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NurExone Planning to Establish First U.S. Commercial Manufacturing Facility in Indiana

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NurExone Biologic (OTCQB: NRXBF) has announced plans to establish its first U.S. commercial exosome production facility in Indianapolis, Indiana through its subsidiary Exo-Top Inc. The company has secured an incentive offer of up to $255,000 for this expansion.

The planned GMP-compliant facility will serve as Exo-Top's U.S. manufacturing base, producing exosomes for both NurExone's therapeutic pipeline and business-to-business opportunities in regenerative aesthetics. The expansion aligns with Indiana's robust life sciences sector, which generates over $99 billion in annual economic output and has attracted more than $1.5 billion in venture investments since 2019.

This strategic move supports NurExone's progress toward first-in-human clinical trials of ExoPTEN and its plans to uplist to a major U.S. stock exchange.

NurExone Biologic (OTCQB: NRXBF) ha annunciato piani per aprire la sua prima struttura statunitense di produzione commerciale di esosomi tramite la controllata Exo-Top Inc. L'azienda ha ottenuto un’offerta di incentivo fino a $255,000 per questa espansione.

La struttura pianificata, conforme alle GMP, servirà come base di produzione negli Stati Uniti per Exo-Top, producendo esosomi sia per il portafoglio terapeutico di NurExone sia per opportunità business-to-business nel campo della rigenerazione estetica. L’espansione si allinea con il forte settore delle scienze della vita in Indiana, che genera oltre $99 miliardi di output economico annuo e ha attirato oltre $1,5 miliardi di investimenti in venture capital dal 2019.

Questa mossa strategica sostiene i progressi di NurExone verso i trial clinici di prima somministrazione sull’uomo di ExoPTEN e i piani di quotarsi su una importante borsa statunitense.

NurExone Biologic (OTCQB: NRXBF) ha anunciado planes para establecer su primera instalación de producción comercial de exosomas en Estados Unidos, en Indianápolis, Indiana, a través de su filial Exo-Top Inc. La empresa ha asegurado una oferta de incentivo de hasta $255,000 para esta expansión.

La instalación planificada, conforme a GMP, servirá como base de fabricación en EE. UU. para Exo-Top, produciendo exosomas tanto para el programa terapéutico de NurExone como para oportunidades b2b en estética regenerativa. La expansión está alineada con el sólido sector de ciencias de la vida de Indiana, que genera más de $99 mil millones en producción económica anual y ha atraído más de $1.5 mil millones en inversiones de capital de riesgo desde 2019.

Este movimiento estratégico apoya el progreso de NurExone hacia ensayos clínicos en humanos de ExoPTEN y sus planes de ingresar a una bolsa importante en Estados Unidos.

NurExone Biologic (OTCQB: NRXBF)가 Exo-Top Inc.를 통해 미국에서 처음으로 상업용 엑소좀 생산 시설을 인디애나폴리스, 인디애나주에 설립하겠다고 발표했습니다. 이 확장을 위해 최대 $255,000의 인센티브를 확보했습니다.

예정된 GMP 준수 시설은 Exo-Top의 미국 제조 기지로서 엑소좀을 NurExone의 치료 파이프라인과 재생 미용 분야의 B2B 기회 모두를 위해 생산할 예정입니다. 이 확장은 연간 990억 달러 이상을 창출하는 인디애나의 강력한 생명과학 부문과 2019년 이후 벤처 투자를 통해 $15억 이상을 끌어들인 점과도 맞물려 있습니다.

이 전략적 움직임은 ExoPTEN의 사람 대상 임상 1상 시험 진행과 미국 주요 증권거래소 상장을 향한 NurExone의 계획을 뒷받침합니다.

NurExone Biologic (OTCQB: NRXBF) a annoncé son projet d’établir sa première installation de production commerciale d’exosomes aux États-Unis, à Indianapolis, dans l’Indiana, par l’intermédiaire de sa filiale Exo-Top Inc. La société a obtenu une offre d’incitation allant jusqu’à $255,000 pour cette expansion.

L’installation envisagée, conforme aux BPF, servira de base de fabrication aux États‑Unis pour Exo-Top, produisant des exosomes à la fois pour le pipeline thérapeutique de NurExone et pour des opportunités B2B dans le domaine de l’esthétique régénérative. Cette expansion s’inscrit dans le cadre du secteur des sciences de la vie florissant de l’Indiana, qui génère plus de $99 milliards de production économique annuelle et a attiré plus de $1,5 milliard d’investissements en capital-risque depuis 2019.

