8-K
Abvc Biopharma, Inc. (ABVC)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 15, 2024
ABVC BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 001-40700 | 26-0014658 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 44370 Old Warm Springs Blvd.<br><br> <br>Fremont, CA | 94538 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number including area code:
(510) 668-0881
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | ABVC | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into Material Definitive Agreements
On May 14, 2024, the Company entered into a definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands (“Oncox”), pursuant to which the Company will grant Oncox an exclusive right to develop and commercialize ABVC’s BLEX 404 single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer (the “LicensedProducts”), within a certain territory, specified as 50% of the Worldwide Markets for 20 years (the “Oncox Agreement”). In consideration thereof, Oncox shall pay ABVC a total of $6,250,000 (or 1,250,000 Oncox shares valued at $5 per share^1^) 30 days after entering into the Oncox Agreement, with an additional milestone payment of $625,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee. Oncox may remit cash payments of at least $100,000 towards the licensing fees and deductible from the second milestone payment; ABVC is also entitled to royalties of 5% of Net Sales, as defined in the Oncox Agreement, from the first commercial sale of the Licensed Product in the noted territory, which remains uncertain. The Company will permit Oncox to pay the license fee in installments or in a lump sum and will allow Oncox to use its revenue to fund such payments. Oncox entered into the same agreement with ABVC’s affiliate, Biolite, Inc.
The foregoing description of the agreements is not complete and is qualified in its entirety by reference to the full text of the agreements, copies of which are attached as Exhibit 10.1 and Exhibit 10.2 to this Current Report on Form 8-K and incorporated herein by reference.
Neither this Current Report on Form 8-K, nor any exhibit attached hereto, is an offer to sell or the solicitation of an offer to buy the Securities described herein. Such disclosure does not constitute an offer to sell, or the solicitation of an offer to buy nor shall there be any sales of the Company’s securities in any state in which such an offer, solicitation or sale would be unlawful. The securities mentioned herein have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the Securities Act and applicable state securities laws.
Item 9.01 Financial Statement and Exhibits
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 10.1 | Definitive License Agreement between the Company and OncoX BioPharma, Inc. May 14, 2024 |
| 10.2 | Definitive License Agreement between Biolite, Inc. and OncoX BioPharma, Inc. dated May 14, 2024 |
| 99.1 | Press Release |
| 104 | Cover Page Interactive Data File, formatted in Inline XBRL |
| ^1^ | Price<br>was determined through private negotiations between the parties; no third party valuation was completed. |
| --- | --- |
1
SIGNATURE
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ABVC BioPharma, Inc. | ||
|---|---|---|
| May 15, 2024 | By: | /s/ Uttam Patil |
| Uttam Patil | ||
| Chief Executive Officer |
2
Exhibit 10.1
Definitive Licensing Agreement
This Definitive Licensing Agreement (“Agreement”) is entered into this May 14, 2024 (the “Effective Date”) by and between:
(1) ABVC BioPharma, Inc., a company registered in Nevada. (“ABVC”); and
(2) OncoX BioPharma, Inc. (“ONCOX”), a company registered in the British Virgin Islands.; and ABVC and ONCOX shall be referred to individually as a “Party” and collectively as the “Parties”.
WHEREAS, the parties have agreed to the Key Terms (see Exhibit A) as outlined in the Term Sheet, and now formalize their understanding in this Definitive Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties agree as follows:
Upon signing this Definitive Agreement, ONCOX shall have the exclusive right, until the expiration of this agreement, to negotiate and execute a definitive licensing agreement for the licensed products with ABVC.
ONCOX has the right to team with partner(s) or transfer the right to a third party to negotiate and execute a definitive licensing agreement for the licensed products with ABVC.
ONCOX has satisfactorily completed a due diligence investigation of the Licensed Product.
ABVC and its Representatives shall deal exclusively with ONCOX with respect to any licensing in the same scope or similar arrangement surrounding the Licensed Product.
IN WITNESS WHEREOF, the parties hereto have executed this Definitive Agreement as of the Effective Date.
