BioLineRx Reports Significant Progress Across Oncology Programs and Provides Third Quarter Financial Update

 

TEL AVIV, Israel, Nov. 8, 2018 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, today reports its financial results for the third quarter ended September 30, 2018 and provided a corporate update.

Highlights and achievements during the third quarter 2018 and subsequent period:

  • Reported positive results from lead-in period of Phase 3 GENESIS trial in stem-cell mobilization; data from first lead-in patient cohort prompted Data Monitoring Committee to recommend early continuation to randomized placebo-controlled part 2 of trial;
  • Presented data from ongoing Phase 2a COMBAT/KEYNOTE-202 pancreatic cancer study in collaboration with Merck at the ESMO 2018 Congress demonstrating that BL-8040 in combination with KEYTRUDA® (pembrolizumab) showed encouraging disease control and overall survival in patients with metastatic pancreatic cancer; compelling pharmacodynamic data also demonstrated T-cell infiltration into tumors and a reduction of the tumor immuno-suppressive microenvironment;
  • Based on COMBAT/KEYNOTE-202 results, announced expansion of immuno-oncology collaboration with Merck to include a triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy;
  • Entered into agreement with Biokine Therapeutics to increase the Company's economic stake in BL-8040 to 80% from the previous level of 60%;
  • Initiated Phase 1/2a multicenter, open-label clinical study in the UK and Israel for AGI-134, a novel immunotherapy evoking a direct anti-tumor response and vaccine effect for the treatment of solid tumors;

"We made significant progress during the third quarter and subsequent period advancing clinical development of both of our oncology programs – BL-8040 and AGI-134," said Philip Serlin, Chief Executive Officer of BioLineRx. "The Phase 3 GENESIS study in stem-cell mobilization is now advancing in the randomized placebo-controlled part 2 of the trial. We are also rapidly moving forward in our expanded collaboration with Merck in pancreatic cancer, on the basis of the encouraging results recently presented at ESMO, with an additional cohort adding chemotherapy to the BL-8040/KEYTRUDA combination. Further, we are very pleased to have initiated the first-in-human clinical study for AGI-134, our unique immunotherapy cancer vaccine. These achievements follow BL-8040's very promising results in relapsed/refractory AML that were presented at the recent EHA Congress during the second quarter, showing significantly improved overall survival compared to historical data."

"BL-8040 is currently being evaluated in eight Phase 2 or Phase 3 clinical trials in multiple oncology indications, four of which are being run under collaborations with global pharma companies. In addition, based on the very promising data seen in relapsed/refractory AML, we intend to further pursue this indication and we continue to evaluate the optimal clinical development pathway going forward. The broad dataset from BL-8040's robust clinical development program was the motivation behind our recent decision to significantly increase our economics in BL-8040, and sets the stage for a catalyst-rich 2019," Mr. Serlin concluded.

Expected significant milestones through end of 2019:

  • Initiation of Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck by the end of 2018;
  • Potential interim results from Phase 2 AML consolidation study in mid-2019;
  • Initial safety results from part 1 of Phase 1/2a trial for AGI-134 in second half of 2019;
  • Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck toward the end of 2019;
  • Top-line results from one or more of the solid tumor trials under collaboration with Genentech during 2019.

Financial Results for the Third Quarter Ended September 30, 2018 

Research and development expenses for the three months ended September 30, 2018 were $5.0 million, a decrease of $0.6 million, or 11.1 %, compared to $5.6 million for the three months ended September 30, 2017. The decrease resulted primarily from higher expenses associated with drug product development and manufacturing for AGI-134 in the 2017 period. Research and development expenses for the nine months ended September 30, 2018 were $14.6 million, an increase of $1.3 million, or 9.6 %, compared to $13.3 million for the nine months ended September 30, 2017. The increase in the 2018 period resulted primarily from higher expenses associated with BL-8040, including the GENESIS and COMBAT trials; preparations for initiation of the AGI-134 clinical trial; and BL-1230.

Sales and marketing expenses for the three months ended September 30, 2018 were $0.3 million, similar to the comparable period in 2017. Sales and marketing expenses for the nine months ended September 30, 2018 were $1.1 million, a decrease of $0.1 million, or 6.7%, compared to $1.2 million for the nine months ended September 30, 2017. The decrease resulted primarily from one-time legal fees related to AGI-134 paid in the 2017 period.

General and administrative expenses for the three months ended September 30, 2018 were $0.9 million, a decrease of $0.3 million, or 22.7%, compared to $1.2 million for the three months ended September 30, 2017. The decrease resulted from a decrease in fees paid for consulting services. General and administrative expenses for the nine months ended September 30, 2018 were $2.9 million, a decrease of $0.2 million, or 5.9%, compared to $3.0 million for the nine months ended September 30, 2017. The decrease also resulted from a decrease in fees paid for consulting services.

