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BioLineRx Ltd.
Quarterly Report • Aug 6, 2019
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Quarterly Report
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2019 _______________________
BioLineRx Ltd.
(Translation of registrant's name into English) _______________________
2 HaMa'ayan Street Modi'in 7177871, Israel
(Address of Principal Executive Offices) _______________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F ☑ Form 40-F ☐
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
Yes ☐ No ☑
On August 6, 2019, the registrant will issue a press release announcing its financial results for the three and six months ended June 30, 2019. The registrant is also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of June 30, 2019 and for the three and six months then ended. Attached hereto are the following exhibits:
Exhibit 1: Registrant's press release dated August 6, 2019;
Exhibit 2: Registrant's condensed consolidated interim financial statements as of June 30, 2019, and for the three and six months and then ended; and
Exhibit 3 - Registrant's operating and financial review as of June 30, 2019, and for the three and six months then ended.
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioLineRx Ltd.
By: /s/ Philip A. Serlin Philip A. Serlin
Chief Executive Officer
Dated: August 6, 2019
For Immediate Release
BioLineRx Reports Second Quarter 2019 Financial Results and Provides Corporate Update
On track for Phase 2 data read-out in pancreatic cancer by year-end 2019
Management to hold conference call today, August 6, at 10:00 am EDT
TEL AVIV, Israel, August 6, 2019 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2019 and provides a corporate update.
Highlights and achievements during the second quarter 2019 and subsequent period:
- Continued to advance multiple clinical trials of its lead therapeutic candidates, BL-8040 and AGI-134, and anticipates top-line data from the triple combination arm of the COMBAT/KEYNOTE-202 pancreatic cancer trial by year-end.
- Received approval from the FDA for an 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.
"BL-8040, our lead drug candidate, is rapidly advancing in multiple promising programs. The triple combination arm of our ongoing COMBAT/KEYNOTE-202 Phase 2 study of BL-8040, KEYTRUDA® and chemotherapy in metastatic pancreatic cancer is progressing as planned, and top-line results are expected by year end. AML consolidation also remains an important indication in our BL-8040 development plan, and we, with our partners, continue to progress our BLAST Phase 2b study towards a robust interim analysis. In addition, the GENESIS Phase 3 study in stem cell mobilization, our most advanced indication and most direct path to registration, is progressing as planned with top-line results expected in the second half of next year," stated Philip Serlin, Chief Executive Officer of BioLineRx.
"Regarding our second clinical candidate, the universal anti-cancer vaccine AGI-134, we continue to advance our phase 1/2a clinical trial toward initial safety data later this year, and with the acceptance of our IND, we look forward to the next part of the study, which will assess potential efficacy. Taken together, we believe our broad development pipeline provides multiple opportunities for long-term value creation and we are diligently working toward that goal," Mr. Serlin concluded.
Upcoming Milestones
Second half of 2019
- Top-line results from COMBAT/KEYNOTE-202 Phase 2 pancreatic cancer trial
- Initial safety results from part 1 of Phase 1/2a trial of AGI-134
- Potential interim results from Phase 2b AML consolidation study
- Initiation of monotherapy basket arm of Part 2 of Phase 1/2a trial of AGI-134
2020
- Progression-free survival (PFS) and overall survival (OS) data from COMBAT/KEYNOTE-202 trial in mid-2020
- Top-line results from Phase 3 GENESIS registration trial in stem-cell mobilization in second half of 2020
Financial Results for the Second Quarter Ended June 30, 2019
Research and development expenses for the three months ended June 30, 2019 were \$5.3 million, an increase of \$0.8 million, or 18%, compared to \$4.5 million for the three months ended June 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials. Research and development expenses for the six months ended June 30, 2019 were \$9.7 million, an increase of \$0.1 million, or 2%, compared to \$9.6 million for the six months ended June 30, 2018. The small increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated, as well as a decrease in payroll and related expenses.
Sales and marketing expenses for the three months ended June 30, 2019 were \$0.2 million, a decrease of \$0.1 million, or 37%, compared to \$0.3 million for the three months ended June 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses. Sales and marketing expenses for the six months ended June 30, 2019 were \$0.5 million, a decrease of \$0.4 million, or 43%, compared to \$0.9 million for the six months ended June 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses, including a one-time compensation payment in the 2018 period.
General and administrative expenses for the three months ended June 30, 2019 were \$0.9 million, similar to the comparable period in 2018. General and administrative expenses for the six months ended June 30, 2019 were \$1.9 million, similar to the comparable period in 2018.
The Company's operating loss for the three months ended June 30, 2019 was \$6.5 million, compared to \$5.7 million for the three months ended June 30, 2018. The Company's operating loss for the six months ended June 30, 2019 was \$12.1 million, compared to \$12.4 million for the comparable period in 2018.
Non-operating income for the three and six months ended June 30, 2019 primarily relates to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses. Non-operating income for the six months ended June 30, 2018 primarily relates to fair-value adjustments of warrant liabilities on the Company's balance sheet, as well as a capital gain from realization of the investment in iPharma.
Net financial expenses amounted to \$0.3 million for the three months ended June 30, 2019 compared to net financial income of \$0.3 million for the three months ended June 30, 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 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 expenses amounted to \$0.5 million for the six months ended June 30, 2019 compared to net financial income of \$0.3 million for the six months ended June 30, 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 income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions.
The Company's net loss for the three months ended June 30, 2019 amounted to \$5.5 million, compared with a net loss of \$4.8 million for the comparable period in 2018. The Company's net loss for the six months ended June 30, 2019 amounted to \$11.6 million, compared with a net loss of \$11.0 million for the comparable period in 2018.
The Company held \$35.2 million in cash, cash equivalents and short-term bank deposits as of June 30, 2019.
Net cash used in operating activities was \$11.1 million for the six months ended June 30, 2019, compared with net cash used in operating activities of \$13.0 million for the six months ended June 30, 2018. The \$1.9 million decrease in net cash used in operating activities during the six-month period in 2019, compared to the six-month period in 2018, was primarily the result of changes in operating asset and liability items in the two periods., i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a higher decrease in accounts payable and accruals in 2018.
Net cash used in investing activities was \$3.1 million for the six months ended June 30, 2019, compared to net cash provided by investing activities of \$10.8 million for the six months ended June 30, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and the realization of the investment in iPharma in 2018.
Net cash provided by financing activities was \$15.7 million for the six months ended June 30, 2019, compared to net cash provided by financing activities of \$2.8 million for the six months ended June 30, 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, August 6, 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 August 8, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5904 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 two Phase 1b/2 studies for solid tumor indications.
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 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.
