Full Press Release Details
ABVC BioPharma Inc. Reports Q3 2024 Financial
and Operational Milestones
Fremont, CA (November 14, 2024) - ABVC BioPharma, Inc. (NASDAQ:
ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, is
pleased to announce its financial results and key operational highlights for the third quarter ended September 30, 2024.
Key Financial and Operational Highlights:
1. Financial Performance:
2. Strategic and Operational Milestones:
Advances in Clinical Development:
ABVC completed Phase II trials for ABV-1504 in
Major Depressive Disorder (MDD) and is preparing for an FDA End-of-Phase 2 meeting to finalize the Phase III protocol.
Progress continues in our ADHD program with Phase
IIb trials at multiple prominent sites. We aim to have an interim report by Q4 2024.
Additionally, ABVC's first-in-class vitreous
substitute, Vitargus , for retinal detachment surgery, is advancing through regulatory stages with approvals for further trials in
3. Strengthening Partnerships:
ABVC has secured multiple long-term licensing
agreements, notably with ForSeeCon Eye Corporation for Vitargus , which could potentially generate $187 million in revenue
In Q3, ABVC's continued collaboration with OncoX
expanded the oncology pipeline, positioning the Company for strong future growth in partnership-driven revenue streams.
Expanded Intellectual Property Portfolio: ABVC
has been granted multiple patents in the U.S., Taiwan, and Australia, covering a range of CNS and ophthalmology treatments. These patents
reflect our innovative R&D approach and commitment to protecting our groundbreaking therapies.
ABVC will continue working closely together with
its strategic partners, AiBtl BioPharma Inc., ForSeeCon Eye Corporation, and OncoX BioPharma Inc., on international business and clinical
developments of CNS new drugs, Ophthalmology products and Oncology new drugs, respectively.
Management Commentary:
Dr. Uttam Patil, ABVC Chief Executive Officer,
commented, "Our third-quarter results showcase the impact of our strategic direction and dedicated team. Our strengthened financial
position and exciting progress in CNS and oncology programs should enable us to drive future shareholder value. We thank our investors
for their continued confidence as we advance ABVC's growth trajectory. For the first time in its history, ABVC BioPharma achieved an operational
profit in the third quarter of 2024, marking a transformative milestone for the Company and underscoring the effectiveness of our strategic
approach. This significant achievement is a testament to our dedicated focus on operational efficiency, robust cost management, and the
strength of our pipeline. The company receiving licensing income has successfully turned an operational loss into operational income for
the first time. However, due to higher interest expenses arising from the accounting treatment of amortization expenses related to convertible
debt, the EPS stands at -$0.02. Despite this slight negative EPS, the core business has achieved profitability, reflecting strong operational
improvements driven by the licensing income. This milestone demonstrates the company's ability to generate income, positioning us
toward sustained financial growth as we manage these interest-related expenses. We believe ABVC is poised to maintain this upward growth
trajectory through its global licensing agreements, which are anticipated to deliver a strong and recurring income stream. These partnerships
have the potential to fortify our financial position and enable ABVC to expand its reach in key therapeutic markets, which should pave
the way for sustained, long-term growth and increased shareholder value."
Board of Directors Statement:
"With a stronger financial foundation, strategic
partnerships, and a promising pipeline, we believe that ABVC is well-positioned for continued growth. The Company anticipates further
revenue growth through strategic collaborations, ongoing clinical developments, and new market entries. ABVC remains committed to advancing
its high-potential CNS, oncology, and ophthalmology programs to bring life-changing therapies to patients worldwide."
Operational Highlights
Patents and FDA Approvals
The Company received a US patent (US 16/936,032),
valid until September 04, 2040, a Taiwanese (TW I821593) Patent, valid until July 22, 2040, and an Australian (AU2021314052B2) Patent,
valid until April 09, 2041, for Polygala extract for the treatment of major depressive disorder. The Company received a US (US17/120,965),
valid until December 20, 2040, and Taiwanese (TW 110106546), valid until February 24, 2041, Patent for Polygala Extract for treating Attention
Deficit Hyperactive Disorder. A Taiwanese Patent (TW I792427) for Storage Media for the Preservation of Corneal Tissue was obtained on
February 11, 2023, and is valid till July 19, 2041. As we work towards expanding our patent map into global coverage, we eagerly await
the results of patent applications in the European Union, China, Japan, and others.
