Tivic Health Acquires Exclusive Worldwide Rights to Phase III TLR5 Agonist from Statera Biopharma
Tivic Health Systems (NASDAQ: TIVC) has acquired worldwide exclusive license rights from Statera Biopharma for Entolimod™, a late-stage TLR5 agonist targeting acute radiation syndrome (ARS). The agreement includes an exclusive option for five additional indications for Entolimod and its derivative, Entalasta™.
This strategic move transforms Tivic from a single-product, direct-to-consumer company into a diversified therapeutics company. Entolimod has received FDA Fast Track and Orphan Drug designation for ARS treatment and has undergone over forty animal and human trials with $140 million in prior investment.
The global ARS market is valued at $5.2 billion in 2024, with a projected 5% annual growth rate through 2031. The acquisition positions Tivic to address immune and autonomic dysregulation through both neural and molecular pathways, with potential FDA approval within 24 months.
Tivic Health Systems (NASDAQ: TIVC) ha acquisito i diritti di licenza esclusiva a livello mondiale da Statera Biopharma per Entolimod™, un agonista TLR5 in fase avanzata che mira a trattare la sindrome da radiazione acuta (ARS). L'accordo include un'opzione esclusiva per cinque ulteriori indicazioni per Entolimod e il suo derivato, Entalasta™.
Questa mossa strategica trasforma Tivic da un'azienda focalizzata su un singolo prodotto, diretta ai consumatori, in un'azienda di terapeutiche diversificate. Entolimod ha ricevuto la designazione Fast Track e Orphan Drug da parte della FDA per il trattamento dell'ARS e ha partecipato a oltre quaranta trial clinici su animali e umani con un investimento precedente di 140 milioni di dollari.
Il mercato globale dell'ARS è valutato 5,2 miliardi di dollari nel 2024, con un tasso di crescita annuale previsto del 5% fino al 2031. L'acquisizione posiziona Tivic per affrontare la disregolazione immunitaria e autonomica attraverso vie sia neurali che molecolari, con una potenziale approvazione da parte della FDA entro 24 mesi.
Tivic Health Systems (NASDAQ: TIVC) ha adquirido derechos de licencia exclusivos a nivel mundial de Statera Biopharma para Entolimod™, un agonista TLR5 en etapa avanzada dirigido al tratamiento del síndrome de radiación aguda (ARS). El acuerdo incluye una opción exclusiva para cinco indicaciones adicionales de Entolimod y su derivado, Entalasta™.
Este movimiento estratégico transforma a Tivic de una empresa de un solo producto, dirigida al consumidor, en una compañía de terapias diversificadas. Entolimod ha recibido la designación Fast Track y Orphan Drug de la FDA para el tratamiento del ARS y ha pasado por más de cuarenta ensayos en animales y humanos con una inversión previa de 140 millones de dólares.
El mercado global del ARS está valorado en 5.2 mil millones de dólares en 2024, con una tasa de crecimiento anual proyectada del 5% hasta 2031. La adquisición posiciona a Tivic para abordar la disregulación inmune y autonómica a través de vías neurales y moleculares, con una posible aprobación de la FDA en un plazo de 24 meses.
티빅 헬스 시스템(Tivic Health Systems, NASDAQ: TIVC)은 스태테라 바이오파마(Statera Biopharma)로부터 급성 방사선 증후군(ARS)을 목표로 하는 후기 단계 TLR5 작용제인 엔톨리모드(Entolimod™)에 대한 전 세계 독점 라이선스 권리를 인수했습니다. 이 계약에는 엔톨리모드와 그 파생물인 엔탈라스타(Entalasta™)에 대한 추가 5개의 적응증에 대한 독점 옵션이 포함되어 있습니다.
이 전략적 움직임은 티빅을 단일 제품, 소비자 직접 판매 회사에서 다각화된 치료 회사로 변모시킵니다. 엔톨리모드는 ARS 치료를 위해 FDA의 패스트 트랙 및 오르판 약물 지정 승인을 받았으며, 1억 4천만 달러의 이전 투자로 40개 이상의 동물 및 인간 임상 시험을 거쳤습니다.
2024년 글로벌 ARS 시장은 52억 달러로 평가되며, 2031년까지 연평균 5%의 성장률이 예상됩니다. 이번 인수는 티빅이 신경 및 분자 경로를 통해 면역 및 자율 신경계의 불균형을 해결할 수 있는 위치에 놓이게 하며, 24개월 이내에 FDA 승인을 받을 가능성이 있습니다.