Contact: Tim McCarthy LifeSci Advisors, LLC +1-212-915-2564 [email protected]
or
Tsipi Haitovsky Public Relations +972-52-598-9892 [email protected]
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED)
| 2018 2019 in USD thousands Assets CURRENT ASSETS Cash and cash equivalents 3,404 Short-term bank deposits 26,747 Prepaid expenses 488 Other receivables 1,339 Total current assets 31,978 NON-CURRENT ASSETS Long-term prepaid expenses 56 Property and equipment, net 2,227 Right-of-use assets - Intangible assets, net 21,972 Total non-current assets 24,255 Total assets 56,233 Liabilities and equity CURRENT LIABILITIES Current maturities of long-term loans 895 Accounts payable and accruals: Trade 4,493 Other 1,363 Lease liabilities - Total current liabilities 6,751 NON-CURRENT LIABILITIES Warrants 323 Long-term loans, net of current maturities 7,838 Lease liabilities - Total non-current liabilities 8,161 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 14,912 EQUITY Ordinary shares 3,110 Share premium 250,192 Capital reserve 11,955 Other comprehensive loss (1,416) Accumulated deficit (222,520) Total equity 41,321 Total liabilities and equity 56,233 61,958 |
December 31, | June 30, | |
|---|---|---|---|
| 4,972 30,256 451 528 36,207 60 2,047 1,716 21,928 25,751 61,958 2,395 4,565 927 672 8,559 3,938 6,583 1,096 11,617 20,176 4,001 261,522 11,835 (1,416) (234,160) 41,782 |
|||
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
| Three months ended June 30, | Six months ended June 30, | ||||
|---|---|---|---|---|---|
| 2018 | 2019 | 2018 | 2019 | ||
| in USD thousands | in USD thousands | ||||
| RESEARCH AND DEVELOPMENT EXPENSES | (4,484) | (5,302) | (9,554) | (9,694) | |
| SALES AND MARKETING EXPENSES | (360) | (226) | (844) | (482) | |
| GENERAL AND ADMINISTRATIVE EXPENSES | (883) | (949) | (1,958) | (1,879) | |
| OPERATING LOSS | (5,727) | (6,477) | (12,356) | (12,055) | |
| NON-OPERATING INCOME, NET | 663 | 1,261 | 1,125 | 921 | |
| FINANCIAL INCOME | 287 | 171 | 462 | 381 | |
| FINANCIAL EXPENSES | (11) | (440) | (217) | (887) | |
| NET LOSS AND COMPREHENSIVE LOSS | (4,788) | (5,485) | (10,986) | (11,640) | |
| in USD | in USD | ||||
| LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.05) | (0.04) | (0.10) | (0.08) | |
| WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
106,630,704 | 145,461,598 | 106,524,332 | 139,270,178 | |
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)
| Other | ||||||
|---|---|---|---|---|---|---|
| Ordinary | Share | Capital | Comprehensive | Accumulated | ||
| shares | premium | reserve | loss | deficit | Total | |
| in USD thousands | ||||||
| BALANCE AT JANUARY 1, 2018 | 2,836 | 240,682 | 10,337 | (1,416) | (199,558) | 52,881 |
| CHANGES FOR SIX MONTHS ENDED JUNE 30, | ||||||
| 2018: | ||||||
| Issuance of share capital, net | 83 | 2,764 | - | - | - | 2,847 |
| Employee stock options exercised | 1 | 38 | (39) | - | - | - |
| Employee stock options forfeited and expired | - | 399 | (399) | - | - | - |
| Share-based compensation | - | - | 1,444 | - | - | 1,444 |
| Comprehensive loss for the period | - | - | - | - | (10,986) | (10,986) |
| BALANCE AT JUNE 30, 2018 | 2,920 | 243,883 | 11,343 | (1,416) | (210,544) | 46,186 |
| Other | ||||||
|---|---|---|---|---|---|---|
| Ordinary shares |
Share premium |
Capital reserve |
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 |
| 8 |
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)
| Six months ended June 30, | ||
|---|---|---|
| 2018 | 2019 | |
| in USD thousands | ||
| CASH FLOWS - OPERATING ACTIVITIES | ||
| Comprehensive loss for the period | (10,986) | (11,640) |
| Adjustments required to reflect net cash used in operating activities (see appendix below) | (2,054) | 573 |
| Net cash used in operating activities | (13,040) | (11,067) |
| CASH FLOWS - INVESTING ACTIVITIES | ||
| Investments in short-term deposits | (15,000) | (27,510) |
| Maturities of short-term deposits | 24,385 | 24,441 |
| Proceeds from realization of long-term investment | 1,500 | - |
| Purchase of property and equipment | (76) | (53) |
| Purchase of intangible assets | (37) | - |
| Net cash provided by (used in) investing activities | 10,772 | (3,122) |
| CASH FLOWS - FINANCING ACTIVITIES | ||
| Issuances of share capital and warrants, net of issuance cost | 2,847 | 15,879 |
| Employee stock options exercised | - | 1 |
| Repayments of loans | (47) | (47) |
| Repayments of lease liabilities | - | (110) |
| Net cash provided by financing activities | 2,800 | 15,723 |
| INCREASE IN CASH AND CASH EQUIVALENTS | 532 | 1,534 |
| CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD | 5,110 | 3,404 |
| EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 147 | 34 |
| CASH AND CASH EQUIVALENTS - END OF PERIOD | 5,789 | 4,972 |
BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)
| Six months ended June 30, | |||
|---|---|---|---|
| 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 | 288 | 439 | |
| Long-term prepaid expenses | (2) | (4) | |
| Exchange differences on cash and cash equivalents | (147) | (34) | |
| Gain on adjustment of warrants to fair value | (625) | (1,354) | |
| Gain on realization of long-term investment | (500) | - | |
| Share-based compensation | 1,444 | 773 | |
| Warrant issuance costs | - | 417 | |
| Interest and exchange rate differences on short-term deposits | (351) | (440) | |
| Interest on loans | (1) | 292 | |
| 106 | 89 | ||
| Changes in operating asset and liability items: | |||
| Decrease (increase) in prepaid expenses and other receivables | (776) | 848 | |
| Decrease in accounts payable and accruals | (1,384) | (364) | |
| (2,160) | 484 | ||
| (2,054) | 573 | ||
| Supplemental information on interest received in cash | 377 | 442 | |
| Supplemental information on interest paid in cash | 167 | 477 | |
| Supplemental information on non-cash transaction - | |||
| Initial establishment of right-of-use assets against lease liabilities | - | 1,878 | |
Exhibit 2
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2019
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2019
TABLE OF CONTENTS
| Page | |
|---|---|
| Condensed consolidated interim statements of financial position | F-1 |
| Condensed consolidated interim statements of comprehensive loss | F-2 |
| Condensed consolidated interim statements of changes in equity | F-3 |