The Company's operating loss for the three months ended September 30, 2018 amounted to $6.2 million, compared with an operating loss of $7.1 million for the corresponding 2017 period. The Company's operating loss for the nine months ended September 30, 2018 amounted to $18.6 million, compared with an operating loss of $17.6 million for the corresponding 2017 period.

Non-operating income (expenses) for the three and nine months ended September 30, 2018 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet and the capital gain from realization of the investment in iPharma. Non-operating income (expenses) for the three and nine months ended September 30, 2017 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet.

Net financial income amounted to $0.1 million for the three months ended September 30, 2018, similar to the comparable period in 2017. Net financial income for both periods relates primarily to gains recorded on foreign currency hedging transactions and investment income earned on bank deposits. Net financial income amounted to $0.4 million for the nine months ended September 30, 2018, compared to net financial income of $0.9 million for the nine months ended September 30, 2017. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions. Net financial income for the 2017 period relates primarily to gains recorded on foreign currency hedging transactions and investment income earned on bank deposits.

The Company's net loss for the three months ended September 30, 2018 amounted to $6.3 million, compared with a net loss of $7.2 million for the corresponding period. The Company's net loss for the nine months ended September 30, 2018 amounted to $17.3 million, compared with a net loss of $17.0 million for the corresponding 2017 period.

The Company held $35.0 million in cash, cash equivalents and short-term bank deposits as of September 30, 2018.

Net cash used in operating activities was $19.1 million for the nine months ended September 30, 2018, compared with net cash used in operating activities of $14.2 million for the nine months ended September 30, 2017. The $4.9 million increase in net cash used in operating activities during the nine-month period in 2018, compared to the nine-month period in 2017, was the result of increased research and development expenses in the 2018 period, as well as a decrease in accounts payable and increase in prepaid expenses and other receivables.

Net cash provided by investing activities was $16.0 million for the nine months ended September 30, 2018, compared to net cash used in investing activities of $19.5 million for the nine months ended September 30, 2017. The changes in cash flows from investing activities relate primarily relate primarily to investments in, and maturities of, short-term bank deposits, as well as the investment in Agalimmune in 2017 and the realization of the investment in iPharma in 2018.

Net cash provided by financing activities was $2.8 million for the nine months ended September 30, 2018, compared to net cash provided by financing activities of $37.7 million for the nine months ended September 30, 2017. The decrease in cash flows from financing activities reflects the public offering completed in April 2017.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 8, 2018 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 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 10, 2018; please dial +1-888-326-9310 from the U.S. or +972-3-925-5925 internationally.

(Tables follow)

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. 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 has initiated a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which has recently initiated 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 Facebook, Twitter, and LinkedIn.

Forward Looking Statement

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 6, 2018. 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,

September 30,

 

2017

2018

 

in USD thousands

Assets

   

CURRENT ASSETS

   

Cash and cash equivalents

5,110

4,703

Short-term bank deposits

44,373

30,300

Prepaid expenses

307

1,266

Other receivables

586

835

          Total current assets

50,376

37,104

     

NON-CURRENT ASSETS

   

Long-term prepaid expenses

61

66

Long-term investment

1,000

-

Property and equipment, net

2,505

2,197

Intangible assets, net

7,023

7,033

          Total non-current assets

10,589

9,296

          Total assets

60,965

46,400

     

Liabilities and equity

   

CURRENT LIABILITIES

   

Current maturities of long-term bank loan

93

93

Accounts payable and accruals:

   

     Trade

5,516

3,804

     Other

1,113

1,028

          Total current liabilities

6,722

4,925

NON-CURRENT LIABILITIES

   

Long-term bank loan, net of current maturities

157

86

Warrants

1,205

804

          Total non-current liabilities

1,362

890

COMMITMENTS AND CONTINGENT LIABILITIES

   

    Total liabilities

8,084

5,815

     

EQUITY

   

Ordinary shares

2,836

2,922

Share premium

240,682

244,058

Other comprehensive loss

10,337

11,889

Capital reserve

(1,416)

(1,416)

Accumulated deficit

(199,558)

(216,868)

          Total equity

52,881

40,585

          Total liabilities and equity

60,965

46,400

 

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

 
 
 

Three months ended
September 30,

 

Nine months ended
September 30,

 

2017

2018

2017

2018

 

in USD thousands

in USD thousands

RESEARCH AND DEVELOPMENT EXPENSES

(5,654)

(5,027)

(13,306)

(14,581)

SALES AND MARKETING EXPENSES

(249)

(293)

(1,218)

(1,137)

GENERAL AND ADMINISTRATIVE EXPENSES

(1,154)

(892)

(3,028)

(2,850)

OPERATING LOSS

(7,057)

(6,212)

(17,552)

(18,568)

NON-OPERATING INCOME (EXPENSES), NET

(333)

(255)

(342)

870

FINANCIAL INCOME

153

154

914

534

FINANCIAL EXPENSES

(6)

(11)

(15)

(146)

         

NET LOSS AND COMPREHENSIVE LOSS

(7,243)

(6,324)

(16,995)

(17,310)