[Signature Page]
| ABVC BioPharma, Inc. | OncoX BioPharma, Inc. | ||
|---|---|---|---|
| Authorized Signature/Seal | Authorized Signature/Seal | ||
| Name： | Uttam Yashwant Patil | Name： | Yen Wen Pin |
| Title: | CEO | Title： | CEO |
2
Exhibit A
| LICENSEE | OncoX BioPharma, Inc. (“ONCOX”) |
|---|---|
| LICENSOR | ABVC BioPharma, Inc. (“ABVC”) and its affiliates |
| THIRD PARTY | “Third Party” means a person or entity other than ONCOX or ABVC or their respective affiliates. |
| EFFECTIVE DATE | The effective dates of Definitive Agreement related to the Licensed Product that would be the result of Parties’ discussions |
| LICENSED PRODUCT<br><br> <br>**** | ABVC’s BLEX 404, single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer |
| TERRITORY | 50% of the Worldwide Markets |
| GOVERNING LAW | Laws of the United States |
| FIELD OF USE | Tripple Negative Breast Cancer |
| RIGHTS GRANTED<br><br> <br>**** | ABVC shall grant to ONCOX an exclusive right within the Territory license to develop and commercialize the Licensed Product in the Territory within the Field of Use. |
| RESPONSIBILITIES & OBLIGATIONS<br><br> <br>**** | ABVC<br> will be responsible for conducting the clinical development of the Licensed Product outside Territory and communicating the results as<br> part of the Product Transfer (PT), which includes delivering the Licensed Product sufficient to support the clinical studies in Territory,<br> delivering associated documents, manufacturing protocols, QC protocols, to enable ONCOX to<br> develop and commercialize the Licensed Product in Territory.<br><br> <br><br><br> <br>ABVC<br> will be responsible to secure the supply of the Licensed Product to ONCOX in<br> the Territory with an agreed price and quantity while A will secure the purchase of the Licensed Products from ABVC in the Territory with<br> committed volume.<br><br> <br><br><br> <br>ONCOX shall<br> be responsible for completing regulatory filing of IND in the Territory.<br><br> <br><br><br> <br>ABVC<br> will be responsible for providing the Licensed Product to ONCOX at cost,<br> to support clinical development in the Field of Use in the Territory.<br><br> <br><br><br> <br>ONCOX will<br> be responsible for further development and commercialization of the Licensed Product in the Field of Use in the Territory, including any<br> clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Product.<br><br> <br><br><br> <br>As<br> part of this license, ONCOX will grant ABVC a perpetual, royalty-free<br> right to use and reference any development, regulatory, and market data associated with the Licensed Product in ONCOX’s<br> control. |
3
| EXCLUSIVITY/<br><br> <br>NON-COMPETE | During the collaboration, neither Parties nor its affiliates will work on the development of or commercialize in the Territory any products containing Maitake Mushroom as the sole active ingredient or in combination with one or more other active ingredients other than with respect to any other product or usage for which the same parties have previously agreed or will agree to work on together or without a specific mutually agreed to written plan for depression indication. |
|---|---|
| TECHNOLOGY SHARING | After the Effective Date, and at a time to be agreed upon by ONCOX and ABVC in the Definitive Agreement, ABVC would transfer to ONCOX in English that data related to any Licensed Products in ABVC’s possession and control that is required by regulatory authorities for opening an IND, NDA. |
| INTELLECTUAL PROPERTY RIGHTS<br><br> <br>**** | Intellectual<br> Property means any patent, copyright, trade secret, trademark or other proprietary right; including<br> all their applications , registrations, renewals and extensions.<br><br> <br><br><br> <br>Each Party or its Affiliates owns all rights, title and interest of<br> the Intellectual Property developed or controlled by itself and will be responsible for filing and maintaining the Intellectual Property<br> in the Territory at its own cost.<br><br> <br><br><br> <br>Each Party warrants it does not and will not infringe, violate or misappropriate<br> any trademark, patent, copyright, industrial design, trade secret or any other intellectual property or proprietary right of any Third<br> Party.<br><br> <br><br><br> <br>No right, title or interest is granted to the other Party in the Definitive<br> Agreement, whether expressly or by implication, to any technology or Intellectual Property rights owned by a Party other than pursuant<br> to the terms of the Definitive Agreement.<br><br> <br><br><br> <br>Each Party will retain an unconditional and<br>unlimited right of access, inclusion, citation, electronic or photo copy, and regulatory cross reference, without limitation, to any<br>and all regulatory, technical, and scientific documentations, and any and all communications with any and all regulatory authorities<br>in the other Party’s Territory for all matters related to each Licensed Product during the License Term. |