| Condensed consolidated interim cash flow statements | F-4 - F-5 |
| Notes to the condensed consolidated interim financial statements | F-6 - F-9 |
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
| December 31, | June 30, | ||
|---|---|---|---|
| 2018 | 2019 | ||
| in USD thousands | |||
| Assets | |||
| CURRENT ASSETS | |||
| Cash and cash equivalents | 3,404 | 4,972 | |
| Short-term bank deposits | 26,747 | 30,256 | |
| Prepaid expenses | 488 | 451 | |
| Other receivables | 1,339 | 528 | |
| Total current assets | 31,978 | 36,207 | |
| NON-CURRENT ASSETS | |||
| Long-term prepaid expenses | 56 | 60 | |
| Property and equipment, net | 2,227 | 2,047 | |
| Right-of-use assets | - | 1,716 | |
| Intangible assets, net | 21,972 | 21,928 | |
| Total non-current assets | 24,255 | 25,751 | |
| Total assets | 56,233 | 61,958 | |
| Liabilities and equity | |||
| CURRENT LIABILITIES | |||
| Current maturities of long-term loans | 895 | 2,395 | |
| Accounts payable and accruals: | |||
| Trade | 4,493 | 4,565 | |
| Other | 1,363 | 927 | |
| Lease liabilities | - | 672 | |
| Total current liabilities | 6,751 | 8,559 | |
| NON-CURRENT LIABILITIES | |||
| Warrants | 323 | 3,938 | |
| Long-term loans, net of current maturities | 7,838 | 6,583 | |
| Lease liabilities | - | 1,096 | |
| Total non-current liabilities | 8,161 | 11,617 | |
| COMMITMENTS AND CONTINGENT LIABILITIES | |||
| Total liabilities | 14,912 | 20,176 | |
| EQUITY | |||
| Ordinary shares | 3,110 | 4,001 | |
| Share premium | 250,192 | 261,522 | |
| Capital reserve | 11,955 | 11,835 | |
| Other comprehensive loss | (1,416) | (1,416) | |
| Accumulated deficit | (222,520) | (234,160) | |
| Total equity | 41,321 | 41,782 | |
| Total liabilities and equity | 56,233 | 61,958 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2018 | 2019 | 2018 | 2019 | |
| in USD thousands | in USD thousands | |||
| RESEARCH AND DEVELOPMENT EXPENSES | (4,484) | (5,302) | (9,554) | (9,694) |
| SALES AND MARKETING EXPENSES | (360) | (226) | (844) | (482) |
| GENERAL AND ADMINISTRATIVE EXPENSES | (883) | (949) | (1,958) | (1,879) |
| OPERATING LOSS | (5,727) | (6,477) | (12,356) | (12,055) |
| NON-OPERATING INCOME, NET | 663 | 1,261 | 1,125 | 921 |
| FINANCIAL INCOME | 287 | 171 | 462 | 381 |
| FINANCIAL EXPENSES | (11) | (440) | (217) | (887) |
| NET LOSS AND COMPREHENSIVE LOSS | (4,788) | (5,485) | (10,986) | (11,640) |
| in USD | in USD | |||
| LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.05) | (0.04) | (0.10) | (0.08) |
| WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE |
106,630,704 | 145,461,598 | 106,524,332 | 139,270,178 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
BioLineRx Ltd. CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)
| Other | ||||||
|---|---|---|---|---|---|---|
| Ordinary shares |
Share premium |
Capital reserve |
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 SIX MONTHS ENDED JUNE 30, | ||||||
| 2018: | ||||||
| Issuance of share capital, net | 83 | 2,764 | - | - | - | 2,847 |
| Employee stock options exercised | 1 | 38 | (39) | - | - | - |
| Employee stock options forfeited and expired | - | 399 | (399) | - | - | - |
| Share-based compensation | - | - | 1,444 | - | - | 1,444 |
| Comprehensive loss for the period | - | - | - | - | (10,986) | (10,986) |
| BALANCE AT JUNE 30, 2018 | 2,920 | 243,883 | 11,343 | (1,416) | (210,544) | 46,186 |
| Ordinary | Share | Capital | Other Comprehensive |
Accumulated |
| shares | premium | reserve | loss | 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 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
| Six months ended June 30, | |||
|---|---|---|---|
| 2018 | 2019 | ||
| in USD thousands | |||
| CASH FLOWS - OPERATING ACTIVITIES | |||
| Comprehensive loss for the period | (10,986) | (11,640) | |
| Adjustments required to reflect net cash used in operating activities (see appendix below) | (2,054) | 573 | |
| Net cash used in operating activities | (13,040) | (11,067) | |
| CASH FLOWS - INVESTING ACTIVITIES | |||
| Investments in short-term deposits | (15,000) | (27,510) | |
| Maturities of short-term deposits | 24,385 | 24,441 | |
| Proceeds from realization of long-term investment | 1,500 | - | |
| Purchase of property and equipment | (76) | (53) | |
| Purchase of intangible assets | (37) | - | |
| Net cash provided by (used in) investing activities | 10,772 | (3,122) | |
| CASH FLOWS - FINANCING ACTIVITIES | |||
| Issuances of share capital and warrants, net of issuance cost | 2,847 | 15,879 | |
| Employee stock options exercised | - | 1 | |
| Repayments of loans | (47) | (47) | |
| Repayments of lease liabilities | - | (110) | |
| Net cash provided by financing activities | 2,800 | 15,723 | |
| INCREASE IN CASH AND CASH EQUIVALENTS | 532 | 1,534 | |
| CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD | 5,110 | 3,404 | |
| EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | 147 | 34 | |
| CASH AND CASH EQUIVALENTS - END OF PERIOD | 5,789 | 4,972 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
| Six months ended June 30, | ||
|---|---|---|
| 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 | 288 | 439 |
| Long-term prepaid expenses | (2) | (4) |
| Exchange differences on cash and cash equivalents | (147) | (34) |
| Gain on adjustment of warrants to fair value | (625) | (1,354) |
| Gain on realization of long-term investment | (500) | - |
| Share-based compensation | 1,444 | 773 |
| Warrant issuance costs | - | 417 |
| Interest and exchange rate differences on short-term deposits | (351) | (440) |
| Interest on loans | (1) | 292 |
| 106 | 89 | |
| (776) | 848 | |
| Changes in operating asset and liability items: Decrease )increase(in prepaid expenses and other receivables Decrease in accounts payable and accruals |
(1,384) | (364) |
| (2,160) | 484 | |
| (2,054) | 573 | |
| Supplemental information on interest received in cash | 377 | 442 |
| Supplemental information on interest paid in cash | 167 | 477 |
| Supplemental information on non-cash transaction - | ||
| Initial establishment of right-of-use assets against lease liabilities | - | 1,878 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
BioLineRx Ltd. NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1 – GENERAL INFORMATION
a. General
BioLineRx Ltd. ("BioLineRx"), headquartered in Modi'in, Israel, was incorporated and commenced operations in April 2003.
