ABVC BioPharma Enters Into $3.0 Million Clinical Services Contract with NeuCen BioMed

Rhea-AI Summary

ABVC Biopharma, Inc. (NASDAQ: ABVC) announced a $3.0 million clinical services contract with NeuCen BioMed Co. Ltd. for two drug products, CEN501 and NEU001, to advance their Phase II clinical studies under U.S. FDA IND requirements. CEN501 is a nasal strip for treating allergic rhinitis, already validated in Taiwan, while NEU001 is an orphan drug for nasopharyngeal carcinoma. Over three years, BioKey will receive payments based on regulatory milestones, and ABVC will lend NeuCen $1.0 million through convertible debentures, potentially acquiring a 9% stake in NeuCen.

Positive

• Secured a $3.0 million contract to advance CEN501 and NEU001.
• CEN501 has proven effectiveness and safety in early trials.
• Potential to acquire a 9% stake in NeuCen through a loan.

Negative

• No specific milestones or timelines provided for regulatory achievements.
• Dependency on regulatory approval for continued progress can introduce risks.

FREMONT, CA, May 03, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that BioKey, a wholly-owned subsidiary of the company based in Fremont, California, has entered into a $3.0 million clinical services contract with NeuCen BioMed Co. Ltd. to guide two NeuCen drug products, CEN501 and NEU001, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements.

CEN501 is a nasal strip product used as a local nasal immunotherapy (LNIT) for the treatment of mite-induced allergic rhinitis patients. Clinical effectiveness and safety of CEN501 have been tested and proven in two early clinical trials in Taiwan. NEU001 is a novel drug entity that has received orphan-drug designation from the U.S. FDA for the treatment of nasopharyngeal carcinoma. 

Under the terms of the contract, BioKey will receive payments totaling $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained in connection with CEN501. BioKey’s management team is confident that, based upon their initial examination, CEN501 is likely to successfully complete Phases I and II within the 3-year contract period. In a separate agreement, BioKey’s parent company, ABVC BioPharma, and certain ABVC affiliates expect to provide a $1.0 million loan to NeuCen through a series of convertible debentures that, if fully converted, will result in ABVC owning approximately 9% of NeuCen. 

“We are pleased to enter into this clinical service contract with NeuCen BioMed to advance two promising drug products, CEN501 and NEU001, using BioKey’s clinical and regulatory capabilities,” said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma. “We expect this contract, together with the recently executed agreement with Define BioTech to purchase $800,000 of our maitake dietary supplement over the next year, will allow BioKey to achieve financial profitability earlier in 2022 than anticipated.”

About ABVC BioPharma

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact:
ICR, LLC
Lucy Peng
Phone: +1 646-677-1872
Email: Lucy.Peng@icrinc.com

FAQ

What is the significance of ABVC's $3.0 million contract with NeuCen?

The contract aims to support Phase II studies of CEN501 and NEU001, advancing ABVC's drug portfolio.

How does CEN501 work for treating allergic rhinitis?

CEN501 is a nasal strip designed for local nasal immunotherapy to address mite-induced allergic rhinitis.

What are the potential financial implications of the $1.0 million loan to NeuCen?

The loan could lead to ABVC owning about 9% of NeuCen, enhancing its investment portfolio.

What is the timeline for the clinical studies mentioned in the press release?

The contract spans three years, with payments contingent on achieving regulatory milestones.