昱展新藥生技股份有限公司 (TPEx 6785) 2026Q1 法說會簡報

Company Overview

公司名稱: 昱展新藥生技股份有限公司 (Alar Pharmaceuticals Inc.) 股票代號: TPEx 6785 法人說明會日期: May, 2026 總經理: 文永順 博士

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-1000 (Opioid Use Disorder (OUD))

ALA-1000 in Human OUD

• Completion of Phase 2 multiple dose PK study and developmental and reproductive toxicology studies.
• Amendment agreement:
  • (1) 昱展新藥將持有美國外的全球市場所有權利，包含產品開發、製造、專利智財權及商業化權利。Indivior保有美國的商業化權利，惟昱展新藥仍保有在美國的開發、製造及相關智財權。
  • (2) 原合約訂定的開發里程碑金，包含美國及主要市場如歐洲(法德英義等)、日本等，將改為於美國領證後，Indivior一次性支付在美國的商業里程碑金5,000萬美元。
  • (3) 銷售分潤權利金方面，起始銷售分潤比例將由10%提升至12.5%，並於達成特定銷售門檻後，由12.5%進一步提前提高至15%之高分潤區間。
  • (4) 本次修約未變更銷售里程碑金。

Taiwan Marketing Potential in Pet Pain Management

• Taiwan (2025)¹:
  • ~1.5 million pet dogs
  • ~1.7 million pet cats
• Osteoarthritis (OA) pain:
  • Nearly 40% Dog has OA diagnosed
  • 40% Cat has signs of OA pain²
• More than 1 million companion animals are affected by OA pain.
• Additional opportunities may include cancer pain and post-operative pain management.
  • ¹ https://www.moa.gov.tw/theme_data.php?theme=news&sub_theme=agri&id=10118
  • ² Understanding The New Science Of Canine OA Pain - Zoetis PH. https://www2.ph.zoetis.com/oa-pain/canine-oa-pain

ALA-1000 in Pet Pain Management

• 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%)

  • Reached treatment success by Lameness²: >85%
  • Improved Quality of Life by HRQL³: >75%
• 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.
  • ¹ Same 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)
  • ² Same 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
  • ³ Health Related Quality of Life, HRQL, scored by 1-10

ALA-1000 vs. Librela™ | Feature | ALA-1000 (Monthly buprenorphine injection) ALA-3000 eliminates the "Peak-driven" psychotropic side effects, allowing for sustained therapeutic levels without the dissociative distress common in IV/IN routes.

• 1. Ther Adv Psychopharmacol. 2025 Nov 13;15:20451253251394127. 2) Expert Opin Drug Saf. 2020 Aug;19(8):1031-1040.3) BMC Psychiatry. 2021 Oct 25;21(1):526. 4) Am J Psychiatry. 2019 Jun 1;176(6):428-438.

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 and REMS-related restrictions, removing the 2-hour observation requirement typical of current therapies and improving patient throughput.
• 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

• https://www.europeanpharmaceuticalreview.com/news/111823/nice-does-not-recommend-esketamine-for-treatment-resistant-depression/

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

• https://www.vyalev.com/vyalev-pump; https://www.onapgohcp.com/about-onapgo
• All photos within this website are actor portrayals.

Intellectual Property Portfolio

• Global intellectual property portfolio, including composition of matter, polymorph, and formulation.
• Written Opinion of PCT patent:
  • International application No. PCT/CN2025/131643
  • 1. Statement
    • Novelty (N): Claims 1-24 (YES), Claims None (NO)
    • Inventive step (IS): Claims 1-24 (YES), Claims None (NO)
    • Industrial applicability (IA): Claims 1-24 (YES), Claims None (NO)

ALA-5000 (Schizophrenia)

Advantages of Cariprazine (CAR)

• Fewer Side Effects: Compared with first- and second-generation antipsychotics, CAR is associated with fewer side effects.
• Effective for Negative Symptoms: A first-line treatment option for negative symptoms of schizophrenia.
• Broad Therapeutic Benefits: CAR is also effective in treating bipolar I disorder and major depressive disorder (MDD).
• Potential of Anti-addiction: Preclinical rat models suggest CAR may reduce cocaine-induced reward effects and decrease the likelihood of relapse.¹
  • ¹ Román V, Gyertyán I, Sághy K, Kiss B, Szombathelyi Z. Psychopharmacology (Berl). 2013

VRAYLAR Global Net Revenues

• Global Net Revenues ($ billion):
  • 2021: 1.6
  • 2022: 2.0
  • 2023: 2.6
  • 2024: 3.2
  • 2025: 3.621
• Global Vraylar Net Revenues were $905 million in Q1 2026.
• AbbVie Financial Results

ALA-5000 Key Advantages

• https://www.vraylarhcp.com/dosing

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:
  • Daily: 30 Punctures / Month
  • Weekly: 4 Punctures / Month
  • Our Platform: 1 Puncture / Month

Outlook & Strategy

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.

2026 Operational Focus

• ALA-1000:
  • Support NADA in TW
  • Veterinary study in feline (recruiting)
• 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

Financial Highlights

Financial Statement

Unit: Thousand, NTD

• As of the end of 2025, the Company had cash on hand of NT$2.303 billion.

Additional Data

Contact Us

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