BioLineRx and its subsidiaries (collectively, the "Company") are engaged in the development of therapeutics, primarily in clinical-stages, with a focus on the field of oncology.
In February 2007, BioLineRx listed its ordinary shares on the Tel Aviv Stock Exchange ("TASE") and they have been traded on the TASE since that time. Since July 2011, BioLineRx's American Depositary Shares ("ADSs") have also been traded on the NASDAQ Capital Market.
In March 2017, the Company acquired Agalimmune Ltd. ("Agalimmune"), a privately-held company incorporated in the United Kingdom, with a focus on the field of immunooncology.
Although the Company has generated significant revenues from a number of out-licensing transactions in the past, the Company cannot determine with reasonable certainty when and if it will have sustainable profits.
b. Approval of financial statements
The condensed consolidated interim financial statements of the Company as of June 30, 2019, and for the three and six months then ended, were approved by the Board of Directors on August 6, 2019, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer and the Chief Financial Officer.
NOTE 2 – BASIS OF PREPARATION
The Company's condensed consolidated interim financial statements as of June 30, 2019 and for the three and six months then ended (the "interim financial statements") have been prepared in accordance with International Accounting Standard No. 34, "Interim Financial Reporting" ("IAS 34"). These interim financial statements, which are unaudited, do not include all disclosures necessary for a fair statement of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards ("IFRS"). The condensed consolidated interim financial statements should be read in conjunction with the Company's annual financial statements as of December 31, 2018 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS. The results of operations for the three and six months ended June 30, 2019 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
BioLineRx Ltd. NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES
The accounting policies and calculation methods applied in the preparation of these interim financial statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2018 and for the year then ended, except for the adoption of IFRS No. 16, "Leases".
a. Adjustments recognized on adoption of IFRS 16
The Company has adopted IFRS 16 retrospectively from January 1, 2019 but has not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in the standard. On adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as "operating leases" under the principles of IAS 17, "Leases." These liabilities were measured at the present value of the remaining lease payments, discounted using the lessee's incremental borrowing rate as of January 1, 2019. The remeasurements to the lease liabilities were recognized as adjustments to the related right-of-use assets immediately after the date of initial application. The associated right-of-use assets for property leases were measured on a retrospective basis as if the new rules had always been applied. Other right-of use assets were measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognized in the balance sheet as of December 31, 2018. The lessee's weighted average incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 15.1%.
| January 1, | June 30, | ||
|---|---|---|---|
| 2019 | 2019 | ||
| Composition of right-of-use assets by type: | |||
| Property | 1,552 | 1,485 | |
| Motor vehicles | 326 | 231 | |
| Total right-of-use asset | 1,878 | 1,716 | |
| Composition of lease liabilities recognized as of January 1, 2019: | |||
| Current lease liabilities | 713 | ||
| Non-current lease liabilities | 1,165 | ||
| 1,878 |
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
b. Practical expedients applied on adoption of IFRS 16
In applying IFRS 16 for the first time, the Company has used the following practical expedients permitted by the standard:
- Use of a single discount rate to a portfolio of leases with reasonably similar characteristics;
- Reliance on previous assessments on whether leases are onerous;
- Accounting for operating leases with a remaining lease term of less than 12 months as of January 1, 2019, as short-term leases;
- Exclusion of initial direct costs for the measurement of the right-of-use asset at the date of initial application;
- Use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease.
The Company has also elected not to reassess whether a contract is, or contains, a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4, "Determining whether an Arrangement contains a Lease."
c. Other information relating to IFRS 16
As of June 30, 2019, the weighted average remaining lease term on the Company's existing leases was 11.0 years for its property lease and 1.2 years for motor vehicle leases. Lease expense (substantially all of which is non-cash) for the six months ended June 30, 2019 amounted to \$0.2 million. Cash paid for amounts included in the measurement of the operating lease liabilities for the six months ended June 30, 2019 was \$0.1 million.
NOTE 4 – ISSUANCES OF SHARE CAPITAL AND WARRANTS
a. At-the-market ("ATM") sales agreement with BTIG
In October 2017, the Company entered into an at-the-market ("ATM") sales agreement with BTIG, LLC ("BTIG"), pursuant to which the Company may, at its sole discretion, offer and sell through BTIG, acting as sales agent, ADSs having an aggregate offering price of up to \$30.0 million throughout the period during which the ATM facility remains in effect. The Company will pay BTIG a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. From the effective date of the agreement through June 30, 2019, 9,655,387 ADSs were sold under the program for total net proceeds of approximately \$7.0 million, leaving an available balance under the facility of approximately \$23.0 million as of June 30, 2019.
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 4 – ISSUANCES OF SHARE CAPITAL AND WARRANTS (cont.)
b. Underwritten public offering
In February 2019, the Company completed an underwritten public offering of 28,000,000 of its ADSs and warrants to purchase 28,000,000 ADSs, at a public offering price of \$0.55 per ADS and accompanying warrant. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of \$0.75 per ADS. The offering raised a total of \$15.4 million, with net proceeds of \$14.1 million, after deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was \$5.0 million. Total issuance costs initially allocated to the warrants were \$0.4 million.
The warrants issued have been classified as a non-current financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the date the contract was entered into and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive loss.
The fair value of the warrants is computed using the Black and Scholes option pricing model. The fair value of the warrants upon issuance was computed based on the then current price of an ADS, a risk-free interest rate of 2.50% and an average standard deviation of 62.8%. The fair value of the warrants as of June 30, 2019 was based on the then current price of an ADS, a risk-free interest rate of 1.76% and an average standard deviation of 65.2%. The change in fair value from the date of issuance through June 30, 2019 amounted to \$1.3 million.
NOTE 5 – SHAREHOLDERS' EQUITY
As of December 31, 2018 and June 30, 2019, share capital is composed of ordinary shares, as follows:
| Number of ordinary shares | ||
|---|---|---|
| December 31, | June 30, | |
| 2018 | 2019 | |
| Authorized share capital | 250,000,000 | 250,000,000 |
| Issued and paid-up share capital | 114,933,144 | 147,183,744 |
| In USD and NIS | ||
| December 31, | June 30, | |
| 2018 | 2019 | |
| Authorized share capital (in NIS) | 25,000,000 | 25,000,000 |
| Issued and paid-up share capital (in NIS) | 11,493,314 | 14,718,374 |
| Issued and paid-up share capital (in USD) | 3,109,746 | 4,000,676 |
NOTE 6 – EVENT SUBSEQUENT TO THE BALANCE SHEET DATE
On July 15, 2019, the Company implemented a change in the ratio of its ADSs to ordinary shares, from one ADS representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares.
