BLRX BioLineRx Ltd.

2.88
-0.16  -5%
Previous Close 3.04
Open 2.98
52 Week Low 1.4
52 Week High 6.34
Market Cap $136,219,847
Shares 47,298,558
Float 47,298,558
Enterprise Value $69,315,226
Volume 337,372
Av. Daily Volume 427,595
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Upcoming Catalysts

Drug Stage Catalyst Date
AGI-134
Solid tumors
Phase 1/2
Phase 1/2
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Motixafortide (BL-8040) - (GENESIS)
Stem-cell mobilization for autologous transplantation
NDA Filing
NDA Filing
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Motixafortide (BL-8040) and LIBTAYO (cemiplimab)
First-line pancreatic ductal adenocarcinoma
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Motixafortide (BL-8040)
Acute respiratory distress syndrome (ARDS) secondary to COVID-19
Phase 1b
Phase 1b
Phase 1b initiation announced November 18, 2020.
Motixafortide (BL-8040) and KEYTRUDA (pembrolizumab)
Pancreatic cancer
Phase 2a
Phase 2a
Phase 2a data presented at ESMO December 13, 2019.
Motixafortide (BL-8040) and KEYTRUDA (pembrolizumab) - COMBAT trial
Pancreatic cancer
Phase 2
Phase 2
Phase 2 data released December 16, 2020. ORR 21%; PFS 4 months; OS 6.5 months.
Motixafortide (BL-8040) - BLAST
Consolidation treatment for AML cancer patients
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint - November 23, 2020.

Latest News

  1. TEL AVIV, Israel, Oct. 13, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial. These results, together with the highly significant…

    TEL AVIV, Israel, Oct. 13, 2021 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial. These results, together with the highly significant and clinically meaningful data from the GENESIS trial, strongly support the potential use of Motixafortide, on top of G-CSF, as the standard of care in SCM for ASCT.

    The study concluded that the addition of Motixafortide to G-CSF (the current standard of care) is associated with a statistically significant decrease in health resource utilization (HRU) during the ASCT process, compared to G-CSF alone. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions, lifetime estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$17,000 (not including the cost of Motixafortide), versus G-CSF alone. The study findings, combined with model estimates, suggest that the use of Motixafortide, on top of G-CSF, as the standard of care in mobilization for ASCT, could be a cost-effective option in the US, based on accepted willingness-to-pay (WTP) values for healthcare payers.

    "The compelling cost savings identified by this rigorously designed study strongly support the Company's view that Motixafortide, in combination with G-CSF, can become the new standard of care as an upfront, or primary, therapy for all multiple myeloma patients undergoing autologous stem cell transplantation," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Based on data from the GENESIS trial showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, versus less than 10% for G-CSF alone, the pharmacoeconomic study demonstrates that use of Motixafortide on top of G-CSF can save $17,000 per patient, not including the cost of Motixafortide. These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.

    "It is also important to note that fewer administrations and apheresis sessions confer meaningful safety and time benefits to patients. In addition, the significantly higher median number of cells collected in one apheresis session – ~11 million using Motixafortide on top of G-CSF versus ~2 million for G-CSF alone – not only enables transplantation of an optimal number of cells, with the potential to significantly save on time to engraftment, it also permits the retention of enough cells for cryopreservation in the event that an additional transplantation is required in the future. Lastly, higher levels of certainty regarding the number of apheresis sessions required for mobilization could enable more efficient utilization of apheresis units at transplantation institutions, where there is often a shortage of available machines.

    "We believe the data from the GENESIS study, together with the results from this pharmacoeconomic study, set Motixafortide apart from all other mobilization agents either currently available or in development. If approved, Motixafortide represents a significant advancement in SCM to the benefit of patients and payers alike, and, to that end, we remain on track to submit a New Drug Application (NDA) to the FDA in the first half of next year," Mr. Serlin concluded.

    About the Pharmacoeconomic Study

    The pharmacoeconomic study analyzed healthcare resource utilization (HRU) observed during the Phase 3 GENESIS trial, which randomized 122 patients into two arms: Motixafortide plus G-CSF (n=80) or placebo plus G-CSF (n=42). HRU data points collected include: (1) the number of Motixafortide and G-CSF doses, as well as the number of apheresis sessions performed, in primary mobilization; (2) the percentage of patients needing rescue mobilization due to poor primary mobilization, including the number of apheresis sessions needed and the number of G-CSF and plerixafor doses required; and (3) hospitalization costs related to conditioning and transplantation, including length of stay. Quality-adjusted life years gained (QALY) from published literature were also incorporated into the model. Motixafortide plus G-CSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to standard-of-care G-CSF alone. Given the higher number of mobilized cells and lower number of apheresis sessions, lifetime estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$17,000 (not including the cost of Motixafortide), versus the current standard of care.

    About the GENESIS Phase 3 Trial

    The GENESIS Phase 3 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. 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 the target number of cells for transplantation with only one administration of Motixafortide and in only one apheresis session.

    About Stem Cell Mobilization for Autologous Stem Cell Transplantation

    Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma, non-Hodgkin's lymphoma and other lymphomas. In eligible patients, ASCT is performed after initial (induction) therapy, and, in most cases, requires consecutive-day clinic visits for the mobilization and apheresis (harvesting) phases, and full hospitalization for the conditioning chemotherapy and transplantation phases until engraftment. The associated burden is therefore significant – patients experience clinically relevant deteriorations in their quality of life during ASCT, and healthcare resource use throughout the ASCT phases is particularly intense. Therefore, new interventions impacting the ASCT process have the potential for relieving some of the clinical burden for transplanted patients, the logistical burden for the apheresis units, and the financial burden for healthcare providers and payers.

    Described simply, ASCT consists of: (1) mobilizing the patient's own stem cells from his/ her bone marrow to the peripheral blood for removing (harvesting) via an apheresis procedure; (2) freezing and storing the harvested cells until they are needed for transplantation; (3) providing a conditioning treatment, such as high-dose chemotherapy or radiation, to kill the remaining cancer cells the day before transplant; and (4) infusing the stored stem cells back to the patient intravenously via a catheter.

    To mobilize the patient's stem cells from the bone marrow to the peripheral blood for harvesting, the current standard of care includes the administration of 5-8 daily doses of granulocyte colony stimulating factor (G-CSF), and the performance of 1-4 apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out, consisting of 1-4 doses of plerixafor on top of G-CSF, and the performance of an additional number of apheresis sessions as necessary. In light of this, an agent with superior mobilization activity may significantly reduce the mobilization and harvesting burden and associated risks of the ASCT process and lead to significant clinical and resource benefits.

    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, as well as reporting positive results from a pre-planned pharmacoeconomic study, 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

    Cision View original content:https://www.prnewswire.com/news-releases/biolinerx-announces-positive-results-from-pharmacoeconomic-study-positioning-motixafortide-as-potential-standard-of-care-in-stem-cell-mobilization-301399211.html

    SOURCE BioLineRx Ltd.

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  2. 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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  3. 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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  4. 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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  5. 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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