BioLineRx Reports Third Quarter 2025 Financial Results and Provides Corporate Update

- Establishes joint venture with Hemispherian AS to advance GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other cancers -

- Phase 1/2a clinical trial of GLIX1 expected to commence in Q1 2026 -

- Management to host conference call today, November 24 th, at 8:30 am EST -

TEL AVIV, Israel, Nov. 24, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended September 30, 2025, and provided a corporate update.

"The clear highlight of the third quarter was our announcement in September that we established a joint venture with Hemispherian, expanding our development pipeline into additional high-need cancer indications, leading with glioblastoma, in addition to our ongoing PDAC program," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Hemispherian's lead asset, GLIX1, is a versatile molecule with a novel mechanism of action that targets the DNA repair mechanism in cancer cells and has demonstrated compelling efficacy in numerous pre-clinical models. Importantly, the development path is straightforward and efficient, and we are eager to initiate a Phase 1/2a first-in-human study in the first quarter of next year while also advancing pre-clinical activities in support of future potential trials of GLIX1 in other cancers."

"At the same time, the ongoing CheMo4METPANC Phase 2b clinical trial of motixafortide in metastatic pancreatic cancer, which is being led by Columbia University and supported by both Regeneron and BioLineRx, continues to progress, giving us a second opportunity to leverage our drug development expertise to bring true innovation to patients with difficult-to-treat cancers," Mr. Serlin concluded.

Corporate Updates

Financial Updates

Clinical Updates

GLIX1

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

Sickle Cell Disease (SCD) & Gene Therapy

APHEXDA Performance Update

Financial Results for the Quarter Ended September 30, 2025

Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 26, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC) and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University.

In addition, BioLineRx has established a joint venture with Hemispherian AS to develop GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial is planned to be initiated in the first quarter of 2026.

Learn more about who we are, what we do, and how we do it at  www.biolinerx.com, or on  X and  LinkedIn.

Forward Looking Statement

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide and GLIX1, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contacts:

United States

Irina Koffler

LifeSci Advisors, LLC

IR@biolinerx.com

Israel

Moran Meir

LifeSci Advisors, LLC

moran@lifesciadvisors.com

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)

December 31,

September 30,

2024

2025

in USD thousands

Assets

CURRENT ASSETS

Cash and cash equivalents

10,436

7,914

Short-term bank deposits

9,126

17,298

Trade receivables

2,476

Prepaid expenses

443

432

Other receivables

1,478

699

Inventory

3,145

2,181

Total current assets

27,104

28,524

NON-CURRENT ASSETS

Property and equipment, net

386

168

Right-of-use assets, net

967

724

Intangible assets, net

10,449

10,388

Total non-current assets

11,802

11,280

Total assets

38,906

39,804

Liabilities and equity

CURRENT LIABILITIES

Current maturities of long-term loan

4,479

Accounts payable and accruals:

Trade

5,583

3,537

Other

3,131

2,127

Current maturities of lease liabilities

522

297

Warrants

1,691

3,229

Total current liabilities

15,406

13,669

NON-CURRENT LIABILITIES

Long-term loan, net of current maturities

8,958

5,599

Lease liabilities

1,081

1,003

Total non-current liabilities

10,039

6,602

COMMITMENTS AND CONTINGENT LIABILITIES

Total liabilities

25,445

20,271

EQUITY

Ordinary shares

38,097

73,428

Share premium

353,693

327,257

Warrants

5,367

3,686

Capital reserve

17,547

16,195

Other comprehensive loss

(1,416)

Accumulated deficit

(399,827)

(399,617)

Total equity

13,461

19,533

Total liabilities and equity

38,906

39,804

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(UNAUDITED)

Three months ended

September 30,

Nine months ended

September 30,

2024

2025

2024

2025

in USD thousands

REVENUES:

License revenues

3,221

427

12,702

986

Product sales, net

1,722

4,489

Total revenues

4,943

427

17,191

986

COST OF REVENUES

(822)

(84)

(3,174)

(190)

GROSS PROFIT

4,121

343

14,017

796

RESEARCH AND DEVELOPMENT EXPENSES

(2,565)

(1,719)

(7,284)

(5,668)

SALES AND MARKETING EXPENSES

(5,553)

(18,310)

GENERAL AND ADMINISTRATIVE EXPENSES

(1,390)

(831)

(4,405)

(2,029)

