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 2021
Commission file number: 001-35223
_______________________
(Translation of registrant’s name into English)
_______________________
2 HaMa’ayan Street
Modi’in 7177871, Israel
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 if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
On August 18, 2021, the Registrant issued a press release announcing its financial results for the three and six months ended June 30, 2021. The Registrant is also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of June 30, 2021 and for the three and six months then ended. Attached hereto are the following exhibits:
This Form 6-K, the text under the heading “Financial Results for the Quarter Ended June 30, 2021” in Exhibit 1, and Exhibit 2 and Exhibit 3 are 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.
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BioLineRx Ltd.
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By:
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/s/ Philip Serlin
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Philip Serlin
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Chief Executive Officer
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Dated: August 18, 2021
Exhibit 1
For Immediate Release
BioLineRx Reports Second Quarter 2021 Financial Results
and Provides Corporate Update
- Company aggressively proceeding with activities in support of NDA submission
for Motixafortide in stem cell mobilization targeted for H1 2022 -
- Cash and cash equivalents of $66 million at June 30, 2021 -
- Management to hold conference call today, August 18, at 10:00 am EDT -
Tel Aviv, Israel, August 18, 2021 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company
focused on oncology, today reports its financial results for the quarter ended June 30, 2021 and provides a corporate update.
Significant events and achievements during the second quarter 2021 and subsequent period:
| • |
Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met
all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized enough cells for transplantation with only one administration of
Motixafortide and in only one apheresis session.
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| • |
Based on the positive results from the GENESIS study, the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization
anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year. This is consistent with prior guidance.
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| • |
Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard-of-care and primary
mobilization agent (in combination with G-CSF). The aim of the study is to demonstrate significant clinical benefits and cost savings from reduced numbers of doses and apheresis sessions, higher rates of transplantation and quality-of-life
benefits in Motixafortide- treated patients; initial data on track to be announced in the second half of this year.
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| • |
Ended the second quarter on a solid financial footing, with cash and cash equivalents of $66 million.
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“Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we
announced in May, we are working vigorously to submit an NDA in the first half of next year,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “If approved, this would be transformative for BioLineRx as we would have a commercial-stage
molecule in multiple myeloma and significant potential clinical utility in other cancer indications as well, most notably pancreatic cancer.”
Mr. Serlin continued, “GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem
cells necessary for transplantation – in approximately 90% of cases with only one dose of Motixafortide and in one apheresis session – potentially resulting in significant clinical benefits for patients and cost savings for payers. We believe there
is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard-of-care for all multiple myeloma patients, not only for those patients who are poor mobilizers. To that end, we are advancing a
pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new stem-cell-mobilization treatment paradigm.
“In parallel with these activities, the versatility of Motixafortide demonstrated in studies to date has attracted interest from
potential partners, and we continue to engage in productive discussions.”
“We are very well financed with $66 million of cash, sufficient to bring Motixafortide through potential FDA approval in SCM while
continuing to advance our other clinical programs,” concluded Mr. Serlin.
Upcoming Significant Expected Milestones:
| • |
Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021;
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| • |
Pre-NDA meeting with the FDA for SCM in the second half of 2021;
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| • |
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
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| • |
NDA submission for SCM in the first half of 2022;
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| • |
Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined.
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2
Financial Results for the Quarter Ended June 30, 2021
Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%,
compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary
reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide,
and a timing difference related to a tax credit received in respect of AGI-134. Research and development expenses for the six months ended June 30, 2021 were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the six
months ended June 30, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials and a timing difference related to a tax credit received in respect of AGI-134; offset by higher
expenses related to Motixafortide NDA supporting activities and by an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period.
Sales and marketing expenses for the three months ended June 30, 2021 were $0.3 million, an increase of $0.1 million, or 81.3%,
compared to $0.2 million for the three months ended June 30, 2020. The increase resulted primarily from consultancy services related to Motixafortide. Sales and marketing expenses for the six months ended June 30, 2021 were $0.5 million, an
increase of $0.1 million, or 35.6%, compared to $0.4 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.
General and administrative expenses for the three months ended June 30, 2021 were $1.0 million, an increase of $0.3 million, or 40.3%,
compared to $0.7 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the six months ended June 30, 2021 were $2.1 million,
an increase of $0.1 million, or 3.7%, compared to $2.0 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.
The Company's operating loss for the three months ended June 30, 2021 amounted to $6.5 million, compared to an operating loss of $5.6
million for the comparable period in 2020. The Company’s operating loss for the six months ended June 30, 2021 was $12.0 million, compared to $12.4 million for the comparable period in 2020.
