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BioLineRx Reports First Quarter 2019 Financial Results and Provides Corporate Update
On track for Phase 2 data read-outs in pancreatic cancer and consolidation AML by year-end 2019
Management to hold conference call today, May 14, at 10:00 am EDT

TEL AVIV, Israel, May 14, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended March 31, 2019 and provided a corporate update.

Highlights and achievements during the first quarter 2019 and subsequent period:

  • Presented successful engraftment data from Phase 3 GENESIS trial of BL-8040 in multiple myeloma patients at 45th Annual Meeting of European Society for Blood and Marrow Transplantation. These data follow previously announced successful mobilization data which led the Data Monitoring Committee to recommend proceeding to the randomized placebo-controlled Part 2 of the study.
  • Received FDA Orphan Drug Designation for BL-8040 for the treatment of pancreatic cancer. This is an addition to prior orphan drug designations that have been granted for BL-8040 in AML and stem cell mobilization.
  • Received approval from the FDA for Investigational New Drug (IND) application for AGI-134, which will enable expansion of the ongoing Phase 1/2a study, currently being carried out in the UK and Israel, to the US by the first half of 2020.

"As we progress through 2019, we are approaching important data milestones with our lead program, the CXCR4 antagonist BL-8040, in two cancer indications with high unmet medical need," said Philip Serlin, Chief Executive Officer of BioLineRx. "In pancreatic cancer, an extremely difficult cancer indication to treat, we are optimistic that we can build upon the encouraging results that we observed in the dual combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 and Merck's KEYTRUDA with the addition of chemotherapy, and we are eager to see top-line results for the triple combination arm of the study by the end of this year. Similarly, in consolidation AML, we look forward to important data from our Phase 2b trial that will help inform later stage development of this promising program."

"In parallel, our second clinical candidate, AGI-134, is progressing through a phase 1/2a clinical trial, and we anticipate initial safety data later this year as we look to efficiently advance this promising candidate into the second part of the study where we can assess efficacy in multiple tumor types. We continue to execute on our clinical development plan, and believe these upcoming data readouts can drive near-term value creation while generating additional partnering interest," Mr. Serlin concluded.

Expected significant milestones through end of 2019 and early 2020:

  • Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under the Company's collaboration with Merck in the second half of 2019;
  • Potential interim results from the Phase 2 AML consolidation study in the second half of 2019;
  • Initial safety results from part 1 of the Phase 1/2a trial of AGI-134 in the second half of 2019;
  • Top-line results from one or more of the ongoing solid tumor trials under the Company's collaboration with Genentech, potentially by the end of 2019 or early 2020.

Financial Results for the Quarter Ended March 31, 2019 

Research and development expenses for the quarter ended March 31, 2019 were $4.4 million, a decrease of $0.7 million, or 13.4%, compared to $5.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

Sales and marketing expenses for the quarter ended March 31, 2019 were $0.3 million, a decrease of $0.2 million, or 47%, compared to $0.5 million for the comparable period in 2018. The decrease resulted primarily from a one-time compensation payment in the 2018 period, as well as a decrease in share-based compensation.

General and administrative expenses for the quarter ended March 31, 2019 were $0.9 million, a decrease of $0.2 million, or 13.5% compared to $1.1 million for the comparable period in 2018. The decrease resulted primarily from a decrease in share-based compensation.

The Company's operating loss for the quarter ended March 31, 2019 amounted to $5.6 million, compared with an operating loss of $6.6 million for the comparable period in 2018.

Non-operating expenses amounted to $0.3 million for the quarter ended March 31, 2019, compared with non-operating income of $0.5 million for the comparable period in 2018. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on our balance sheet. Non-operating income for the three months ended March 31, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet. These fair-value adjustments were highly influenced by the Company's share price at each period end (revaluation date).

Net financial expenses amounted to $0.2 million for the quarter ended March 31, 2019 compared to an immaterial amount of net financial expenses for the three months ended March 31, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the 2018 period primarily relate to losses recorded on foreign currency hedging transactions, offset by investment income earned on bank deposits.

The Company's net loss for the quarter ended March 31, 2019 amounted to $6.2 million, similar to the comparable period in 2018.

The Company held $40.6 million in cash, cash equivalents and short-term bank deposits as of March 31, 2019.

Net cash used in operating activities was $4.6 million for the three months ended March 31, 2019, compared with net cash used in operating activities of $6.8 million for the three months ended March 31, 2018. The $2.2 million decrease in net cash used in operating activities during the three-month period in 2019, compared to the three-month period in 2018, was primarily the result of changes in operating asset and liability items between the two periods – i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a decrease in accounts payable and accruals in 2018.

Net cash used in investing activities was $9.3 million for the three months ended March 31, 2019, compared to net cash provided by investing activities of $8.1 million for the three months ended March 31, 2018. 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 $14.9 million for the three months ended March 31, 2019, compared to net cash provided by financing activities of $1.4 million for the three months ended March 31, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, May 14, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. 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 May 16, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5925 internationally.

(Tables follow)

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is being investigated in a Phase 1/2a study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD, on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and KEYTRUDA® (pembrolizumab), and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications and AML.

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

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 28, 2019. 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.