On December 30, 2022, the Company received US
FDA approval for the IND ABV-1519 to proceed with the Combination therapy for treating Advanced Inoperable or Metastatic EGFR Wild-type
Non-Small Cell Lung Cancer was approved and the study can proceed. The IND was then submitted to the Taiwan FDA, and the approval was
received on January 04, 2024. The United States Food & Drug Administration (US FDA) has approved four INDs, ABV-1501 for Triple Negative
Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic
The MDD Phase II trials for ABV-1504 were completed
successfully with good tolerance to the drug, and no serious adverse effects were reported. The product is ready for an End-of-Phase 2
meeting with the FDA to finalize the protocol for Phase III trials. At the same time, we commenced the ADHD Phase IIb trials at the University
of California, San Francisco (UCSF) and five other sites in Taiwan. The trials are heading for the interim report, which we expect to
complete by the end of Q3 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation
Visit (SIV). The study is set to initiate by the end of 2024.
On July 31, 2023, ABVC signed a legally binding
term sheet with a Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd, for the exclusive licensing of ABV-1504 for Major
Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit Hyperactivity Disorder in mainland China. Under this agreement, Xinnovation
will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for MDD and ADHD in the Chinese market
and shall bear the costs for clinical trials and product registration in China. We are negotiating definitive agreements with Xinnovation
and are excited that the licensing deal carries a possible aggregate income of $20 million for ABVC if all expected sales are made, of
which there can be no guarantee. This transaction remains subject to the negotiation of definitive documents and therefore there is no
guarantee that this transaction will occur.
In November 2023, each of ABVC and one of its
subsidiaries, BioLite, Inc. ("BioLite"), entered a multi-year, global licensing agreement with AIBL for the Company and BioLite's
CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder). The potential license
will cover the licensed products' clinical trials, registration, manufacturing, supply, and distribution rights. The licensed products
for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation. The parties are determined to collaborate
on the global development of the licensed products. The parties are also working to strengthen new drug development and business collaboration,
including technology, interoperability, and standards development. As per each of the respective agreements, each of ABVC and BioLite
shall receive 23 million shares of AIBL stock that the parties value at $10 per share (not independently validated) and if certain milestones
are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million, which is not guaranteed.
Vitargus , a vitreous substitute,
is a groundbreaking, advanced-staged R&D product that we believe will be the first biodegradable hydrogel used in retinal detachment
surgery. Vitargus has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods
Administration (TGA) to initiate the next trial phase in two participating sites. This is vital to obtaining final regulatory approval
for Vitargus in Australia.
The Science Park Administration in Taiwan approved
ABVC's plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus and to pursue the process
development work for manufacturing optimization. We are undertaking this project, proposed by ABVC's Taiwan affiliate and co-development
partner, BioFirst Corporation, to upgrade the Vitargus manufacturing processes so it can ultimately handle the clinical
trial supply. ABVC and BioFirst Corporation expect to complete the facility's upgradation in Hsinchu Biomedical Science Park, Taiwan,
The United States Food & Drug Administration
(US FDA) approved the Investigational New Drug (IND) application for the proposed clinical investigation of BLEX 404, the primary active
ingredient in ABV-1519, for advanced inoperable or metastatic EGFR wild-type non-small cell lung cancer. This treatment is being co-developed
by BioKey, Inc. ("BioKey") and by the Rgene Corporation, Taiwan. The study received approval from the Taiwan FDA. This is the
fourth IND approved by the US FDA for BLEX 404. The previous three INDs are for the combination therapies of triple-negative breast cancer,
myelodysplastic syndromes (MDS), and pancreatic cancer.
BioKey, a wholly-owned subsidiary of the Company