BLRX BioLineRx Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
|
Phase 3
Phase 3
|
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|
|
Motixafortide (BL-8040) - BLAST
Consolidation treatment for AML cancer patients
|
Phase 2b
Phase 2b
|
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|
|
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
|
Phase 2
Phase 2
|
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|
|
AGI-134
Solid tumors
|
Phase 1/2
Phase 1/2
|
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
|
Phase 2a
Phase 2a
|
Phase 2a data presented at ESMO December 13, 2019.
|
Latest News
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TEL AVIV, Israel, Aug. 19, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that a sufficient number of patients (~65% of the original planned sample size) have been enrolled in the ongoing GENESIS Phase 3 trial to allow for an interim efficacy analysis to take place in the second half of 2020. This ongoing registrational study is investigating motixafortide (BL-8040) for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in patients with multiple myeloma. If the primary endpoint is met at the time of the interim analysis, the Company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size. In this case, top-line results are expected in the first half of 2021, in order to maintain study blinding for all study endpoints, including those related to engraftment, for a period of 100 days subsequent to transplantation. If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.
"A significantly lower than anticipated patient dropout rate in the GENESIS trial triggered our decision to conduct an interim efficacy analysis, for which we have now enrolled a sufficient number of patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "Once this analysis is complete, we will have enough information to decide whether to cease further enrollment or continue until completion of the original target enrollment of 177 patients. We expect the interim analysis to be completed within the next few months."
The GENESIS trial was initiated in December 2017. GENESIS is 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 HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that motixafortide on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.
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 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
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
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-achieves-enrollment-target-in-phase-3-genesis-trial-for-planned-interim-analysis-301114721.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, Aug. 6, 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 June 30, 2020 and provides a corporate update.
Highlights and achievements during the second quarter 2020 and subsequent period:
- Continued to advance clinical programs, with three key data readouts in pancreatic cancer, stem cell mobilization and AML expected between now and year-end;
- Announced publication in the peer-reviewed journal Nature Medicine of previously disclosed biomarker and clinical data from the COMBAT/KEYNOTE-202 trial in pancreatic cancer, showing encouraging clinical activity, as well as proof-of-mechanism;
- Strengthened balance sheet with $13.4 million in gross proceeds from two registered direct offerings.
"We continue to eagerly await important survival data from the triple combination arm of our COMBAT/KEYNOTE-202 clinical trial of motixafortide in combination with KEYTRUDA and chemotherapy in metastatic pancreatic cancer," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The compelling data on 22 patients that we reported in December give us conviction that this combination has the potential to be a real breakthrough in one of the most difficult to treat cancers. As this is an event-driven trial, we are obviously very pleased that there are still patients on study, although we now anticipate a modest delay of a few months in announcing the data from our original expectation."
"Turning to stem cell mobilization, this continues to be our most efficient path to registration. Given a significantly lower patient dropout rate than we had anticipated in our Phase 3 GENESIS trial, we now plan to conduct an interim analysis in the second half of this year. If the primary endpoint is met, we plan to immediately announce cessation of recruitment, without the need to enroll the full planned sample size. In order to maintain study blinding for all study endpoints, including those related to engraftment for a period of 100 days subsequent to transplantation, we expect to announce top-line results in the first half of 2021. At the same time, our Phase 2b BLAST consolidation study in AML is progressing, and we anticipate results from a planned interim analysis in the second half of this year."
"As we indicated last quarter, development of our second clinical candidate, AGI-134, has been impacted by COVID-19, as enrollment in the Phase 1/2a trial has been temporarily suspended. We have, however, recently begun activities to restart study recruitment and we expect data from that study in the second half of next year."
"The COVID-19 pandemic has caused significant disruptions in drug development timelines across the industry. We are pleased that we expect to report on three important and potentially value-creating data readouts by the end of the year, and with the additional $13.4 million that we raised during the second quarter, we have the resources to reach these important milestones. We believe the broad clinical utility of motixafortide across a wide range of cancer indications that we have observed in data generated to date highlight its potential as a promising new treatment option, and we look forward to reporting these data as they become available," concluded Mr. Serlin.
