1. TEL AVIV, Israel, Aug. 18, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2021 and provides a corporate update.

    Significant events and achievements during the second quarter 2021 and subsequent period:

    TEL AVIV, Israel, Aug. 18, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2021 and provides a corporate update.

    Significant events and achievements during the second quarter 2021 and subsequent period:

    • Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized enough cells for transplantation with only one administration of Motixafortide and in only one apheresis session.
    • Based on the positive results from the GENESIS study, the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year. This is consistent with prior guidance.
    • Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard-of-care mobilization agent (in combination with G-CSF). The aim of the study is to demonstrate the cost benefits related to the use of Motixafortide, due to a reduction in the number of doses of G-CSF and apheresis sessions required, a reduction in the number of rescue therapies required, higher rates of transplantation, and quality-of-life benefits in Motixafortide-treated patients; initial data on track to be announced in the second half of this year.
    • Ended the second quarter on a solid financial footing, with cash and cash equivalents of $66 million.

    "Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we announced in May, we are working vigorously to submit an NDA in the first half of next year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "If approved, this would be transformative for BioLineRx as we would have a commercial-stage molecule in stem cell mobilization for transplantation in multiple myeloma, the standard of treatment for this disease, along with significant potential clinical utility in other cancer indications, most notably pancreatic cancer."

    Mr. Serlin continued, "GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem cells necessary for transplantation – in approximately 90% of cases with only one dose of Motixafortide and in one apheresis session – potentially resulting in significant clinical benefits for patients and cost savings for payers. We believe there is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard-of-care for all multiple myeloma patients. To that end, we are advancing a pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new SCM treatment paradigm.

    "In parallel with these activities, the versatility of Motixafortide demonstrated in studies to date has attracted interest from potential partners, and we continue to engage in productive discussions.

    "We are very well financed with $66 million of cash, sufficient to bring Motixafortide through potential FDA approval in stem-cell mobilization, while continuing to advance our other clinical programs, including our second asset, AGI-134, a novel agent in immunotherapy currently being investigated in a Phase 1/2a  study, with initial results expected by the end of this year," concluded Mr. Serlin.

    Upcoming Significant Expected Milestones:

    • Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021;
    • Pre-NDA meeting with the FDA for SCM in the second half of 2021;
    • Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
    • NDA submission for SCM in the first half of 2022;
    • Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined.

    Financial Results for the Quarter Ended June 30, 2021

    Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%, compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide, and a timing difference related to a tax credit received in respect of AGI-134. Research and development expenses for the six months ended June 30, 2021 were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the six months ended June 30, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials and a timing difference related to a tax credit received in respect of AGI-134; offset by higher expenses related to Motixafortide NDA supporting activities and by an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period.

    Sales and marketing expenses for the three months ended June 30, 2021 were $0.3 million, an increase of $0.1 million, or 81.3%, compared to $0.2 million for the three months ended June 30, 2020. The increase resulted primarily from consultancy services related to Motixafortide. Sales and marketing expenses for the six months ended June 30, 2021 were $0.5 million, an increase of $0.1 million, or 35.6%, compared to $0.4 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

    General and administrative expenses for the three months ended June 30, 2021 were $1.0 million, an increase of $0.3 million, or 40.3%, compared to $0.7 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in directors' and officers' insurance. General and administrative expenses for the six months ended June 30, 2021 were $2.1 million, an increase of $0.1 million, or 3.7%, compared to $2.0 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

    The Company's operating loss for the three months ended June 30, 2021 amounted to $6.5 million, compared to an operating loss of $5.6 million for the comparable period in 2020. The Company's operating loss for the six months ended June 30, 2021 was $12.0 million, compared to $12.4 million for the comparable period in 2020.

    Non-operating expenses for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet.

    Net financial expenses for the three months ended June 30, 2021 amounted to $0.1 million compared to net financial expenses of $0.4 million for the three months ended June 30, 2020. Net financial expenses for the six months ended June 30, 2021 amounted to $0.3 million compared to net financial expenses of $0.6 million for the six months ended June 30, 2020. Net financial expenses for all periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

    The Company's net loss for the three months ended June 30, 2021 amounted to $6.8 million, similar to the comparable period in 2020. The Company's net loss for the six months ended June 30, 2021 amounted to $17.0 million, compared with a net loss of $13.4 million for the comparable period in 2020. The increase in net loss between the six-month periods results from an increase in 2021 non-operating expenses in connection with fair-value adjustments of warrant liabilities on the Company's balance sheet.

    The Company held $66 million in cash, cash equivalents and short-term bank deposits as of June 30, 2021.

    Net cash used in operating activities was $13.1 million for the six months ended June 30, 2021, compared with net cash used in operating activities of $12.3 million for the six months ended June 30, 2020. The $0.8 million increase in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a larger increase in prepaid expenses and other receivables in 2021 versus 2020, as well as a larger decrease in accounts payable and accruals in 2021 versus 2020.

    Net cash used in investing activities was $42.3 million for the six months ended June 30, 2021, compared to net cash provided by investing activities of $0.6 million for the six months ended June 30, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

    Net cash provided by financing activities was $56.0 million for the six months ended June 30, 2021, compared to net cash provided by financing activities of $12.0 million for the six months ended June 30, 2020. The cash flows in 2021 primarily reflect an underwritten public offering of the Company's ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Wednesday, August 18, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until August 20, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

    (Tables follow)

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com



     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

    (UNAUDITED)







    December 31,



    June 30,



    2020



    2021



    in USD thousands

    Assets







    CURRENT ASSETS







    Cash and cash equivalents

    16,831



    17,484

    Short-term bank deposits

    5,756



    48,083

    Prepaid expenses

    152



    837

    Other receivables

    141



    668

              Total current assets

    22,880



    67,072









    NON-CURRENT ASSETS







    Property and equipment, net

    1,341



    1,136

    Right-of-use assets, net

    1,355



    1,415

    Intangible assets, net

    21,714



    21,706

              Total non-current assets

    24,410



    24,257

              Total assets

    47,290



    91,329









    Liabilities and equity







    CURRENT LIABILITIES







    Current maturities of long-term loan

    3,092



    3,354

    Accounts payable and accruals:







         Trade

    5,918



    5,318

         Other

    1,440



    1,071

    Lease liabilities

    191



    174

              Total current liabilities

    10,641



    9,917

    NON-CURRENT LIABILITIES







    Warrants

    10,218



    4,812

    Long-term loan, net of current maturities

    2,740



    1,006

    Lease liabilities

    1,661



    1,701

              Total non-current liabilities

    14,619



    7,519

    COMMITMENTS AND CONTINGENT LIABILITIES







         Total liabilities

    25,260



    17,436









    EQUITY







    Ordinary shares

    9,870



    20,496

    Share premium

    279,241



    335,887

    Warrants

    -



    975

    Capital reserve

    12,322



    12,972

    Other comprehensive loss

    (1,416)



    (1,416)

    Accumulated deficit

    (277,987)



    (295,021)

              Total equity

    22,030



    73,893

              Total liabilities and equity

    47,290



    91,329

     

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

    (UNAUDITED)





    Three months ended June 30,



    Six months ended June 30,



    2020



    2021



    2020



    2021



    in USD thousands



    in USD thousands

    RESEARCH AND DEVELOPMENT EXPENSES

    (4,640)



    (5,139)



    (10,062)



    (9,417)

    SALES AND MARKETING EXPENSES

    (182)



    (330)



    (357)



    (484)

    GENERAL AND ADMINISTRATIVE EXPENSES

    (744)



    (1,044)



    (1,987)



    (2,061)

    OPERATING LOSS

    (5,566)



    (6,513)



    (12,406)



    (11,962)

    NON-OPERATING EXPENSES, NET

    (843)



    (217)



    (374)



    (4,778)

    FINANCIAL INCOME

    35



    130



    175



    247

    FINANCIAL EXPENSES

    (396)



    (242)



    (810)



    (541)

    NET LOSS AND COMPREHENSIVE LOSS

    (6,770)



    (6,842)



    (13,415)



    (17,034)



















    in USD



     

    in USD

    LOSS PER ORDINARY SHARE - BASIC AND DILUTED

    (0.03)



    (0.01)



    (0.07)



    (0.03)

















    WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE

    220,317,889



    669,138,994



    198,277,447



    614,780,845



































     

     

    BioLineRx Ltd.

    CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY

    (UNAUDITED)





     

    Ordinary



     

    Share







     

    Capital



    Other

    Comprehensive



     

    Accumulated







    shares



    premium



    Warrants



    reserve



    loss



    deficit



    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2020

    4,692



    265,938



    -



    12,132



    (1,416)



    (247,966)



    33,380

    CHANGES FOR SIX MONTHS ENDED

    JUNE 30, 2020:



























    Issuance of share capital, net

    3,581



    4,754



    -



    -



    -



    -



    8,335

    Employee stock options exercised

    8



    224



    -



    (224)



    -



    -



    8

    Employee stock options forfeited and expired

    -



    191



    -



    (191)



    -



    -



    -

    Share-based compensation     

    -



    -



    -



    922



    -



    -



    922

    Comprehensive loss for the period

    -



    -



    -



    -



    -



    (13,415)



    (13,415)

    BALANCE AT JUNE 30, 2020

    8,281



    271,107



    -



    12,639



    (1,416)



    (261,381)



    29,230































     

    Ordinary



     

    Share







     

    Capital



    Other

    Comprehensive



     

    Accumulated







    shares



    premium



    Warrants



    reserve



    loss



    deficit



    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2021

    9,870



    279,241



    -



    12,322



    (1,416)



    (277,987)



    22,030

    CHANGES FOR SIX MONTHS ENDED

    JUNE 30, 2021:



























    Issuance of share capital and warrants, net

    8,386



    37,495



    975



    -



    -



    -



    46,856

    Warrants exercised

    2,235



    18,967



    -



    -



    -



    -



    21,202

    Employee stock options exercised

    5



    41



    -



    (39)



    -



    -



    7

    Employee stock options forfeited and expired

    -



    143



    -



    (143)



    -



    -



    -

    Share-based compensation     

    -



    -



    -



    832



    -



    -



    832

    Comprehensive loss for the period

    -



    -



    -



    -



    -



    (17,034)



    (17,034)

    BALANCE AT JUNE 30, 2021

    20,496



    335,887



    975



    12,972



    (1,416)



    (295,021)



    73,893





























     

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

    (UNAUDITED)





     

    Ordinary



     

    Share







     

    Capital



    Other

    Comprehensive



     

    Accumulated







    shares



    premium



    Warrants



    reserve



    loss



    deficit



    Total



    in USD thousands

    BALANCE AT APRIL 1, 2020

    4,907



    267,140



    -



    12,488



    (1,416)



    (254,611)



    28,508

    CHANGES FOR THREE MONTHS ENDED JUNE 30, 2020:



























    Issuance of share capital, net

    3,373



    3,859



    -



    -



    -



    -



    7,232

    Employee stock options exercised

    1



    20



    -



    (20)



    -



    -



    1

    Employee stock options forfeited and expired

    -



    88



    -



    (88)



    -



    -



    -

    Share-based compensation     

    -



    -



    -



    259



    -



    -



    259

    Comprehensive loss for the period

    -



    -



    -



    -



    -



    (6,770)



    (6,770)

    BALANCE AT JUNE 30, 2020

    8,281



    271,107



    -



    12,639



    (1,416)



    (261,381)



    29,230































     

    Ordinary



     

    Share







     

    Capital



    Other

    Comprehensive



     

    Accumulated







    shares



    premium



    Warrants



    reserve



    loss



    deficit



    Total



    in USD thousands

    BALANCE AT APRIL 1, 2021

    18,731



    321,920



    975



    12,616



    (1,416)



    (288,179)



    64,647

    CHANGES FOR THREE MONTHS ENDED JUNE 30, 2021:



























    Issuance of share capital, net

    1,581



    12,516



    -



    -



    -



    -



    14,097

    Warrants exercised

    184



    1,444



    -



    -



    -



    -



    1,628

    Employee stock options exercised

    -



    3



    -



    (1)



    -



    -



    2

    Employee stock options forfeited and expired

    -



    4



    -



    (4)



    -



    -



    -

    Share-based compensation     

    -



    -



    -



    361



    -



    -



    361

    Comprehensive loss for the period

    -



    -



    -



    -



    -



    (6,842)



    (6,842)

    BALANCE AT JUNE 30, 2021

    20,496



    335,887



    975



    12,972



    (1,416)



    (295,021)



    73,893





























     

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)





    Six months ended June 30,



    2020



    2021



    in USD thousands









    CASH FLOWS - OPERATING ACTIVITIES







    Comprehensive loss for the period

    (13,415)



    (17,034)

    Adjustments required to reflect net cash used in operating activities

    (see appendix below)

    1,112



    3,977

    Net cash used in operating activities

    (12,303)



    (13,057)









    CASH FLOWS – INVESTING ACTIVITIES







    Investments in short-term deposits

    (23,751)



    (58,000)

    Maturities of short-term deposits

    24,335



    15,776

    Purchase of property and equipment

    (1)



    (38)

    Net cash provided by (used in) investing activities

    583



    (42,262)









    CASH FLOWS – FINANCING ACTIVITIES







    Issuance of share capital and warrants, net of issuance costs

    13,411



    46,856

    Exercise of warrants

    -



    10,907

    Employee stock options exercised

    8



    7

    Repayments of loans

    (1,331)



    (1,648)

    Repayments of lease liabilities

    (121)



    (122)

    Net cash provided by financing activities

    11,967



    56,000









    INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

    247



    681

    CASH AND CASH EQUIVALENTS - BEGINNING

       OF PERIOD

    5,297



    16,831

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

    (21)



    (28)

    CASH AND CASH EQUIVALENTS - END OF PERIOD

    5,523



    17,484









     

     

    BioLineRx Ltd.

    APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)





    Six months ended June 30,



    2020



    2021



    in USD thousands

















    Adjustments required to reflect net cash used in operating activities:







    Income and expenses not involving cash flows:







    Depreciation and amortization

    533



    362

    Exchange differences on cash and cash equivalents

    21



    28

    Fair value adjustments of warrants

    (250)



    4,889

    Share-based compensation

    922



    832

    Warrant issuance costs

    593



    -

    Interest and exchange differences on short-term deposits

    (171)



    (103)

    Interest on loans

    36



    176

    Exchange differences on lease liability 

    (8)



    (26)



    1,676



    6,158









    Changes in operating asset and liability items:







    Increase in prepaid expenses and other receivables

    (146)



    (1,212)

      Decrease in accounts payable and accruals

    (418)



    (969)



    (564)



    (2,181)



    1,112



    3,977

















    Supplemental information on interest received in cash

    300



    39









    Supplemental information on interest paid in cash

    534



    350









    Supplemental information on non-cash transactions:







    Acquisition of right-of-use asset 

    -



    171









    Exercise of warrants (portion related to accumulated

    fair value adjustments)

    -



    10,295









     

    Cision View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2021-financial-results-and-provides-corporate-update-301357777.html

    SOURCE BioLineRx Ltd.

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  2. TEL AVIV, Israel, Aug. 12, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended June 30, 2021 on Wednesday, August 18, 2021, before the US markets open.

    The Company will host a conference call on Wednesday, August 18, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference…

    TEL AVIV, Israel, Aug. 12, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended June 30, 2021 on Wednesday, August 18, 2021, before the US markets open.

    The Company will host a conference call on Wednesday, August 18, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0644 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until August 20, 2021; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

    Cision View original content:https://www.prnewswire.com/news-releases/biolinerx-to-report-second-quarter-2021-results-on-august-18-2021-301354370.html

    SOURCE BioLineRx Ltd.

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  3. TEL AVIV, Israel, May 26, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2021 and provides a corporate update.

    Significant events and achievements during the first quarter 2021 and subsequent period:

    • 88.3% of patients receiving Motixafortide + G-CSF underwent transplantation after only ONE administration of Motixafortide…

    TEL AVIV, Israel, May 26, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2021 and provides a corporate update.

    Significant events and achievements during the first quarter 2021 and subsequent period:

    • Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001).
    • 88.3% of patients receiving Motixafortide + G-CSF underwent transplantation after only ONE administration of Motixafortide and in only ONE apheresis session, compared to 10.8% for G-CSF alone; potentially supports Motixafortide on top of G-CSF as new standard-of-care mobilization agent in autologous bone-marrow transplantation.
    • The Company is proceeding with activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year.
    • Presented data at the 2021 American Association for Cancer Research (AACR) Annual Meeting analyzing results by liver metastasis status from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study testing Motixafortide in metastatic pancreatic cancer. The analysis further strengthened the results reported from the study in December 2020, since not only were substantially all patients initially diagnosed with stage 4 disease, but the vast majority (~80%) of the patients had liver metastases, emphasizing the extremely difficult patient population in this study.
    • Strengthened balance sheet with underwritten public offering resulting in gross proceeds of $34.5 million.

    "Subsequent to the end of the first quarter, we were extremely excited to announce positive topline results from our GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The results demonstrated, with a high degree of statistical significance, a meaningful clinical benefit from adding Motixafortide to the current standard of care, G-CSF, for the mobilization of the targeted number of stem cells required for transplantation. While this was not a head-to-head study, our results compare very favorably to the registrational study of plerixafor.

    "Importantly, almost 90% of patients in the treatment cohort underwent transplantation after only one administration of Motixafortide and in only one apheresis session, compared to 10.8% for G-CSF alone. We believe this positions Motixafortide to become the new standard of care in this indication, with a clear clinical benefit of 'one dose, one apheresis, 90% mobilization success rate.' We are working diligently to submit a New Drug Application to the FDA in the first half of next year. If approved, this would be transformative for BioLineRx, and a huge milestone in the Company's history.

    "Regarding our PDAC program, the compelling liver metastases data that we recently presented at AACR further strengthen an already robust case for continued development in this very challenging indication. We continue to engage in discussions with potential partners regarding future development.

    "To support these and other initiatives, including continued advancement of our second clinical candidate, the anti-cancer vaccine AGI-134, we raised $34.5 million in January that we believe will finance the Company through multiple potentially value-creating milestones," concluded Mr. Serlin.

    Upcoming Significant Expected Milestones:

    • Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
    • Pre-NDA meeting with the FDA for SCM in the second half of 2021;
    • NDA submission for SCM in the first half of 2022.

    Financial Results for the Quarter Ended March 31, 2021

    Research and development expenses for the quarter ended March 31, 2021 were $4.3 million, a decrease of $1.1 million, or 21.1%, compared to $5.4 million for the quarter ended March 31, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide COMBAT clinical trial, as well as lower expenses associated with the AGI-134 study.

    Sales and marketing expenses for the quarter ended March 31, 2021 were $0.2 million, similar to sales and marketing expenses for the quarter ended March 31, 2020.

    General and administrative expenses for the quarter ended March 31, 2021 were $1.0 million, a decrease of $0.2 million, or 18.2% compared to $1.2 million for the quarter ended March 31, 2020. The decrease resulted primarily from a decrease in share-based compensation.

    The Company's operating loss for the quarter ended March 31, 2021 amounted to $5.5 million, compared to an operating loss of $6.8 million for the quarter ended March 31, 2020.

    Non-operating expenses amounted to $4.6 million for the quarter ended March 31, 2021, compared to non-operating income of $0.5 million for the quarter ended March 31, 2020. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet.

    Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2021, compared to net financial expenses of $0.3 million for the quarter ended March 31, 2020. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

    The Company's net loss for the quarter ended March 31, 2021 amounted to $10.2 million, compared with a net loss of $6.6 million for the quarter ended March 31, 2020.

    The Company held $58.1 million in cash, cash equivalents and short-term bank deposits as of March 31, 2021.

    Net cash used in operating activities was $6.2 million for the quarter ended March 31, 2021, compared with net cash used in operating activities of $6.7 million for the quarter ended March 31, 2020. The $0.5 million decrease in net cash used in operating activities between the two periods was primarily the result of a decrease in research and development expenses.

    Net cash used in investing activities was $36.3 million for the quarter ended March 31, 2021, compared to net cash provided by investing activities of $6.2 million for the quarter ended March 31, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

    Net cash provided by financing activities was $41.9 million for the quarter ended March 31, 2021, compared to net cash provided by financing activities of $0.4 million for the quarter ended March 31, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of the Company's ADSs in January 2021, warrant exercises and net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital. The cash flows in 2020 primarily reflect the net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Wednesday, May 26, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until May 28, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

    (Tables follow)

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

     

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

    (UNAUDITED)















    December 31,

    March 31,



    2020

    2021



    in USD thousands

    Assets





    CURRENT ASSETS





    Cash and cash equivalents

    16,831

    16,047

    Short-term bank deposits

    5,756

    42,036

    Prepaid expenses

    152

    1,079

    Other receivables

    141

    190

              Total current assets

    22,880

    59,352







    NON-CURRENT ASSETS





    Property and equipment, net

    1,341

    1,243

    Right-of-use assets, net

    1,355

    1,297

    Intangible assets, net

    21,714

    21,707

              Total non-current assets

    24,410

    24,247

              Total assets

    47,290

    83,599







    Liabilities and equity





    CURRENT LIABILITIES





    Current maturities of long-term loans

    3,092

    3,220

    Accounts payable and accruals:





         Trade

    5,918

    5,756

         Other

    1,440

    1,100

    Lease liabilities

    191

    140

              Total current liabilities

    10,641

    10,216

    NON-CURRENT LIABILITIES





    Warrants

    10,218

    5,247

    Long-term loans, net of current maturities

    2,740

    1,891

    Lease liabilities

    1,661

    1,598

              Total non-current liabilities

    14,619

    8,736

    COMMITMENTS AND CONTINGENT LIABILITIES





         Total liabilities

    25,260

    18,952







    EQUITY





    Ordinary shares

    9,870

    18,731

    Share premium

    279,241

    321,920

    Warrants

    -

    975

    Capital reserve

    12,322

    12,616

    Other comprehensive loss

    (1,416)

    (1,416)

    Accumulated deficit

    (277,987)

    (288,179)

              Total equity

    22,030

    64,647

              Total liabilities and equity

    47,290

    83,599

     

     



    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

    (UNAUDITED)

     



    Three months ended March 31,



    2020

    2021



    in USD thousands

    RESEARCH AND DEVELOPMENT EXPENSES

    (5,422)

    (4,278)

    SALES AND MARKETING EXPENSES

    (175)

    (154)

    GENERAL AND ADMINISTRATIVE EXPENSES

    (1,243)

    (1,017)

    OPERATING LOSS

    (6,840)

    (5,449)

    NON-OPERATING INCOME (EXPENSES), NET

    469

    (4,561)

    FINANCIAL INCOME

    140

    117

    FINANCIAL EXPENSES

    (414)

    (299)

    NET LOSS AND COMPREHENSIVE LOSS

    (6,645)

    (10,192)











    LOSS PER ORDINARY SHARE - BASIC AND DILUTED

    (0.04)

    (0.02)







    WEIGHTED AVERAGE NUMBER OF SHARES USED IN

        CALCULATION OF LOSS PER ORDINARY SHARE

    176,454,423

    559,537,952









     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

    (UNAUDITED)



     

    Ordinary shares

     

    Share premium

     

     

    Warrants

     

    Capital Reserve

    Other

    comprehensive loss

     

    Accumulated deficit

     

     

    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2020

    4,692

    265,938

    -

    12,132

    (1,416)

    (247,966)

    33,380

    CHANGES FOR THREE MONTHS ENDED MARCH 31, 2020:















    Issuance of share capital, net

    208

    895

    -

    -

    -

    -

    1,103

    Employee stock options exercised

    7

    204

    -

    (204)

    -

    -

    7

    Employee stock options forfeited and expired   

    -

    103

    -

    (103)

    -

    -

    -

    Share-based compensation     

    -

    -

    -

    663

    -

    -

    663

    Comprehensive loss for the period

    -

    -

    -

    -

    -

    (6,645)

    (6,645)

    BALANCE AT MARCH 31, 2020

    4,907

    267,140

    -

    12,488

    (1,416)

    (254,611)

    28,508



















     

    Ordinary shares

     

    Share premium

     

     

    Warrants

     

    Capital Reserve

    Other

    comprehensive loss

     

    Accumulated deficit

     

     

    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2021

    9,870

    279,241

    -

    12,322

    (1,416)

    (277,987)

    22,030

    CHANGES FOR THREE MONTHS ENDED MARCH 31, 2021:















    Issuance of share capital and warrants, net

    6,805

    24,979

    975

    -

    -

    -

    32,759

    Warrants exercised

    2,051

    17,523

    -

    -

    -

    -

    19,574

    Employee stock options exercised

    5

    38

    -

    (38)

    -

    -

    5

    Employee stock options forfeited and expired

    -

    139

    -

    (139)

    -

    -

    -

    Share-based compensation     

    -

    -

    -

    471

    -

    -

    471

    Comprehensive loss for the period

    -

    -

    -

    -

    -

    (10,192)

    (10,192)

    BALANCE AT MARCH 31, 2021

    18,731

    321,920

    975

    12,616

    (1,416)

    (288,179)

    64,647

















     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)

     







    Three months ended

    March 31,



    2020

    2021



    in USD thousands







    CASH FLOWS - OPERATING ACTIVITIES





    Comprehensive loss for the period

    (6,645)

    (10,192)

    Adjustments required to reflect net cash used in operating activities

     (see appendix below)

    (93)

    3,963

    Net cash used in operating activities

    (6,738)

    (6,229)







    CASH FLOWS - INVESTING ACTIVITIES





    Investments in short-term deposits 

    (6,000)

    (42,000)

    Maturities of short-term deposits

    12,191

    5,758

    Purchase of property and equipment

    -

    (19)

    Net cash provided by (used in) investing activities

    6,191

    (36,261)







    CASH FLOWS - FINANCING ACTIVITIES





    Issuance of share capital and warrants, net of issuance costs

    1,103

    42,765

    Employee stock options exercised

    7

    5

    Repayments of loans

    (682)

    (814)

    Repayments of lease liabilities

    (41)

    (49)

    Net cash provided by financing activities

    387

    41,907







    DECREASE IN CASH AND CASH EQUIVALENTS

    (160)

    (583)

    CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD           

    5,297

    16,831

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

    (65)

    (201)

    CASH AND CASH EQUIVALENTS - END OF PERIOD

    5,072

    16,047







     

     

    BioLineRx Ltd.

    APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)

     







    Three months ended

    March 31,



    2020

    2021



    in USD thousands













    Adjustments required to reflect net cash used in operating activities:





    Income and expenses not involving cash flows:





    Depreciation and amortization

    321

    182

    Exchange differences on cash and cash equivalents

    65

    201

    Fair value adjustments of warrants

    (476)

    4,597

    Share-based compensation

    663

    471

    Interest and exchange differences on short-term deposits

    (108)

    (38)

    Interest on loans

    44

    93

    Exchange differences on lease liability 

    (82)

    (65)



    427

    5,441







    Changes in operating asset and liability items:





    Increase in prepaid expenses and other receivables

    (238)

    (976)

    Decrease in accounts payable and accruals

    (282)

    (502)



    (520)

    (1,478)



    (93)

    3,963



















    Supplemental information on interest received in cash

    184

    22







    Supplemental information on interest paid in cash

    275

    200







    Supplemental information on non-cash portion oftransaction related to exercised warrants

    -

    9,568







     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2021-financial-results-and-provides-corporate-update-301299676.html

    SOURCE BioLineRx Ltd.

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  4. TEL AVIV, Israel, May 20, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended March 31, 2021 on Wednesday, May 26, 2021, before the US markets open.

    The Company will host a conference call on Wednesday, May 26, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call…

    TEL AVIV, Israel, May 20, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended March 31, 2021 on Wednesday, May 26, 2021, before the US markets open.

    The Company will host a conference call on Wednesday, May 26, 2021 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0610 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until May 28, 2021; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 internationally.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-to-report-first-quarter-2021-results-on-may-26-2021-301295733.html

    SOURCE BioLineRx Ltd.

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  5. TEL AVIV, Israel, May 4, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company's GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

    An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared…

    TEL AVIV, Israel, May 4, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive top-line results from the Company's GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients.

    An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF. In addition, the combination was found to be safe and well tolerated.

    The primary endpoint of the study demonstrated a 4.9-fold increase (70.0% vs 14.3%; difference 54.6%; 95% CI 39.7-69.5%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm mobilizing ≥ 6 million CD34+ cells/kg in up to two apheresis sessions, and after only one administration of Motixafortide. This translates to an odds-ratio of 12.9.

    The study also achieved its main secondary endpoint, demonstrating a 14.1-fold increase (67.5% vs 4.8%; difference 61.7%; 95% CI 49.5-73.8%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm, who mobilized ≥ 6 million CD34+ cells/kg in just one apheresis session. This translates to an odds-ratio of 56.0.