4
| MILESTONE & ROYALTY PAYMENTS | See Exhibit B. |
|---|---|
| TAX<br><br> <br>**** | Payments to Licensor as detailed in Exhibit B are likely considered Licensor’s income generated in Territory. Licensor is responsible for income tax, value-added tax, and other related fees levied by Territory government authorities on these payments. If and to the extent that provision is made in law or regulation of Territory for withholding of taxes with respect to any such payment, Licensee shall pay such taxes on behalf of Licensor and provide Licensor with original receipt of such tax payments or withholding. |
| NET SALES | “Net Sales” means the total amount of<br> invoices issued by the Licensee for selling the Product of each pack size in the Territory to the Third Parties responsible for distribution<br> / logistics, minus the amount of allowable deduction items related to the Product actually provided to non-affiliates as follows:<br><br> <br><br><br> <br>a) sales<br> value added tax<br><br> <br><br><br> <br>b) allowance,<br> discount or rebate for rejection, defect, recall, return, retroactive price reduction<br><br> <br><br><br> <br>Net Sales shall be accounted in accordance with<br> arm-length principles, industry standards and practices of the Territory, covering all sales of the Product to the Field of Use in the<br> Territory. Any allowance, discount or rebate for any Third Party sales and marketing activities shall not be deducted from the Net Sales<br> calculation.<br><br> <br><br><br> <br>Licensee shall allow Licensor to appoint<br>a Third Party independent auditor to audit the financial accounts of Licensee or its affiliates to confirm the reasonableness and accuracy<br>of the Net Sales calculation of the Product each year during the License Term. |
| LICENSE TERMS | The term of licensing for the Licensed Product in the Territory is 20 years. |
| MANUFACTURING<br><br> <br>**** | Both Parties desire Licensee is responsible for<br> the Licensed Product API manufacturing under CMO model as global primary supplier. Both Parties agree further study and analysis are to<br> be performed for the feasibility from technical and financial perspective before the execution of related manufacturing agreement.<br><br> <br><br><br> <br>Manufacturing of Licensed Product finished product<br> is subject to negotiation by both Parties. |
5
Exhibit B
All payments below are pre-tax total payments in USD.
| Milestones |
|---|
| Upfront |
| A cash payment of 100,000 and above at any time will then be deducted from the second milestone payment. |
| Completion<br> Of<br> Fundraising |
| Total Licensing Fee |
| Royalties |
All values are in US Dollars.
Royalties shall be payable quarterly on annual Net Sales of the Licensed Product from the first commercial sale of a Licensed Product in the Territory to the end of License Terms.
6
Exhibit 10.2
Definitive Licensing Agreement
This Definitive Licensing Agreement (“Agreement”) is entered into this May 14, 2024 (the “Effective Date”) by and between:
(1) BIOLITE, INC., a company registered in Taiwan. (“BIOLITE”); and
(2) OncoX BioPharma, Inc. (“ONCOX”), a company registered in the British Virgin Islands.; and BIOLITE and ONCOX shall be referred to individually as a “Party” and collectively as the “Parties”.
WHEREAS, the parties have agreed to the Key Terms (see Exhibit A) as outlined in the Term Sheet, and now formalize their understanding in this Definitive Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties agree as follows:
Upon signing this Definitive Agreement, ONCOX shall have the exclusive right, until the expiration of this agreement, to negotiate and execute a definitive licensing agreement for the licensed products with BIOLITE.
