to third-party biotech companies. Valion Bio 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 www.valionbio.com.Forward-Looking StatementsThis 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 Valion Bio, 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; 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 Valion Bio's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, 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 + Media Contact
Rich Cockrell
CG Capital
vbio@cg.capital View original content to download multimedia:https://www.prnewswire.com/news-releases/valion-bio-to-report-first-quarter-2026-financial-results-on-may-14-2026-302767800.htmlSOURCE Valion Bio, Inc. Original: Valion Bio to Report First Quarter 2026 Financial Results on May 14, 2026
US Market News
2月前
Tivic Health Systems Rebrands as Valion Bio, Reflecting Completed Transformation into a Late-Stage Biopharmaceutical Company with Government-Backed Asset and Potential Multiple Revenue Stream ModelApril 23, 2026 4:05 PM
PR Newswire (US)
Ticker Symbol to Change from TIVC to VBIO Effective April 28, 2026; Company Advancing Entolimod™ Toward BARDA Funding and Strategic National Stockpile Procurement While Velocity Bioworks CDMO Builds Independent Revenue BaseSAN ANTONIO, April 23, 2026 /PRNewswire/ -- Tivic Health Systems, Inc. (Nasdaq: TIVC) today announced it is changing its corporate name to Valion Bio, Inc. and its Nasdaq ticker symbol from TIVC to VBIO, effective at market open on Tuesday, April 28, 2026. The CUSIP number for the company's common stock will remain unchanged.
The rebrand is not merely cosmetic. It reflects the completion of a fundamental strategic transformation — the deliberate unwinding of a consumer medical device business and its replacement with a focused late-stage biopharmaceutical platform anchored by a government-priority asset with over 15 years and more than $140 million in cumulative development investment, and supported by a wholly owned biomanufacturing subsidiary.A Differentiated Asset at the Intersection of National Preparedness and OncologyValion Bio's lead drug candidate, Entolimod™, is a novel Toll-like receptor 5 (TLR5) agonist with a differentiated, dual-utility profile. As a medical countermeasure for Acute Radiation Syndrome (ARS), Entolimod has received FDA Fast Track and Orphan Drug designations and is being advanced under the FDA's Animal Rule pathway — a regulatory framework that enables approval based on animal efficacy data when human trials are not feasible or ethical, substantially reducing clinical execution risk. The company is actively engaged with BARDA, DTRA, NIAID, and allied government agencies regarding Entolimod's inclusion in the U.S. Strategic National Stockpile (SNS), where a procurement contract — if secured — would represent a non-dilutive, potentially nine-figure revenue event.Critically, Entolimod's mechanism — cytoprotection of bone marrow and gastrointestinal epithelial tissue through NF-?B signaling — positions it for parallel development in oncology supportive care. The global neutropenia treatment market exceeds $22 billion and is projected to approach $30 billion by the early 2030s. Valion Bio is targeting physician-sponsored clinical trials in chemotherapy-induced neutropenia in 2026, with Phase IIb readiness as the objective. Entolasta™, a next-generation TLR5 agonist, provides additional pipeline depth and intellectual property extension across both indications."The Valion Bio name reflects the company we have become. We have a late-stage asset with validated biology, regulatory designations, a clear government procurement pathway, and a world-class manufacturing operation under one roof. This is a different company than the one that existed 18 months ago — and the new name should make that unmistakable to every investor, partner, and government stakeholder we engage."