Upcoming Expected 2020 and 2021 Milestones
- Overall results, including progression free survival (PFS) and overall survival (OS) data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in the second half of this year;
- Newly planned interim analysis of the Phase 3 GENESIS registrational study in stem cell mobilization in the second half of this year. If the primary endpoint is reached, recruitment would be stopped immediately (and announced); topline data are expected in the first half of 2021;
- Interim analysis from the BLAST Phase 2b AML consolidation study during the second half of 2020, unchanged from prior guidance;
- Initial results from Part 2 of Phase 1/2a trial of AGI-134 in the second half of 2021.
Financial Results for the Second Quarter Ended June 30, 2020
Research and development expenses for the three months ended June 30, 2020 were $4.6 million, a decrease of $0.7 million, or 12.5%, compared to $5.3 million for the three months ended June 30, 2019. The decrease resulted primarily 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 quarter of 2020. Research and development expenses for the six months ended June 30, 2020 were $10.1 million, an increase of $0.4 million, or 3.8%, compared to $9.7 million for the six months ended June 30, 2019. The increase resulted primarily from higher expenses associated with the motixafortide COMBAT and GENESIS clinical trials, offset by a decrease in expenses associated with the AGI-134 study.
Sales and marketing expenses for the three months ended June 30, 2020 were $0.2 million, similar to the comparable period in 2019. Sales and marketing expenses for the six months ended June 30, 2020 were $0.4 million, a decrease of $0.1 million, or 25.9%, compared to $0.5 million for the six months ended June 30, 2019. The decrease resulted primarily from a decrease in payroll and related expenses related to a decrease in share-based compensation from the 2019 period.
General and administrative expenses for the three months ended June 30, 2020 were $0.7 million, a decrease of $0.2 million, or 21.6% compared to $0.9 million for the three months ended June 30, 2019. The decrease resulted primarily from 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 quarter of 2020, as well as a decrease in professional fees. General and administrative expenses for the six months ended June 30, 2020 were $2.0 million, an increase of $0.1 million, or 5.7%, compared to $1.9 million for the six months ended June 30, 2019. The increase resulted primarily from an increase in share-based compensation.
The Company's operating loss for the three months ended June 30, 2020 amounted to $5.6 million, compared to an operating loss of $6.5 million for the three months ended June 30, 2019. The Company's operating loss for the six months ended June 30, 2020 was $12.4 million, compared to $12.1 million for the comparable period in 2019.
Non-operating income (expenses) for the three and six months ended June 30, 2020 and for the three and six months ended June 30, 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses.
Net financial expenses for the three months ended June 30, 2020 amounted to $0.4 million compared to net financial expenses of $0.3 million for the three months ended June 30, 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 six months ended June 30, 2020 amounted to $0.6 million compared to net financial expenses of $0.5 million for the six months ended June 30, 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 June 30, 2020 amounted to $6.8 million, compared with a net loss of $5.5 million for the comparable period in 2019. The Company's net loss for the six months ended June 30, 2020 amounted to $13.4 million, compared with a net loss of $11.6 million for the comparable period in 2019.
The Company held $27.3 million in cash, cash equivalents and short-term bank deposits as of June 30, 2020.
Net cash used in operating activities was $12.3 million for the six months ended June 30, 2020, compared with net cash used in operating activities of $11.1 million for the six months ended June 30, 2019. The $1.2 million increase in net cash used in operating activities during the six-month period in 2020 was primarily the result of changes in operating asset and liability items in two periods, i.e., an increase in prepaid expenses and other receivables in 2020 versus a decrease in 2019, as well as a larger decrease in accounts payable and accruals in 2020 versus 2019.