Non-operating expenses for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 primarily
relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.
3
Net financial expenses for the three months ended June 30, 2021 amounted to $0.1 million compared to net financial expenses of $0.4
million for the three months ended June 30, 2020. Net financial expenses for the six months ended June 30, 2021 amounted to $0.3 million compared to net financial expenses of $0.6 million for the six months ended June 30, 2020. Net financial
expenses for all periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.
The Company's net loss for the three months ended June 30, 2021 amounted to $6.8 million, similar to the comparable period in 2020.
The Company’s net loss for the six months ended June 30, 2021 amounted to $17.0 million, compared with a net loss of $13.4 million for the comparable period in 2020. The increase in net loss between the six-month periods results from an increase in
2021 non-operating expenses in connection with fair-value adjustments of warrant liabilities on the Company’s balance sheet.
The Company held $66 million in cash, cash equivalents and short-term bank deposits as of June 30, 2021.
Net cash used in operating activities was $13.1 million for the six months ended June 30, 2021, compared with net cash used in
operating activities of $12.3 million for the six months ended June 30, 2020. The $0.8 million increase in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in
the two periods, i.e., a larger increase in prepaid expenses and other receivables in 2021 versus 2020, as well as a larger decrease in accounts payable and accruals in 2021 versus 2020.
Net cash used in investing activities was $42.3 million for the six months ended June 30, 2021, compared to net cash provided by
investing activities of $0.6 million for the six months ended June 30, 2020. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.
Net cash provided by financing activities was $56.0 million for the six months ended June 30, 2021, compared to net cash provided by
financing activities of $12.0 million for the six months ended June 30, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of our ADSs in January 2021, warrant exercises, and net proceeds from the ATM Facility, offset
by repayments of the loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.
Conference Call and Webcast Information
BioLineRx will hold a conference call today, Wednesday, August 18, 2021 at 10:00 a.m. EDT. To access the conference call, please dial
+1-866-744-5399 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.
4
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 20, 2021; please dial +1-888-295-2634 from the US or
+972-3-925-5904 internationally.
(Tables follow)
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business
model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company’s lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study
in stem-cell mobilization for autologous bone-marrow transplantation, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination
with KEYTRUDA® and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO® and chemotherapy as a first-line
PDAC therapy.
BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is
currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company’s website at www.biolinerx.com, where you can review the Company’s SEC filings, press releases, announcements and events.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These
forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or
implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing,
progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical
studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's
therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's
therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the
scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of
BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and
BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section
of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on February 23, 2021. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not
be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com
or
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
moran@lifesciadvisors.com
5
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
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December 31,
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June 30,
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|||||||
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2020
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2021
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|||||||
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in USD thousands
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||||||||
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Assets
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||||||||
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CURRENT ASSETS
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||||||||
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Cash and cash equivalents
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16,831
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17,484
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||||||
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Short-term bank deposits
|
5,756
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48,083
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Prepaid expenses
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152
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837
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Other receivables
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141
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668
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Total current assets
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22,880
