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$(R)$ (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.
Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.
Cautionary Note Regarding Forward-Looking Statements (BioLineRx)
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, expectations with regard to clinical trials of motixafortide, statements relating to the equity investment offering, including as to the consummation of the offering described above, the expected gross proceeds therefrom and the timing of the closings of the offering and the license agreement. 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 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 BioLineRx's collaboration partners will be able to execute on collaboration goals in a timely manner; 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; 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; 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, operationalize and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; 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, including any unexpected costs or delays in the commercial launch of APHEXDA; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic, the Russian invasion of Ukraine, the declared war by Israel against Hamas and the military campaigns against Hamas and other terrorist organizations, 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 26, 2024. 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
John Lacey
BioLineRx
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,
------------ -------------
2023 2024
------------ -------------
in USD thousands
---------------------------
Assets
CURRENT ASSETS
Cash and cash equivalents 4,255 8,836
Short-term bank deposits 38,739 20,337
Trade receivables 358 3,611
Prepaid expenses 1,048 1,171
Other receivables 830 350
Inventory 1,953 3,544
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Total current assets 47,183 37,849
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NON-CURRENT ASSETS
Property and equipment, net 473 249
Right-of-use assets, net 1,415 1,398
Intangible assets, net 14,854 13,246
------------ -------------
Total non-current assets 16,742 14,893
------------ -------------
Total assets 63,925 52,742
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Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loan 3,145 9,822
Contract liabilities 12,957 2,255
Accounts payable and accruals:
Trade 10,869 4,633
Other 3,353 3,370
Current maturities of lease liabilities 528 517
Warrants 11,932 4,365
------------ -------------
Total current liabilities 42,784 24,962
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NON-CURRENT LIABILITIES
Long-term loan, net of current maturities 6,628 17,982
Lease liabilities 1,290 1,293
------------ -------------
Total non-current liabilities 7,918 19,275
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CONTINGENT LIABILITIES
Total liabilities 50,702 44,237
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EQUITY
Ordinary shares 31,355 34,430
Share premium 355,482 353,005
Warrants 1,408 1,408
Capital reserve 17,000 17,718
Other comprehensive loss (1,416) (1,416)
Accumulated deficit (390,606) (396,640)
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Total equity 13,223 8,505
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Total liabilities and equity 63,925 52,742
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BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
Three months ended Nine months ended
September 30, September 30,
-------------------------- ---------------------------
2023 2024 2023 2024
----------- ------------- ------------ -------------
in USD thousands in USD thousands
-------------------------- ---------------------------
REVENUES - 4,943 - 17,191
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