Cette démarche stratégique soutient les progrès de NurExone vers des essais cliniques chez l’homme du ExoPTEN et ses plans de montée en cotation sur une bourse majeure américaine.

NurExone Biologic (OTCQB: NRXBF) hat Pläne angekündigt, in Indianapolis, Indiana, über die Tochtergesellschaft Exo-Top Inc. die erste kommerzielle Exosomen-Produktionsanlage in den USA zu errichten. Das Unternehmen hat eine Anreizvereinbarung von bis zu $255,000 für diese Expansion gesichert.

Die geplante GMP-konforme Anlage wird als US-Produktionsbasis von Exo-Top dienen und Exosomen sowohl für das therapeutische Portfolio von NurExone als auch für B2B-Möglichkeiten in der regenerativen Ästhetik produzieren. Die Expansion passt zu Indiens anspruchsvollem Lebenswissenschaftssektor, der jährlich über $99 Milliarden an wirtschaftlicher Aktivität generiert und seit 2019 mehr als $1,5 Milliarden an Risikoinvestitionen angezogen hat.

Dieser strategische Schritt unterstützt NurExones Fortschritte bei ersten humanen klinischen Studien von ExoPTEN und deren Plänen, an einer großen US-Börse gelistet zu werden.

NurExone Biologic (OTCQB: NRXBF) قد أعلنت عن خطط لإنشاء أول منشأة إنتاج تجارية خارجية للإكسوزومات في الولايات المتحدة الأمريكية في إنديانابوليس، إنديانا، عبر شركتها الفرعية Exo-Top Inc. وقد أمّنت الشركة عرض حوافز يصل إلى $255,000 لهذا التوسع.

ستنشئ المنشأة المخطط لها وفق مواصفات GMP قاعدة تصنيع في الولايات المتحدة لـ Exo-Top، مع إنتاج الإكسوزومات لكل من خط NurExone العلاجي وفرص الأعمال بين الأعمال في مجال التجميل التجديدي. يتماشى هذا التوسع مع قطاع علوم الحياة القوي في إنديانا، الذي يحقق أكثر من $99 مليار من الناتج الاقتصادي السنوي وقد جذب أكثر من $1.5 مليار من استثمارات رأس المال الجريء منذ 2019.

هذه الخطوة الاستراتيجية تدعم تقدم NurExone نحو تجارب سريرية في البشر لأول مرة لـ ExoPTEN وخططها للارتقاء إلى بورصة أمريكية كبرى.

NurExone Biologic (OTCQB: NRXBF) 已宣布计划通过其子公司 Exo-Top Inc. 在印第安纳波利斯,印第安纳州建立其在美国的首个商业化外泌体生产设施。公司已获得高达 $255,000 的扩张激励报价。

该计划中的符合 GMP 要求的工厂将成为 Exo-Top 的美国制造基地,为 NurExone 的治疗性管线以及在再生美学领域的企业对企业机会生产外泌体。此次扩张符合印第安纳州蓬勃发展的生物科学领域,该领域年产出经济总量超过 $990 亿美元,自 2019 年以来已吸引超过 $15 亿美元 的风险投资。

这一战略举措支持 NurExone 朝向 ExoPTEN 首 inci 人体临床试验的进展,以及其在美国主要证券交易所上市的计划。

Positive
  • Secured up to US$255,000 in incentives for U.S. facility establishment
  • Strategic expansion into Indiana's growing life sciences hub with $99B annual economic output
  • Planned GMP-compliant facility will serve both therapeutic and commercial production needs
  • Positions company for uplisting to major U.S. stock exchange
Negative
  • Facility plans are still preliminary and not finalized
  • Additional capital may be required for facility development and operations

Secures Incentive Offer of up to US$255K to Establish Operations in Indianapolis

TORONTO and HAIFA, Israel and INDIANAPOLIS, Sept. 16, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical innovator in exosome-based regenerative therapies, is pleased to announce that its U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), is planning to establish its first U.S. commercial exosome production facility in Indianapolis, Indiana.

The Indianapolis facility would serve as Exo-Top’s U.S. manufacturing base, transferring NurExone’s proprietary exosome production process into the American market. The GMP compliant site would produce exosomes both for NurExone’s therapeutic pipeline and for a growing business-to-business opportunity in regenerative aesthetics.