— Michael K. Handley, Chief Executive Officer, Valion BioHandley, who previously served as CEO of Statera Biopharma, where he led the advancement of Entolimod, brings direct institutional knowledge of the asset, its regulatory history, and its government agency relationships. His appointment as CEO of Valion Bio in March 2026 consolidated scientific, commercial, and operational leadership of the program under a single decision-maker with a proven track record in biologic drug development at scale.Velocity Bioworks: Manufacturing as a Strategic and Financial AssetValion Bio's wholly owned CDMO subsidiary, Velocity Bioworks, was acquired in December 2025 for approximately $16.3 million and represents a core pillar of the company's strategy — not a peripheral asset. Velocity Bioworks provides the company with domestic, controlled manufacturing capability for Entolimod, enabling supply chain security that is increasingly a prerequisite for government procurement partnerships. The subsidiary also recently completed a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation — on time, within budget, and meeting all purity and potency specifications.Beyond its internal role, Velocity Bioworks operates as a standalone CDMO with the ability to serve third-party early-stage biotech clients, targeting the historically underserved Phase I and Phase II biologics manufacturing gap. At full utilization, management believes Velocity Bioworks has the potential to evolve into a self-sustaining, cash flow-positive operation — providing the company a path to non-dilutive commercial revenue independent of the drug development timeline.Strategic Positioning and Macro TailwindsValion Bio is deliberately headquartered in San Antonio, Texas — proximity to the DoD biodefense ecosystem, including Brooke Army Medical Center, is not coincidental. The company's ARS countermeasure program sits at the intersection of several converging macro forces: a renewed federal focus on domestic biomanufacturing, accelerating global demand for national preparedness infrastructure following heightened nuclear threat awareness, and a bipartisan mandate to rebuild and modernize the Strategic National Stockpile. Allied government agencies are independently evaluating Entolimod for their own national stockpiling programs, creating a potential multi-jurisdictional procurement opportunity.About Valion Bio (Tivic Health Systems, Inc.)Valion Bio is a late-stage biopharmaceutical company developing biologics that activate innate immune pathways for cytoprotection and immune modulation. The company's lead candidate, Entolimod™, is a TLR5 agonist with over 15 years of development history, FDA Fast Track and Orphan Drug designations, and active engagement with U.S. government agencies for potential Strategic National Stockpile inclusion. The company also advances Entolasta™, a next-generation TLR5 agonist, and targets the neutropenia oncology supportive care market. Velocity Bioworks, Valion Bio's wholly owned CDMO subsidiary, supports internal manufacturing and services third-party biotech clients. For more information, visit https://ir.tivichealth.com Forward-Looking StatementsThis 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 Valion Bio, 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; 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 Valion Bio's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, 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
ir@tivichealth.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/tivic-health-systems-rebrands-as-valion-bio-reflecting-completed-transformation-into-a-late-stage-biopharmaceutical-company-with-government-backed-asset-and-potential-multiple-revenue-stream-model-302752163.htmlSOURCE Tivic Health Systems, Inc.
Original: Tivic Health Systems Rebrands as Valion Bio, Reflecting Completed Transformation into a Late-Stage Biopharmaceutical Company with Government-Backed Asset and Potential Multiple Revenue Stream Model
US Market News
3月前
Tivic Receives Formal Request for Information from Ukrainian Ministry of Health Regarding Strategic Stockpiling of EntolimodMarch 31, 2026 8:30 AM
ACCESS NewswireSAN 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 RecoveryEntolimod™ 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-?B 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 OpportunityThe 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 ReadinessThe 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 TivicTivic 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-?B 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.comMedia Contact
DJ Freyman
DJ@FastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic Receives Formal Request for Information from Ukrainian Ministry of Health Regarding Strategic Stockpiling of Entolimod
US Market News
3月前
Tivic CEO To Present at the Upcoming Emerging Growth's April 2026 Virtual ConferenceMarch 27, 2026 11:30 AM
ACCESS NewswirePresentation will Cover Recent Corporate Milestones Including Securing Agreement with NIAIDSAN ANTONIO, TX / ACCESS Newswire / March 27, 2026 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a clinical-stage immunotherapeutics company, today announced that its newly appointed Chief Executive Officer, Michael K Handley, will deliver a corporate update at the Emerging Growth Virtual Conference taking place April 1-2, 2026.During the virtual conference, Mr. Handley will highlight key milestones, including the company's recent agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a preclinical study evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS). If the data of this study demonstrates efficacy, then NIAID may support future studies for the GI-ARS condition using Entolimod.WHO: Michael K Handley, Chief Executive Officer
WHERE: April 1, 2026
WHEN: 2:55-3:05 PM Eastern TimeAttendees are encouraged to attend and/or listen to the presentation. Please register for the event at the below link.https://goto.webcasts.com/starthere.jsp?ei=1748971&tp_key=add80b0ab6&sti=tivcIf attendees cannot join the event live on the day of the conference, an archived webcast will also be made available on www.EmergingGrowth.com.About the Emerging GrowthThe Emerging Growth Virtual Conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment community from the convenience of their office, in a time efficient manner.The Conference focus and coverage includes companies in a wide range of growth sectors, with strong management teams, innovative products & services, focused strategy, execution, and the overall potential for long term growth. Its audience includes potentially tens of thousands of individual and institutional investors, as well as investment advisors and analysts.About TivicTivic 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-?B 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.comMedia Contact
DJ Freyman
