Exhibit 1

 

For Immediate Release

BioLineRx Reports 2024 Financial Results and Provides Corporate Update

- Reports meaningful progress in the evaluation of assets for potential in-licensing

and development in the areas of oncology and rare diseases -

- Executed license agreement with Ayrmid Pharma Ltd. for APHEXDAâ (motixafortide) with

$10 million upfront payment, up to $87 million in commercial milestones, and

high double-digit royalties on net sales -

- Completed financings raising combined gross proceeds of $19 million and reduced operating

expense run rate by 70%, extending the Company’s cash runway through H2 2026 -

- Management to host conference call today, March 31st, at 8:30 am EDT -

TEL AVIV, Israel, March 31, 2025 – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its audited financial results for the year ended December 31, 2024, and provided a corporate update.

“It has been just over four months since we implemented a major strategy shift, highlighted by the transformational exclusive licensing agreement that we entered into with Ayrmid Ltd., granting it the rights to commercialize APHEXDA® (motixafortide) in all non-solid-tumor indications and all territories other than Asia,” said Philip Serlin, Chief Executive Officer of BioLineRx. “Since then, we implemented cost efficiencies across the Company, including the shutdown of our U.S. commercial operations, that have resulted in an approximate 70% reduction in our operating expense base, which, together with recent financings, have put us on a firm footing with a cash runway through the second half of 2026.”

“As we return to our roots as a lean drug development company, with a highly validated development platform focused on oncology and rare diseases, we believe these actions help ensure that we remain nimble and capable of seizing the opportunities in front of us. Our strategy moving forward is to in-license additional assets over the next year that we can advance through clinical proof-of-concept, funded in part by milestones and royalties from our out-licensing transactions. To that end, I am pleased to report that we are evaluating numerous promising candidates. This process is methodical and steady to ensure that our due diligence is thorough as we look for new chemical entities. Based on our deep and validated experience in drug development, I believe we are well positioned to create sustained value for our shareholders. I am excited about what the future holds for our Company this year and beyond,” Mr. Serlin concluded.

 

•

Executed license agreement with Ayrmid Pharma Ltd. to develop and commercialize APHEXDAâ (motixafortide) in all indications except solid tumors, and across all territories except Asia

 

Financial Updates

 

 

 

APHEXDA 2024 Performance Update

•

Aphexda achieved 10 percent market share of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded MOZOBIL and generic plerixafor in all indications

•

BioLineRx generated more than $6 million in net product sales year-to-date through the November 2024 completion of the Ayrmid out-licensing transaction

 

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First patient dosed in the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital.

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Oral presentation delivered at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition detailing initial results from a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in SCD. Sponsored by investigators at Washington University in St. Louis, the findings from this proof-of-concept study suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle.

 

 

 

 

 

 

 

 

 

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 April 2, 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 is APHEXDA® (motixafortide), with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia). BioLineRx is utilizing its end-to-end expertise in development, regulatory affairs, manufacturing and commercialization to advance its innovative pipeline and ensure life-changing discoveries move beyond the bench to the bedside.

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 potential success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, 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:

 

 

 

 

		Year ended December 31,
		2022				2023				2024
		in USD thousands
APPENDIX
Adjustments required to reflect net cash used in operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization			654				1,384				4,065
Exchange differences on cash and cash equivalents			607				224				(22	)
Fair value adjustments of warrants			(6,425	)			11,054				(18,965	)
Share-based compensation			2,245				2,321				1,135
Interest and exchange differences on short-term deposits			(672	)			15				185
Interest on loan			1,117				1,148				(1,126	)
Warrant issuance costs			171				-				669
Exchange differences on lease liabilities			(224	)			(42	)			(31	)
Intangible assets impairment			-				6,703				1,010
Loss on abandonment of right-of-use asset			-				-				246
			(2,527	)			22,807				(12,834	)
Changes in operating asset and liability items:
Increase in trade receivables			-				(358	)			(2,118	)
Increase in inventory			-				(1,953	)			(1,192	)
Increase in prepaid expenses and other receivables			(650	)			(959	)			(43	)
Increase (decrease) in accounts payable and accruals			1,888				5,512				(5,508	)
Increase (decrease) in contract liabilities			-				12,957				(12,957	)
			1,238				15,199				(21,818	)
			(1,289	)			38,006				(34,652	)
Supplemental information on interest received in cash			342				2,020				1,992
Supplemental information on interest paid in cash			593				1,111				10,387
Supplemental information on non-cash transactions:
Changes in right-of-use asset and lease liabilities			706				149				327
Warrant issuance costs			262				-				-
Purchase of property and equipment			28				-				-
Fair value of exercised warrants (portion related to accumulated fair value adjustments)			-				3,631				-

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