“Indiana’s commitment to building its life sciences cluster, outstanding logistics and strong incentives offer make Indianapolis the ideal home for Exo-Top, and we are honored to consider expanding into Indiana with the support of the Indiana Office of Commerce,” said Jacob Licht, CEO of Exo-Top. “By joining this ecosystem, we would contribute to Indiana’s biomanufacturing growth while securing a U.S. foundation for our therapeutic and commercial programs.”

“Indiana would be a natural fit for Exo-Top’s U.S. establishment, and we look forward to the potential high-quality jobs and local economic benefits this investment would create,” said Secretary of Commerce David Adams. “The state offers the right environment for Exo-Top to scale production and strengthen NurExone’s U.S. supply chain.”

Indiana is home to one of the largest life sciences sectors in the U.S., generating more than $99 billion in annual economic outputi and attracting over $1.5 billion in venture investments since 2019ii. Industry employment has grown nearly seven times faster than the broader private sector, supported by global anchors such as Eli Lilly and advanced logistics infrastructureiii. These strengths make Indiana a strategic and attractive location for companies like Exo-Top preparing to scale.

Exo-Top’s potential new Indianapolis operations would anchor NurExone’s North American presence, complementing the Company’s progress toward first-in-human clinical trials of ExoPTEN and its plans to uplist to a major U.S. stock exchange.

About the Indiana Office of Commerce

The State of Indiana’s Office of Commerce was created by Governor Mike Braun to align and accelerate the state’s economic development efforts and is led by Indiana Secretary of Commerce David J. Adams.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsiv. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedInTwitterFacebook, or YouTube.

For more information, please contact:

Mr. Jacob Licht
Chief Executive Officer (ExoTOP)
Phone: +1 240 421 9755
Email: jacob@nurexone.com

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: NurExone establishing a commercial exosome manufacturing facility in Indianapolis, Indiana and the benefits thereof; the Company progressing towards first in-human trials; projected business-to-business opportunities in regenerative aesthetics; the Company’s receipt and utilization of workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: NurExone will establish a commercial exosome manufacturing facility in Indianapolis, Indiana and the realize on the benefits thereof; the Company will progress towards first in-human trials; the Company will receive and utilize workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; and the NurExone platform technology will offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development; lack of revenues to date; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications; failure to meet planned development milestones or achieve commercial breakthroughs; the Company’s inability to have long-term protection of its intellectual property and/or manufacturing process; the Company’s exosomes will be not be regenerative; the Company and Exo-Top will be unable to advance into clinical and/or commercial phases, launch commercial-scale production and/or business-to-business exosome supply, achieve scalability and/or advance their manufacturing methods; the Company will not advance the optimization of ExoPTEN’s manufacturing processes and analytical methods; the Company will not prepare regulatory submissions; the Company will not launch first-in-human clinical trials; NurExone will not establish a commercial exosome manufacturing facility in Indianapolis, Indiana, or at all, and/or the be unable to realize on the benefits thereof; the Company will not receive and/or utilize workforce assistance from the City of Indianapolis’ Indy Economic Development Corporation and EmployIndy Business and Recruitment Solutions initiative; and the NurExone platform technology will offer novel solutions to drug companies; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca . These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.


i https://ihif.org/wp-content/uploads/2023/08/IHIF-Incentivizing-lab-space-white-paper.pdf
ii https://biocrossroads.com/wp-content/uploads/2025/04/Elevating-Indiana-A-Transformative-Year-in-Life-Sciences.pdf
iii https://biocrossroads.com/wp-content/uploads/2025/04/Elevating-Indiana-A-Transformative-Year-in-Life-Sciences.pdf
iv Spinal cord injuryGlaucoma


FAQ

What is the value of incentives offered to NurExone (NRXBF) for its Indiana facility?

NurExone has secured an incentive offer of up to US$255,000 to establish operations in Indianapolis, Indiana.

Where will NurExone's (NRXBF) new U.S. manufacturing facility be located?

The company plans to establish its first U.S. commercial exosome production facility in Indianapolis, Indiana through its subsidiary Exo-Top Inc.

What will NurExone (NRXBF) manufacture at its new Indiana facility?

The GMP-compliant facility will produce exosomes for NurExone's therapeutic pipeline and for business-to-business opportunities in regenerative aesthetics.

How does the Indiana facility align with NurExone's (NRXBF) future plans?

The facility supports NurExone's progress toward first-in-human clinical trials of ExoPTEN and plans to uplist to a major U.S. stock exchange.

Why did NurExone (NRXBF) choose Indiana for its U.S. facility?

Indiana was chosen for its strong life sciences sector (generating $99B in annual economic output), advanced logistics infrastructure, and attractive incentives package.
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