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67,072
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||||||
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NON-CURRENT ASSETS
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||||||||
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Property and equipment, net
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1,341
|
1,136
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||||||
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Right-of-use assets, net
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1,355
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1,415
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Intangible assets, net
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21,714
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21,706
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Total non-current assets
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24,410
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24,257
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Total assets
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47,290
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91,329
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||||||
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Liabilities and equity
|
||||||||
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CURRENT LIABILITIES
|
||||||||
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Current maturities of long-term loan
|
3,092
|
3,354
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||||||
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Accounts payable and accruals:
|
||||||||
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Trade
|
5,918
|
5,318
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||||||
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Other
|
1,440
|
1,071
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Lease liabilities
|
191
|
174
|
||||||
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Total current liabilities
|
10,641
|
9,917
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||||||
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NON-CURRENT LIABILITIES
|
||||||||
|
Warrants
|
10,218
|
4,812
|
||||||
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Long-term loan, net of current maturities
|
2,740
|
1,006
|
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Lease liabilities
|
1,661
|
1,701
|
||||||
|
Total non-current liabilities
|
14,619
|
7,519
|
||||||
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COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
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Total liabilities
|
25,260
|
17,436
|
||||||
|
EQUITY
|
||||||||
|
Ordinary shares
|
9,870
|
20,496
|
||||||
|
Share premium
|
279,241
|
335,887
|
||||||
|
Warrants
|
-
|
975
|
||||||
|
Capital reserve
|
12,322
|
12,972
|
||||||
|
Other comprehensive loss
|
(1,416
|
)
|
(1,416
|
)
|
||||
|
Accumulated deficit
|
(277,987
|
)
|
(295,021
|
)
|
||||
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Total equity
|
22,030
|
73,893
|
||||||
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Total liabilities and equity
|
47,290
|
91,329
|
||||||
6
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
|
2020
|
2021
|
2020
|
2021
|
|||||||||||||
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in USD thousands
|
in USD thousands
|
|||||||||||||||
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RESEARCH AND DEVELOPMENT EXPENSES
|
(4,640
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)
|
(5,139
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)
|
(10,062
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)
|
(9,417
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)
|
||||||||
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SALES AND MARKETING EXPENSES
|
(182
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)
|
(330
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)
|
(357
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)
|
(484
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)
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||||||||
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GENERAL AND ADMINISTRATIVE EXPENSES
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(744
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)
|
(1,044
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)
|
(1,987
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)
|
(2,061
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)
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||||||||
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OPERATING LOSS
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(5,566
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)
|
(6,513
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)
|
(12,406
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)
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(11,962
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)
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NON-OPERATING EXPENSES, NET
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(843
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)
|
(217
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)
|
(374
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)
|
(4,778
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)
|
||||||||
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FINANCIAL INCOME
|
35
|
130
|
175
|
247
|
||||||||||||
|
FINANCIAL EXPENSES
|
(396
|
)
|
(242
|
)
|
(810
|
)
|
(541
|
)
|
||||||||
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NET LOSS AND COMPREHENSIVE LOSS
|
(6,770
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)
|
(6,842
|
)
|
(13,415
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)
|
(17,034
|
)
|
||||||||
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in USD
|
in USD
|
|||||||||||||||