ONCOX has the right to team with partner(s) or transfer the right to a third party to negotiate and execute a definitive licensing agreement for the licensed products with BIOLITE.
ONCOX has satisfactorily completed a due diligence investigation of the Licensed Product.
BIOLITE and its Representatives shall deal exclusively with ONCOX with respect to any licensing in the same scope or similar arrangement surrounding the Licensed Product.
IN WITNESS WHEREOF, the parties hereto have executed this Definitive Agreement as of the Effective Date.
[Signature Page]
| BIOLITE, INC. | OncoX BioPharma, Inc. | ||
|---|---|---|---|
| Authorized Signature/Seal | Authorized Signature/Seal | ||
| Name: | Tsung Shann Jiang | Name: | Yen Wen Pin |
| Title: | Chairman | Title: | CEO |
2
Exhibit A
| LICENSEE | OncoX BioPharma, Inc. (“ONCOX”) |
|---|---|
| LICENSOR | BIOLITE, INC. (“BIOLITE”) and its affiliates |
| THIRD PARTY | “Third Party” means a person or entity other than ONCOX or BIOLITE or their respective affiliates. |
| EFFECTIVE DATE | The effective dates of Definitive Agreement related to the Licensed Product that would be the result of Parties’ discussions |
| LICENSED PRODUCT<br><br> <br>**** | BIOLITE’s BLEX 404, single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Tripple Negative Breast Cancer |
| TERRITORY | 50% of the Worldwide Markets |
| GOVERNING LAW | Laws of the United States |
| FIELD OF USE | Tripple Negative Breast Cancer |
| RIGHTS GRANTED<br><br> <br>**** | BIOLITE shall grant to ONCOX an exclusive right within the Territory license to develop and commercialize the Licensed Product in the Territory within the Field of Use. |
| RESPONSIBILITIES & OBLIGATIONS | BIOLITE<br> will be responsible for conducting the clinical development of the Licensed Product outside Territory and communicating the results as<br> part of the Product Transfer (PT), which includes delivering the Licensed Product sufficient to support the clinical studies in Territory,<br> delivering associated documents, manufacturing protocols, QC protocols, to enable ONCOX to<br> develop and commercialize the Licensed Product in Territory.<br><br> <br><br><br> <br>BIOLITE<br> will be responsible to secure the supply of the Licensed Product to ONCOX in<br> the Territory with an agreed price and quantity while A will secure the purchase of the Licensed Products from BIOLITE in the Territory<br> with committed volume.<br><br> <br><br><br> <br>ONCOX shall<br> be responsible for completing regulatory filing of IND in the Territory.<br><br> <br><br><br> <br>BIOLITE<br> will be responsible for providing the Licensed Product to ONCOX at cost,<br> to support clinical development in the Field of Use in the Territory.<br><br> <br><br><br> <br>ONCOX will<br> be responsible for further development and commercialization of the Licensed Product in the Field of Use in the Territory, including any<br> clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Product.<br><br> <br><br><br> <br>As<br> part of this license, ONCOX will grant BIOLITE a perpetual, royalty-free<br> right to use and reference any development, regulatory, and market data associated with the Licensed Product in ONCOX’s<br> control. |
3
| EXCLUSIVITY/<br><br> <br>NON-COMPETE | During the collaboration, neither Parties nor its affiliates will work on the development of or commercialize in the Territory any products containing Maitake Mushroom as the sole active ingredient or in combination with one or more other active ingredients other than with respect to any other product or usage for which the same parties have previously agreed or will agree to work on together or without a specific mutually agreed to written plan for depression indication. |
|---|---|
| TECHNOLOGY SHARING | After the Effective Date, and at a time to be agreed upon by ONCOX and BIOLITE in the Definitive Agreement, BIOLITE would transfer to ONCOX in English that data related to any Licensed Products in BIOLITE’s possession and control that is required by regulatory authorities for opening an IND, NDA. |