         
 

in USD

in USD

LOSS PER ORDINARY SHARE - BASIC AND DILUTED

(0.07)

(0.06)

(0.20)

(0.16)

         

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

101,874,372

107,110,585

85,106,723

107,040,191

         
           

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

 

 

Ordinary shares

 

Share premium

Other comprehensive loss

 

Capital reserve

 

Accumulated deficit

 

 

Total

 

in USD thousands

BALANCE AT JANUARY 1, 2017

1,513

199,567

(1,416)

10,569

(175,206)

35,027

CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2017:

           

Issuance of share capital, net

1,295

38,388

-

-

-

39,683

Employee stock options exercised

1

326

-

(326)

-

1

Employee stock options forfeited and expired             

-

1,325

-

(1,325)

-

-

Share-based compensation

-

-

-

1,309

-

1,309

Comprehensive loss for the period

-

-

-

-

(16,995)

(16,995)

BALANCE AT SEPTEMBER 30, 2017

2,809

239,606

(1,416)

10,227

(192,201)

59,025

             
             
 

 

Ordinary shares

 

Share premium

Other comprehensive loss

 

Capital reserve

 

Accumulated deficit

 

 

Total

 

in USD thousands

BALANCE AT JANUARY 1, 2018

2,836

240,682

(1,416)

10,337

(199,558)

52,881

CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2018:

           

Issuance of share capital, net

85

2,803

-

-

-

2,888

Employee stock options exercised

1

46

-

(47)

-

-

Employee stock options forfeited and expired

-

527

-

(527)

-

-

Share-based compensation              

-

-

-

2,126

-

2,126

Comprehensive loss for the period

-

-

-

-

(17,310)

(17,310)

BALANCE AT SEPTEMBER 30, 2018

2,922

244,058

(1,416)

11,889

(216,868)

40,585

             

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

 
 

Nine months ended

September 30,

 

2017

2018

 

in USD thousands

     

CASH FLOWS - OPERATING ACTIVITIES

   

Comprehensive loss for the period

(16,995)

(17,310)

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

2,772

(1,741)

Net cash used in operating activities

(14,223)

(19,051)

     

CASH FLOWS - INVESTING ACTIVITIES

   

Investments in short-term deposits

(48,029)

(22,000)

Maturities of short-term deposits

33,327

36,613

Long-term investment

(1,000)

-

Proceeds from realization of long-term investment

-

1,500

Purchase of property and equipment

(109)

(76)

Purchase of intangible assets

(3,721)

(40)

Net cash provided by (used in) investing activities

(19,532)

15,997

     

CASH FLOWS - FINANCING ACTIVITIES

   

Issuance of share capital and warrants, net of issuance costs

37,761

2,888

Repayments of bank loan

(70)

(70)

Net cash provided by financing activities

37,691

2,818

     

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

3,936

(236)

CASH AND CASH EQUIVALENTS – BEGINNING

 OF PERIOD

2,469

5,110

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

307

(171)

CASH AND CASH EQUIVALENTS - END OF PERIOD

6,712

4,703

     

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

   
 

Nine months ended

September 30,

 

2017

2018

 

in USD thousands

     
     

Adjustments required to reflect net cash used in operating activities:

   

Income and expenses not involving cash flows:

   

Depreciation and amortization

381

414

Long-term prepaid expenses

(8)

(5)

Interest and exchange rate differences on short-term deposits

(439)

(540)

Share-based compensation

1,309

2,126

Warrant issuance costs

17

-

Gain on realization of long-term investment   

-

(500)

Interest and linkage differences on bank loan

-

(1)

Exchange differences on cash and cash equivalents

(307)

171

Loss (gain) on adjustment of warrants to fair value

316

(401)

 

1,269

1,264

     

Changes in operating asset and liability items:

   

Increase in prepaid expenses and other receivables

(362)

(1,208)

Increase (decrease) in accounts payable and accruals

1,865

(1,797)

 

1,503

(3,005)

 

2,772

(1,741)

     
     

Supplementary information on interest received in cash

378

598

 

Supplementary non-cash investment

2,985

-

     

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-significant-progress-across-oncology-programs-and-provides-third-quarter-financial-update-300746511.html

SOURCE BioLineRx Ltd.

 
 
Company Codes: Bloomberg:BLNEF@US, Bloomberg:BLRX@IT, Bloomberg:BLRX@US, Frankfurt:YP2, Frankfurt:YP2@GR, ISIN:IL0011015182, ISIN:US09071M1062, NASDAQ-SMALL:BLRX, OTC-BB:BLNEF, RICS:BLNEF.PK, RICS:BLRX.DF, RICS:BLRX.O, RICS:BLRX.OF, RICS:BLRX.OQ, RICS:BLRX.P, RICS:BLRX.PH, RICS:BLRX.TA, RICS:YP2.F, NYSEArca:BLRX, OtherOTC:BLNEF, OtherOTC:BLRX, PHLX:BLRX, RICS:BLNEF, Stuttgart:YP2, TelAviv:BLRX
 

Back to news