Tivic Health Systems (NASDAQ: TIVC) a acquis des droits de licence exclusifs à l'échelle mondiale auprès de Statera Biopharma pour Entolimod™, un agoniste TLR5 en phase avancée ciblant le syndrome d'irradiation aiguë (ARS). L'accord comprend une option exclusive pour cinq indications supplémentaires pour Entolimod et son dérivé, Entalasta™.
Ce mouvement stratégique transforme Tivic d'une entreprise à produit unique, vendue directement aux consommateurs, en une entreprise de thérapeutiques diversifiées. Entolimod a reçu la désignation Fast Track et Orphan Drug de la FDA pour le traitement de l'ARS et a été soumis à plus de quarante essais cliniques sur animaux et humains avec un investissement antérieur de 140 millions de dollars.
Le marché mondial de l'ARS est évalué à 5,2 milliards de dollars en 2024, avec un taux de croissance annuel projeté de 5 % jusqu'en 2031. L'acquisition positionne Tivic pour aborder la dysrégulation immunitaire et autonome à travers des voies neuronales et moléculaires, avec une approbation potentielle de la FDA dans un délai de 24 mois.
Tivic Health Systems (NASDAQ: TIVC) hat weltweit exklusive Lizenzrechte von Statera Biopharma für Entolimod™, einen späten TLR5-Agonisten zur Behandlung des akuten Strahlensyndroms (ARS), erworben. Die Vereinbarung umfasst eine exklusive Option für fünf weitere Indikationen für Entolimod und dessen Derivat, Entalasta™.
Dieser strategische Schritt verwandelt Tivic von einem Unternehmen mit einem einzigen Produkt, das direkt an Verbraucher verkauft, in ein diversifiziertes Therapeutikunternehmen. Entolimod hat von der FDA die Fast Track- und Orphan Drug-Bezeichnung für die Behandlung von ARS erhalten und hat über 40 Tier- und Humanstudien mit einer vorherigen Investition von 140 Millionen US-Dollar durchlaufen.
Der globale ARS-Markt wird im Jahr 2024 auf 5,2 Milliarden US-Dollar geschätzt, mit einer prognostizierten jährlichen Wachstumsrate von 5% bis 2031. Die Übernahme positioniert Tivic, um immunologische und autonome Dysregulationen sowohl über neuronale als auch molekulare Wege anzugehen, mit einer potenziellen FDA-Zulassung innerhalb von 24 Monaten.
- Acquisition of late-stage drug candidate with FDA Fast Track and Orphan Drug designation
- Entry into $5.2B market with 5% annual growth rate
- Access to extensively tested product with $140M prior investment
- Potential FDA approval within 24 months
- Option rights for five additional indications
- Transformation from single-product focus may increase operational complexity
- Additional development costs required for BLA filing and approval process
Insights
This licensing agreement marks a transformative moment for Tivic Health, representing a strategic leap from its current focus on bioelectronic devices to a broader therapeutic platform combining both neural and molecular approaches to immune regulation. The acquisition of Entolimod, a Phase III-ready asset, provides several key advantages:
- The drug candidate has already undergone extensive clinical validation with over 40 trials and
$140 million in prior investment, significantly de-risking the development pathway - The global acute radiation syndrome market, valued at
$5.2 billion , represents a substantial commercial opportunity with competition - FDA Fast Track and Orphan Drug designations provide accelerated regulatory pathways and market exclusivity benefits
- The option rights to five additional indications create multiple shots on goal and potential pipeline expansion opportunities
However, investors should consider several critical factors. The company, with a market cap of approximately
The combination of bioelectronic and biologic approaches could create unique therapeutic synergies, particularly in immune modulation. This dual-platform strategy could position Tivic advantageously in the growing field of bioelectronic medicine while maintaining traditional pharmaceutical development opportunities.
Broad licensing agreement accelerates Tivic’s transformation into a diversified therapeutics company, adds late-stage immunotherapeutic to clinical pipeline. Potential for FDA approval within 24 months.