Exhibit 3
OPERATING AND FINANCIAL REVIEW
You should read the following discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K, as well as in our Annual Report on Form 20-F filed on March 28, 2019 (the "Annual Report").
Forward Looking Statements
The following discussion contains "forward-looking statements," including statements regarding expectations, beliefs, intentions or strategies for the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions, and are subject to risks and uncertainties. You should not put undue reliance on any forwardlooking statements. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those listed below as well as those discussed in the Annual Report (particularly those in "Item 3. Key Information – Risk Factors"). Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements.
Factors that could cause our 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 our preclinical studies, clinical trials and other therapeutic candidate development efforts;
- our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
- our receipt of regulatory approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals;
- the clinical development, commercialization and market acceptance of our therapeutic candidates;
- our ability to establish and maintain corporate collaborations;
- our ability to integrate new therapeutic candidates and new personnel
- the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials;
- the implementation of our business model and strategic plans for our business and therapeutic candidates;
- the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others;
- estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
- risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;
- competitive companies, technologies and our industry; and
- statements as to the impact of the political and security situation in Israel on our business.
Overview
General
We are a clinical-stage biopharmaceutical development company with a strategic focus on oncology. Our current development and commercialization pipeline consists of two clinical-stage therapeutic candidates − BL-8040, a novel peptide for the treatment of hematological malignancies, solid tumors and stem cell mobilization, and AGI-134, an immuno-oncology agent in development for solid tumors. In addition, we have an off-strategy, legacy therapeutic product called BL-5010 for the treatment of skin lesions. We have generated our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic candidates that we believe exhibit a high probability of therapeutic and commercial success. Our strategy includes commercializing our therapeutic candidates through out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on a case by case basis, the commercialization of our therapeutic candidates independently.
Main Therapeutic Candidates
The following is a description of our main programs:
• BL-8040 is a novel, short peptide that functions as a high-affinity antagonist for CXCR4, which we are developing for the treatment of solid tumors, acute myeloid leukemia, or AML, and stem-cell mobilization.
Solid tumors
- ➢ In January 2016, we entered into a collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New Jersey) in the field of cancer immunotherapy. Based on this collaboration, in September 2016 we initiated a Phase 2a study, known as the COMBAT/KEYNOTE-202 study, focusing on evaluating the safety and efficacy of BL-8040 in combination with KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in 37 patients with metastatic pancreatic adenocarcinoma. The study was an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T-cells into the tumor and their reactivity. Top-line results showed that the combination demonstrated encouraging disease control and overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies supported BL-8040's ability to induce infiltration of tumor-reactive T-cells into the tumor, while reducing the number of immune regulatory cells. In July 2018, we announced the expansion of the COMBAT/KEYNOTE-202 study under this collaboration to include a triple combination arm investigating the safety, tolerability and efficacy of BL-8040, KEYTRUDA and chemotherapy. We initiated this arm of the trial in December 2018. Top-line results from the new triple combination arm of the study are expected in the second half of 2019, with overall survival results expected in 2020.
- ➢ In August 2016, in the framework of an agreement with MD Anderson Cancer Center, we entered into an additional collaboration for the investigation of BL-8040 in combination with KEYTRUDA in pancreatic cancer. The focus of this study, in addition to assessing clinical response, is the mechanism of action by which both drugs might synergize, as well as multiple assessments to evaluate the biological anti-tumor effects induced by the combination. We are supplying BL-8040 for this Phase 2b study, which commenced in January 2017. Partial results from this study are anticipated in the second half of 2019, with top-line results expected in 2020.
-
➢ In September 2016, we entered into a collaboration with Genentech, Inc., or Genentech (a member of the Roche Group), in the framework of which both companies would carry out Phase 1b/2 studies investigating BL-8040 in combination with TECENTRIQ® (atezolizumab), Genentech's anti-PDL1 cancer immunotherapy, in various solid tumors and hematologic malignancies. The clinical study collaboration between us and Genentech is part of MORPHEUS, Roche's novel cancer immunotherapy development platform. Genentech commenced a Phase 1b/2 study for the treatment of pancreatic cancer in July 2017, as well as a Phase 1b/2 study in gastric cancer in October 2017. These studies will evaluate the clinical response, safety and tolerability of the combination of these therapies, as well as multiple pharmacodynamic parameters. As we are not the sponsor of these studies, we do not have information about Genentech's data publication plan for these BL-8040-related arms within the MORPHEUS platform.
-
➢ During 2016, we completed and reported on a Phase 2a proof-of-concept trial for the treatment of relapsed or refractory acute myeloid leukemia, or r/r AML, which was conducted on 42 patients at six world-leading cancer research centers in the United States and at five premier sites in Israel. The study included both a dose-escalation and a dose-expansion phase. Results from the trial showed detailed, positive safety and response rate data for subjects treated with a combination of BL-8040 and high-dose cytarabine (Ara-C), or HiDAC. At the annual meeting of the European Hematology Association, or EHA, in June 2018, we presented positive overall survival data from the long-term follow-up part of this study. We continue to monitor long-term survival data for patients in the study and, in parallel, are planning our next clinical development steps in this indication.
- ➢ We are currently investigating BL-8040 as a consolidation treatment together with cytarabine (the current standard of care) for AML patients who have responded to standard induction treatment and are in complete remission and, in this regard, are conducting a significant Phase 2b trial in Germany, in collaboration with the German Study Alliance Leukemia Group. The Phase 2b trial is a double-blind, placebo-controlled, randomized, multi-center study aimed at assessing the efficacy of BL-8040 in addition to standard consolidation therapy in AML patients. Up to 194 patients will be enrolled in the trial. We continue to discuss with our collaboration partners the potential conduct of an interim analysis on this study based on various factors, including the occurrence of a minimum number of reported relapse events and/or exposure to provide a reasonable statistical powering for the analysis. Our current estimate for the timing of such potential interim analysis is in the second half of 2019; however, the occurrence of enough relapse events that would form the basis for a robust interim analysis is difficult to predict at this point in time. Top-line results from the trial are expected in 2021.
- ➢ In September 2017, we initiated a Phase 1b/2 trial in AML, known as the BATTLE trial, under the collaboration with Genentech referred to above in "― Solid tumors." The trial was to have focused on the maintenance treatment of patients with intermediate- and high-risk AML who have achieved a complete response following induction and consolidation therapy. Following several protocol amendments designed to increase study recruitment, we consulted with Genentech regarding feasibility of completing the study, and jointly decided to terminate the trial in August 2019.