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LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(0.03
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)
|
(0.01
|
)
|
(0.07
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)
|
(0.03
|
)
|
||||||||
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WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER
ORDINARY SHARE
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220,317,889
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669,138,994
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198,277,447
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614,780,845
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||||||||||||
7
BioLineRx Ltd.
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
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Total
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||||||||||||||||||||||
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in USD thousands
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||||||||||||||||||||||||||||
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BALANCE AT JANUARY 1, 2020
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4,692
|
265,938
|
-
|
12,132
|
(1,416
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)
|
(247,966
|
)
|
33,380
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|||||||||||||||||||
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CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2020: |
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
3,581
|
4,754
|
-
|
-
|
-
|
-
|
8,335
|
|||||||||||||||||||||
|
Employee stock options exercised
|
8
|
224
|
-
|
(224
|
)
|
-
|
-
|
8
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||||||||||||||||||||
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Employee stock options forfeited and expired
|
-
|
191
|
-
|
(191
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
-
|
-
|
922
|
-
|
-
|
922
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(13,415
|
)
|
(13,415
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2020
|
8,281
|
271,107
|
-
|
12,639
|
(1,416
|
)
|
(261,381
|
)
|
29,230
|
|||||||||||||||||||
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT JANUARY 1, 2021
|
9,870
|
279,241
|
-
|
12,322
|
(1,416
|
)
|
(277,987
|
)
|
22,030
|
|||||||||||||||||||
|
CHANGES FOR SIX MONTHS ENDED
JUNE 30, 2021: |
||||||||||||||||||||||||||||
|
Issuance of share capital and warrants, net
|
8,386
|
37,495
|
975
|
-
|
-
|
-
|
46,856
|
|||||||||||||||||||||
|
Warrants exercised
|
2,235
|
18,967
|
-
|
-
|
-
|
-
|
21,202
|
|||||||||||||||||||||
|
Employee stock options exercised
|
5
|
41
|
-
|
(39
|
)
|
-
|
-
|
7
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
143
|
-
|
(143
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
-
|
-
|
832
|
-
|
-
|
832
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(17,034
|
)
|
(17,034
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2021
|
20,496
|
335,887
|
975
|
12,972
|
(1,416
|
)
|
(295,021
|
)
|
73,893
|
|||||||||||||||||||
8
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT APRIL 1, 2020
|
4,907
|
267,140
|
-
|
12,488
|
(1,416
|
)
|
(254,611
|
)
|
28,508
|
|||||||||||||||||||
|
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2020:
|
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
3,373
|
3,859
|
-
|
-
|
-
|
-
|
7,232
|
|||||||||||||||||||||
|
Employee stock options exercised
|
1
|
20
|
-
|
(20
|
)
|
-
|
-
|
1
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
88
|
-
|
(88
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
-
|
-
|
259
|
-
|
-
|
259
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(6,770
|
)
|
(6,770
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2020
|
8,281
|
271,107
|
-
|
12,639
|
(1,416
|
)
|
(261,381
|
)
|
29,230
|
|||||||||||||||||||
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT APRIL 1, 2021
|
18,731
|
321,920
|
975
|
12,616
|
(1,416
|
)
|
(288,179
|
)
|
64,647
|
|||||||||||||||||||
|
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2021:
|
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
1,581
|
12,516
|
-
|
-
|
-
|
-
|
14,097
|
|||||||||||||||||||||
|
Warrants exercised
|
184
|
1,444
|
-
|
-
|
-
|
-
|
1,628
|
|||||||||||||||||||||
|
Employee stock options exercised
|
-
|
3
|
-
|
(1
|
)
|
-
|
-
|
2
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
4
|
-
|
(4
|
)
|
-
|
-
|
-
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
-
|
-
|
361
|
-
|
-
|
361
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
-
|
-
|
-
|
-
|
(6,842
|
)
|
(6,842
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2021
|
20,496
|
335,887
|
975
|
12,972
|
(1,416
|
)
|
(295,021
|
)
|
73,893
|
|||||||||||||||||||
9
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
|
Six months ended June 30,
|
||||||||
|
2020
|
2021
|
|||||||
|
in USD thousands
|
||||||||
|
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
|
Comprehensive loss for the period
|
(13,415
|
)
|
(17,034
|
)
|
||||
|
Adjustments required to reflect net cash used in operating activities
(see appendix below) |
1,112
|
3,977
|
||||||
|
Net cash used in operating activities
|
(12,303
|
)
|
(13,057
|
)
|
||||
|
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
|
Investments in short-term deposits
|
(23,751
|
)
|
(58,000
|
)
|
||||
|
Maturities of short-term deposits
|
24,335
|
15,776
|
||||||
|
Purchase of property and equipment
|
(1
|
)
|
(38
|
)
|
||||
|
Net cash provided by (used in) investing activities
|
583
|
(42,262
|
)
|
|||||
|
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
|
Issuance of share capital and warrants, net of issuance costs
|
13,411
|
46,856
|
||||||
|
Exercise of warrants
|
-
|
10,907
|
||||||
|
Employee stock options exercised
|
8
|
7
|
||||||
|
Repayments of loans
|
(1,331
|
)
|
(1,648
|
)
|
||||
|
Repayments of lease liabilities
|
(121
|
)
|
(122
|
)
|
||||
|
Net cash provided by financing activities
|
11,967
|
56,000
|
||||||
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
247
