BioLineRx Reports Third Quarter 2021 Financial Results and Provides Corporate Update

<br /> BioLineRx Reports Third Quarter 2021 Financial Results and Provides Corporate Update<br />

PR Newswire



– Positive results from pharmacoeconomic cost effectiveness study




of Motixafortide in stem cell mobilization support its use as




standard of care in combination with G-CSF –



– Pre-NDA meeting with FDA set for mid-December;




NDA submission planned for H1 2022 –



– Cash and cash equivalents at

September 30, 2021

of

$62.2 million





– Management to hold conference call today,

November 18

, at

10:00 am EST




TEL AVIV, Israel

,

Nov. 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

September 30, 2021

and provides a corporate update.


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

  • Announced statistically significant positive results from a pharmacoeconomic cost effectiveness study supporting Motixafortide’s use as the new standard-of-care and primary mobilization agent (in combination with G-CSF) in stem cell mobilization (SCM). The study demonstrated substantial clinical benefits and cost savings in favor of Motixafortide from a significantly higher number of mobilized cells, reduced numbers of apheresis sessions and reduced doses of G-CSF;
  • Announced acceptance of an oral presentation, as well as three poster presentations, at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place

    December 11-14

    . The presentations, which include an oral presentation describing the highly significant and clinically meaningful results from the Company’s GENESIS Phase 3 clinical trial in stem cell mobilization (SCM), reflect the versatility of Motixafortide as the backbone of promising new treatments for both hematological and solid tumor cancers;
  • Finalized preparations for a pre-NDA meeting with FDA, which is set for mid-December;
  • Proceeded with activities in support of a New Drug Application (NDA) submission in stem cell mobilization planned for the first half of 2022;
  • Ended the third quarter on a solid financial footing, with cash and cash equivalents of

    $62.2 million

    .

“The key highlight since our last quarterly update was the statistically significant positive results from a pharmacoeconomic study of Motixafortide in stem cell mobilization for multiple myeloma patients,” stated

Philip Serlin

, Chief Executive Officer of BioLineRx. “The study demonstrated that use of Motixafortide on top of G-CSF resulted in a net cost savings of

$17,000

per patient, not including the cost of Motixafortide, driven by fewer doses of G-CSF and a reduction in the number of apheresis sessions and related costs, versus G-CSF alone. These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.

“These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, which showed that almost 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, strongly support our view that Motixafortide, in combination with G-CSF, can become the new standard of care in SCM as an upfront, or primary, therapy for all multiple myeloma patients. If approved, this represents a significant advancement in SCM to the benefit of patients and payers alike and, to that end, we plan to submit an NDA to the FDA in the first half of next year.

“Our significant progress in SCM, together with the encouraging results we have seen in trials to date in metastatic pancreatic cancer, reflect the versatility of Motixafortide in both hematological and solid tumor cancers, which we have an opportunity to highlight at this year’s ASH meeting next month. Our notable presence at such an important medical conference reflects the excellent progress that we have made to date across these core programs and underscores the momentum that we have entering 2022.

“With over

$62 million

in cash, we believe we are well financed to achieve our upcoming important and potentially value creating milestones,” Mr. Serlin concluded.


Upcoming Expected Milestones:

  • Complete pre-NDA meeting with the FDA for SCM, scheduled for

    mid-December 2021

    ;
  • Complete recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors by end of 2021;
  • Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in first half of 2022;
  • Submit NDA for Motixafortide in SCM in first half of 2022.


Financial Results for the Quarter Ended

September 30, 2021

Research and development expenses for the three months ended

September 30, 2021

were

$4.9 million

, an increase of

$1.4 million

, or 41.3%, compared to

$3.5 million

for the three months ended

September 30, 2020

. The increase resulted primarily from an increase in expenses associated with the AGI-134 study and a timing difference related to a tax credit received in respect of AGI-134, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period. Research and development expenses for the nine months ended

September 30, 2021

were

$14.3 million

, an increase of

$0.8 million

, or 5.9%, compared to

$13.5 million

for the nine months ended

September 30, 2020

. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the three months ended

September 30, 2021

were

$0.2 million

, a decrease of

$0.1 million

, or 20.1%, compared to

$0.3 million

for the three months ended

September 30, 2020

. The decrease resulted primarily from lower consultancy services related to Motixafortide. Sales and marketing expenses for the nine months ended

September 30, 2021

were

$0.7 million

, similar to the comparable period in 2020.