DJ@FastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic CEO To Present at the Upcoming Emerging Growth's April 2026 Virtual Conference
US Market News
3月前
Tivic Reports Full Year 2025 ResultsMarch 25, 2026 4:05 PM
ACCESS NewswireCompletes Strategic Transformation into an Immunotherapy Company and Continues to Advance Entolimod Platform Toward Potential Funding PartnershipsConference Call to be Held Today at 1:30 PM PT / 4:30 PM ETSAN ANTONIO, TX / ACCESS Newswire / March 25, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a development-stage immunotherapy company, today reported financial and operational results for the year ended December 31, 2025, and provided a business update highlighting the company's strategic transformation and focus on the development of its Entolimod™ platform."2025 was a defining year for Tivic as we marked our transformation into a focused immunotherapy company anchored by Entolimod and its next-generation molecule, Entolasta," said Michael K. Handley, chief executive officer of Tivic. "During the year, we secured global rights to Entolimod and advanced regulatory and development readiness, while initiating discussions with U.S. government agencies regarding its potential as a medical countermeasure. We believe that Entolimod's differentiated cytoprotective properties, immune-enhancing mechanism, and extensive development history make it a promising candidate for national preparedness programs. We are optimistic that our ongoing discussions with the BARDA, the Department of War, and the National Institute of Allergy and Infectious Disease will advance toward a potential funding or sponsorship arrangement."Handley added, "While Entolimod for acute radiation syndrome remains our lead indication, its development is the first phase of a broader strategic roadmap to penetrate the multi-billion-dollar oncology supportive care market. Our immediate focus is on Neutropenia, where we are targeting the severe and often fatal side effects of chemo and radiation therapy. We are on track to advance this program into physician-sponsored clinical trials later this year."Simultaneously, the vertical integration provided by Velocity Bioworks has already significantly reduced our manufacturing timelines and costs. Beyond internal efficiencies, we have positioned Velocity Bioworks as a standalone contract development and manufacturing organization, or CDMO, to service third-party development projects. This creates an immediate opportunity for a new revenue stream and supports our long-term objective of transforming our manufacturing capabilities into a high margin profit center for the broader biotech industry."2025 Corporate Highlights and Subsequent Events ?Acquired exclusive global rights to Entolimod™ for acute radiation syndrome, including a comprehensive clinical, regulatory, and nonclinical development package from Statera Biopharma, Inc. Statera's CEO Michael K. Handley joined Tivic in 2025, and in March 2026 was appointed CEO, succeeding Jennifer Ernst, who was Tivic's CEO since 2016 ?Engaged with U.S. government agencies, including BARDA, Defense Threat Reduction Agency, National Institutes of Health, and NIAID, regarding potential development funding and Strategic National Stockpile procurement of Entolimod™ ?Acquired biomanufacturing assets to establish Velocity Bioworks, a wholly owned CDMO subsidiary ?Discontinued ClearUP® operations and suspended the non-core neuromodulation, or VNS, program ?Relocated corporate headquarters to San Antonio, TexasFinancial Results for the Year Ended December 31, 2025, Compared to 2024 ?Operating expenses for the year ended December 31, 2025 were $7.9 million, compared to $4.5 million for the year ended December 31, 2024. The increase was primarily due to the introduction of the biopharma business in February 2025, when the company licensed certain biologics assets and increased headcount and consultant services to support the development of Entolimod™. Additional increases occurred in December 2025 when we formed Velocity Bioworks and hired 45 employees to support the CDMO operations. ?Loss from discontinued operations decreased by $300,000 to $900,000 for the year ended December 31, 2025. Discontinued operations included all activities related to the consumer product business that Tivic exited in 2025. ?Net loss before discontinued operations for the year ended December 31, 2025 is expected to be in the range of $7.9 million to $8.1 million, compared with $4.5 million for the year ended December 31, 2024. ?Net loss for the year ended December 31, 2025 is expected to be in the range of $8.8 million to $9.1 million, compared with $5.7 million for the year ended December 31, 2024. ?The company is in the process of finalizing certain accounting matters related to the $16.3 million Senior Secured Convertible Note Payable dated December 10, 2025. All of the proceeds from the debt offering were used to acquire the assets now used by Velocity Bioworks. ?Cash and cash equivalents at December 31, 2025 totaled $12.6 million, compared with $2.0 million at December 31, 2024. The company had working capital of $12.4 million at December 31, 2025.Conference Call and Webcast InformationTeleconference
Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 910220Webcast Link
https://www.webcaster5.com/Webcast/Page/2865/53678An audio replay of the call will be available for 90 days on the investor page of the company's website at https://tivichealth.com/investor/.About TivicTivic 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-?B 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 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 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://tivichealth.com/investors/.Forward-Looking StatementsThis 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 EntolimodTM; 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 EntolimodTM 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.comMedia Contact:
DJ Freyman
DJ@FastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic Reports Full Year 2025 Results
US Market News
3月前
Tivic Health CEO Letter to ShareholdersMarch 24, 2026 9:30 AM
ACCESS NewswireSAN ANTONIO, TX / ACCESS Newswire / March 24, 2026 / Tivic Health Systems (Nasdaq:TIVC)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 BiopharmaTivic 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 CareWith 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 PartnershipsA 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 RadiationSyndrome (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 ControlOur 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 AheadTivic 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 TivicTivic 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-?B 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 StatementsThis 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.