|
681
|
||||||
|
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
5,297
|
16,831
|
||||||
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(21
|
)
|
(28
|
)
|
||||
|
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
5,523
|
17,484
|
||||||
10
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
|
Six months ended June 30,
|
||||||||
|
2020
|
2021
|
|||||||
|
in USD thousands
|
||||||||
|
Adjustments required to reflect net cash used in operating
activities:
|
||||||||
|
Income and expenses not involving cash flows:
|
||||||||
|
Depreciation and amortization
|
533
|
362
|
||||||
|
Exchange differences on cash and cash equivalents
|
21
|
28
|
||||||
|
Fair value adjustments of warrants
|
(250
|
)
|
4,889
|
|||||
|
Share-based compensation
|
922
|
832
|
||||||
|
Warrant issuance costs
|
593
|
-
|
||||||
|
Interest and exchange differences on short-term deposits
|
(171
|
)
|
(103
|
)
|
||||
|
Interest on loans
|
36
|
176
|
||||||
|
Exchange differences on lease liability
|
(8
|
)
|
(26
|
)
|
||||
|
1,676
|
6,158
|
|||||||
|
Changes in operating asset and liability items:
|
||||||||
|
Increase in prepaid expenses and other receivables
|
(146
|
)
|
(1,212
|
)
|
||||
|
Decrease in accounts payable and accruals
|
(418
|
)
|
(969
|
)
|
||||
|
(564
|
)
|
(2,181
|
)
|
|||||
|
1,112
|
3,977
|
|||||||
|
Supplemental information on interest received in cash
|
300
|
39
|
||||||
|
Supplemental information on interest paid in cash
|
534
|
350
|
||||||
|
Supplemental information on non-cash transactions:
|
||||||||
|
Acquisition of right-of-use asset
|
-
|
171
|
||||||
|
Exercise of warrants (portion related to accumulated fair value adjustments)
|
-
|
10,295
|
||||||
11
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2021
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF JUNE 30, 2021
TABLE OF CONTENTS
Page | ||
F-1 | ||
F-2 | ||
F-3-F-4 | ||
F-5-F-6 | ||
F-7-F-10 |
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)
|
December 31,
|
June 30,
|
|||||||
|
2020
|
2021
|
|||||||
|
in USD thousands
|
||||||||
|
Assets
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
|
|
||||||
|
Short-term bank deposits
|
|
|
||||||
|
Prepaid expenses
|
|
|
||||||
|
Other receivables
|
|
|
||||||
|
Total current assets
|
|
|
||||||
|
NON-CURRENT ASSETS
|
||||||||
|
Property and equipment, net
|
|
|
||||||
|
Right-of-use assets, net
|
|
|
||||||
|
Intangible assets, net
|
|
|
||||||
|
Total non-current assets
|
|
|
||||||
|
Total assets
|
|
|
||||||
|
Liabilities and equity
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Current maturities of long-term loan
|
|
|
||||||
|
Accounts payable and accruals:
|
||||||||
|
Trade
|
|
|
||||||
|
Other
|
|
|
||||||
|
Lease liabilities
|
|
|
||||||
|
Total current liabilities
|
|
|
||||||
|
NON-CURRENT LIABILITIES
|
||||||||
|
Warrants
|
|
|
||||||
|
Long-term loan, net of current maturities
|
|
|
||||||
|
Lease liabilities
|
|
|
||||||
|
Total non-current liabilities
|
|
|
||||||
|
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
|
Total liabilities
|
|
|
||||||
|
EQUITY
|
||||||||
|
Ordinary shares
|
|
|
||||||
|
Share premium
|
|
|
||||||
|
Warrants
|
|
|
||||||
|
Capital reserve
|
|
|
||||||
|
Other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
|
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
|
Total equity
|
|
|
||||||
|
Total liabilities and equity
|
|
|
||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
|
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
|
2020
|
2021
|
2020
|
2021
|
|||||||||||||
|
in USD thousands
|
in USD thousands
|
|||||||||||||||
|
RESEARCH AND DEVELOPMENT EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
SALES AND MARKETING EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
GENERAL AND ADMINISTRATIVE EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
OPERATING LOSS
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
NON-OPERATING EXPENSES, NET
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
FINANCIAL INCOME
|
|
|
|
|
||||||||||||
|
FINANCIAL EXPENSES
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
NET LOSS AND COMPREHENSIVE LOSS
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
in USD
|
in USD
|
|||||||||||||||
|
LOSS PER ORDINARY SHARE - BASIC AND DILUTED
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
|
|
|
|
|
||||||||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
F - 2
CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT JANUARY 1, 2020
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2020:
|
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Employee stock options exercised
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2020
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT JANUARY 1, 2021
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
CHANGES FOR SIX MONTHS ENDED JUNE 30, 2021:
|
||||||||||||||||||||||||||||
|
Issuance of share capital and warrants, net
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Warrants exercised
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Employee stock options exercised
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2021
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
F - 3
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
(UNAUDITED)
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT APRIL 1, 2020
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2020:
|
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Employee stock options exercised
|
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2020
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
Ordinary
|
Share
|
Capital
|
Other
Comprehensive
|
Accumulated
|
||||||||||||||||||||||||
|
shares
|
premium
|
Warrants
|
reserve
|
loss
|
deficit
|
Total
|
||||||||||||||||||||||
|
in USD thousands
|
||||||||||||||||||||||||||||
|
BALANCE AT APRIL 1, 2021
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
|
CHANGES FOR THREE MONTHS ENDED JUNE 30, 2021:
|
||||||||||||||||||||||||||||
|
Issuance of share capital, net
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Warrants exercised