    Other important data from the study include median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs 1.5 million in the control arm) – a 5.6-fold increase. The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. Engraftment endpoints, including the number of days needed for engraftment, success of engraftment and the durability of engraftment 100 days post-transplant, further support the study's success.

    "The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session," stated John DiPersio, MD, Washington University School of Medicine, and lead investigator of the study. "This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation."

    "These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The statistical significance across all primary and secondary endpoints was consistent across twelve different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone-marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.  

    "We are working aggressively to gain regulatory approval for Motixafortide in this transplant setting for multiple myeloma patients – with plans to make an NDA submission in the first half of next year – and we are also pressing forward to unlock the full potential of this therapy in this and other stem-cell mobilization indications. I would like to express our sincere thanks to the patients and investigators who participated in the study and enabled its great success," Mr. Serlin concluded.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Tuesday, May 4, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-860-9642 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available for a limited time approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until May 6, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

    About the GENESIS Trial

    The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. Local laboratories and a central laboratory were used to determine CD34+ cell yields. For regulatory purposes, efficacy endpoints were calculated using the percentage of CD34+ cells determined by the central laboratory. The local laboratory values were used for all clinical decisions, including the number of apheresis days and the decision to proceed to transplantation.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-positive-top-line-results-from-genesis-phase-3-trial-of-motixafortide-in-stem-cell-mobilization-for-autologous-bone-marrow-transplantation-in-multiple-myeloma-patients-301282969.html

    SOURCE BioLineRx Ltd.

    View Full Article Hide Full Article
  6. TEL AVIV, Israel, April 15, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company has presented a poster at the AACR Annual Meeting, which is being held April 10-15 on a virtual basis."

    The poster, entitled: "A Multi-Center Phase 2a Trial of the CXCR4 inhibitor Motixafortide (BL-8040) in Combination with Pembrolizumab and Chemotherapy, in Patients with Metastatic Pancreatic Adenocarcinoma, the COMBAT Study," includes new analyses from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer, further detailing the clinical effect of the combination in patients with and without…

    TEL AVIV, Israel, April 15, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company has presented a poster at the AACR Annual Meeting, which is being held April 10-15 on a virtual basis."

    The poster, entitled: "A Multi-Center Phase 2a Trial of the CXCR4 inhibitor Motixafortide (BL-8040) in Combination with Pembrolizumab and Chemotherapy, in Patients with Metastatic Pancreatic Adenocarcinoma, the COMBAT Study," includes new analyses from the Company's Phase 2a COMBAT/KEYNOTE-202 triple combination study of motixafortide in metastatic pancreatic cancer, further detailing the clinical effect of the combination in patients with and without liver metastases.

    The COMBAT/KEYNOTE-202 study evaluated BioLineRx's lead clinical candidate, motixafortide, in combination with KEYTRUDA® and chemotherapy in patients with advanced pancreatic ductal adenocarcinoma, or PDAC. Top-line results from the study were announced in December 2020.

    "Liver metastases are a critical factor driving poor prognoses for patients with metastatic PDAC," stated Dr. Abi Vainstein, Chief Medical Officer of BioLineRx. "We are very pleased to present this additional analysis, which further strengthens the results reported from the COMBAT/KEYNOTE-202 trial in December 2020, since not only were substantially all patients initially diagnosed with stage 4 disease, but the vast majority (~80%) of the patients had liver metastases, emphasizing the extremely difficult patient population in this study. These data should be further confirmed in a randomized trial, and we continue to work diligently to define next steps for the program with potential collaboration partners."

    Summary data:

    Endpoint

    Evaluable Patients (N=38)

    Liver Metastases

    (N=30)

    No Liver Metastases

    (N=8)

    mOS (months)

    (95% CI)

    6.5

    (4.5-9.6)

    5.9

    (4.4-9.6)

    8.4

    (3.5-10.8)

    mPFS (months)

    (95% CI)

    4.0

    (1.5-5.6)

    1.9

    (1.5-5.7)

    5.4

    (1.5-8.0)

    ORR

    (95% CI)

    21.1%

    (8.1%-34.0%)

    16.7%

    (3.3%-30.0%)

    37.5%

    (4.0%-71.0%)

    DCR

    (95% CI)

    63.2%

    (47.8%-78.5%)

    56.7%

    (38.9%-74.4%)

    87.5%

    (64.6%-100.0%)

    "We believe these incremental data provide strong support for continued development of motixafortide as the backbone of a new regimen for the treatment of PDAC and will likely prove beneficial as we advance discussions with potential collaboration partners," stated Philip Serlin, Chief Executive Officer of BioLineRx. "At the same time, we are very much looking forward to final data from our Phase 3 GENESIS study in stem cell mobilization in the next few weeks, which we hope will give us a clear pathway to potential registration and highlight the versatility of motixafortide across both hematological and solid tumor cancer types."   

    A copy of the poster is now available on the Company's website, www.biolinerx.com.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-presentation-at-2021-american-association-for-cancer-research-aacr-annual-meeting-301269730.html

    SOURCE BioLineRx Ltd.

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  7. TEL AVIV, Israel, Feb. 23, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the year ended December 31, 2020 and provides a corporate update.

    Significant events and achievements during the fourth quarter 2020 and subsequent period:

    • Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177…

    TEL AVIV, Israel, Feb. 23, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the year ended December 31, 2020 and provides a corporate update.

    Significant events and achievements during the fourth quarter 2020 and subsequent period:

    • Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177 originally planned), and top-line data, including full primary and secondary efficacy endpoints, is anticipated in early second quarter of 2021. In parallel, the Company is proceeding with all activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of 2021.

     

    • Reported positive final results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 study evaluating motixafortide in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC). The results of the study showed substantial improvement as compared to historical results across all study endpoints. The Company is currently planning next development steps for this program, including discussions with potential collaboration partners and development of a protocol for a randomized controlled study.

     

    • Announced initiation of a Phase 2 investigator-initiated clinical trial evaluating motixafortide in combination with LIBTAYO® and chemotherapy in first-line metastatic PDAC. The study is led by Columbia University.

     

    • Announced initiation of a Phase 1b investigator-initiated clinical trial evaluating motixafortide in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.

     

    • Completed underwritten public offering with gross proceeds of $34.5 million.

     

    "The fourth quarter 2020 was perhaps our most significant so far, having achieved positive data milestones in two programs with significant unmet medical needs – stem-cell mobilization and PDAC," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The Phase 3 SCM interim data that we reported in October were overwhelmingly positive, and based on the DMC's recommendation, we ceased enrollment at 122 out of the originally planned 177 patients. We now look forward to presenting full top-line results from the study, including data related to 100 days of post-transplantation follow-up, by early second quarter of this year. SCM remains our most expeditious path to registration, and we therefore view these data as potentially transformational for our company. In parallel, we are moving forward very aggressively with all activities in support of an NDA submission, which we expect in the first half of next year.

    "We are equally excited about the final results from our Phase 2a COMBAT/KEYNOTE-202 PDAC study that we announced in December last year. The data demonstrated that the triple combination of motixafortide, KEYTRUDA and chemotherapy outperformed historical data across all endpoints, including median overall survival, median progression free survival, confirmed and overall response rates and disease control rate. In a cancer population as difficult to treat as second-line metastatic PDAC, and even more specifically those patients initially diagnosed with unresectable stage IV disease, we view these results as highly encouraging and are planning our next development steps forward in this program, likely in collaboration with a biopharmaceutical partner.

    "Finally, subsequent to the end of the year, we strengthened our balance sheet through a financing that resulted in gross proceeds of $34.5 million. These funds will allow us to continue to execute on our strategy for motixafortide in both SCM and PDAC, while in parallel advancing our second clinical candidate, the anti-cancer immunotherapy AGI-134, through clinical development. In summary, we exited 2020 on a very positive note, with two data sets that demonstrate both the effectiveness and versatility of motixafortide across multiple indications, and we plan to build upon these successes this year," concluded Mr. Serlin.

    Upcoming Significant Expected Milestones

    • Top-line results from the Phase 3 GENESIS trial in SCM in early Q2 2021.

     

    • Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.

     

    • Pre-NDA meeting with the FDA for SCM in the second half of 2021

     

    • NDA submission for SCM in the first half of 2022

    Financial Results for the Year Ended December 31, 2020

    Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2 million, or 22.5%, compared to $23.4 million for the year ended December 31, 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019, from lower expenses associated with the motixafortide  COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share-based compensation and payroll due to a company-wide salary reduction related to the COVID-19 pandemic.

    Sales and marketing expenses for the year ended December 31, 2020 were $0.8 million, similar to sales and marketing expenses for the year ended December 31, 2019.

    General and administrative expenses for the year ended December 31, 2020 were $3.9 million, an increase of $0.1 million, or 2.6% compared to $3.8 million for the year ended December 31, 2019. The increase resulted primarily from an increase in D&O insurance expenses and share-based compensation, offset by small decreases in a number of G&A expenses.

    The Company's operating loss for the year ended December 31, 2020 amounted to $22.9 million, compared to an operating loss of $28.1 million for the year ended December 31, 2019.

    Non-operating expenses amounted to $5.7 million for the year ended December 31, 2020, compared to non-operating income of $4.2 million for the year ended December 31, 2019. Non-operating expenses for the year ended December 31, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, warrant offering expenses and ATM issuance expenses. Non-operating income for the year ended December 31, 2019 primarily relates to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses.

    Net financial expenses amounted to $1.4 million for the year ended December 31, 2020, compared to net financial expenses of $1.5 million for the year ended December 31, 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

    The Company's net loss for the year ended December 31, 2020 amounted to $30.0 million, compared with a net loss of $25.5 million for the year ended December 31, 2019.