Stem cell mobilization
- ➢ In March 2015, we reported successful top-line safety and efficacy results from a Phase 1 safety and efficacy trial for the use of BL-8040 as a novel stem cell mobilization treatment for allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem.
- ➢ In March 2016, we initiated a Phase 2 trial for BL-8040 in allogeneic stem cell transplantation, conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology. In May 2018, we announced positive top-line results of this study showing, among other things, that a single injection of BL-8040 mobilized sufficient amounts of CD34+ cells required for transplantation at a level of efficacy similar to that achieved by using 4-6 injections of G-CSF, the current standard of care.
- ➢ In December 2017, we commenced a randomized, controlled Phase 3 registrational trial for BL-8040, known as the GENESIS trial, for the mobilization of HSCs for autologous transplantation in patients with multiple myeloma. The trial began with a lead-in period for dose confirmation, which was to include 10-30 patients and then progress to the placebocontrolled main part, which is designed to include 177 patients in more than 25 centers. Following review of the positive results from treatment of the first 11 patients, the Data Monitoring Committee recommended that the lead-in part of the study should be stopped and that we should move immediately to the second part. Additional positive results from the lead-in period were reported at the annual meeting of the European Society for Blood and Marrow Transplantation held in March 2019, where it was announced that HSCs mobilized by BL-8040 in combination with G-CSF were successfully engrafted in all 11 patients. Top-line results of this randomized, placebo-controlled main part of the study are expected in the second half of 2020.
3
AML
Other matters
- ➢ In addition to the above, we are currently conducting, or planning to conduct, a number of investigator-initiated, open-label studies in a variety of indications, to support the interest of the scientific and medical communities in exploring additional uses for BL-8040. These studies serve to further elucidate the mechanism of action for BL-8040.
- ➢ In September 2013, the FDA granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of AML; and in January 2014, the FDA granted an Orphan Drug Designation to BL-8040 as a treatment for stem cell mobilization. In January 2015, the FDA modified this Orphan Drug Designation for BL-8040 for use either as a single agent or in combination with G-CSF. In February 2019, the FDA granted Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of pancreatic cancer.
- AGI-134, a clinical therapeutic candidate in-licensed by Agalimmune, is a synthetic alpha-Gal glycolipid immunotherapy in development for solid tumors. AGI-134 harnesses the body's pre-existing, highly abundant, anti-alpha-Gal antibodies to induce a hyper-acute, systemic, specific anti-tumor response to the patient's own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. In August 2018, we initiated a Phase 1/2a clinical study for AGI-134 that is primarily designed to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in unresectable metastatic solid tumors. The multi-center, open-label study is currently being carried out in the UK and Israel and, following recent approval by the FDA for our Investigational New Drug (IND) application, is expected to expand to the US by the first half of 2020. Initial safety results from the first part of the study are expected in the second half of 2019; initial efficacy results of the monotherapy arm from the second part of the study are expected by the end of 2020.
- Our commercialized, legacy therapeutic product, BL-5010, is a customized, proprietary pen-like applicator containing a novel, acidic, aqueous solution for the non-surgical removal of skin lesions. In December 2014, we entered into an exclusive out-licensing arrangement with Perrigo Company plc, or Perrigo, for the rights to BL-5010 for over-the-counter, or OTC, indications in Europe, Australia and additional selected countries. In March 2016, Perrigo received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal of warts. The commercial launch of this first OTC indication (warts/verrucas) commenced in Europe in the second quarter of 2016. Since then, Perrigo has invested in improving the product and expects to launch an improved version of the product during 2019.
Principal Partnering and Collaboration Agreements
Since December 2014 we have been collaborating with Novartis for the co-development of selected Israeli-sourced novel drug candidates.
In December 2014, we entered into an exclusive out-licensing arrangement with Perrigo Company plc, or Perrigo, for the rights to BL-5010 for over-the-counter or OTC indications in the territory of Europe, Australia and additional selected countries. We retain all OTC rights to BL-5010 in the United States and the rest of the world, as well as all non-OTC rights on a global basis. Perrigo fulfilled its obligation to launch a licensed product commercially in the Territory in 2016. In addition, Perrigo is obligated to use commercially reasonable best efforts to obtain regulatory approval in the Territory for at least one more OTC indication and to commercialize BL-5010 for that indication. Compensation by Perrigo for the exclusive license includes an agreed amount for each unit sold. We will have full access to all clinical and research and development data, as well as manufacturing data, generated during the performance of the development plan and may use these data in order to develop or license the product in other territories and fields of use where we retain the rights.
For information on our collaborations with Merck, Genentech and MD Anderson Cancer Center, see "― Main Therapeutic Candidates" above.
Funding
We have funded our operations primarily through the sale of equity securities (both in public and private offerings), funding received from a government body which previously was called the Office of the Chief Scientist of the Israeli Ministry of the Economy (OCS) (and which in 2016 was replaced by the newly-established Israel Innovation Authority, or IIA), payments received under out-licensing arrangements, and interest earned on investments. We expect to continue to fund our operations over the next several years through our existing cash resources, potential future milestone and royalty payments that we may receive from our existing out-licensing agreement, potential future upfront, milestone or royalty payments that we may receive from out-licensing transactions for our other therapeutic candidates, interest earned on our investments and additional capital to be raised through public or private equity offerings or debt financings. As of June 30, 2019, we held \$35.2 million of cash, cash equivalents and short-term bank deposits.
Recent Company Developments
AGI-134 – Regulatory
In May 2019, the FDA approved our IND application for AGI-134. This approval will enable us to expand the Phase 1/2a clinical study described above to the US by the first half of 2020.
Corporate matters
On December 3, 2018, we received written notice (the "Notification Letter") from The Nasdaq Stock Market ("Nasdaq") stating that we were not in compliance with the \$1.00 minimum bid price requirement set forth in Nasdaq's rules for continued listing on The Nasdaq Capital Market. On July 29, 2019, we received written notice from Nasdaq confirming that we had regained compliance with the \$1.00 minimum bid price requirement.
On July 15, 2019, we implemented a change in the ratio of the Company's ADSs to ordinary shares, from one ADS representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares. The change in exchange ratio for the ADSs had the same effect as a 1-for-15 reverse stock split of the ADSs. In light of this change, all ADS amounts in this Operating and Financial Review have been stated based on the new ratio (i.e., subsequent to the 1-for-15 ratio change). The Company's ordinary shares, which are not affected by the change, continue to trade on the Tel Aviv Stock Exchange.
Revenues
Our revenues to date have been generated primarily from milestone payments under previously existing out-licensing agreements.
We expect our revenues, if any, for the next several years to be derived primarily from future payments under our current out-licensing agreement with Perrigo and other potential collaboration arrangements, including future royalties on product sales.