OPERATING LOSS

(5,387)

(2,207)

(15,982)

(6,901)

NON-OPERATING INCOME (EXPENSES), NET

756

1,157

13,053

6,950

FINANCIAL INCOME

434

377

1,534

1,161

FINANCIAL EXPENSES

(1,625)

(304)

(4,639)

(1,000)

NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)

(5,822)

(977)

(6,034)

210

in USD

EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED

(0.00)

(0.01)

0.00

WEIGHTED AVERAGE NUMBER OF SHARES USED IN

CALCULATION OF BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE

1,199,485,845

2,607,025,540

1,161,448,634

2,399,573,101

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

Ordinary

premium

Warrants

Capital

reserve

Other

comprehensive

loss

Accumulated

deficit

Total

in USD thousands

BALANCE AT JANUARY 1, 2024

31,355

355,482

1,408

17,000

(1,416)

(390,606)

13,223

CHANGES FOR NINE MONTHS ENDED

SEPTEMBER 30, 2024:

Issuance of share capital, net

3,056

(3,056)

Employee stock options exercised

(48)

Employee stock options expired

523

(523)

Share-based compensation

1,289

Comprehensive loss for the period

(6,034)

BALANCE AT SEPTEMBER 30, 2024

34,430

353,005

1,408

17,718

(1,416)

(396,640)

8,505

Ordinary

premium

Warrants

Capital

reserve

Other

comprehensive

loss

Accumulated

deficit

Total

in USD thousands

BALANCE AT JANUARY 1, 2025

38,097

353,693

5,367

17,547

(1,416)

(399,827)

13,461

CHANGES FOR NINE MONTHS ENDED

SEPTEMBER 30, 2025:

Issuance of share capital, pre-funded warrants and

warrants, net

27,273

(22,260)

501

5,514

Pre-funded warrants exercised

8,058

(5,876)

(2,182)

Employee stock options expired

1,700

(1,700)

Share-based compensation

348

Comprehensive income for the period

210

BALANCE AT SEPTEMBER 30, 2025

73,428

327,257

3,686

16,195

(1,416)

(399,617)

19,533

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

Nine months ended

September 30,

2024

2025

in USD thousands

CASH FLOWS - OPERATING ACTIVITIES

Comprehensive income (loss) for the period

(6,034)

210

Adjustments required to reflect net cash used in operating activities

(see appendix below)

(29,229)

(5,084)

Net cash used in operating activities

(35,263)

(4,874)

CASH FLOWS - INVESTING ACTIVITIES

Investments in short-term deposits

(26,350)

(29,027)

Maturities of short-term deposits

44,626

20,819

Purchase of property and equipment

(59)

Net cash provided by (used in) investing activities

18,217

(8,208)

CASH FLOWS - FINANCING ACTIVITIES

Issuance of share capital, pre-funded warrants and warrants,

net of issuance costs

5,358

13,894

Employee stock options exercised

Net proceeds from loan

19,223

Repayments of loan

(2,461)

(3,359)

Repayments of lease liabilities

(380)

(399)

Net cash provided by financing activities

21,767

10,136

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

4,721

(2,946)

CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD

4,255

10,436

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

(140)

424

CASH AND CASH EQUIVALENTS - END OF PERIOD

8,836

7,914

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

Nine months ended

September 30,

2024

2025

in USD thousands

Adjustments required to reflect net cash used in operating activities:

Income and expenses not involving cash flows:

Depreciation and amortization

2,213

460

Exchange differences on cash and cash equivalents

140

(424)

Fair value adjustments of warrants

(13,567)

(7,544)

Share-based compensation

1,289

348

Interest on short-term deposits

126

Interest on loan

1,269

Exchange differences on lease liabilities

158

Warrant issuance costs

642

702

(7,821)

(6,264)

Changes in operating asset and liability items:

Decrease (increase) in trade receivables

(3,253)

2,476

Decrease in prepaid expenses and other receivables

357

790

Decrease (increase) in inventory

(1,591)

964

Decrease in accounts payable and accruals

(6,219)

(3,050)

Decrease in contract liabilities

(10,702)

(21,408)

1,180

(29,229)

(5,084)

Supplemental information on interest received in cash

1,644

874

Supplemental information on interest paid in cash

1,586

1,126

Supplemental information on non-cash transactions:

Changes in right-of-use asset and lease liabilities

305

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SOURCE BioLineRx Ltd.