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ANLNasdaq

Adlai Nortye Ltd.

Pharmaceutical preparations·Phase 3·North Brunswick, NJ, United States·CEO: Mr. Yang Lu EMBA
Oncology

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BioSniper AI · ANL

Adlai Nortye Ltd. is a clinical-stage biopharmaceutical company focused on developing oncology drug candidates, with a pipeline including AN9025, AN4035, and AN8025, and has not yet obtained regulatory approval for any product.

Key risk: No approved products

3.5/10

BioSniper Score

Based on 4 of 6 signals

Market Cap

$890.0M

Cash Runway

3.6 mo

Lead Asset

Financial data as of Dec 31, 2024.

Tracking 7 clinical trials · 1 catalyst for Adlai Nortye Ltd..

AI OverviewAI overview is shown in English only.

Adlai Nortye Ltd. is a clinical-stage biopharmaceutical company focused on developing oncology drug candidates, with a pipeline including AN9025, AN4035, and AN8025, and has not yet obtained regulatory approval for any product.

  • Adlai Nortye has a pipeline of drug candidates including AN9025, AN4035, and AN8025, all in clinical or preclinical stages [sec · filed 2026-08-14].
  • As of 2024-12-31, the company reported cash & equivalents of $60.9M, net income of -$51.9M, and shareholders' equity of -$185.4M [sec].
  • The company has incurred net losses and expects to continue incurring losses for the foreseeable future, with research and development expenses of $44.9M in 2024 [sec · filed 2025-04-30].
  • Adlai Nortye is a foreign private issuer and an emerging growth company, allowing it to take advantage of reduced reporting requirements [sec · filed 2025-04-30].

What works

  • The company recently expanded its Scientific Advisory Board with two leading medical oncologists from MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, which may enhance clinical development expertise [sec · filed 2026-08-14].
  • Adlai Nortye has a pipeline with multiple drug candidates (AN9025, AN4035, AN8025) advancing through clinical trials, with initial data expected in 2026 and 2027 [sec · filed 2026-08-14].
  • The company leverages in-licensed drug candidates and engages contract research organizations to manage clinical trials, potentially reducing internal development costs [sec · filed 2025-04-30].

What to weigh

  • None of Adlai Nortye's drug candidates have been approved for marketing in any jurisdiction, and the company has a limited operating history with significant net losses [sec · filed 2025-04-30].
  • The company's business depends substantially on the success of its preclinical and clinical drug candidates, and any failure or delay could materially harm the business [sec · filed 2026-04-10].
  • Adlai Nortye may need additional financing to fund its drug development programs, as expenses are expected to increase with advancing clinical trials [sec · filed 2026-04-10].
  • The company is a 'controlled company' under Nasdaq rules, which may exempt it from certain corporate governance requirements that protect shareholders [sec · filed 2025-04-30].

From the filings

Quoted directly from source documents.

  • The company has not yet obtained regulatory approval for any drug candidate.

    None of our drug candidates has been approved for marketing in the U.S., Europe, China, or any other jurisdiction.

    SEC filings · April 10, 2026

  • The company expects to incur significant expenses as it advances clinical development.

    We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the clinical development of our drug candidates, initiate additional clinical trials of these and other future drug candidates, and seek regulatory approvals for them.

    SEC filings · April 10, 2026

  • The company has a limited operating history and has incurred net losses.

    We have a limited operating history, have incurred net losses and anticipate that we will continue to incur net losses for the foreseeable future.

    SEC filings · April 30, 2025

  • The company's business depends on the success of its drug candidates.

    Our business depends substantially on the success of our preclinical and clinical drug candidates. If we are unable to successfully develop drug candidates or experience significant delays in doing so, our business will be materially harmed.

    SEC filings · April 10, 2026

Catalyst timeline

  • 2026-09-23 · Phase 1 Start for AN9025Initiation of a multi-center, open-label, Phase I study evaluating safety, tolerability, pharmacokinetics, and anti-tumor activity.
Risks & what to watch (4)

Key risks

  • No approved productsNone of the company's drug candidates have been approved for marketing in any jurisdiction [sec · filed 2026-04-10].
  • History of net lossesThe company has incurred net losses and expects to continue for the foreseeable future, with net income of -$51.9M as of 2024-12-31 [sec].
  • Need for additional financingThe company may need additional financing to fund drug development programs as expenses increase [sec · filed 2026-04-10].
  • Controlled company statusAs a controlled company, Adlai Nortye may be exempt from certain corporate governance requirements that protect shareholders [sec · filed 2025-04-30].

What to watch

  • Initial Phase Ia clinical data from AN9025 QD arm expected in 1H27 [sec · filed 2026-08-14].
  • First patient dosing for AN4035 global Phase I trial expected in 2H26, with initial data in 2H27 [sec · filed 2026-08-14].
  • AN8025 Phase I dose escalation completion expected by YE 2026 [sec · filed 2026-08-14].
  • The company's ability to secure additional financing to support ongoing R&D activities [sec · filed 2026-04-10].

Sources: SEC filings · Generated August 29, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 4 of 6 signals · derived from public data

No clinical pipeline tracked — this score reflects financial & catalyst signals only.

Cash Runway1.0

3.6 months

Financial Health4.6

D/E 1.80

Pipeline MaturityN/A

No tracked pipeline phase

Pipeline BreadthN/A

No tracked pipeline candidates

Catalyst Momentum4.0

1 upcoming, next in ~24d

Insider Signal4.3

0 buys · 1 sell (180d)

Runway

Catalysts

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

21

Total value held

$23.3M

Showing top 10 of 21 institutional holders of Adlai Nortye Ltd.. Open the full 13F history after sign-in.

Short Interest

as of May 1, 2026
% of float
4.9%
Days to cover
5.3
Shares short
2,294,430
Daily short volume
-

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

ANL short interest

Frequently asked questions

What is the AI investment thesis for Adlai Nortye Ltd.?

Adlai Nortye Ltd. is a clinical-stage biopharmaceutical company focused on developing oncology drug candidates, with a pipeline including AN9025, AN4035, and AN8025, and has not yet obtained regulatory approval for any product.

What is Adlai Nortye Ltd.'s next catalyst?

Adlai Nortye Ltd.'s next tracked catalyst is a Phase1_Start event — "Phase 1 Start: A Multi-center, Open-label, Phase I Study Evaluating Safety, Tolerability, Pharmacokinetics and Anti" — expected September 23, 2026.

Who is the CEO of Adlai Nortye Ltd.?

Mr. Yang Lu EMBA is the chief executive officer of Adlai Nortye Ltd. (ANL).

Where is Adlai Nortye Ltd. headquartered?

Adlai Nortye Ltd. (ANL) is headquartered in North Brunswick, NJ, United States.

What therapeutic areas does Adlai Nortye Ltd. focus on?

Adlai Nortye Ltd. develops therapies across Oncology.

925 companies232,681 SEC filings21,419 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.