Research and Development
Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to external service providers, up-front and milestone payments under our license agreements, patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory supplies and costs for facilities and equipment. We primarily use external service providers to manufacture our product candidates for clinical trials and for the majority of our preclinical and clinical development work. We charge all research and development expenses to operations as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop our therapeutic candidates.
The following table identifies our current major research and development projects:
| Project | Status | Expected Near Term Milestones |
|---|---|---|
| 1. Phase 2a study for relapsed or refractory AML completed | 1. Follow-up for overall survival is ongoing; evaluation and decision regarding next clinical development steps |
|
| 2. Phase 2b study in AML consolidation treatment line (BLAST) ongoing |
2. Possible interim results in H2 2019; top-line results expected in 2021 | |
| 3. Phase 2 study in allogeneic stem-cell mobilization completed | 3. Follow-up on acute and chronic GvHD by H2 2019 | |
| BL-8040 | 4. Phase 2a in pancreatic cancer under Merck collaboration (COMBAT/KEYNOTE-202) ongoing; top-line results from dual combination arm announced in October 2018 |
4. Top-line results from triple combination arm expected in H2 2019; overall survival results expected in 2020 |
| 5. Phase 2b study in pancreatic cancer, in collaboration with MD Anderson Cancer Center, ongoing |
5. Partial results from this study are anticipated in H2 2019; top-line results expected in 2020 |
|
| 6. Phase 3 registration study in autologous stem-cell mobiliza-tion (GENESIS), ongoing |
6. Top-line results from randomized, placebo-controlled main part of study expected in H2 2020 |
|
| AGI-134 | Phase 1/2a study commenced in August 2018 | Initial safety results from part 1 of study in H2 2019; initial efficacy results of monotherapy arm from part 2 of study expected by end of 2020 |
| BL-5010 | Out-licensed to Perrigo; CE mark approval obtained; commercial launch of first OTC indication in Europe commenced |
Launch of improved product during 2019; pursuit of potential out-licensing partner(s) for OTC and non-OTC rights still held by us |
We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes and given the early stage of our preclinical product development projects, we are unable to estimate with any certainty the costs we will incur in the continued development of the therapeutic candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate. If we are not able to enter into an out-licensing arrangement with respect to any therapeutic candidate prior to the commencement of later stage clinical trials, we may fund the trials for the therapeutic candidate ourselves.
While we are currently focused on advancing each of our product development projects, our future research and development expenses will depend on the clinical success of each therapeutic candidate, as well as ongoing assessments of each therapeutic candidate's commercial potential. In addition, we cannot forecast with any degree of certainty which therapeutic candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain therapeutic candidates or projects in order to focus our resources on more promising therapeutic candidates or projects. Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a therapeutic candidate.
The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:
- the number of sites included in the clinical trials;
- the length of time required to enroll suitable patients;
- the number of patients that participate in the clinical trials;
- the duration of patient follow-up;
- whether the patients require hospitalization or can be treated on an out-patient basis;
- the development stage of the therapeutic candidate; and
- the efficacy and safety profile of the therapeutic candidate.
We expect our research and development expenses to remain our most significant cost as we continue the advancement of our clinical trials and preclinical product development projects and place significant emphasis on in-licensing new product candidates. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Due to the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of compensation for employees in business development and marketing functions. Other significant sales and marketing costs include costs for marketing and communication materials, professional fees for outside market research and consulting, legal services related to partnering transactions and travel costs.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in executive and operational functions, including accounting, finance, legal, investor relations, information technology and human resources. Other significant general and administration costs include facilities costs, professional fees for outside accounting and legal services, travel costs, insurance premiums and depreciation.
Non-Operating Expense and Income
Non-operating expense and income includes fair-value adjustments of liabilities on account of the warrants issued in equity financings we carried out in July 2017 and February 2019, as well as from debt financing we received in October 2018. These fair-value adjustments are highly influenced by our share price at each period end (revaluation date). Non-operating expense and income also includes the pro-rata share of issuance expenses from the placements related to the warrants, as well as the capital gain from realization of our investment in iPharma, a joint venture our holdings in which we sold in April 2018. Sales-based royalties and other revenue from the license agreement with Perrigo have also been included as part of non-operating income, as the outlicensed product is not an integral part of our strategy and the amounts are not material.
Financial Expense and Income
Financial expense and income consists of interest earned on our cash, cash equivalents and short-term bank deposits; interest on loans, bank fees and other transactional costs. In addition, it may also include gains/losses on foreign exchange hedging transactions, which we carry out from time to time to protect against a portion of our NIS-denominated expenses (primarily compensation) in relation to the dollar.
Significant Accounting Policies and Estimates
We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements for the year ended December 31, 2018.
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which we prepare in accordance with IFRS. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in greater detail below. We base our estimates on historical experience and on various assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Results of Operations – Overview
Revenues
We did not record any revenues during each of the three- or six-month periods ended June 30, 2019 and 2018.
Cost of revenues
We did not record any cost of revenues during each of the three- or six-month periods ended June 30, 2019 and 2018.
Research and development expenses
At December 31, 2016, our drug development pipeline consisted of eight therapeutic candidates. During 2017, we terminated two therapeutic candidates in our pipeline and added one therapeutic candidate to the pipeline, so that our drug development pipeline as of December 31, 2017 consisted of seven therapeutic candidates. During 2018, we terminated four therapeutic candidates in our pipeline, so that our drug development pipeline as of December 31, 2018 and of the date of this report consists of three therapeutic candidates.
Operating Results Comparison between Periods
Revenues and cost of revenues
See discussion under "Results of Operations - Overview" above.
Research and development expenses
| Three months ended June 30, | Six months ended June 30, | |||||
|---|---|---|---|---|---|---|
| 2018 | 2019 | Increase (decrease) | 2018 | 2019 | Increase (decrease) | |
| (in thousands of U.S. dollars) | ||||||
| Research and development expenses, net | 4,484 | 5,302 | 818 | 9,554 | 9,694 | 140 |
Comparison of three-month periods ending June 30, 2019 and 2018
Research and development expenses for the three months ended June 30, 2019 were \$5.3 million, an increase of \$0.8 million, or 18%, compared to \$4.5 million for the three months ended June 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials.
Comparison of six-month periods ending June 30, 2019 and 2018
Research and development expenses for the six months ended June 30, 2019 were \$9.7 million, an increase of \$0.1 million, or 2%, compared to \$9.6 million for the six months ended June 30, 2018. The small increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated, as well as a decrease in payroll and related expenses.