| INTELLECTUAL PROPERTY RIGHTS<br><br> <br>**** | Intellectual<br> Property means any patent, copyright, trade secret, trademark or other proprietary right；including<br> all their applications , registrations, renewals and extensions.<br><br> <br><br><br> <br>Each Party or its Affiliates owns all rights, title and interest of<br> the Intellectual Property developed or controlled by itself and will be responsible for filing and maintaining the Intellectual Property<br> in the Territory at its own cost.<br><br> <br><br><br> <br>Each Party warrants it does not and will not infringe, violate or misappropriate<br> any trademark, patent, copyright, industrial design, trade secret or any other intellectual property or proprietary right of any Third<br> Party.<br><br> <br><br><br> <br>No right, title or interest is granted to the other Party in the Definitive<br> Agreement, whether expressly or by implication, to any technology or Intellectual Property rights owned by a Party other than pursuant<br> to the terms of the Definitive Agreement.<br><br> <br><br><br> <br>Each Party will retain an unconditional and unlimited right of access,<br> inclusion, citation, electronic or photo copy, and regulatory cross reference, without limitation, to any and all regulatory, technical,<br> and scientific documentations, and any and all communications with any and all regulatory authorities in the other Party’s Territory<br> for all matters related to each Licensed Product during the License Term. |
4
| MILESTONE & ROYALTY PAYMENTS | See Exhibit B. |
|---|---|
| TAX<br><br> <br>**** | Payments to Licensor as detailed in Exhibit B are likely considered Licensor’s income generated in Territory. Licensor is responsible for income tax, value-added tax, and other related fees levied by Territory government authorities on these payments. If and to the extent that provision is made in law or regulation of Territory for withholding of taxes with respect to any such payment, Licensee shall pay such taxes on behalf of Licensor and provide Licensor with original receipt of such tax payments or withholding. |
| NET SALES | “Net Sales” means the total amount of<br> invoices issued by the Licensee for selling the Product of each pack size in the Territory to the Third Parties responsible for distribution<br> / logistics, minus the amount of allowable deduction items related to the Product actually provided to non-affiliates as follows:<br><br> <br><br><br> <br>a) sales<br> value added tax<br><br> <br><br><br> <br>b) allowance,<br> discount or rebate for rejection, defect, recall, return, retroactive price reduction<br><br> <br><br><br> <br>Net Sales shall be accounted in accordance with<br> arm-length principles, industry standards and practices of the Territory, covering all sales of the Product to the Field of Use in the<br> Territory. Any allowance, discount or rebate for any Third Party sales and marketing activities shall not be deducted from the Net Sales<br> calculation.<br><br> <br><br><br> <br>Licensee shall allow Licensor to appoint a Third<br> Party independent auditor to audit the financial accounts of Licensee or its affiliates to confirm the reasonableness and accuracy of<br> the Net Sales calculation of the Product each year during the License Term. |
| LICENSE TERMS | The term of licensing for the Licensed Product in the Territory is 20 years. |
| MANUFACTURING<br><br> <br>**** | Both Parties desire Licensee is responsible for<br> the Licensed Product API manufacturing under CMO model as global primary supplier. Both Parties agree further study and analysis are to<br> be performed for the feasibility from technical and financial perspective before the execution of related manufacturing agreement.<br><br> <br><br><br> <br>Manufacturing of Licensed Product finished product<br> is subject to negotiation by both Parties. |
5
Exhibit B
All payments below are pre-tax total payments in USD.
| Milestones |
|---|
| Upfront |
| A cash payment of 100,000 and above at any time will then be deducted from the second milestone payment. |
| Completion <br> Of<br> Fundraising |
| Total Licensing Fee |
| Royalties |
All values are in US Dollars.
Royalties shall be payable quarterly on annual Net Sales of the Licensed Product from the first commercial sale of a Licensed Product in the Territory to the end of License Terms.
