昱展新藥生技股份有限公司 (TPEx 6785) [time:2026Q2] 法說會簡報

Company Overview

Company Name: 昱展新藥生技股份有限公司 (Alar Pharmaceuticals Inc.) Presenter: 總經理 文永順 博士 (Dr. Yung-Shun Wen, General Manager) Date: April, 2026

Disclaimer: Due to the nature of the work described in this document, results of any work described hereunder cannot be guaranteed; however, Alar Pharmaceuticals Inc. (“Alar”) will use good faith efforts in performing the work outlined in this document to achieve the objectives. The audience acknowledges that the results of the work(s) described herein is inherently uncertain, due to various reasons, including but not limited to the result(s) of research and development activities of Alar, the decision of regulators regarding the filings for pharmaceutical products, result(s) for clinical trial(s), delays or adverse supply event(s) in Alar's manufacturing activities, alteration of applicable regulations or rules, or even uncertainties of general economic, political, commercial, regulatory regimes or market relevant circumstances, and that accordingly, there can be no assurance, representation or warranty by Alar either express, implied or otherwise that the actual scientific or pharmaceutical results of the services hereunder can or will necessarily meet Client's desired scientific or other results. Alar also disclaims any implied warranties or merchantability, fitness for any updated information, event or other matters occur or appear to Alar's knowledge after the date hereof.

Products & Technologies

Pipeline Overview

ALA-3000: Treatment-Resistant Depression (TRD)

The Ketamine Gap in Care: Ketamine therapy has shown revolutionary efficacy but remains hindered by pharmacological limitations:

• Short Half-life: Rapid metabolism (2-3 hours) requires frequent clinical visits.
• Dissociative Spikes: Peak concentrations (Cmax) cause hallucination, and blood pressure spikes.
• Patient Burden: Due to the intensive dosing schedule of IV or Nasal routes and ≥2-hour monitoring post-dose.

ALA-3000 Breaks Key Barriers: A Differentiated Long-Acting Ketamine:

• Sustained-Release: without volatile spikes
• Extended Half-Life: Transformed from hours to days.
• Subcutaneous Delivery: Simple administration in a primary care setting.

First in Human Study Overview:

• Population: 37 TRD patients enrolled in a multiple-dose, dose-escalation study.
• Study Sites: Multi-center study in the United States.
• Treatment: ALA-3000 + Oral Antidepressant.
• Objectives: Primary focus on safety, tolerability, PK profile and explore preliminary efficacy of the proprietary LAI formulation, ALA-3000.
• Status: Successfully met all primary endpoints.

Key Safety Highlight:

• Favorable Safety & Tolerability: All AEs were Mild to Moderate. Zero discontinuations due to AEs.
• No Blood Pressure Elevation: Successfully mitigated the acute blood pressure spikes typically associated with ketamine.
• No Urinary Toxicity: No urinary tract AEs related to ALA-3000 reported, a major hurdle for chronic ketamine use.
• Improved Psychiatric Safety Profile: No Dissociation, Sedation, Psychosis-like symptoms observed.
• No Abuse Signals: Absence of drug-seeking behavior or abuse-related adverse effects. No clinically meaningful indication of withdrawal symptoms after cessation.
• Zero Suicidal Behavior: No reports of worsening suicidal ideation or suicidal behavior during the study.

Psychotropic Safety - Dissociation:

• ALA-3000 eliminates the "Peak-driven" psychotropic side effects, allowing for sustained therapeutic levels without the dissociative distress common in IV/IN routes.

Psychotropic Safety - Sedation:

Stable Plasma Concentrations:

• Sustained Therapeutic Levels: Phase 1 pharmacokinetics (PK) data confirms that ALA-3000 achieves and maintains therapeutic plasma concentrations steadily.
• Zero-Order Release Profile: confirmed across all dose levels escalation.
• Flattened PK profile eliminates Cmax-driven CNS side effects.

Exploratory Efficacy: Change in Montgomery-Åsberg Depression Rating Scale (MADRS):

• Early onset: MADRS total scores decreased as early as 24 hours post-dose.
• Sustained improvement: From Day 9 to Day 36, Superior to Placebo: -3 to -6 pts (150mg) | -2 to -4 pts (250mg).
• Robust Response rates (≥50% depression reduction):
  • Placebo + Oral AD: 36~45% Response
  • ALA-3000 (150 mg) + Oral AD: ≥60% Response
  • ALA-3000 (250 mg) + Oral AD: 54~69% Response
• Encouraging Remission rates (MADRS ≤10):
  • ALA-3000 (150 mg) + Oral AD: 50%
  • ALA-3000 (250 mg) + Oral AD: 31%
  • Placebo + Oral AD: 18%

Redefining Patient Access & Clinical Care:

• CLINICAL EFFICIENCY - Eliminating Monitoring Constraints: ALA-3000 has the potential to eliminate mandatory prolonged post-dose monitoring, removing the 2-hour observation requirement typical of current therapies.
• MARKET REACH - Expanding Beyond Boundaries: By reducing reliance on specialized psychedelic-assisted psychotherapy, ALA-3000 scales treatment to a much broader patient population in primary care settings.

Strategic Competitive Landscape (ALA-3000):

Key Milestones (ALA-3000):

• Completion of Phase 1 TRD Patient Study (US).
• Completion of nonclinical fibromyalgia POC.
• Submitted pre-IND meeting regarding fibromyalgia.
• Patent granted in 54 countries/areas. (expiration 2040).

