FREMONT, CA - 
(NewMediaWire) - May 22, 2024 - – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, today published a Corporate Update and Letter to Shareholders from Chief Executive Officer, Dr. Uttam Patil.
Dear Fellow Shareholders,
As the CEO of ABVC BioPharma, Inc., I am honored to address you and share our achievements and future aspirations. This year has been a period of transformation, marked by significant business development milestones and unprecedented challenges in preparing for the US FDA's Phase III requirements for MDD. I am proud to lead our team through these endeavors.
Reflecting on the past year and looking ahead, I want to express my deep appreciation to each of you, our esteemed shareholders. Your unwavering support and confidence in our Company are the pillars of our success. Your belief in our vision and mission inspires us and drives us to strive for excellence daily. Your support is invaluable and we are truly grateful for it. I am proud to share with you the progress we have made.
The past year has been marked with significant growth and learning for us. Despite our challenges, we've demonstrated remarkable resilience, a testament to our unwavering commitment to our mission. We've made substantial strides in several key areas, executing definitive licensing agreements for cash licensing fees with three strategic partners: AiBtl BioPharma Inc. ("AIBL"), OncoX BioPharma, Inc. (OncoX), and ForSeeCon Eye Corporation ("FEYE"). These anticipated licensing agreements are projected to generate cash revenue totaling up to $24M (AIBL = $7M, FEYE = $7M, OncoX = $10M), bolstering the Company's financial stability. These achievements are a testament to our talented team's dedication and hard work.
While we celebrate our achievements, we also recognize that the journey to sustained success is ongoing. We are acutely aware of our industry's dynamic nature and the challenges it presents. However, we remain steadfast in our commitment to our strategic objectives, designed to achieve continued growth and success and to pioneer new frontiers in the biopharmaceutical industry. This commitment is unwavering, and we are confident in navigating the future.
Innovation and Product Development: We will continue to invest in research and development to bring cutting-edge solutions to the market. Our pipeline of products is robust, and we are excited about the potential these innovations.
$7.6 Million Land Deal: As we prepare to take our MDD trials into Phase III, which requires enrollment of 600-700 subjects, several US FDA requirements must be addressed, related mostly to the purity and stability of our botanical drugs. Based on a third-party valuation, ABVC’s subsidiary AiBtl agreed to exchange ownership stakes in certain real estate valued at approximately $7.6 million for shares of our common stock. This land is being prepared to build our own controlled condition farms for botanical drugs under Good Agricultural Practice (GAP) compliance, which is essential for several reasons. Controlled condition farms allow for precisely regulating environmental factors such as light, temperature, humidity, and soil conditions, which helps to ensure the plants grow under optimal conditions. Those conditions greatly contribute to consistent levels of active compounds crucial for producing reliable and effective botanical drugs; maintaining consistent growing conditions minimizes the plant's chemical composition variability. This uniformity is vital for ensuring the safety and efficacy of the drugs derived from these plants. Controlled environments facilitate better traceability of plant materials, from seed to final product. This is important for regulatory compliance, too, as it ensures that all steps in the cultivation and processing are documented and can be audited. Regulatory bodies often require stringent quality standards for botanical drugs. Controlled condition farms can more easily meet these standards, ensuring the products are safe and effective for consumer use.
Operational Excellence: Efficiency and agility are critical in today's competitive landscape. We are optimizing our operations to ensure we can respond swiftly to market changes while maintaining high standards of quality and service.
$55M-$467M Licensing Deals: ABVC executed licensing deals of up to $467M with AIBL, $33.5M with FEYE, and $55M with OncoX. We believe partnering with private entities will allow us to enhance our team with the necessary skills and resources while opening up new revenue streams through innovative collaborations and market expansion. By leveraging the strengths and capabilities of our partners, we strive to achieve sustainable growth, improved innovation, and a competitive edge in the market. These partnerships allow us to focus on our core strengths while relying on partners to manage other aspects of the business, such as logistics and business development support. We believe these partnerships will benefit us and set the stage for long-term success and resilience.
Financial Discipline: Prudence in financial management remains a cornerstone of our strategy. We will allocate resources wisely to ensure long-term profitability and shareholder value.
Looking ahead, our strategic priorities are clear, and we have the right team to execute our plans effectively. Our operations are strengthened through specialized partnerships that we believe will accelerate our development of key pipelines and, ultimately, strengthen our balance sheet and market position. This will give us a solid foundation for future growth and improve our market position.
We value your trust and are committed to maintaining transparent communication with you. We can work together to achieve our common goals by keeping you informed and engaged.
Thank you once again for your continued support. We are excited about the future and look forward to sharing our success.
Sincerely,
Uttam Patil, Ph.D.
Chief Executive Officer,
ABVC BioPharma, Inc.
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, 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, 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
Chief Financial Officer,
ABVC BioPharma, Inc.
Email: leedschow@ambrivis.com