ir@tivichealth.comMedia Contact:
DJ Freyman
DJ@fastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic Health CEO Letter to Shareholders
US Market News
3月前
Tivic To Report 2025 Year-End Financial Results Via Conference Call and Webcast on March 25th at 1:30pm PT / 4:30pm ETMarch 20, 2026 3:35 PM
ACCESS NewswireSAN ANTONIO, TX / ACCESS Newswire / March 20, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that it will report its year-end financial results for 2025 via pre-recorded conference call and webcast on Wednesday, March 25, 2026 at 1:30 PM PT / 4:30 PM ET.Conference Call and Webcast InformationTeleconference Details:
Toll Free: 888-506-0062
International: 973-528-0011
Participant Access Code: 910220Webcast Linkhttps://www.webcaster5.com/Webcast/Page/2865/53678An audio replay of the call will be available for the next 90 days from the investor page on the Tivic website at https://tivichealth.com/investor/.About TivicTivic 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-?B 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 StatementsThis 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.
ir@tivichealth.comMedia Contact:
DJ Freyman
DJ@fastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic To Report 2025 Year-End Financial Results Via Conference Call and Webcast on March 25th at 1:30pm PT / 4:30pm ET
US Market News
4月前
Biotech Veteran Michael K. Handley Named CEO of Tivic Health Systems to Spearhead Strategic Expansion in BiopharmaMarch 4, 2026 8:30 AM
ACCESS NewswireSAN FRANCISCO, CA / ACCESS Newswire / March 4, 2026 / Tivic Health Systems, Inc. (Nasdaq:TIVC) ("Tivic" or the "Company"), a late-stage immunotherapeutics company, today announced that its Board of Directors has appointed Michael K. Handley as Chief Executive Officer of Tivic, effective immediately. Mr. Handley succeeds Jennifer Ernst, who has served as CEO since its founding in 2016 and is stepping down from the CEO role as the Company enters its next chapter. Ms. Ernst will continue to support the Company through this strategic transition.The appointment of Mr. Handley marks a decisive shift in Tivic's strategic direction as the Company aligns its leadership and resources toward the high-growth Biopharma sector. With an increased focus on late-stage immunotherapies and the launch of Tivic's contract biomanufacturing subsidiary, Velocity Bioworks, Mr. Handley's extensive background in life sciences and commercialization will be instrumental in navigating the Company's next phase of growth.Mr. Handley brings over two decades of executive leadership in the biopharmaceutical and medical device industries. His career is distinguished by his success in navigating complex regulatory landscapes and leading multiple high-value commercial launches. Notably, Mr. Handley has played a pivotal role in the US approval and commercialization of seventeen products, generating billions of dollars in revenue and providing life-altering treatments for tens of thousands of patients. His foundational expertise was developed at world-renowned organizations, including Amgen and Genentech.A visionary leader, Mr. Handley is a passionate advocate for the development of innovative immunotherapies that utilize immune modulation as a cornerstone for disease mitigation and correction."Michael is a proven leader with an exceptional track record of building and scaling high-growth life sciences companies," said Sheryle Bolton, Chair of the Board of Tivic Health Systems. "As we transition toward late-stage immunotherapies and broader biopharma opportunities, his strategic vision and operational depth will be indispensable. On behalf of the Board, we extend our sincere appreciation to Jennifer Ernst for her dedicated leadership and meaningful contributions in positioning Tivic for its next phase of growth.""I am honored to lead Tivic at this pivotal juncture," said Michael K. Handley, Chief Executive Officer. "We are entering a transformative new era for the Company, focused on high-growth biopharma opportunities and late-stage assets, such as Entolimod. By leveraging our foundational strengths and integrating advanced biomanufacturing through Velocity Bioworks, we are positioned to deliver profound value to patients and stakeholders alike.""I am incredibly proud of what we've accomplished together in transforming this company and positioning it for growth," said Jennifer Ernst. "It has been an honor to lead such a talented team, and I look forward to watching the company continue to grow, innovate, and make an impact in the years ahead."About Tivic Health Systems, Inc.Tivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod™ to treat ARS, is in late-stage development. Entolimod™ is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. Tivic's pipeline includes Entolimod™ to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta™, an immunologically optimized variant of Entolimod for chronic applications.Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO based in San Antonio, Texas. 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. To learn more about Tivic, visit: https://tivichealth.com/About EntolimodEntolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA's Animal Rule and, in animal models, has demonstrated robust survival rates, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/Forward-Looking StatementsThis 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.
