Harvard Apparatus Regenerative Technology Announces $5 Million Financing to Continue Clinical Trial
Harvard Apparatus Regenerative Technology (OTCQB: HRGN) has secured a $5 million financing through a private placement of shares to a new investor. The funds will accelerate the clinical development of HRGN's lead product, the HRGN Esophageal Implant (BEI). The FDA has approved a ten-patient phase one and phase two clinical trial to study esophageal repair in adults affected by cancer or injury. There's potential to expand the trial to include pediatric subjects with esophageal birth defects. The private placement involves the sale of 1,388,888 shares at $3.60 per share. CEO Jerry He expressed enthusiasm about the new strategic investor and the opportunity to advance HRGN's clinical trials and pipeline development.
Harvard Apparatus Regenerative Technology (OTCQB: HRGN) ha ottenuto un finanziamento di 5 milioni di dollari attraverso un collocamento privato di azioni a un nuovo investitore. I fondi accelereranno lo sviluppo clinico del prodotto principale di HRGN, l'Impianto Esofageo HRGN (BEI). La FDA ha approvato uno studio clinico di fase uno e due con dieci pazienti per studiare la riparazione esofagea in adulti affetti da cancro o da infortuni. C'è il potenziale per espandere lo studio includendo soggetti pediatrici con difetti esofagei congeniti. Il collocamento privato prevede la vendita di 1.388.888 azioni a 3,60 dollari per azione. Il CEO Jerry He ha espresso entusiasmo riguardo al nuovo investitore strategico e all'opportunità di far avanzare gli studi clinici e lo sviluppo del pipeline di HRGN.
Harvard Apparatus Regenerative Technology (OTCQB: HRGN) ha asegurado un financiamiento de 5 millones de dólares mediante una colocación privada de acciones a un nuevo inversor. Los fondos acelerarán el desarrollo clínico del producto principal de HRGN, el Implante Esofágico HRGN (BEI). La FDA ha aprobado un ensayo clínico de fase uno y dos con diez pacientes para estudiar la reparación esofágica en adultos afectados por cáncer o lesiones. Existe el potencial para ampliar el ensayo e incluir sujetos pediátricos con defectos congénitos del esófago. La colocación privada implica la venta de 1.388.888 acciones a 3,60 dólares por acción. El CEO Jerry He expresó entusiasmo por el nuevo inversor estratégico y la oportunidad de avanzar en los ensayos clínicos y el desarrollo de la cartera de HRGN.
하버드 어패러터스 재생 기술 (OTCQB: HRGN)은 새로운 투자자에게 주식의 사모 배치를 통해 500만 달러의 자금을 확보했습니다. 이 자금은 HRGN의 주요 제품인 HRGN 식도 이식편 (BEI)의 임상 개발을 가속화할 것입니다. FDA는 암이나 부상으로 영향을 받은 성인의 식도 수리를 연구하기 위해 10명의 환자를 대상으로 하는 1상 및 2상 임상 시험을 승인했습니다. 소아의 식도 선천적 결함을 포함하는 시험으로의 확장 가능성도 있습니다. 이 사모 배치는 1,388,888 주를 주당 3.60 달러에 판매하는 내용을 포함하고 있습니다. CEO 제리 헤는 새로운 전략적 투자자와 HRGN의 임상 시험 및 파이프라인 개발을 진전시킬 기회에 대해 열정을 표현했습니다.
Harvard Apparatus Regenerative Technology (OTCQB: HRGN) a sécurisé un financement de 5 millions de dollars grâce à un placement privé d'actions à un nouvel investisseur. Les fonds permettront d'accélérer le développement clinique du produit phare de HRGN, l'Implant Œsophagien HRGN (BEI). La FDA a approuvé un essai clinique de phase un et deux avec dix patients pour étudier la réparation œsophagienne chez les adultes atteints de cancer ou de blessures. Il existe un potentiel d'expansion de l'essai pour inclure des sujets pédiatriques présentant des malformations congénitales de l'œsophage. Le placement privé concerne la vente de 1.388.888 actions au prix de 3,60 dollars par action. Le PDG Jerry He a exprimé son enthousiasme pour ce nouvel investisseur stratégique et l'opportunité de faire progresser les essais cliniques et le développement du pipeline de HRGN.
Harvard Apparatus Regenerative Technology (OTCQB: HRGN) hat sich über eine private Platzierung von Aktien bei einem neuen Investor 5 Millionen Dollar Finanzierung gesichert. Die Gelder werden die klinische Entwicklung des Hauptprodukts von HRGN, dem HRGN Speiseröhrenimplantat (BEI), beschleunigen. Die FDA hat eine Phase-1- und Phase-2-Studie mit zehn Patienten genehmigt, um die Reparatur der Speiseröhre bei Erwachsenen mit Krebs oder Verletzungen zu untersuchen. Es besteht die Möglichkeit, die Studie auf pädiatrische Probanden mit angeborenen Speiseröhrenfehlern auszudehnen. Die private Platzierung umfasst den Verkauf von 1.388.888 Aktien zu einem Preis von 3,60 Dollar pro Aktie. CEO Jerry He äußerte seine Begeisterung über den neuen strategischen Investor und die Möglichkeit, die klinischen Studien und die Entwicklung der Produktpipeline von HRGN voranzutreiben.
- Secured $5 million in financing through private placement
- FDA approval for phase one and phase two clinical trial
- Potential expansion of trial to include pediatric subjects
- Strategic investor involvement
- Dilution of existing shareholders due to new share issuance
Holliston, MA, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced that it has raised approximately
The funds will be used to accelerate the clinical development of HRGN’s lead product candidate, the HRGN Esophageal Implant, or BEI. The FDA has approved a ten-patient phase one and phase two clinical trial to study the repair of damage to the esophagus in adults caused by cancer or injury. The FDA has indicated a willingness to consider expanding this clinical trial to include pediatric subjects with birth defects in the esophagus once the safety of the implant is shown in adults. Hence, the Company expects the repair of birth defects in the esophagus to be an additional indication for which HRGN will seek FDA approval.
HRGN’s Chief Executive Officer, Director and Chairman, Jerry He stated, “I am very pleased to welcome our new strategic investor. This private placement will accelerate our clinical trial and pipeline development. We look forward to making HRGN a success both for its patients and shareholders”.
Details of the Private Placement
On August 19, 2024, Harvard Apparatus Regenerative Technology, Inc. (the “Company”) entered into a Securities Purchase Agreement (a “Purchase Agreement”) with an investor (the “Investor”) pursuant to which the Investor agreed to purchase in a private placement an aggregate of 1,388,888 shares of common stock for the aggregate purchase price of
About Harvard Apparatus Regenerative Technology, Inc.
We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.
We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.
HRGN has 15 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, 2 U.S. orphan-drug designations which can provide seven years of market exclusivity in the US market after market approval from the FDA and 1 EMA orphan drug designation, which can provide ten years of market exclusivity in the European market after market approval from the EMA.
For more information, please visit www.hregen.com and connect with the Company on LinkedIn.
Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company’s products, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or described in the Company’s other public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor Relations Contact
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com
FAQ
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