“Today, we have aggressively accelerated Tivic’s strategic transformation from a single-product, direct-to-consumer company to a diversified therapeutics company—one with a growing pipeline of clinically validated product candidates,” said Jennifer Ernst, Chief Executive Officer of Tivic. “Statera’s TLR5 immunotherapy program strongly complements our work on non-invasive vagus nerve stimulation, positioning us to address immune and autonomic dysregulation—and associated diseases—through both neural and molecular pathways.”
The lead product candidate in the licensing program is a TLR5 agonist, Entolimod for the treatment of acute radiation syndrome (ARS). Market research firm CoherentMI estimates the global acute radiation syndrome (ARS) market to be valued at
Entolimod and its immunologically optimized derivative, Entalasta, have been the subject of more than forty animal and human trials and
The FDA has granted Fast Track and Orphan Drug designation to Entolimod for the prevention or treatment of ARS and to prevent death following a potential lethal dose of total body ionization irradiation during or after a radiation disaster.
“Based on extensive prior research, development and numerous clinical trials of Entolimod, this important immunotherapy drug will now be advanced through the final steps toward a BLA filing and potential FDA approval under the skilled execution of the Tivic team,” added Michael K. Handley, Chief Executive Officer of Statera. “We believe this agreement has the potential to provide considerable value for both Statera and Tivic shareholders.”
About the TLR5 Immunotherapy Program
TLRs play a key role in the innate immune system. Entolimod’s mechanism of action provides unique, highly sought-after attributes in the treatment of radiation-related illness.
For ARS, animal studies have shown a three-fold increase in survival with a single dose 25-hours after exposure to lethal levels of radiation. Entolimod was effective without additional supportive care, showed gastrointestinal protective attributes, and exhibited no dose-limiting toxicity at even the highest dosing levels.
Other studies have shown the potential to address additional applications. Tivic has secured exclusive options to these indications subject to certain milestones and payment conditions. These include:
- Immunosenescence - the gradual age-related decline in the immune system's ability to fight infections and respond to vaccines.
- Lymphocyte exhaustion – a condition in which immune cells, particularly T cells, become less effective after being exposed to infection, cancer, and/or cancer treatments.
- Neutropenia - a condition characterized by an abnormally low number of neutrophils, which can result from chemotherapy, radiation, bone marrow disorders, and certain autoimmune conditions.
- Vaccine enhancement – use as a vaccine adjuvant to enhance immune response to vaccines.
- Chronic radiation syndrome - a condition caused by long-term exposure to low levels of radiation that gradually damages tissues and organs.
Terms of the Agreement
Under the agreement, Tivic will initially pay Statera
Importantly, the structure of the agreement allows Tivic to strategically manage its investment while maximizing potential returns in line with shareholder interests. Select team members of Statera will join Tivic to establish Tivic’s biopharmaceutical capabilities and advance product candidates towards commercialization.
The transaction also includes exclusive rights and options for more than sixty patents and patents pending, associated know-how, and ownership of previously manufactured and tested materials.
Additional information about this news, including an informational PowerPoint presentation, will be available at: https://ir.tivichealth.com
Craft Capital Management LLC acted as the sole and exclusive investment banking firm in the transaction.
About Tivic Health
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health takes a multi-pronged approach to treating diseases caused by immune dysregulation and dysautonomia. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches.
Tivic Health’s first FDA approved product ClearUP™ is clinically proven to treat sinus pain and pressure. ClearUP is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com
About Statera Biopharma
Statera Biopharma, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has a large platform of toll-like receptor (TLR) agonists with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and Entalasta. Statera has clinical and preclinical programs for Crohn’s disease (STAT-201), hematology (Entolimod) and inflammation (STAT-300) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera, visit www.staterabiopharma.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tivic’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to Tivic's ability to maintain its Nasdaq listing; the development of Tivic’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tivic does not undertake an obligation to update or revise any forward-looking statement. Investors should read Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”, as well as the company’s subsequent filings with the SEC. All of Tivic’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250212860402/en/
Investor Contact Information:
Hanover International, Inc.
ir@tivichealth.com
Source: Tivic Health Systems, Inc.
FAQ
What is the market value and growth rate for acute radiation syndrome (ARS) that TIVC is entering?
How many clinical trials has TIVC's newly acquired Entolimod undergone?
What FDA designations has TIVC's Entolimod received for ARS treatment?
When could TIVC potentially receive FDA approval for Entolimod?
How many additional indications does TIVC have options to license for Entolimod?