    The Company held $22.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2020. Subsequent to year end, the Company raised gross proceeds of $34.5 million in an underwritten public offering, and received another $9.8 million in gross proceeds from the exercise of outstanding warrants.

    Net cash used in operating activities for the year ended December 31, 2020 was $23.2 million, compared to $22.7 million for the year ended December 31, 2019. The $0.5 million increase in 2020 was primarily the result of a decrease in accounts payable and accruals.

    Net cash provided by investing activities for the year ended December 31, 2020 was $16.7 million, compared to $5.3 million for the year ended December 31, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

    Net cash provided by financing activities for the year ended December 31, 2020 was $17.9 million, compared to $19.2 million for the year ended December 31, 2019. The cash flows in 2020 primarily reflect the registered direct offerings of the Company's ADSs in May and June 2020, as well as net proceeds from the ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of the Company's ADSs in February 2019, as well as net proceeds from the ATM program.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, Thursday, February 23, 2021 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610  internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 internationally.

    (Tables follow)

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem-cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 February 23, 2021. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com



     

     

    BioLineRx Ltd.

    CONSOLIDATED STATEMENTS OF FINANCIAL POSITION







    December 31,



    2019

    2020



    in USD thousands

    Assets





    CURRENT ASSETS





    Cash and cash equivalents

    5,297

    16,831

    Short-term bank deposits

    22,192

    5,756

    Prepaid expenses

    108

    152

    Other receivables

    613

    141

              Total current assets

    28,210

    22,880







    NON-CURRENT ASSETS





    Property and equipment, net

    1,816

    1,341

    Right-of-use assets, net

    1,650

    1,355

    Intangible assets, net

    21,891

    21,714

              Total non-current assets

    25,357

    24,410

              Total assets

    53,567

    47,290







    Liabilities and equity





    CURRENT LIABILITIES





    Current maturities of long-term loans

    2,692

    3,092

    Accounts payable and accruals:





         Trade

    7,794

    5,918

         Other

    1,280

    1,440

    Lease liabilities

    202

    191

              Total current liabilities

    11,968

    10,641







    NON-CURRENT LIABILITIES





    Warrants

    658

    10,218

    Long-term loans, net of current maturities

    5,799

    2,740

    Lease liabilities

    1,762

    1,661

              Total non-current liabilities

    8,219

    14,619







    COMMITMENTS AND CONTINGENT LIABILITIES





              Total liabilities

    20,187

    25,260







    EQUITY





    Ordinary shares

    4,692

    9,870

    Share premium

    265,938

    279,241

    Capital reserve

    12,132

    12,322

    Other comprehensive loss

    (1,416)

    (1,416)

    Accumulated deficit

    (247,966)

    (277,987)

              Total equity

    33,380

    22,030

              Total liabilities and equity

    53,567

    47,290

     



     



    BioLineRx Ltd.



    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS





    Year ended December 31,





    2018

    2019

    2020





    in USD thousands











    RESEARCH AND DEVELOPMENT EXPENSES

    (19,808)

    (23,438)

    (18,173)

    SALES AND MARKETING EXPENSES

    (1,362)

    (857)

    (840)

    GENERAL AND ADMINISTRATIVE EXPENSES

    (4,435)

    (3,816)

    (3,914)

    OPERATING LOSS

    (25,605)

    (28,111)

    (22,927)

    NON-OPERATING INCOME (EXPENSES), NET

    2,397

    4,165

    (5,701)

    FINANCIAL INCOME

    719

    777

    236

    FINANCIAL EXPENSES

    (473)

    (2,277)

    (1,629)

    NET LOSS AND COMPREHENSIVE LOSS

    (22,962)

    (25,446)

    (30,021)











    in USD



    LOSS PER ORDINARY SHARE – BASIC AND DILUTED

    (0.21)

    (0.17)

    (0.12)











    WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE

    108,595,702

    146,407,055

    252,844,394

























     

     

    BioLineRx Ltd.



    STATEMENTS OF CHANGES IN EQUITY





     

    Ordinary shares

     

    Share premium

     

    Capital reserve

    Other comprehensive

     loss

     

    Accumulated deficit

     

     

    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2018

    2,836

    240,682

    10,337

    (1,416)

    (199,558)

    52,881

    CHANGES IN 2018:













      Issuance of share capital, net

    263

    8,567

    -

    -

    -

    8,830

      Employee stock options exercised

    11

    415

    (380)

    -

    -

    46

      Employee stock options forfeited and expired

    -

    528

    (528)

    -

    -

    -

      Share-based compensation   

    -

    -

    2,526

    -

    -

    2,526

      Comprehensive loss for the year

    -

    -

    -

    -

    (22,962)

    (22,962)

    BALANCE AT DECEMBER 31, 2018

    3,110

    250,192

    11,955

    (1,416)

    (222,520)

    41,321

    CHANGES IN 2019:













      Issuance of share capital, net

    1,580

    14,165

    -

    -

    -

    15,745

      Employee stock options exercised

    2

    83

    (84)

    -

    -

    1

      Employee stock options forfeited and expired

    -

    1,498

    (1,498)

    -

    -

    -

      Share-based compensation   

    -

    -

    1,759

    -

    -

    1,759

      Comprehensive loss for the year

    -

    -

    -

    -

    (25,446)

    (25,446)

    BALANCE AT DECEMBER 31, 2019

    4,692

    265,938

    12,132

    (1,416)

    (247,966)

    33,380

    CHANGES IN 2020:













      Issuance of share capital, net

    4,777

    9,395

    -

    -

    -

    14,172

      Warrants exercised

    393

    2,826

    -

    -

    -

    3,219

      Employee stock options exercised

    8

    228

    (228)

    -

    -

    8

      Employee stock options forfeited and expired

    -

    854

    (854)

    -

    -

    -

      Share-based compensation   

    -

    -

    1,272

    -

    -

    1,272

      Comprehensive loss for the year

    -

    -

    -

    -

    (30,021)

    (30,021)

    BALANCE AT DECEMBER 31, 2020

    9,870

    279,241

    12,322

    (1,416)

    (277,987)

    22,030

     



     

    BioLineRx Ltd.



    CONSOLIDATED CASH FLOW STATEMENTS





    Year ended December 31,



    2018

    2019

    2020



    in USD thousands

    CASH FLOWS - OPERATING ACTIVITIES







         Net loss

    (22,962)

    (25,446)

    (30,021)

         Adjustments required to reflect net cash used in operating activities (see appendix below)

    (1,230)

    2,780

    6,815

    Net cash used in operating activities

    (24,192)

    (22,666)

    (23,206)









    CASH FLOWS - INVESTING ACTIVITIES







         Realization of long-term investment

    1,500

    -

    -

         Investments in short-term deposits

    (26,500)

    (43,545)

    (33,500)

         Maturities of short-term deposits

    44,771

    48,875

    50,168

         Purchase of property and equipment

    (173)

    (67)

    -

         Purchase of intangible assets

    (10,043)

    (6)

    -

    Net cash provided by investing activities

    9,555

    5,257

    16,668









    CASH FLOWS - FINANCING ACTIVITIES







         Issuance of share capital and warrants, net of issuance cost

    3,830

    20,297

    21,215

         Employee stock options exercised

    46

    1

    8

         Proceeds of long-term loan and warrants, net of issuance costs

    9,632

    -

    -

         Repayment of loans

    (411)

    (889)

    (3,133)

         Repayments of lease liabilities

    -

    (215)

    (224)

    Net cash provided by financing activities

    13,097

    19,194

    17,866









    INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

    (1,540)

    1,785

    11,328

    CASH AND CASH EQUIVALENTS - BEGINNING

       OF YEAR

    5,110

    3,404

    5,297

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

    (166)

    108

    206

    CASH AND CASH EQUIVALENTS - END OF YEAR

    3,404

    5,297

    16,831









     

     

    BioLineRx Ltd.



    CONSOLIDATED CASH FLOW STATEMENTS





    Year ended December 31,



    2018

    2019

    2020



    in USD thousands

    APPENDIX















    Adjustments required to reflect net cash used in operating activities:







    Income and expenses not involving cash flows:







    Depreciation and amortization

    545

    940

    934

    Long-term prepaid expenses

    5

    56

    -

    Exchange differences on cash and cash equivalents

    166

    (108)

    (206)

    Fair value adjustments of warrants

    (1,743)

    (4,634)

    5,142

    Share-based compensation

    2,526

    1,759

    1,272

    Interest and exchange differences on short-term deposits

    (645)

    (775)

    (232)

    Interest on loans

    123

    647

    474

    Gain on realization of long-term investment

    (500)

    -

    -

    Warrant issuance costs

    -

    417

    594

    Exchange differences on lease liability 

    -

    154

    125



    477

    (1,544)

    8,103









    Changes in operating asset and liability items:







    Decrease (increase) in prepaid expenses and other receivables

    (934)

    1,106

    428

    Increase (decrease) in accounts payable and accruals

    (773)

    3,218

    (1,716)



    (1,707)

    4,324

    (1,288)











    (1,230)

    2,780

    6,815

























    Supplemental information on interest received in cash

    834

    868

    381









    Supplemental information on interest paid in cash

    165

    1,198

    994









    Supplemental information on non-cash transactions

    5,000

    147

    1,251

























     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-year-end-2020-financial-results-and-provides-corporate-update-301233309.html

    SOURCE BioLineRx Ltd.

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  8. TEL AVIV, Israel, Feb. 17, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its audited financial results for the year ended December 31, 2020 on Tuesday, February 23, 2021, before the US markets open.

    The Company will host a conference call on Tuesday, February 23, 2021 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer, and other members of the management team. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the…

    TEL AVIV, Israel, Feb. 17, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its audited financial results for the year ended December 31, 2020 on Tuesday, February 23, 2021, before the US markets open.