Net cash provided by investing activities was $0.6 million for the six months ended June 30, 2020, compared to net cash used in investing activities of $3.1 for the six months ended June 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 $12.0 for the six months ended June 30, 2020, compared to net cash provided by financing activities of $15.7 million for the six months ended June 30, 2019. The cash flows in 2020 primarily reflect the May and June financings, and the net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering completed in February 2019, as well as net proceeds from the ATM facility.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, August 6, 2020 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-668-9141 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 August 8, 2020; please dial +1-888-782-4291 from the US or +972-3-925-5921 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 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
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. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. 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
[email protected]BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED)
December 31,
June 30,
2019
2020
in USD thousands
Assets
CURRENT ASSETS
Cash and cash equivalents
5,297
5,523
Short-term bank deposits
22,192
21,779
Prepaid expenses
108
426
Other receivables
613
441
Total current assets
28,210
28,169
NON-CURRENT ASSETS
Property and equipment, net
1,816
1,580
Right-of-use assets, net
1,650
1,490
Intangible assets, net
21,891
21,750
Total non-current assets
25,357
24,820
Total assets
53,567
52,989
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loans
2,692
2,867
Accounts payable and accruals:
Trade
7,794
7,396
Other
1,280
1,260
Lease liabilities
202
200
Total current liabilities
11,968
11,723
NON-CURRENT LIABILITIES
Warrants
658
6,077
Long-term loans, net of current maturities
5,799
4,329
Lease liabilities
1,762
1,630
Total non-current liabilities
8,219
12,036
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities
20,187
23,759
EQUITY
Ordinary shares
4,692
8,281
Share premium
265,938
271,107
Capital reserve
12,132
12,639
Other comprehensive loss
(1,416)
(1,416)
Accumulated deficit
(247,966)
(261,381)
Total equity
33,380
29,230
Total liabilities and equity
53,567
52,989
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
Three months ended June 30,
Six months ended June 30,
2019
2020
2019
2020
in USD thousands
in USD thousands
RESEARCH AND DEVELOPMENT EXPENSES
(5,302)
(4,640)
(9,694)
(10,062)
SALES AND MARKETING EXPENSES
(226)
(182)
(482)
(357)
GENERAL AND ADMINISTRATIVE EXPENSES
(949)
(744)
(1,879)
(1,987)
OPERATING LOSS
(6,477)
(5,566)
(12,055)
(12,406)
NON-OPERATING INCOME (EXPENSES), NET
1,261
(843)
921
(374)
FINANCIAL INCOME
171
35
381
175
FINANCIAL EXPENSES
(440)
(396)
(887)
(810)
NET LOSS AND COMPREHENSIVE LOSS
(5,485)
(6,770)
(11,640)
(13,415)
in USD
in USD
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
(0.04)
(0.03)
(0.08)
(0.07)
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
145,461,598
220,317,889
139,270,178
198,277,447
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 SIX MONTHS ENDED JUNE 30, 2019:
Issuance of share capital, net
890
10,437
-
-
-
11,327
Employee stock options exercised
1
27
(27)
-
-
1
Employee stock options forfeited and expired
-
866
(866)
-
-
-
Share-based compensation
-
-
773
-
-
773
Comprehensive loss for the period
-
-
-
-
(11,640)
(11,640)
BALANCE AT JUNE 30, 2019
4,001
261,522
11,835
(1,416)
(234,160)
41,782
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 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
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)
Ordinary shares
Share premium
Capital
reserveOther Comprehensive loss
Accumulated deficit
Total
in USD thousands
BALANCE AT APRIL 1, 2019
3,928
259,860
12,191
(1,416)
(228,675)
45,888
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2019:
Issuance of share capital, net
73
817
-
-
-
890
Employee stock options exercised
-
9
(9)
-
-
-
Employee stock options forfeited and expired
-
836
(836)
-
-
-
Share-based compensation
-
-
489
-
-
489
Comprehensive loss for the period
-
-
-
-
(5,485)
(5,485)
BALANCE AT JUNE 30, 2019
4,001
261,522
11,835
(1,416)
(234,160)
41,782
Ordinary
sharesShare
premiumCapital
reserveOther Comprehensive
lossAccumulated
deficitTotal
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
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)
Six months ended June 30,
2019
2020
in USD thousands
CASH FLOWS - OPERATING ACTIVITIES
Comprehensive loss for the period
(11,640)
(13,415)
Adjustments required to reflect net cash used in operating activities
(see appendix below)
573
1,112
Net cash used in operating activities
(11,067)
(12,303)
CASH FLOWS - INVESTING ACTIVITIES
Investments in short-term deposits
(27,510)
(23,751)
Maturities of short-term deposits
24,441
24,335
Purchase of property and equipment
(53)
(1)
Net cash provided by (used in) investing activities
(3,122)
583
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital and warrants, net of issuance costs
15,879
13,411
Employee stock options exercised
1
8
Repayments of loans
(47)
(1,331)
Repayments of lease liabilities
(110)
(121)
Net cash provided by financing activities
15,723
11,967
INCREASE IN CASH AND CASH EQUIVALENTS
1,534
247
CASH AND CASH EQUIVALENTS - BEGINNING
OF PERIOD
3,404
5,297
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
34
(21)
CASH AND CASH EQUIVALENTS - END OF PERIOD
4,972
5,523
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)
Six months ended June 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
439
533
Long-term prepaid expenses
(4)
-
Exchange differences on cash and cash equivalents
(34)
21
Fair value adjustments of warrants
(1,354)
(250)
Share-based compensation