General and administrative expenses for the three months ended

September 30, 2021

were

$1.1 million

, an increase of

$0.2 million

, or 22.3%, compared to

$0.9 million

for the three months ended

September 30, 2020

. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the nine months ended

September 30, 2021

were

$3.1 million

, an increase of

$0.3 million

, or 9.3%, compared to

$2.8 million

for the nine months ended

September 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

September 30, 2021

amounted to

$6.2 million

, compared to an operating loss of

$4.6 million

for the quarter ended

September 30, 2020

. The Company’s operating loss for the nine months ended

September 30, 2021

was

$18.2 million

, compared to

$17.1 million

for the comparable period in 2020.

Non-operating income (expenses) for the three and nine months ended

September 30, 2021

primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet and issuance expenses of the ATM.  Non-operating income (expenses)  for the three and nine months ended

September 30, 2020

primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses and issuance expenses of the ATM.

Net financial expenses for the three months ended

September 30, 2021

amounted to

$0.2 million

compared to net financial expenses of

$0.3 million

for the three months ended

September 30, 2020

. Net financial expenses for the nine months ended

September 30, 2021

amounted to

$0.5 million

compared to net financial expenses of

$0.9 million

for the nine months ended

September 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

September 30, 2021

amounted to

$5.7 million

, compared with a net loss of

$4.6 million

for the comparable period in 2020. The Company’s net loss for the nine months ended

September 30, 2021

amounted to

$22.8 million

, compared with a net loss of

$18.0 million

for the comparable period in 2020.

The Company held

$62.2 million

in cash, cash equivalents and short-term bank deposits as of

September 30, 2021

.

Net cash used in operating activities was

$18.1 million

for the nine months ended

September 30, 2021

, compared with net cash used in operating activities of

$17.8 million

for the nine months ended

September 30, 2020

. The

$0.3 million

increase in net cash used in operating activities in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities was

$42.2 million

for the nine months ended

September 30, 2021

, compared to net cash provided by investing activities of $8.1


million for the nine months ended

September 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

$57.6 million

for the nine months ended

September 30, 2021

, compared to net cash provided by financing activities of

$10.9 million

for the nine months ended

September 30, 2020

. The cash flows in 20

2

1 primarily reflect the underwritten public offering of our ADSs in

January 2021

, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the 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,

Thursday, November 18, 2021

, at

10:00 a.m. EST

. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0644 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

November 21, 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, has reported 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


[email protected]

or


Moran Meir


LifeSci Advisors, LLC

+972-54-476-4945


[email protected]



BioLineRx Ltd.


CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION


(UNAUDITED)



December 31,



September 30,



2020



2021



in USD thousands



Assets



CURRENT ASSETS


Cash and cash equivalents


16,831


14,077


Short-term bank deposits


5,756


48,128


Prepaid expenses


152


449


Other receivables


141


192


Total current assets


22,880


62,846



NON-CURRENT ASSETS


Property and equipment, net


1,341


1,016


Right-of-use assets, net


1,355


1,338


Intangible assets, net


21,714


21,705


Total non-current assets


24,410


24,059



Total assets


47,290


86,905



Liabilities and equity



CURRENT LIABILITIES


Current maturities of long-term loans


3,092


3,575


Accounts payable and accruals:


Trade


5,918


5,441


Other


1,440


1,128


Lease liabilities


191


169


Total current liabilities


10,641


10,313



NON-CURRENT LIABILITIES


Warrants


10,218


4,013


Long-term loans, net of current maturities


2,740




Lease liabilities


1,661


1,678


Total non-current liabilities


14,619


5,691



COMMITMENTS AND CONTINGENT LIABILITIES


Total liabilities


25,260


16,004



EQUITY


Ordinary shares


9,870


20,874


Share premium


279,241


338,051


Warrants




975


Capital reserve


12,322


13,154


Other comprehensive loss


(1,416)


(1,416)


Accumulated deficit


(277,987)


(300,737)


Total equity


22,030


70,901



Total liabilities and equity


47,290


86,905




BioLineRx Ltd.


CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS


(UNAUDITED)



Three months ended September 30,



Nine months ended



September 30,



2020



2021



2020



2021



in USD thousands



in USD thousands



RESEARCH AND DEVELOPMENT EXPENSES


(3,484)


(4,923)


(13,546)


(14,340)



SALES AND MARKETING EXPENSES


(309)


(247)


(666)


(731)



GENERAL AND ADMINISTRATIVE EXPENSES


(856)


(1,047)


(2,843)


(3,108)



OPERATING LOSS


(4,649)


(6,217)


(17,055)


(18,179)



NON-OPERATING INCOME (EXPENSES), NET


294


710


(80)


(4,068)



FINANCIAL INCOME


39


52


214


299



FINANCIAL EXPENSES


(302)


