ABVC

Company profile

• Early-stage biotechnology company focused on central nervous system (CNS) disorders and oncology/hematology.
• Pipeline of seven drug candidates and one medical device, all licensed from related parties.
• Leadership: Dr. Uttam Patil (CEO) and Dr. Tsung-Shann Jiang (founder and majority shareholder).

Business model

• Primary revenue streams: out-licensing intellectual property and contract development and manufacturing organization (CDMO) services.
• Sources and licenses drug and device candidates from research institutions in the Asia‑Pacific region and coordinates development and trials with principal investigators in the U.S., Australia, and Taiwan.
• Maintains in-house GMP manufacturing capability through BioKey to support clinical trial supply (INDs) from Phase I through Phase III.

Pipeline

Central Nervous System (CNS)

• ABV-1504 — Botanical norepinephrine reuptake inhibitor for Major Depressive Disorder (MDD)
  • Preclinical radioligand-binding assays indicate high norepinephrine inhibition.
  • Phase I completed in Taiwan (2013); U.S. FDA IND approved for Phase II (March 2014); Taiwan FDA IND for Phase II (June 2014).
  • Phase II results announced May 23, 2019: high-dose (2 × 380 mg) showed a statistically meaningful improvement on MADRS versus placebo; high-dose formula planned for Phase III.
• ABV-1505 — Attention Deficit Hyperactivity Disorder (ADHD), same API as ABV-1504
  • FDA-accepted IND for Phase II (January 2016).
  • Phase II design: randomized, double-blind, placebo-controlled dose-escalation study in the U.S. and Taiwan.
  • UCSF initiated Phase II Part I (January 14, 2020); Part I completed July 15, 2020; clinical study report issued October 24, 2020.
  • Part I results: ITT improvement 83.3% (N=5); PP improvement 80.0% (N=4) on ADHD-RS-IV at eight weeks; primary endpoints met. Part II recruitment and additional analyses were planned to support further development.

Other programs and device

• ABV-1601 — Major depression in cancer patients (Phase I/II).
• ABV-1701 — Vitargus®, a vitrectomy medical device (Phase II initiated in Australia and Thailand across multiple sites).
• ABV-1519 — Non‑Small Cell Lung Cancer (NSCLC); planned Phase I/II in Taiwan (scheduled 3Q2026).
• ABV-1703 — Advanced inoperable or metastatic pancreatic cancer; Phase II planned (scheduled 3Q2026).
• Strategy: pursue partnerships with larger pharmaceutical companies after Phase II to complete Phase III and commercialization, subject to regulatory approvals.

Manufacturing and facilities

• BioKey GMP manufacturing facility (owned) qualified to supply clinical trial quantities (Phase I–III).
• Capabilities: API supply; capsule blending and filling; encapsulation; tablet compression, coating, and packaging for solid dosage forms; analytical testing and support for IND submissions.
• Facility components: GMP suite, development area, analytical laboratory, storage, and two warehouses.
• Current manufacturing licenses allow manufacture under IND through December 2, 2024; renewal and upgrade efforts are in progress.
• In 2022, BioKey expanded into maitake mushroom dietary supplement production sourced from Define Biotech (Taiwan), targeted at high‑end grocery stores with online distribution in the U.S., Canada, and Taiwan.
• Distribution arrangement: Define Biotech Co., Ltd. holds exclusive rights to distribute the maitake supplement in China and Taiwan; agreement auto‑renews through December 6, 2026 and includes a $3.0 million purchase commitment over three years.

Partnerships and collaborators

• Revenue model combines IP out‑licensing and CDMO services for external clients.
• Key partnership: exclusive distribution agreement with Define Biotech for the maitake supplement in China and Taiwan (see above).
• Clinical trials and development activities involve collaborations with academic medical centers and principal investigators, including UCSF, Stanford Depression Research Clinic, and Taipei Veterans General Hospital.

Regulatory and listing status

• Nasdaq compliance timeline:
  • July 10, 2024: Nasdaq notified the company that the minimum bid price fell below $1.00 (non‑compliance with Rule 5550(a)(2)); initial compliance deadline set for January 6, 2025.
  • January 9, 2025: Nasdaq granted an additional 180 days (to July 7, 2025) to regain compliance.
  • May 13, 2025: Nasdaq notified the company that the bid price requirement was met; no reverse stock split required.
  • April 24, 2025: Nasdaq notified the company that, based on 4/23/2025 stockholders’ equity of $723,959, it did not meet alternatives under Listing Rule 5550(b)(1).
  • May 5, 2025: Nasdaq notified the company that stockholders’ equity as of 3/31/2025 was $7,956,295 and the company complied with Listing Rule 5550; the matter was closed.

Intellectual property and risk context

• Business depends on licensing agreements and IP protection across multiple jurisdictions.
• Ongoing risk considerations include regulatory approvals, competition, manufacturing and supply chain, IP protection, international operations, and financing needs.

Financials

• Revenue sources include out‑licensing of intellectual property and CDMO manufacturing services.