773
922
Warrant issuance costs
417
593
Interest and exchange differences on short-term deposits
(440)
(171)
Interest on loans
292
36
Exchange differences on lease liability
-
(8)
89
1,676
Changes in operating asset and liability items:
Decrease (increase( in prepaid expenses and other receivables
848
(146)
Decrease in accounts payable and accruals
(364)
(418)
484
(564)
573
1,112
Supplemental information on interest received in cash
442
300
Supplemental information on interest paid in cash
477
534
View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2020-financial-results-and-provides-corporate-update-301107517.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, July 31, 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 June 30, 2020 on Thursday, August 6, 2020, before the US markets open.
The Company will host a conference call on Thursday, August 6, 2020 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 +1-888-668-9141 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 August 8, 2020; please dial +1-888-782-4291 from the U.S. or +972-3-925-5921 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 currently 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. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
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.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-to-report-second-quarter-2020-results-on-august-6-2020-301103774.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, June 1, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that it has entered into definitive agreements with several healthcare-focused, institutional and accredited investors for the purchase and sale of 2,510,286 of the Company's American Depositary Shares (ADSs), at a purchase price of $1.75 per ADS, in a registered direct offering. BioLineRx has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 2,510,286 ADSs. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about June 3, 2020, subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The warrants will have an exercise price of $2.25 per ADS and will be exercisable at any time upon issuance and will expire two and one-half years from the date of issuance.
The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent's fees and other estimated offering expenses payable by the Company, are expected to be $4.39 million. BioLineRx intends to use the net proceeds for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.
The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222332) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on December 28, 2017 and declared effective by the SEC on January 19, 2018. The offering of the ADSs will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the 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 [email protected].
The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such 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 currently 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. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
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, such as statements relating to the registered direct 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. Some of these risks are: market and other conditions, changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. 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
[email protected]or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-4-39-million-registered-direct-offering-301068460.htmlSOURCE BioLineRx Ltd.
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TEL AVIV, Israel, May 26, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced that it has entered into definitive agreements with several healthcare-focused, institutional and accredited investors for the purchase and sale of 5,142,859 of the Company's American Depositary Shares (ADSs), at a purchase price of $1.75 per ADS, in a registered direct offering. BioLineRx has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 5,142,859 ADSs. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about May 28, 2020, subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The warrants will have an exercise price of $2.25 per ADS and will be exercisable at any time upon issuance and will expire two and one-half years from the date of issuance.
The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent's fees and other estimated offering expenses payable by the Company, are expected to be $9.0 million. BioLineRx intends to use the net proceeds for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.
The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222332) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on December 28, 2017 and declared effective by the SEC on January 19, 2018. The offering of the ADSs will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the 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 [email protected].
The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such 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 currently 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. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.
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, such as statements relating to the registered direct 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. Some of these risks are: market and other conditions, changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. 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.
Contacts:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
[email protected]Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
[email protected]
View original content:http://www.prnewswire.com/news-releases/biolinerx-announces-9-0-million-registered-direct-offering-301065124.htmlSOURCE BioLineRx Ltd.