ABVC BioPharma Executes a Global Licensing Term Sheet for Oncology/Hematology Products, Expecting Licensing Income of $55M and Royalties of up to $50M

Rhea-AI Summary

ABVC BioPharma, Inc. (NASDAQ: ABVC) announced a potential licensing deal with OncoX BioPharma, Inc. for its Oncology/Hematology pipeline, involving $50M in licensing fees, milestone payments, and royalties. The company has FDA-approved INDs for various cancer treatments using innovative active ingredients. The partnership aims to revolutionize the sector and create significant value for stakeholders.

Positive

• ABVC BioPharma, Inc. enters a term sheet with OncoX BioPharma, Inc. for a potential licensing deal in Oncology/Hematology.
• The agreement involves $50,000,000 in licensing fees, milestone payments, and royalties for the Licensed Products.
• The FDA has approved four INDs for cancer treatments using innovative active ingredients.
• The partnership aims to redefine industry standards, drive innovation, and create value for stakeholders.
• The licensing deal signifies a significant milestone for both companies, showcasing their commitment to excellence and shared vision for the future.

Negative

• None.

Financial Analyst

The licensing agreement between ABVC BioPharma and OncoX BioPharma for ABVC's Oncology/Hematology pipeline represents a significant financial event that could influence the company's revenue streams and market position. The upfront licensing fee of $50 million, with additional milestone payments and royalties, provides ABVC with immediate capital infusion and a sustained income source contingent on product success. The deal's structure, combining cash and shares, could also affect ABVC's balance sheet and shareholder equity. Investors should note the potential dilution of shares if the payment is primarily in stock. The long-term royalty of 5% of net sales, capped at $50 million, offers a revenue-sharing model that aligns the interests of both parties but also caps the upside for ABVC, which investors might view as a conservative approach in a high-stakes industry like biopharma.

Medical Research Analyst

The approval of four INDs by the US FDA for ABVC's pipeline drugs is a promising development, suggesting a degree of confidence in the therapeutic potential of these compounds. BLEX 404, derived from maitake mushrooms, represents an innovative approach within the oncology sector, potentially tapping into the growing interest in natural and functional foods for medical purposes. The clinical investigation of BLEX 404 for various cancers indicates a unique value proposition in a competitive market. The therapeutic areas targeted, such as Triple Negative Breast Cancer and Non-Small Cell Lung Cancer, are areas with high unmet medical needs, which could lead to substantial market opportunities if clinical trials result in successful outcomes. However, the long road from IND approval to market launch, with rigorous clinical trials and regulatory hurdles, should temper immediate expectations.

Market Research Analyst

The strategic partnership between ABVC and OncoX may reshape competitive dynamics within the Oncology/Hematology sector. ABVC's focus on therapeutic solutions that incorporate bioactive constituents from natural sources taps into a niche but growing segment of the market interested in alternative and complementary cancer therapies. The collaboration could leverage OncoX's marketing experience with dietary supplements to support the commercialization of the licensed products, potentially creating a unique brand identity. However, the success of this strategy will depend on consumer and physician acceptance of such treatments, which often require substantial education and evidence of efficacy. Market penetration could be challenged by established players and conventional therapies, making the partnership's execution critical for achieving the projected impact.

FREMONT, CA, April 10, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today that the Company together with its affiliates BioLite, Inc., and Rgene Corporation entered into a term sheet with OncoX BioPharma, Inc. (OncoX) for the Company's Oncology/Hematology pipeline(the "Licensed Products"). Subject to negotiation and execution of the definitive agreement, this license would cover the Licensed Products' clinical trial, registration, manufacturing, supply, and distribution rights. ABVC is set to receive $50,000,000 as licensing fees in the form of Cash/Shares within 30 days of execution of the Definitive Agreement, with an additional milestone payment of $5,000,000 in cash after the first fundraising round and Royalties of 5% of net sales, up to $50,000,000, after the launch of the Licensed Products.

