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BLRXNasdaq

BioLineRx Ltd.

Pharmaceutical preparations·Phase 3·Hevel Modi'in, Israel·CEO: Mr. Philip A. Serlin CPA, M.B.A.
Oncology

BLRX evidence brief

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BioSniper AI · BLRX

BioLineRx Ltd. is a biopharmaceutical company focused on oncology and rare diseases, with one FDA-approved product (APHEXDA) and a pipeline including motixafortide for pancreatic cancer and GLIX1, but faces significant financial challenges with a going concern qualification and accumulated losses of $401 million.

Key risk: Going concern risk

4.9/10

BioSniper Score

Based on 2 of 6 signals

Limited data coverage

Market Cap

$11.4M

Cash Runway

Lead Asset

Financial data as of Dec 31, 2025.

Tracking 4 clinical trials · 1 catalyst for BioLineRx Ltd..

AI OverviewAI overview is shown in English only.

BioLineRx Ltd. is a biopharmaceutical company focused on oncology and rare diseases, with one FDA-approved product (APHEXDA) and a pipeline including motixafortide for pancreatic cancer and GLIX1, but faces significant financial challenges with a going concern qualification and accumulated losses of $401 million.

  • BioLineRx's first approved product, APHEXDA (motixafortide), was approved by the FDA on September 8, 2023, for stem cell mobilization in multiple myeloma [sec · filed 2026-03-23].
  • The company has incurred accumulated losses of $401 million through December 31, 2025, and expects to continue incurring losses [sec · filed 2026-03-23].
  • As of December 31, 2025, BioLineRx had cash and equivalents of $0.6 million and total debt of $5.4 million [latest reported financials].
  • The independent registered public accounting firm included a 'going concern' explanatory paragraph in its report on the financial statements for the year ended December 31, 2025 [sec · filed 2026-03-23].
  • BioLineRx is advancing motixafortide for pancreatic cancer and other solid tumors, and developing GLIX1 [sec · filed 2026-03-23].

What works

  • APHEXDA (motixafortide) received FDA approval in September 2023, providing a commercial-stage asset and potential for royalty and milestone revenue from out-licensing partners [sec · filed 2026-03-23].
  • The company has a disciplined in-licensing strategy and experience in executing transactions with back-ended, success-based consideration [sec · filed 2026-03-23].
  • BioLineRx is pursuing innovative therapies in oncology and rare diseases with a focus on candidates offering differentiation from current treatments [sec · filed 2026-03-23].

What to weigh

  • BioLineRx has incurred significant losses since inception, with an accumulated deficit of $401 million as of December 31, 2025, and expects to continue losing money [sec · filed 2026-03-23].
  • The company's independent auditor has issued a going concern opinion, indicating substantial doubt about its ability to continue as a viable entity [sec · filed 2026-03-23].
  • Cash and equivalents were only $0.6 million as of December 31, 2025, with total debt of $5.4 million, raising concerns about near-term liquidity [latest reported financials].
  • Revenue from APHEXDA product sales and milestones has not been sufficient to sustain operations, and there is no assurance of significant future revenue [sec · filed 2026-03-23].

From the filings

Quoted directly from source documents.

  • FDA approval of APHEXDA in September 2023

    Our first approved product is APHEXDA (motixafortide), a novel peptide for the treatment of stem-cell mobilization and solid tumors which, on September 8, 2023, was approved by the FDA for use in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

    SEC filings · March 23, 2026

  • Going concern qualification by auditor

    Our independent registered public accounting firm has included a "going concern" explanatory paragraph in its report on our financial statements for the year ended December 31, 2025.

    SEC filings · March 23, 2026

  • Accumulated deficit of $401 million

    We have incurred accumulated losses in the amount of $401 million through December 31, 2025

    SEC filings · March 23, 2026

Catalyst timeline

  • 2029-09-30 · Phase3_ToplineTopline results from a Phase III randomized, placebo-controlled study evaluating safety and tolerability of a candidate (likely motixafortide in pancreatic cancer).
Risks & what to watch (4)

Key risks

  • Going concern riskAuditor's going concern opinion indicates substantial doubt about BioLineRx's ability to continue as a viable entity [sec · filed 2026-03-23].
  • Liquidity and capital needsCash of $0.6M and debt of $5.4M as of 2025-12-31; company expects to need substantial future capital [latest reported financials; sec · filed 2026-03-23].
  • History of lossesAccumulated deficit of $401M through 2025-12-31; may never achieve profitability [sec · filed 2026-03-23].
  • Clinical and regulatory setbacksAdvanced clinical trials may fail despite earlier positive results; e.g., prior AML trial halted at interim [sec · filed 2026-03-23].

What to watch

  • Ability to raise additional capital to fund operations and avoid liquidity crisis [sec · filed 2026-03-23].
  • Commercial uptake and revenue generation from APHEXDA (motixafortide) in multiple myeloma [sec · filed 2026-03-23].
  • Progress of motixafortide in pancreatic cancer and other solid tumor indications [sec · filed 2026-03-23].
  • Development milestones for GLIX1 and potential out-licensing or partnership deals [sec · filed 2026-03-23].

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

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Evidence & data

Score breakdownBased on 2 of 6 signals · derived from public data

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

Cash RunwayN/A

Cash runway data unavailable

Financial Health7.7

D/E 0.75

Pipeline MaturityN/A

No tracked pipeline phase

Pipeline BreadthN/A

No tracked pipeline candidates

Catalyst Momentum2.0

1 upcoming, next in ~1127d

Insider SignalN/A

No insider transactions in the last 180 days

Catalysts

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

11

Total value held

$67K

Showing top 10 of 11 institutional holders of BioLineRx Ltd.. Open the full 13F history after sign-in.

Short Interest

as of May 1, 2026
% of float
3.6%
Days to cover
8.9
Shares short
154,748
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 →

BLRX short interest

Frequently asked questions

What is the AI investment thesis for BioLineRx Ltd.?

BioLineRx Ltd. is a biopharmaceutical company focused on oncology and rare diseases, with one FDA-approved product (APHEXDA) and a pipeline including motixafortide for pancreatic cancer and GLIX1, but faces significant financial challenges with a going concern qualification and accumulated losses of $401 million.

What is BioLineRx Ltd.'s next catalyst?

BioLineRx Ltd.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability " — expected September 30, 2029.

Who is the CEO of BioLineRx Ltd.?

Mr. Philip A. Serlin CPA, M.B.A. is the chief executive officer of BioLineRx Ltd. (BLRX).

Where is BioLineRx Ltd. headquartered?

BioLineRx Ltd. (BLRX) is headquartered in Hevel Modi'in, Israel.

What therapeutic areas does BioLineRx Ltd. focus on?

BioLineRx 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.