 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)






December 31,

March 31,


2018

2019


in USD thousands

Assets



CURRENT ASSETS



Cash and cash equivalents

3,404

4,384

Short-term bank deposits

26,747

36,224

Prepaid expenses

488

583

Other receivables

1,339

458

          Total current assets

31,978

41,649




NON-CURRENT ASSETS



Long-term prepaid expenses

56

55

Property and equipment, net

2,227

2,143

Right-of-use assets 

-

1,797

Intangible assets, net

21,972

21,950

          Total non-current assets

24,255

25,945

          Total assets

56,233

67,594




Liabilities and equity



CURRENT LIABILITIES



Current maturities of long-term loans

895

1,636

Accounts payable and accruals:



     Trade

4,493

4,817

     Other

1,363

989

Lease liabilities

-

693

          Total current liabilities

6,751

8,135

NON-CURRENT LIABILITIES



Warrants

323

5,213

Long-term loans, net of current maturities

7,838

7,228

Lease liabilities

-

1,130

          Total non-current liabilities

8,161

13,571

COMMITMENTS AND CONTINGENT LIABILITIES



     Total liabilities

14,912

21,706




EQUITY



Ordinary shares

3,110

3,928

Share premium

250,192

259,860

Capital reserve

11,955

12,191

Other comprehensive loss

(1,416)

(1,416)

Accumulated deficit

(222,520)

(228,675)

          Total equity

41,321

45,888

          Total liabilities and equity

56,233

67,594

 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)



Three months ended March 31,


2018

2019


in USD thousands

RESEARCH AND DEVELOPMENT EXPENSES

(5,070)

(4,392)

SALES AND MARKETING EXPENSES

(484)

(256)

GENERAL AND ADMINISTRATIVE EXPENSES

(1,075)

(930)

OPERATING LOSS

(6,629)

(5,578)

NON-OPERATING INCOME (EXPENSES), NET

462

(340)

FINANCIAL INCOME

175

210

FINANCIAL EXPENSES

(206)

(447)

NET LOSS AND COMPREHENSIVE LOSS

(6,198)

(6,155)






LOSS PER ORDINARY SHARE - BASIC AND DILUTED

(0.06)

(0.05)




WEIGHTED AVERAGE NUMBER OF SHARES USED IN

    CALCULATION OF LOSS PER ORDINARY SHARE

106,169,273

132,979,984




 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED 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, 2018

2,836

240,682

10,337

(1,416)

(199,558)

52,881

CHANGES FOR THREE MONTHS ENDED MARCH 31, 2018:







Issuance of share capital, net

37

1,386

-

-

-

1,423

Employee stock options exercised

1

29

(30)

-

-

-

Employee stock options forfeited and expired             

-

80

(80)

-

-

-

Share-based compensation              

-

-

916

-

-

916

Comprehensive loss for the period

-

-

-

-

(6,198)

(6,198)

BALANCE AT MARCH 31, 2018

2,874

242,177

11,143

(1,416)

(205,756)

49,022









 

 

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 THREE MONTHS ENDED MARCH 31, 2019:







Issuance of share capital, net

817

9,620

-

-

-

10,437

Employee stock options exercised

1

18

(18)

-

-

1

Employee stock options forfeited and expired

-

30

(30)

-

-

-

Share-based compensation              

-

-

284

-

-

284

Comprehensive loss for the period

-

-

-

-

(6,155)

(6,155)

BALANCE AT MARCH 31, 2019

3,928

259,860

12,191

(1,416)

(228,675)

45,888








 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)





Three months ended

March 31,


2018

2019


in USD thousands




CASH FLOWS - OPERATING ACTIVITIES



Comprehensive loss for the period

(6,198)

(6,155)

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

(609)

1,533

Net cash used in operating activities

(6,807)

(4,622)




CASH FLOWS - INVESTING ACTIVITIES



Investments in short-term deposits 

(4,000)

(21,510)

Maturities of short-term deposits

12,167

12,228

Purchase of property and equipment

(54)

(31)

Purchase of intangible assets

(29)

-

Net cash provided by (used in) investing activities

8,084

(9,313)




CASH FLOWS - FINANCING ACTIVITIES



Issuance of share capital and warrants, net of issuance costs

1,423

14,989

Employee stock options exercised

-

1

Repayments of loans

(23)

(23)

Repayments of lease liabilities

-

(50)

Net cash provided by financing activities

1,400

14,917




INCREASE IN CASH AND CASH EQUIVALENTS

2,677

982

CASH AND CASH EQUIVALENTS – BEGINNING

   OF PERIOD

5,110

3,404

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

23

(2)

CASH AND CASH EQUIVALENTS - END OF PERIOD

7,810

4,384




 

 

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)





Three months ended

March 31,


2018

2019


in USD thousands







Adjustments required to reflect net cash used in operating activities:



Income and expenses not involving cash flows:



Depreciation and amortization

140

213

Long-term prepaid expenses

1

1

Exchange differences on cash and cash equivalents

(23)

2

Gain on adjustment of warrants to fair value

(465)

(79)

Share-based compensation

916

284

Warrant issuance costs

-

417

Interest and exchange differences on short-term deposits

(182)

(195)

Interest and linkage differences on loans

(1)

154


386

797




Changes in operating asset and liability items:



Decrease (increase) in prepaid expenses and other receivables

(453)

786

Decrease in accounts payable and accruals

(542)

(50)


(995)

736


(609)

1,533




Supplemental information on interest received in cash

167

229




Supplemental information on non-cash transaction:

        Initial establishment of right-of-use assets against lease liabilities

-

1,878




 

Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com

or

Tsipi Haitovsky
Public Relations
+972-52-598-9892  
tsipihai5@gmail.com

  

Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-first-quarter-2019-financial-results-and-provides-corporate-update-300849581.html

SOURCE BioLineRx Ltd.


Interview with Philip Serlin, CEO
December 2016