ALA-4000: Parkinson's Disease

Target Product Profile:

• Product Overview: A transformative drug delivery system designed to solve the "OFF" period fluctuations in Parkinson's Disease patients. By utilizing advanced sustained-release technology via SC injection, we provide stable plasma concentrations for 7-14 days.
• Zero Training, Maximum Convenience: No specialized and complex devices, and zero home-management stress. Simply visit at regular clinics.

Key Clinical Advantages:

• Reduced Dosing Frequency: Weekly/Biweekly vs. Daily Oral/continue attached pump.
• Steady Pharmacokinetics: Elimination of peaks and troughs.
• Superior Safety: Lower risk of nausea and drug-induced dyskinesia.
• High Adherence: Optimized for elderly dexterity and compliance.
• Mitigate Injection Site Burden: Decrease invasive puncture numbers and time, tolerable formulation.

ALA-4000 Key Advantages:

ALA-5000: Schizophrenia

Program Progress:

• 01 Process Development: Completion of API and formulation process development and scale-up.
• 02 Pharmacokinetic Studies: Successful PK profile verification in rat, dog, and minipig models.
• 03 Toxicology Studies: Completion of Pilot toxicology studies in rats with favorable safety data.
• 04 Regulatory Engagement: Completion of pre-IND meeting; Pipeline ready for IND enabling studies.

ALA-1000: Opioid Use Disorder (OUD)

ALA-1000 In Human OUD:

• Completion of Phase 2 DMPK study.
• Advancing manufacturing development activities to support clinical supply.

Benefits of ALA-1000, Long-Acting Analgesic:

• Animals:

  • 90% Enhanced Quality of Life*

  • More Efficient*
    • 100% showed Pain Severity↓
    • Treatment Success >80%
  • Better Safety Profile
    • Known, mild BUP-related AEs
    • None or less AEs after 2nd dose
    • No drug-related ISRs
  • Safe for Renal/Hepatic Impairment
  • No OA Structural Progression
• Pet Owners:
  • Time-Saving
  • Reduced Burden in
    • Daily Dosing
    • Frequent Visits
    • Anxiety over AEs
  • No At-Home Misuse
• Veterinarians:
  • Precise In-clinic Administration
  • Predictable Follow-ups
  • Minimized AEs Risk
  • Broader Applicability
  • Improved Client Satisfaction (Abbreviations: BUP: buprenorphine; AE: Adverse event; ISR: Injection site reaction; OA: osteoarthritis. *Data pooled from the pilot study and the field study)

ALA-1000 Efficacy in OA pain Dogs:

• 75% dogs reached treatment success by CBPI¹ higher than Librela™ (45.2%).

• 85% Reached treatment success by Lameness².

• 75% Improved Quality of Life by HRQL³.

• Key Findings:
  • 100% dogs have pain relief assessed by CBPI PSS.
  • Analgesic efficacy did not exhibit tolerance: In dogs receiving continuous monthly dosing of ALA-1000 for more than 1 year, no evidence of tolerance was observed based on efficacy assessments. (¹Same definition of treatment success with Librela (From Baseline to Day 28, CBPI (Canine Brief Pain Inventory) Pain Severity Score (PSS) reduce at least 1 grade AND Pain Interference Score (PIS) reduce at least 2 grade in dogs with baseline PSS ≥2 and PIS ≥2). ²Same definition of treatment success with PREVICOX (From Baseline to Day 28, Lameness scoring Lameness overall reduce at least 1 grade OR Lameness total reduce at least 2 grade; ³Health Related Quality of Life, HRQL, scored by 1-10)

Innovative Long-acting Peptide Platform

• Wide Utility: Broadly applicable across metabolic peptide therapeutics (e.g., GLP-1, GIP, amylin).
• Optimized PK Profile: Gradual concentration rise mimics natural titration, reducing side effects (e.g., GI).
• Superior Convenience: Eliminates invasive burden and frequent clinic visits with sustained exposure ≥ 1 month. Minimal interference in daily social and work life.

Injection Burden:

Financial Highlights

Financial Statement (Unit: Thousand, NTD)

• As of the end of 2025, the Company had cash on hand of NT$2.412 billion.

Outlook & Strategy

2026 Operational Focus

• ALA-1000:
  • Support NADA in TW.
  • Veterinary study in feline.
• ALA-3000:
  • Plan subsequent clinical studies for TRD.
  • Explore the application in fibromyalgia.
• ALA-4000:
  • Pre-IND meeting.
  • Manufacture development to support IND.
  • Pilot toxicology assessments.
• ALA-5000:
  • Manufacture for nonclinical supply.
  • Initiate IND-enabling studies.

Additional Data

Intellectual Property Portfolio

• Global intellectual property portfolio, including composition of matter, polymorph, and formulation.
• Written Opinion of PCT patent:
  • Novelty (N): Claims 1-24: YES
  • Inventive step (IS): Claims 1-24: YES
  • Industrial applicability (IA): Claims 1-24: YES

Contact Information

• Email: alar@alarpharm.com
• Phone: +886-4-24637115
• Address: 5F., No. 32, Keya Rd., Daya Dist., Taichung City, 428015, Taiwan
• Website: https://alarpharm.com/