    The Company will host a conference call on Tuesday, February 23, 2021 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer, and other members of the management team. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 internationally.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    Contacts:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

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    SOURCE BioLineRx Ltd.

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  9. TEL AVIV, Israel, Jan. 22, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced the closing of its previously announced underwritten offering of 14,375,000 American Depositary Shares (ADSs) of the Company, inclusive of the full exercise by Wainwright of its option to purchase 1,875,000 additional ADSs, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions…

    TEL AVIV, Israel, Jan. 22, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced the closing of its previously announced underwritten offering of 14,375,000 American Depositary Shares (ADSs) of the Company, inclusive of the full exercise by Wainwright of its option to purchase 1,875,000 additional ADSs, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions and offering expenses, are approximately $34.5 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

    The securities described above were offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) previously filed with the Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities offered have been filed with the SEC and are available on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at placements@hcwco.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events, such as statements relating to the bought deal offering, including as to the intended use of proceeds. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.

    Company contact:

     

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com  

     

    or

     

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com  



     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-closing-of-34-5-million-bought-deal-offering-and-full-exercise-of-the-option-of-the-underwriter-301213408.html

    SOURCE BioLineRx Ltd

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  10. TEL AVIV, Israel, Jan. 20, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 12,500,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company. The closing of the offering is expected to occur on or about January 22, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running…

    TEL AVIV, Israel, Jan. 20, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 12,500,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company. The closing of the offering is expected to occur on or about January 22, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to additional 1,875,000 ADSs at the public offering price, less underwriting discounts and commissions.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter's option to purchase additional ADSs, are expected to be approximately $30 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

    The securities described above are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) previously filed with the Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered have been filed with the SEC and are available on the SEC's website at http://www.sec.gov.  A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and, upon filing, may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at placements@hcwco.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events, such as statements relating to the bought deal offering, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering. These forward-looking statements involve known and unknown risks and uncertainties 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: market and other conditions, 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.

    Company contact:

     

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com  

     

    or

     

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com  



     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-increases-previously-announced-bought-deal-offering-to-30-million-301211410.html

    SOURCE BioLineRx Ltd.

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  11. TEL AVIV, Israel, Jan. 19, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 4,166,667 American Depositary Shares (ADSs) of the Company, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company. The closing of the offering is expected to occur on or about January 22, 2021, subject to satisfaction of customary closing conditions. 

    H.C. Wainwright & Co. is acting as the…

    TEL AVIV, Israel, Jan. 19, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 4,166,667 American Depositary Shares (ADSs) of the Company, at a price to the public of $2.40 per ADS, less underwriting discounts and commissions. Each ADS represents fifteen ordinary shares, par value NIS 0.10 per share, of the Company. The closing of the offering is expected to occur on or about January 22, 2021, subject to satisfaction of customary closing conditions. 

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to additional 625,000 ADSs at the public offering price, less underwriting discounts and commissions.

    The gross proceeds to BioLineRx, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter's option to purchase additional ADSs, are expected to be approximately $10 million. The Company intends to use the net proceeds from this offering for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

    The securities described above are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) previously filed with the Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at placements@hcwco.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events, such as statements relating to the bought deal offering, including as to the consummation of the offering described above, the expected proceeds from the offering, the intended use of proceeds and the timing of the closing of the offering. These forward-looking statements involve known and unknown risks and uncertainties 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: market and other conditions, 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.



    Company contact:

     

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com 

     

    or

     

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com 



     

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    SOURCE BioLineRx Ltd.

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  12. TEL AVIV, Israel, Dec. 16, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 clinical study evaluating motixafortide (BL-8040) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC).

    A total of 43 patients initially diagnosed with unresectable stage IV metastatic PDAC, who had progressed following first-line gemcitabine-based therapy, were enrolled in the triple combination arm. Patients received motixafortide monotherapy priming treatment for five days, followed by combination cycles…

    TEL AVIV, Israel, Dec. 16, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced results from the triple combination arm of the Company's COMBAT/KEYNOTE-202 clinical study evaluating motixafortide (BL-8040) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC).

    A total of 43 patients initially diagnosed with unresectable stage IV metastatic PDAC, who had progressed following first-line gemcitabine-based therapy, were enrolled in the triple combination arm. Patients received motixafortide monotherapy priming treatment for five days, followed by combination cycles of motixafortide, KEYTRUDA and chemotherapy (Onivyde®/5-fluorouracil/leucovorin) until progression. The primary endpoint of the study is the objective response rate (ORR); secondary endpoints include confirmed objective response rate (cORR), overall survival (OS), progression free survival (PFS), and disease control rate (DCR).

    The results of the study showed substantial improvement as compared to historical results across all study endpoints. Data are summarized below for the evaluable patients in the study (n=38).

    Data summary:



    COMBAT/KEYNOTE

    HISTORICAL DATA

    Median overall survival (mOS)

    6.5 months

    4.7 months1

    Median progression free survival (mPFS)

    4.0 months

    2.7-3.1 months2,3

    Confirmed overall response rate (cORR)

    13.2%

    7.7%3

    Overall response rate (ORR)

    21.2%

    16%1

    Disease control rate (DCR)

    63.2%

    29-52%2,4

    1 Macarulla Mercade et al, Pancreas 2020

    2 Petrelli et al Eu J Cancer 2017

    3 Onivyde prescribing information

    4 Wang Gillam Eu J Cancer 2019

    The combination was generally well tolerated, with a safety profile consistent with the individual safety profile of each component alone; adverse event (AE) and severe adverse event (SAE) profiles were as expected with chemotherapy-based treatment regimens. Of note, certain safety advantages were demonstrated by the triple combination of motixafortide, KEYTRUDA and chemotherapy, when compared to historical data relating to the specific chemotherapy used in the study. These safety advantages include incidence of grade 3 neutropenia (7% versus historical data of 20%) and incidence of grade 3 infections (7% versus historical data of 17%).

    "These results are highly encouraging in light of the extremely challenging population, even among PDAC patients, in this study cohort," said Manuel Hidalgo, MD, PhD, Chief of the Division of Hematology and Medical Oncology and a Senior Member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and principal investigator of this study. "All patients were initially diagnosed at stage IV, and greater than 70% had liver metastases, key contributing factors to very poor prognoses. I believe the results from this study strongly support further development."

    "We are extremely pleased with these results, which demonstrate a meaningful improvement versus historical data across all study endpoints," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The consistent improvement across all study endpoints represents a key differentiating factor relative to other compounds that showed improvement in only one endpoint in their initial studies and eventually failed in advanced studies. These positive results are further supported by a long-lasting median durability of clinical benefit of 5.6 months that we observed in this trial.  

    "Pancreatic cancer is one of the most difficult cancers to treat, with five-year survival rates of just 9% overall, and 3% for the greater-than-50% of patients initially diagnosed at stage IV. Therefore, even marginal improvements in survival endpoints in pivotal studies have been considered clinically meaningful and sufficient for regulatory approval. These positive efficacy results across all endpoints give us a high degree of confidence in their repeatability in a randomized trial and we plan to meet with the regulatory authorities in order to agree on the fastest pathway forward in this indication. 

    "In addition, we believe these results clearly support investigating the  motixafortide/immune-checkpoint-inhibitor platform with other standard-of-care chemotherapies in earlier PDAC treatment lines, as well as in other 'cold' solid tumors. To that end, we are currently investigating motixafortide in combination with an anti-PD-1 and chemotherapy (gemcitabine and nab-paclitaxel) in first-line pancreatic cancer, and we are assessing potential combinations in other solid-tumor indications as well.

    "These data are particularly exciting in light of the strikingly positive results of the interim analysis from our Phase 3 GENESIS study of motixafortide in stem cell mobilization that we recently announced in October. Motixafortide has now demonstrated clinical utility in two therapeutic areas through multiple mechanisms of action, supporting our belief that it can serve as the backbone of a number of promising combination therapies to treat a broad range of cancer types," Mr. Serlin concluded.  

    BioLineRx plans to present the full data set at an upcoming medical conference.

    KOL Webinar Information

    BioLineRx will host a KOL webinar today, December 16, 2020 at 8:00 a.m. EST. The webinar will feature presentations by Key Opinion Leaders (KOLs) Gulam Manji, M.D., Ph.D. (Columbia University Medical Center), Manuel Hidalgo, M.D., Ph.D. (Weill Cornell Medicine), and Talia Golan, M.D. (Sheba Medical Center), who will discuss the current treatment landscape and unmet medical need in treating patients with pancreatic cancer, and the COMBAT study data. BioLineRx's management team will also discuss the COMBAT results. Drs. Hidalgo and Golan will be available to answer questions following the formal presentations.

    Interested parties can register for the webinar here.

    About COMBAT/KEYNOTE-202

    The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multinational, multicenter, single-arm trial to evaluate the safety, tolerability and efficacy of the dual combination of motixafortide and KEYTRUDA®, an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in 37 subjects with metastatic pancreatic adenocarcinoma (2L-5L). The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA® and BioLineRx was the study sponsor and owns all rights to motixafortide.

    In July 2018, the Company announced the expansion of the collaboration with MSD to include a triple combination arm, as part of the COMBAT/KEYNOTE-202 study investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy in 43 patients initially diagnosed with unresectable stage IV metastatic PDAC, who had progressed following first-line gemcitabine-based therapy. These results are being announced today.

    The study was carried out primarily in the US, Spain and Israel.