ir@tivichealth.comMedia Contact:
DJ Freyman
DJ@fastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Biotech Veteran Michael K. Handley Named CEO of Tivic Health Systems to Spearhead Strategic Expansion in Biopharma
US Market News
4月前
Tivic and BARDA Continue Discussions of Entolimod for Acute Radiation Syndrome on March 10February 18, 2026 9:15 AM
ACCESS NewswireInitial presentation on January 26, 2026 showcased Entolimod's potential to mitigate and prevent both gastrointestinal and hematopoietic injury from ionizing radiation exposure.FREMONT, CA / ACCESS Newswire / February 18, 2026 / Tivic (Nasdaq:TIVC), a late-stage immuno-therapeutics company, today announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) has been scheduled for March 10, 2026, to continue discussions focused on clinical data and the potential for funding and, ultimately, stockpiling Entolimod™ for Acute Radiation Syndrome (ARS).On January 26, 2026, Tivic attended an initial TechWatch meeting with BARDA and presented clinical data for Tivic's Toll-like Receptor 5 (TLR5) agonist, Entolimod™, to potentially be used as a radiation countermeasure. The presentation discussed characteristics of Entolimod that are expected to distinguish it mechanistically from currently approved ARS therapies. Tivic also highlighted the company's manufacturing readiness, enabled through Tivic's newly formed biomanufacturing subsidiary Velocity Bioworks.Following this meeting, key government attendees recommended a follow-up meeting as soon as possible."We see this invitation by the U.S. government to return for further discussions on the differentiated properties of Entolimod as a promising sign," said Tivic Chief Executive Officer Jennifer Ernst. "Our goal for this meeting is to explore potential government support for continued development of Entolimod, including activities necessary to pursue FDA approval and potentially incorporating Entolimod into the Strategic National Stockpile.""In studies conducted under the FDA's Animal Rule framework, Entolimod has demonstrated improved survival in relevant animal models of radiation exposure, along with evidence of gastrointestinal and hematopoietic protection," said Michael K. Handley, COO of Tivic and President of Biopharma. "Entolimod represents a highly differentiated approach compared to currently approved ARS treatments. We look forward to further discussing its strategic benefits with the U.S. government."About BARDA
BARDA is part of the Administration for Strategic Preparedness and Response operating within the U.S. Department of Health and Human Services agency to develop, procure, and stockpile medical countermeasures that address chemical, biologic, radiologic, and nuclear public health threats.About Entolimod
Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA's Animal Rule and, in animal models, has demonstrated improved survival rates in well characterized animal models, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/About Tivic
Tivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod™ for Acute Radiation Syndrome, is in advanced development under the FDA's Animal Rule. Entolimod™ is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. Tivic's pipeline includes Entolimod™ to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta™, an immunologically optimized variant of Entolimod for chronic applications.Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service contract development and manufacturing organization based in San Antonio, Texas. 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. To learn more about Tivic, visit: https://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; 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.