6
Exhibit 99.1
Promising Combination Therapy for Tripple Negative Breast Cancer Treatment: A Milestone Collaboration Between ABVC and OncoX, Potential Income of $13.75M and Royalties of up to $12.50M
Fremont, CA (May 16, 2024) – 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 in its fight against breast cancer, the Company, together with its subsidiary BioLite, Inc. entered into a definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands, to collaborate on combination therapy it believes will help treat Triple Negative Breast Cancer and improve patient outcomes. The agreement establishes an aggregate license fee of $12,500,000 in the form of cash or shares of OncoX securities within 30 days of executing the agreement, with an additional milestone payment of $1,250,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee. OncoX may remit partial cash payments of at least $ 100,000 to the licensing fees, which would be deductible from the second milestone payment, and royalties of 5% of net sales, up to $12,500,000, after the launch of the licensed product, which remains uncertain. There is no guarantee that ABVC or its subsidiary will receive any of the fees listed.
The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1501 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1519 (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 for ABV-1703 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy. 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 a functional food for a long time in daily life.^1^
TNBC is a subtype of breast cancer that lacks estrogen, progesterone, and HER2 receptors. Unmet demands in TNBC typically refer to areas where current treatments or approaches fall short in addressing the needs of patients.^2^ While some TNBC patients benefit from immunotherapy, many do not; it’s important to understand better which patients are most likely to respond to immunotherapy and develop strategies to enhance its efficacy.^3^ Maitake mushrooms are rich in bioactive polysaccharides, especially D-fraction, which is the key ingredient of BLEX 404, the combination drug proposed in the contract. These protein polysaccharides have well-documented immune-protecting and antitumor properties.^4^
| ^1^ | https://www.sciencedirect.com/science/article/abs/pii/S0960852407001083?via%3Dihub |
|---|---|
| ^2^ | https://pubmed.ncbi.nlm.nih.gov/21161370/ |
| --- | --- |
| ^3^ | https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-023-01850-7#:~:text=Main%20body,and%20formulate%20individualized%20immunotherapy%20schedules. |
| --- | --- |
“This partnership represents a concerted effort to address the urgent need for more effective treatments for TNBC, a particularly aggressive form of breast cancer that lacks targeted treatment options. TNBC accounts for a substantial proportion of breast cancer cases worldwide, posing significant challenges due to its resistance to conventional hormonal therapies and targeted treatments^5^,” said Dr. Uttam Patil, ABVC’s Chief Executive Officer. He added, “In response to this critical unmet medical need, ABVC and OncoX have joined forces to explore a novel therapeutic approach that holds promise for improving outcomes and quality of life for TNBC patients. The proposed combination therapy draws upon companies’ complementary expertise and innovative research. By leveraging their drug development and oncology strengths, both companies aim to create a synergistic treatment regimen targeting multiple pathways involved in TNBC progression.”
“We are excited to embark on this collaborative journey with ABVC to advance the field of oncology and bring hope to patients battling TNBC,” said Wen-Pin Yen, CEO of OncoX. “This partnership underscores our shared commitment to harnessing the power of combination therapies to address the complexities of TNBC and improve patient outcomes. The agreement encompasses a comprehensive research and development program, including preclinical studies, clinical trials, and regulatory initiatives. Both companies will contribute their resources, expertise, and intellectual property to accelerate the development timeline and maximize the therapeutic potential of the combined approach.”
Under the terms of the agreement, ABVC grants OncoX exclusive rights to develop, manufacture, and commercialize BLEX 404, a promising therapeutic agent for treating Tripple Negative Breast Cancer within a specified territory.
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.^6^ The global TNBC market’s expected CAGR is around 5.50% in the mentioned forecast period and it was valued at USD 953.8 million in 2022 and would grow to USD 1,463.82 million by 2030.^7^
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 websitefor 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.
| ^4^ | https://www.webmd.com/diet/maitake-mushroom-health-benefits |
|---|---|
| ^5^ | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5352107/ |
| --- | --- |
| ^6^ | https://www.precedenceresearch.com/cancer-therapeutics-market |
| --- | --- |
| ^7^ | https://www.databridgemarketresearch.com/reports/global-triple-negative-breast-cancer-market |
| --- | --- |
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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
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