    About Motixafortide in Cancer Immunotherapy

    Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

    Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

    In a number of clinical and preclinical studies, motixafortide has been shown to affect multiple modes of action in 'cold' tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor microenvironment, turning 'cold' tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

    About Pancreatic Cancer

    Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2% of new cancer cases. In 2018, approximately 450,000 individuals globally were diagnosed with this condition, 55,000 of them in the US; and the incidence of pancreatic cancer is expected to continue to increase. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis. Even among patients who undergo resection for pancreatic cancer and have tumor-free margins, the five-year survival rate is only 10%-25%. The overall five-year survival rate among pancreatic cancer patients is 9%, which constitutes the highest mortality rate among solid tumor malignancies. The overall median survival is less than one year from diagnosis, highlighting the need for the development of new therapeutic options.

    Despite advances in chemotherapeutics and immunotherapy, increases in median and overall survival rates in pancreatic cancer have been modest. Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane®) in combination with gemcitabine for first-line treatment in 2013 and Onivyde® in combination with fluorouracil and leucovorin for second-line treatment in 2015. The limited clinical benefits demonstrated by these existing standard treatment options reinforce the need for additional approaches.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line PDAC therapy.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

    Dr. Hidalgo is a paid consultant for  InxMed, Agenus, and Tolero Pharmaceuticals, which are clinical-stage companies focused on treatments for cancer and other diseases. Dr. Hidalgo also has stock in Agenus, Inxmed, PharmaCyte Biotech Inc., as well as Champions Oncology Inc., a company that supports oncology drug development.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

    or

    Moran Meir

    LifeSci Advisors, LLC

    +972-54-476-4945

    moran@lifesciadvisors.com

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-final-results-from-phase-2a-combatkeynote-202-triple-combination-study-of-motixafortide-in-second-line-metastatic-pancreatic-cancer-pdac-301193912.html

    SOURCE BioLineRx Ltd.

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  13. TEL AVIV, Israel, Nov. 23, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2020 and provides a corporate update.

    Significant events and achievements during the third quarter 2020 and subsequent period:

    • Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In…

    TEL AVIV, Israel, Nov. 23, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2020 and provides a corporate update.

    Significant events and achievements during the third quarter 2020 and subsequent period:

    • Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In accordance with the DMC's recommendation, study enrollment was completed at 122 patients (instead of 177 as originally planned). SCM is the Company's most efficient path to registration;
    • Announced initiation of Phase 2 investigator-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC. The study is being run by Columbia University;
    • Announced initiation of investigator-initiated Phase 1b study, led by Wolfson Medical Center in Holon, Israel, to evaluate motixafortide in patients hospitalized with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections;
    • Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which had been temporarily suspended in the second quarter of 2020 due to clinical operating risks associated with the COVID-19 pandemic;
    • Conducted interim analysis for Phase 2b BLAST study in consolidation AML; analysis did not demonstrate statistically significant effect in primary endpoint; DMC recommended not to continue the study.

    "The past several months have been very exciting for BioLineRx, highlighted by the very positive result of the interim analysis of our Phase 3 GENESIS study in stem cell mobilization" stated Philip Serlin, Chief Executive Officer of BioLineRx. "A statistically significant benefit in the primary endpoint was observed by combining motixafortide with the standard of care, G-CSF, leading the DMC to recommend that we cease study enrollment at 122 patients, instead of the 177 originally planned. We look forward to publishing final results of the study in the first half of next year, as we continue to advance motixafortide toward registration.

    "With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we've had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.

    "Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year's ESMO IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA®, together with chemotherapy, will prove beneficial to survival as well.

    "The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers," Mr. Serlin concluded.

    Upcoming Expected Milestones

    • Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020;
    • Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021;
    • Preliminary results of the Phase 1b study in ARDS in the first half of 2021;
    • Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
    • Data from the Columbia University-initiated study of motixafortide in combination with LIBTAYO® and chemotherapy in first-line PDAC in mid-2022;

    Financial Results for the Quarter Ended September 30, 2020

    Research and development expenses for the three months ended September 30, 2020 were $3.5 million, a decrease of $2.1 million compared to $5.6 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 and from lower expenses associated with the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Research and development expenses for the nine months ended September 30, 2020 were $13.5 million, a decrease of $1.7 million, compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic mentioned above.

    Sales and marketing expenses for three months ended September 30, 2020 were $0.3 million, an increase of $0.1 million compared to $0.2 million for the comparable period in 2019. The increase resulted primarily from consultancy services and market research for motixafortide offset by a decrease in payroll and related expenses related to a reduction in headcount. Sales and marketing expenses for the nine months ended September 30, 2020 were $0.7 million, similar to the comparable period in 2019.

    General and administrative expenses for the three months ended September 30, 2020 were $0.9, similar to the comparable period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $2.8 million, similar to the comparable period in 2019.

    The Company's operating loss for the three months ended September 30, 2020 amounted to $4.6 million, compared to an operating loss of $6.6 million for the comparable period in 2019. The Company's operating loss for the nine months ended September 30, 2020 was $17.1 million, compared to $18.7 million for the comparable period in 2019.

    Non-operating income (expenses) for the three- and nine-month periods ended September 30, 2020 and 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses and issuance expenses of the Company's ATM program.

    Net financial expenses for the three months ended September 30, 2020 amounted to $0.3 million compared to net financial expenses of $0.4 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the nine months ended September 30, 2020 amounted to $0.9 million, similar to the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

    The Company's net loss for the three months ended September 30, 2020 amounted to $4.6 million, compared with a net loss of $3.9 million for the comparable period in 2019. The Company's net loss for the nine months ended September 30, 2020 amounted to $18.0 million, compared with a net loss of $15.6 million for the comparable period in 2019.

    The Company held $20.8 million in cash, cash equivalents and short-term bank deposits as of September 30, 2020.

    Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2020, compared with net cash used in operating activities of $17.2 million for the nine months ended September 30, 2019. The $0.6 million increase in net cash used in operating activities during the nine-month period in 2020 was primarily the result of the decrease in accounts payable and accruals in the 2020 period.

    Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2020, compared to net cash provided by investing activities of $2.1 million for the nine months ended September 30, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

    Net cash provided by financing activities was $10.9 million for the nine months ended September 30, 2020, compared to net cash provided by financing activities of $16.6 million for the nine months ended September 30, 2019. The cash flows in 2020 primarily reflect the May and June financings and the net proceeds from the Company's ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of our ADSs in February 2019, as well as net proceeds from the ATM facility.

    Conference Call and Webcast Information

    BioLineRx will hold a conference call today, November 23, 2020 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0664 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until November 25, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5929 internationally.

    (Tables follow)

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.

    Contact:

    Tim McCarthy

    LifeSci Advisors, LLC

    +1-212-915-2564

    tim@lifesciadvisors.com

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

    (UNAUDITED)















    December 31,

    September 30,



    2019

    2020



    in USD thousands

    Assets





    CURRENT ASSETS





    Cash and cash equivalents

    5,297

    6,552

    Short-term bank deposits

    22,192

    14,275

    Prepaid expenses

    108

    269

    Other receivables

    613

    327

              Total current assets

    28,210

    21,423







    NON-CURRENT ASSETS





    Property and equipment, net

    1,816

    1,462

    Right-of-use assets, net

    1,650

    1,423

    Intangible assets, net

    21,891

    21,731

              Total non-current assets

    25,357

    24,616

              Total assets

    53,567

    46,039







    Liabilities and equity





    CURRENT LIABILITIES





    Current maturities of long-term loans

    2,692

    2,969

    Accounts payable and accruals:





         Trade

    7,794

    5,933

         Other

    1,280

    1,374

    Lease liabilities

    202

    200

              Total current liabilities

    11,968

    10,476

    NON-CURRENT LIABILITIES





    Warrants

    658

    5,600

    Long-term loans, net of current maturities

    5,799

    3,554

    Lease liabilities

    1,762

    1,601

              Total non-current liabilities

    8,219

    10,755

    COMMITMENTS AND CONTINGENT LIABILITIES





         Total liabilities

    20,187

    21,231







    EQUITY





    Ordinary shares

    4,692

    8,281

    Share premium

    265,938

    271,107

    Capital reserve

    12,132

    12,835

    Other comprehensive loss

    (1,416)

    (1,416)

    Accumulated deficit

    (247,966)

    (265,999)

              Total equity

    33,380

    24,808

              Total liabilities and equity

    53,567

    46,039

         

     

    BioLineRx Ltd.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

    (UNAUDITED)





    Three months ended September 30,

    Nine months ended

    September 30,



    2019

    2020

    2019

    2020



    in USD thousands

    in USD thousands

    RESEARCH AND DEVELOPMENT EXPENSES

    (5,558)

    (3,484)

    (15,252)

    (13,546)

    SALES AND MARKETING EXPENSES

    (201)

    (309)

    (683)

    (666)

    GENERAL AND ADMINISTRATIVE EXPENSES

    (884)

    (856)

    (2,763)

    (2,843)

    OPERATING LOSS

    (6,643)

    (4,649)

    (18,698)

    (17,055)

    NON-OPERATING INCOME (EXPENSES), NET

    3,055

    294

    3,976

    (80)

    FINANCIAL INCOME

    247

    39

    628

    214

    FINANCIAL EXPENSES

    (597)

    (302)

    (1,484)

    (1,112)











    NET LOSS AND COMPREHENSIVE LOSS

    (3,938)

    (4,618)

    (15,578)

    (18,033)













    in USD

    in USD

    LOSS PER ORDINARY SHARE - BASIC AND DILUTED

    (0.03)

    (0.02)

    (0.11)

    (0.08)











    WEIGHTED AVERAGE NUMBER OF SHARES USED IN

    CALCULATION OF LOSS PER ORDINARY SHARE

     

    148,920,707

    296,508,550

    142,527,942

    231,380,969























     



    BioLineRx Ltd.

    CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY

    (UNAUDITED)





















    Ordinary Shares

    Share premium

    Capital reserve

    Other

    comprehensive

    loss

    Accumulated deficit

    Total



     

    in USD thousands

    BALANCE AT JANUARY 1, 2019

    3,110

    250,192

    11,955

    (1,416)

    (222,520)

    41,321

    CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30,

    2019:













    Issuance of share capital, net

    1,018

    11,266

    -

    -

    -

    12,284

    Employee stock options exercised

    1

    53

    (53)

    -

    -

    1

    Employee stock options forfeited and expired

    -

    919

    (919)

    -

    -

    -

    Share-based compensation              

    -

    -

    1,170

    -

    -

    1,170

    Comprehensive loss for the period

    -

    -

    -

    -

    (15,578)

    (15,578)

    BALANCE AT SEPTEMBER 30, 2019

    4,129

    262,430

    12,153

    (1,416)

    (238,098)

    39,198

















    Ordinary Shares

    Share premium











    Capital reserve

    Other 

    Comprehensive
    Loss

    Accumulated deficit

    Total



    in USD thousands

    BALANCE AT JANUARY 1, 2020

    4,692

    265,938

    12,132

    (1,416)

    (247,966)

    33,380

    CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2020:













    Issuance of share capital, net

    3,581

    4,754

    -

    -

    -

    8,335

    Employee stock options exercised

    8

    224

    (224)

    -

    -

    8

    Employee stock options forfeited and expired

    -

    191

    (191)

    -

    -

    -

    Share-based compensation              

    -

    -

    1,118

    -

    -

    1,118

    Comprehensive loss for the period

    -

    -

    -

    -

    (18,033)

    (18,033)

    BALANCE AT SEPTEMBER 30, 2020

    8,281

    271,107

    12,835

    (1,416)

    (265,999)

    24,808















     



    BioLineRx Ltd.

    CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY

    (UNAUDITED)

     



    Ordinary

    Share

    Capital

    Other

    Comprehensive

    Accumulated





    Shares

    premium

    reserve

    Loss

    deficit

    Total



    in USD thousands

    BALANCE AT JULY 1, 2019

    4,001

    261,522

    11,835

    (1,416)

    (234,160)

    41,782

    CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2019:













    Issuance of share capital, net

    128

    829

    -

    -

    -

    957

    Employee stock options exercised

    -

    26

    (26)

    -

    -

    -

    Employee stock options forfeited and expired

    -

    53

    (53)

    -

    -

    -

    Share-based compensation              

    -

    -

    397

    -

    -

    397

    Comprehensive loss for the period

    -

    -

    -

    -

    (3,938)

    (3,938)

    BALANCE AT SEPTEMBER 30, 2019

    4,129

    262,430

    12,153

    (1,416)

    (238,098)

    39,198

















     

    Ordinary

     

    Share

     

    Capital

    Other

    Comprehensive

     

    Accumulated





    Shares

    premium

    Reserve

    Loss

    deficit

    Total



    in USD thousands

    BALANCE AT JULY 1, 2020

    8,281

    271,107

    12,639

    (1,416)

    (261,381)

    29,230

    CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2020:













    Issuance of share capital, net

    -

    -

    -

    -

    -

    -

    Employee stock options exercised

    -

    -

    -

    -

    -

    -

    Employee stock options forfeited and expired

    -

    -

    -

    -

    -

    -

    Share-based compensation              

    -

    -

    196

    -

    -

    196

    Comprehensive loss for the period

    -

    -

    -

    -

    (4,618)

    (4,618)

    BALANCE AT SEPTEMBER 30, 2020

    8,281

    271,107

    12,835

    (1,416)

    (265,999)

    24,808















     

    BioLineRx Ltd

    CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)





    Nine months ended September 30,



    2019

    2020



    in USD thousands







    CASH FLOWS - OPERATING ACTIVITIES





    Comprehensive loss for the period

    (15,578)

    (18,033)

    Adjustments required to reflect net cash used in operating activities

     (see appendix below)

    (1,658)

    259







    Net cash used in operating activities

    (17,236)

    (17,774)







    CASH FLOWS - INVESTING ACTIVITIES





    Investments in short-term deposits

    (34,517)

    (28,500)

    Maturities of short-term deposits

    36,637

    36,626

    Purchase of property and equipment

    (54)

    (1)

    Net cash provided by investing activities

    2,066

    8,125







    CASH FLOWS - FINANCING ACTIVITIES





    Issuance of share capital and warrants, net of issuance costs

    16,836

    13,411

    Employee stock options exercised

    1

    8

    Repayments of loans

    (70)

    (2,338)

    Repayments of lease liabilities

    (165)

    (162)

    Net cash provided by financing activities

    16,602

    10,919







    INCREASE IN CASH AND CASH EQUIVALENTS

    1,432

    1,270

    CASH AND CASH EQUIVALENTS - BEGINNING

       OF PERIOD

    3,404

    5,297

    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

    49

    (15)

    CASH AND CASH EQUIVALENTS - END OF PERIOD

    4,885

    6,552









     

    BioLineRx Ltd.

    APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

    (UNAUDITED)







    Nine months ended

    September 30,



    2019

    2020



    in USD thousands













    Adjustments required to reflect net cash used in operating activities:





    Income and expenses not involving cash flows:





    Depreciation and amortization

    667

    737

    Long-term prepaid expenses

    (3)

    -







    Exchange differences on cash and cash equivalents

    (49)

    15

    Fair value adjustments of warrants

    (4,429)

    (727)

    Share-based compensation

    1,170

    1,118

    Warrant issuance costs

    417

    593

    Interest and exchange differences on short-term deposits

    (628)

    (209)

    Interest on loans

    512

    370

    Exchange differences on lease liability 

    -

    4



    (2,343)

    1,901







    Changes in operating asset and liability items:





    Decrease in prepaid expenses and other receivables

    265

    125

      Increase (decrease) in accounts payable and accruals

    420

    (1,767)



    685

    (1,642)



    (1,658)

    259













    Supplemental information on interest received in cash

    628

    342







    Supplemental information on interest paid in cash

    782

    671







     

     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-third-quarter-2020-financial-results-and-provides-corporate-update-301178794.html

    SOURCE BioLineRx Ltd.

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  14. Management to hold a conference call at 10:00 a.m. EST

    TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended September 30, 2020 on Monday, November 23, 2020, before the US markets open.

    The Company will host a conference call on Monday, November 23, 2020 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software…

    Management to hold a conference call at 10:00 a.m. EST

    TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, announced today it will release its unaudited financial results for the quarter ended September 30, 2020 on Monday, November 23, 2020, before the US markets open.

    The Company will host a conference call on Monday, November 23, 2020 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx'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.

    To dial into the conference call, please dial +1-866-744-5399 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until November 25, 2020; please dial +1-877-456-0009 from the U.S. or +972-3-925-5929 internationally.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD, as well as a Phase 2b study in consolidation AML.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on FacebookTwitter, and LinkedIn.

    Contact: 

    Tim McCarthy 

    LifeSci Advisors, LLC  

    +1-212-915-2564   

    tim@lifesciadvisors.com 

    or

    Moran Meir  

    LifeSci Advisors, LLC  

    +972-54-476-4945   

    moran@lifesciadvisors.com

     

    Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-to-report-third-quarter-2020-results-on-november-23-2020-301175789.html

    SOURCE BioLineRx Ltd.

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  15. TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company's lead drug candidate, the CXCR4-inhibitor Motixafortide, will be evaluated in an investigator-initiated clinical trial in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.

    The open-label, single-arm, Phase 1b study will be conducted at the Wolfson Medical Center in Holon, Israel, with Dr. Yasmin Maor, Head of the Infectious Disease Unit, as lead investigator.

    "Severe COVID-19 cases, where patients are hospitalized with ARDS and require ventilation, have generated renewed…

    TEL AVIV, Israel, Nov. 18, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical Company focused on oncology, today announced that the Company's lead drug candidate, the CXCR4-inhibitor Motixafortide, will be evaluated in an investigator-initiated clinical trial in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.

    The open-label, single-arm, Phase 1b study will be conducted at the Wolfson Medical Center in Holon, Israel, with Dr. Yasmin Maor, Head of the Infectious Disease Unit, as lead investigator.

    "Severe COVID-19 cases, where patients are hospitalized with ARDS and require ventilation, have generated renewed interest in the underlying pathology of acute respiratory stress disorder," noted Dr. Maor. "Substantial data is emerging regarding the involvement of neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to COVID-19 and other viral infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed pulmonary tissue. Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, Motixafortide could be of potential benefit for such patients. COVID-19 case counts are again surging in many parts of the world and addressing ARDS has become a top global health priority."

    The primary endpoint of the study is to assess the safety of Motixafortide in patients with ARDS secondary to COVID-19 and other respiratory viral infections. Respiratory parameters and inflammatory biomarkers will be assessed as exploratory endpoints. Up to 25 patients will be enrolled, with a preliminary analysis planned after ten patients have completed the initial treatment period. Based on the preliminary evaluation, a decision to continue or not will be conducted by Dr. Maor, together with the Company.

    "We believe there is strong scientific rationale for exploring Motixafortide in ARDS, and we are grateful to Dr. Maor for initiating this study," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We have compiled a significant body of data demonstrating Motixafortide's utility as a best-in-class CXCR4 inhibitor and we are eager to evaluate its effectiveness in blunting the cytokine storm that is associated with poor COVID-19 infection outcomes. We look forward to results from the preliminary analysis in the first half of next year. 

    "In parallel, we remain on track to announce full data from our Phase 2a COMBAT/KEYNOTE-202 study in pancreatic cancer, as well as interim results from our Phase 2b BLAST study in AML, by the end of this year," Mr. Serlin concluded.

    About BioLineRx

    BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

    The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD, as well as a Phase 2b study in consolidation AML.

    BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

    For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

    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 "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties 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; 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; BioLineRx's ability to establish 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 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; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. 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 12, 2020. 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.