ir@tivichealth.comMedia Contact:
DJ Freyman
DJ@fastrackPR.comSOURCE: Tivic Health SystemsView the original press release on ACCESS NewswireOriginal: Tivic and BARDA Continue Discussions of Entolimod for Acute Radiation Syndrome on March 10
US Market News
5月前
Tivic to Showcase Strategic Pivot and Forward Outlook on Advancing Entolimod(TM) to Commercialization at DealFlow Discovery ConferenceJanuary 26, 2026 3:10 PM
ACCESS NewswireCEO Presentation to Include Updates and Further Information on the Following Topics:Entolimod Cell Line Verification Success;200x Manufacturing Scale-Up with Reproducible Quality;BARDA TechWatch Engagement;Creation of Velocity Bioworks, An Integrated CDMO To Accelerate Commercial Readiness FREMONT, CA / ACCESS Newswire / January 26, 2026 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a late-stage immunotherapeutics company, today announced that the company's CEO will present at the 3rd Annual DealFlow Discovery Conference, set to take place on January 28-29, 2026 in Atlantic City, New Jersey.Event Details3rd Annual DealFlow Discovery ConferenceThe Borgata Hotel, Casino & SpaAtlantic City, NJJanuary 28-29, 2026Investors interested in scheduling a meeting with the Tivic's management team should request an investor pass to attend the conference (no cost to attend).The company's presentation will highlight key value-creating milestones and provide greater clarity on its development and commercialization strategy for Entolimod™. These milestones include the successful scale-up demonstration of Entolimod manufacturing and progress toward cGMP manufacturing in preparation for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration. Ernst will also discuss the strategic integration of Velocity Bioworks, the company's contract development and manufacturing organization (CDMO), which is expected to accelerate commercial readiness. In addition, she will review outcomes from the January 26 TechWatch meeting with the Biomedical Advanced Research and Development Authority (BARDA).About DealFlow Discovery ConferenceThe DealFlow Discovery Conference is the largest event in the U.S. where public and private high-growth companies connect with the investment community. Over two days at the Borgata in Atlantic City, hundreds of companies present their stories directly to institutional investors, family offices, venture capitalists, and private equity firms.The conference combines 1-on-1 meetings with company presentations, expert keynote discussions, and networking activities designed for relationship-building and capital-raising. This conference opens the door to a wider range of investment opportunities, expanding beyond public microcap companies to feature:Venture-Backed Companies - early-stage innovators raising capital and seeking strategic relationshipsPrivate Equity-Backed (Pre-IPO) Companies - growth-stage businesses preparing for the public marketsPublic Companies - U.S.-listed issuers focused on investor engagement and capital raisingForeign Companies - international firms seeking U.S.-based capital and exposureThis conference has expanded in response to a growing trend: institutional interest in private market opportunities. By including private and pre-IPO companies, the DealFlow Discovery Conference is now even more valuable for investors - and for companies looking to raise capital.For more information and to apply to attend or present, visit www.DealFlowDiscoveryConference.com.About EntolimodEntolimod is a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF-kappaB pathway signaling, activating anti-apoptotic and cell protective mechanisms. Entolimod for Acute Radiation Syndrome (ARS) has been the subject of extensive trials under the FDA's Animal Rule and in animal models has demonstrated robust survival rates, enhanced gastrointestinal tract recovery, and improved hematopoiesis. To see the complete Tivic pipeline visit: https://tivichealth.com/pipeline/About TivicTivic is a late-stage immunotherapeutics company whose lead drug candidate, Entolimod to treat ARS, is in late-stage development. Entolimod is a TLR5 agonist that activates an innate immune pathway to prevent cell death in the bone marrow and epithelial tissues across systems impacted by radiation and age. The pipeline includes Entolimod to treat Neutropenia, and lymphocyte exhaustion, as well as Entolasta™, an immunologically optimized variant of Entolimod for chronic applications.Tivic's wholly owned subsidiary, Velocity Bioworks, is a full-service CDMO based in San Antonio, Texas. 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. To learn more about Tivic, visit: https://tivichealth.com/Forward-Looking StatementsThis 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 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; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company's future development of its ncVNS treatment, Entolimod and Entolasta; 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.
ir@tivichealth.comMedia Contact:DJ Freyman
DJ@fastrackPR.comSOURCE: DealFlow EventsView the original press release on ACCESS NewswireOriginal: Tivic to Showcase Strategic Pivot and Forward Outlook on Advancing Entolimod(TM) to Commercialization at DealFlow Discovery Conference
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