The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1519 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1501 (IND 161602) for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 (IND 131300) for Myelodysplastic Syndrome (MDS), and ABV-1703 (IND 136309) for Pancreatic Cancer Therapy. The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life.[1]

"We are thrilled to announce that the term sheet for a potential groundbreaking licensing deal with OncoX has been successfully executed. The agreement sets the stage for a strategic partnership that we hope will revolutionize the Oncology/Hematology sector with our products that are valued at $105M by third-party valuer," said Dr. Uttam Patil, ABVC's Chief Executive Officer.  "After extensive negotiations and meticulous legal scrutiny, both parties have reached mutually beneficial terms that pave the way for a collaborative venture we believe is poised to redefine industry standards and drive innovation. This licensing deal marks a significant milestone for ABVC and OncoX, affirming their commitment to excellence and shared vision for the future. By leveraging each other's strengths, resources, and expertise, the partnership is set to unlock new opportunities and create unparalleled value for stakeholders."

"We are delighted to formalize this partnership with ABVC," said Wen-Pin Yen, CEO of OncoX. “This collaboration underscores our dedication to delivering cutting-edge solutions and reinforces our position in the Oncology/Hematology sector. We believe we are poised to profoundly impact and shape the Oncology/Hematology sector's future.” He added that they've spent time actively marketing dietary supplements produced at BioKey, Inc., CDMO of ABVC. This experience involves researching their efficacy, managing their production process, and promoting them to consumers. It has led to a deep understanding of the supplement industry, including knowledge about various supplements, their ingredients, potential benefits and risks, regulatory requirements, and consumer preferences. We intend to use this exposure in new development, and it is essential for creating products that meet user needs, are easy to use, and ultimately drive user satisfaction and engagement.

Under the proposed agreement, ABVC would grant OncoX an exclusive global rights license to develop and commercialize the Licensed Products within the Field of Use. ABVC would also grant OncoX the right to sublicense to a third party, pre-agreed by ABVC. ABVC would be responsible for securing the supply of the Licensed Products to OncoX with an agreed price and quantity. In contrast, OncoX would secure the purchase of the Licensed Products from ABVC with a committed volume. OncoX would be responsible for completing the regulatory filing of IND. ABVC would provide the Licensed Products to OncoX at a cost to support clinical development in the Field of Use.

OncoX would be responsible for further development and commercialization of the Licensed Products in the Field of Use, including any clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Products. As part of this license, OncoX would grant ABVC a perpetual, royalty-free right to use and reference any development, regulatory, and market data associated with the Licensed Products in OncoX's control.

The terms discussed or agreed upon are conditional and not final until a formal Definitive Agreement is executed by all parties involved.
Management believes the Company's product pipeline has excellent market potential. The global cancer therapeutics market is expected to be worth around US$393.61 billion by 2032, up from US$164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.[2]

For more information about ABVC and its subsidiaries, stay updated on the latest updates or visit https://abvcpharma.com. ABVC urges its shareholders to sign up on the Company's website for the latest news alerts; visit https://abvcpharma.com/?page_id=17707

About ABVC BioPharma & Its Industry
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, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company's network of research institutions includes Stanford University, the University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.

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. None of the outcomes expressed herein are guaranteed. 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.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy any of the Company's securities, nor shall such securities be offered or sold in the United States absent registration or an applicable exemption from registration, nor shall there be any offer, solicitation or sale of any of the Company's securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Contact:
Leeds Chow
Email: leedschow@ambrivis.com

[1] https://www.sciencedirect.com/science/article/abs/pii/S0960852407001083?via%3Dihub

[2] https://www.precedenceresearch.com/cancer-therapeutics-market

What is the ticker symbol for ABVC BioPharma, Inc.?

The ticker symbol for ABVC BioPharma, Inc. is ABVC.

What is the nature of the potential licensing deal announced by ABVC BioPharma, Inc.?

ABVC BioPharma, Inc. announced a potential licensing deal with OncoX BioPharma, Inc. for its Oncology/Hematology pipeline.

What are the financial aspects of the potential licensing deal?

The potential licensing deal involves $50,000,000 in licensing fees, milestone payments, and royalties for the Licensed Products.

How many INDs have been approved by the FDA for ABVC BioPharma, Inc.'s products?

The FDA has approved four INDs for ABVC BioPharma, Inc.'s products, including treatments for Triple Negative Breast Cancer, Non-Small Cell Lung Cancer, Myelodysplastic Syndrome, and Pancreatic Cancer Therapy.

What is the goal of the partnership between ABVC BioPharma, Inc. and OncoX BioPharma, Inc.?

The partnership aims to revolutionize the Oncology/Hematology sector, redefine industry standards, drive innovation, and create significant value for stakeholders.