(261)


(1,112)


(802)



NET LOSS AND COMPREHENSIVE LOSS


(4,618)


(5,716)


(18,033)


(22,750)



in USD



in USD



LOSS PER ORDINARY SHARE – BASIC AND DILUTED


(0.02)


(0.01)


(0.08)


(0.04)



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


296,508,550


708,473,164


231,380,969


646,427,790




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 NINE MONTHS ENDED SEPTEMBER 30, 2020:


Issuance of share capital, net


3,581


4,754










8,335


Employee stock options exercised


8


224




(224)






8


Employee stock options forfeited and expired




191




(191)








Share-based compensation








1,118






1,118


Comprehensive loss for the period












(18,033)


(18,033)



BALANCE AT SEPTEMBER 30, 2020


8,281


271,107




12,835


(1,416)


(265,999)


24,808



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 NINE MONTHS ENDED SEPTEMBER 30, 2021:


Issuance of share capital and warrants, net


8,764


39,569


975








49,308


Warrants exercised


2,235


18,967










21,202


Employee stock options exercised


5


41




(39)






7


Employee stock options forfeited and expired




233




(233)








Share-based compensation








1,104






1,104


Comprehensive loss for the period












(22,750)


(22,750)



BALANCE AT SEPTEMBER 30, 2021


20,874


338,051


975


13,154


(1,416)


(300,737)


70,901



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 JULY 1, 2020


8,281


271,107




12,639


(1,416)


(261,381)


29,230



CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2020:


Share-based compensation








196






196


Comprehensive loss for the period












(4,618)


(4,618)



BALANCE AT SEPTEMBER 30, 2020


8,281


271,107




12,835


(1,416)


(265,999)


24,808



Ordinary



Share



Capital



Other



Comprehensive



Accumulated



Shares



premium



Warrants



Reserve



Loss



deficit



Total



in USD thousands



BALANCE AT JULY 1, 2021


20,496


335,887


975


12,972


(1,416)


(295,021)


73,893



CHANGES FOR THREE MONTHS ENDED SEPTEMBER 30, 2021:


Issuance of share capital, net


378


2,074










2,452


Employee stock options forfeited and expired




90




(90)








Share-based compensation








272






272


Comprehensive loss for the period












(5,716)


(5,716)



BALANCE AT SEPTEMBER 30, 2021


20,874


338,051


975


13,154


(1,416)


(300,737)


70,901



BioLineRx Ltd.


CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS


(UNAUDITED)



Nine months ended September 30,



2020



2021



in USD thousands



CASH FLOWS – OPERATING ACTIVITIES


Comprehensive loss for the period


(18,033)


(22,750)


Adjustments required to reflect net cash used in operating activities


(see appendix below)


259


4,680


Net cash used in operating activities


(17,774)


(18,070)



CASH FLOWS – INVESTING ACTIVITIES


Investments in short-term deposits


(28,500)


(70,000)


Maturities of short-term deposits


36,626


27,813


Purchase of property and equipment


(1)


(35)


Net cash provided by (used in) investing activities


8,125


(42,222)



CASH FLOWS – FINANCING ACTIVITIES


Issuance of share capital and warrants, net of issuance costs


13,411


49,308


Exercise of warrants




10,907


Employee stock options exercised


8


7


Repayments of loans


(2,338)


(2,502)


Repayments of lease liabilities


(162)


(145)


Net cash provided by financing activities


10,919


57,575



INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS


1,270


(2,717)



CASH AND CASH EQUIVALENTS – BEGINNING



OF PERIOD


5,297


16,831



EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS


(15)


(37)



CASH AND CASH EQUIVALENTS – END OF PERIOD


6,552


14,077



BioLineRx Ltd.


APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS


(UNAUDITED)



Nine months ended

September 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


737


529


Exchange differences on cash and cash equivalents


15


37


Fair value adjustments of warrants


(727)


4,090


Share-based compensation


1,118


1,104


Warrant issuance costs


593




Interest and exchange differences on short-term deposits


(209)


(185)


Interest on loans


370


245


Exchange differences on lease liability


4


(3)


1,901


5,817



Changes in operating asset and liability items:


Decrease (increase) in prepaid expenses and other receivables


125


(348)


Decrease in accounts payable and accruals


(1,767)


(789)


(1,642)


(1,137)


259


4,680



Supplemental information on interest received in cash


342


77



Supplemental information on interest paid in cash


671


541



Supplemental information on non-cash transactions:


Changes in right-of-use asset




143


Exercise of warrants (portion related to accumulated

fair value adjustments)




10,295



Cision
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SOURCE BioLineRx Ltd.