FREMONT, CA – July 9, 2024 – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, neurology, and oncology/hematology, announced today that after successful Phase II clinical trials of their medication to treat Major Depressive Disorder (MDD), the Company and AiBtl BioPharma Inc. are working towards a new clinical study on Depression in Cancer Patients by integrating AI-driven solutions.

Depression is a significant concern among cancer patients, often complicating treatment and affecting the overall quality of life.[1]

"This study aims to understand better the prevalence and impact of depression in this vulnerable population and to explore innovative therapeutic approaches. By integrating real-time patient monitoring and improved patient analysis using an AI model, we hope to help ABVC increase the lead time for clinical trials using new and advanced treatment protocols," said Russman Jaimes, CEO of AiBtl BioPharma.

Study Highlights:

Objective: To assess the effectiveness of new treatment protocols for depression in cancer patients.

Collaboration: The study is a joint effort between ABVC, a leader in biopharmaceutical research, and AiBtl, specializing in artificial intelligence-driven healthcare solutions.

Location: The clinical study will be conducted at Cedars-Sinai Medical Center, a world-renowned medical research and patient care institution.

Participants: Cancer patients experiencing depressive symptoms will be recruited for this study. We believe that AI models that scan patient histories can better classify patients.

Methods: The study will utilize advanced AI technologies and employ cutting-edge diagnostic and therapeutic techniques to monitor and treat depression in participants under a doctor's care.

Russman Jaimes added, "Our Medical Digital Agency tools have shown positive results in preliminary tests done by doctors and Healthcare providers treating their current patients. We can now automatically quantify and diagnose several diseases using our AI models. By integrating our AI capabilities with ABVC's innovative research, we aim to provide new insights and treatment options for those suffering from depression during their cancer journey. This study represents a significant step forward in personalized real-time patient care and health awareness, which is vital for people suffering from mental health disorders. With a reported 40% of women with breast cancer reporting mild depression and more having difficulty adjusting to a cancer diagnosis, we believe that a plant-based, all-natural treatment option with no adverse side effects is necessary.[2] Our subsidiary, TTLife, aims at a yearly revenue of US$ 10M, and AiBtl has acquired land assets valued at US$ 7M (third-party evaluation). Adding an AI platform will further enhance our partnership with ABVC, leveraging their extensive clinical research experience, which we expect will boost both companies' profitability."

The market for MDD is expected to reach $14.96 billion by 2032. The study protocol is expected to be completed soon for FDA approval and presented at upcoming conferences.

"We are thrilled to collaborate with AiBtl on this vital study," said Dr. Uttam Patil, ABVC Chief Executive Officer. "We believe that our combined expertise in biopharmaceuticals and AI technology will enable us to develop more effective treatments for depression in cancer patients, ultimately improving their quality of life." He added, "From our Phase MDD II study, randomized, double-blind, placebo-controlled Phase II study enrolled 60 patients diagnosed with MDD; Primary Endpoint suggested that patients treated with PDC1421 showed a clinically meaningful improvement in MADRS scores compared to placebo, suggesting that deeper research should be carried out in Phase III. Secondary Endpoints showed clinical improvements as no SAEs were reported, considering the enrolled subjects' overall functioning and life measures. No signs of drug addiction or suicidal ideation were reported. PDC1421 was well tolerated, with a safety profile consistent with previous studies. These results highlight the potential of PDC1421 to address a critical unmet need in the treatment of Major Depressive Disorder. We look forward to advancing this program into Phase III clinical trials and gaining more insightful data from the AI models to strengthen our claims."

Major Depressive Disorder affects millions of individuals worldwide, often leading to significant impairment in daily functioning.[3] Current treatment options are limited and often have suboptimal efficacy and tolerability.[4] ABVC is committed to developing innovative therapies that improve the lives of patients with MDD and other severe mental health conditions.

About PDC-1421

PDC1421 is a novel Norepinephrine uptake inhibitor. Preclinical studies and early clinical trials have demonstrated its potential efficacy in reducing depressive symptoms and improving patient outcomes. It has completed Phase II clinical studies and plans to initiate an end-of-phase II (EOP 2) meeting with the FDA.

We believe the Company's pipeline products have great market potential. According to the Future Market Insights report, the MDD market was valued at $11.51 billion in 2022 and is expected to reach $14.96 billion by 2032, with a CAGR of 2.8% over the forecast period.[5] According to the Polaris market research report, the global ADHD treatment market was valued at $16.13 billion in 2022 and is expected to reach $32.14 billion by 2030 with a CAGR of 7.1% over the forecast period.[6]

About ABVC BioPharma & Its Industry

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV1701/Vitargus(R)) under development. For its drug products, the Company utilizes unlicensed 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(R), 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 10K and its Quarterly Reports on Form 10Q. 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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