Sales and marketing expenses
| Three months ended June 30, | Six months ended June 30, | |||||
|---|---|---|---|---|---|---|
| 2018 | 2019 | Increase (decrease) | 2018 | 2019 | Increase (decrease) | |
| (in thousands of U.S. dollars) | ||||||
| Sales and marketing expenses | 360 | 226 | (134) | 844 | 482 | (362) |
Comparison of three-month periods ending June 30, 2019 and 2018
Sales and marketing expenses for the three months ended June 30, 2019 were \$0.2 million, a decrease of \$0.1 million, or 37%, compared to \$0.3 million for the three months ended June 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses.
Comparison of six-month periods ending June 30, 2019 and 2018
Sales and marketing expenses for the six months ended June 30, 2019 were \$0.5 million, a decrease of \$0.4 million, or 43%, compared to \$0.9 million for the six months ended June 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses, including a one-time compensation payment in the 2018 period.
General and administrative expenses
| Three months ended June 30, | Six months ended June 30, | |||||
|---|---|---|---|---|---|---|
| 2018 | 2019 | Increase (decrease) | 2018 | 2019 | Increase (decrease) | |
| (in thousands of U.S. dollars) | ||||||
| General and administrative expenses | 883 | 949 | 66 | 1,958 | 1,879 | (79) |
Comparison of three-month periods ending June 30, 2019 and 2018
General and administrative expenses for the three months ended June 30, 2019 were \$0.9 million, similar to the comparable period in 2018.
Comparison of six-month periods ending June 30, 2019 and 2018
General and administrative expenses for the six months ended June 30, 2019 were \$1.9 million, similar to the comparable period in 2018.
Non-operating income (expenses), net
| Three months ended June 30, | Six months ended June 30, | |||||
|---|---|---|---|---|---|---|
| 2018 | 2019 | Increase (decrease) | 2018 | 2019 | Increase (decrease) | |
| (in thousands of U.S. dollars) | ||||||
| Non-operating income (expenses), net | 663 | 1,261 | 598 | 1,125 | 921 | (204) |
Comparison of three-month and six-month periods ending June 30, 2019 and 2018
Non-operating income for the three and six months ended June 30, 2019 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet, offset by warrant offering expenses. Non-operating income for the six months ended June 30, 2018 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet and the capital gain from realization of our investment in iPharma. These fair-value adjustments were highly influenced by our share price at each period end (revaluation date).
Financial income (expenses), net
| Three months ended June 30, | Six months ended June 30, | |||||
|---|---|---|---|---|---|---|
| 2018 | 2019 | Increase (decrease) | 2018 | 2019 | Increase (decrease) | |
| (in thousands of U.S. dollars) | ||||||
| Financial income | 287 | 171 | (116) | 462 | 381 | (81) |
| Financial expenses | (11) | (440) | (429) | (217) | (887) | (670) |
| Net financial income (expense) | 276 | (269) | (545) | 245 | (506) | (751) |
Comparison of three-month periods ending June 30, 2019 and 2018
We recognized net financial expenses of \$0.3 million for the three months ended June 30, 2019 compared to net financial income of \$0.3 million for the three months ended June 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on our bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on our bank deposits, offset by losses recorded on foreign currency hedging transactions.
Comparison of six-month periods ending June 30, 2019 and 2018
We recognized net financial expense of \$0.5 million for the six months ended June 30, 2019 compared to net financial income of \$0.3 million for the six months ended June 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on our bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on our bank deposits, offset by losses recorded on foreign currency hedging transactions.
Liquidity and Capital Resources
Since inception, we have funded our operations primarily through public and private offerings of our equity securities, funding from the IIA, and payments received under our strategic licensing arrangements. At June 30, 2019, we held \$35.2 million in cash, cash equivalents and short-term bank deposits. We have invested substantially all our available cash funds in short-term bank deposits.
Pursuant to our ATM Program with BTIG, LLC, or BTIG, we may sell, from time to time, and at our discretion, up to \$30 million of our ADSs during the term of the program. During the six months ended June 30, 2019, we sold 281,079 ADSs under the program, resulting in net proceeds to BioLine of approximately \$1.8 million (net of \$56,000 in commissions paid to BTIG). As of the date of this report, we have an available balance under the program of approximately \$23.0 million.
Net cash used in operating activities was \$11.1 million for the six months ended June 30, 2019, compared with net cash used in operating activities of \$13.0 million for the six months ended June 30, 2018. The \$1.9 million decrease in net cash used in operating activities during the six-month period in 2019, compared to the six-month period in 2018, was primarily the result of changes in operating asset and liability items in the two periods, i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as a higher decrease in accounts payable and accruals in 2018.
Net cash used in investing activities was \$3.1 million for the six months ended June 30, 2019, compared to net cash provided by investing activities of \$10.8 million for the six months ended June 30, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and the realization of our investment in iPharma in 2018.
Net cash provided by financing activities was \$15.7 million for the six months ended June 30, 2019, compared to net cash provided by financing activities of \$2.8 million for the six months ended June 30, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.
Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. Although we believe our existing cash and other resources will be sufficient to fund our projected cash requirements into 2021, we will require significant additional financing in the future to fund our operations. Our future capital requirements will depend on many factors, including:
- the progress and costs of our preclinical studies, clinical trials and other research and development activities;
- the scope, prioritization and number of our clinical trials and other research and development programs;
- the amount of revenues we receive under our collaboration or licensing arrangements;
- the costs of the development and expansion of our operational infrastructure;
- the costs and timing of obtaining regulatory approval of our therapeutic candidates;
-
the ability of our collaborators to achieve development milestones, marketing approval and other events or developments under our collaboration agreements;
-
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
- the costs and timing of securing manufacturing arrangements for clinical or commercial production;
- the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
- the costs of acquiring or undertaking development and commercialization efforts for any future product candidates;
- the magnitude of our general and administrative expenses;
- any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; and
Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through payments received under our collaborations, debt or equity financings, or by outlicensing other product candidates. We cannot be certain that additional funding will be available to us on acceptable terms, or at all.
If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts.
Off-Balance Sheet Arrangements
Since inception, we have not entered into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support.
Share and per-share information in ADSs
On July 15, 2019, we implemented a change in the ratio of our ADSs to ordinary shares, from one ADS representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares. Accordingly, presented below, for the convenience of the reader, is share and per-share information in ADSs, on the basis of the new ADS ratio.
| Three months ended June 30, | Six months ended June 30, | ||||
|---|---|---|---|---|---|
| 2018 | 2019 | 2018 | 2019 | ||
| (in U.S. dollars) | |||||
| Loss per ADS – basic and diluted | (0.67) | (0.57) | (1.55) | (1.25) | |
| June 30, December 31, |
|||||
| 2018 2019 (in number of ADSs) |
|||||
| Authorized share capital | 16,666,667 16,666,667 |
||||
| Issued and paid-up capital | 7,662,210 9,812,250 |
||||
| 12 |