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Employee stock options exercised
|
-
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Employee stock options forfeited and expired
|
-
|
|
|
(
|
)
|
|
|
|
||||||||||||||||||||
|
Share-based compensation
|
-
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Comprehensive loss for the period
|
-
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||
|
BALANCE AT JUNE 30, 2021
|
|
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
F - 4
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
|
Six months ended June 30,
|
||||||||
|
2020
|
2021
|
|||||||
|
in USD thousands
|
||||||||
|
CASH FLOWS - OPERATING ACTIVITIES
|
||||||||
|
Comprehensive loss for the period
|
(
|
)
|
(
|
)
|
||||
|
Adjustments required to reflect net cash used in operating activities (see appendix below)
|
|
|
||||||
|
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
|
CASH FLOWS – INVESTING ACTIVITIES
|
||||||||
|
Investments in short-term deposits
|
(
|
)
|
(
|
)
|
||||
|
Maturities of short-term deposits
|
|
|
||||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
|
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|||||
|
CASH FLOWS – FINANCING ACTIVITIES
|
||||||||
|
Issuance of share capital and warrants, net of issuance costs
|
|
|
||||||
|
Exercise of warrants
|
|
|
||||||
|
Employee stock options exercised
|
|
|
||||||
|
Repayments of loans
|
(
|
)
|
(
|
)
|
||||
|
Repayments of lease liabilities
|
(
|
)
|
(
|
)
|
||||
|
Net cash provided by financing activities
|
|
|
||||||
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
||||||
|
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
|
|
||||||
|
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(
|
)
|
(
|
)
|
||||
|
CASH AND CASH EQUIVALENTS - END OF PERIOD
|
|
|
||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
F - 5
BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
|
Six months ended June 30,
|
||||||||
|
2020
|
2021
|
|||||||
|
in USD thousands
|
||||||||
|
Adjustments required to reflect net cash used in operating activities:
|
||||||||
|
Income and expenses not involving cash flows:
|
||||||||
|
Depreciation and amortization
|
|
|
||||||
|
Exchange differences on cash and cash equivalents
|
|
|
||||||
|
Fair value adjustments of warrants
|
(
|
)
|
|
|||||
|
Share-based compensation
|
|
|
||||||
|
Warrant issuance costs
|
|
|
||||||
|
Interest and exchange differences on short-term deposits
|
(
|
)
|
(
|
)
|
||||
|
Interest on loans
|
|
|
||||||
|
Exchange differences on lease liability
|
(
|
)
|
(
|
)
|
||||
|
|
|
|||||||
|
Changes in operating asset and liability items:
|
||||||||
|
Increase in prepaid expenses and other receivables
|
(
|
)
|
(
|
)
|
||||
|
Decrease in accounts payable and accruals
|
(
|
)
|
(
|
)
|
||||
|
(
|
)
|
(
|
)
|
|||||
|
|
|
|||||||
|
Supplemental information on interest received in cash
|
|
|
||||||
|
Supplemental information on interest paid in cash
|
|
|
||||||
|
Supplemental information on non-cash transactions:
|
||||||||
|
Acquisition of right-of-use asset
|
|
|
||||||
|
Exercise of warrants (portion related to accumulated fair value adjustments)
|
|
|
||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
F - 6
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.
The Company’s American Depositary Shares (“ADSs”) are traded on the NASDAQ Capital Market, and its ordinary shares are traded on the Tel Aviv Stock Exchange (“TASE”). Each ADS represents 15 ordinary shares.
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 immuno-oncology.
Although the Company has succeeded in generating significant revenues from a number of out-licensing transactions in the past, it cannot determine with reasonable certainty if and when it will become profitable on a current basis. Management believes that the Company’s current cash and other resources will be sufficient to fund its projected cash requirements into the first half of 2024. However, in the event that the Company does not begin to generate sustainable cash flows from its operating activities in the future, the Company will need to carry out significant cost reductions or raise additional funding.
|
| b. |
Approval of financial statements
The condensed consolidated interim financial statements of the Company as of June 30, 2021, and for the six months then ended, were approved by the Board of Directors on August 15, 2021, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer and the Chief Financial Officer.
|
F - 7
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 2 – BASIS OF PREPARATION
The Company’s condensed consolidated interim financial statements as of June 30, 2021 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, 2020 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, 2021 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
The preparation of financial statements in conformity with IFRS requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity and expenses, as well as the related disclosures of contingent assets and liabilities, in the process of applying the Company’s accounting policies. These inputs also consider, among other things, the implications of the COVID-19 pandemic on the Company’s activities, and the resultant effects on critical and significant accounting estimates, most significantly in relation to the value of intangible assets. The COVID-19 pandemic has spread to many countries throughout the world, including to the United States, Europe and Israel, where the Company currently manufactures its therapeutic candidates and conducts its clinical trials. The Company has previously experienced some recruitment delays from the deepening and extended impact of COVID-19 on its clinical trials; however, at present, the Company does not believe these delays will significantly impact its clinical development plans. Future developments related to COVID-19 are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as its overall economic impact, and more specifically its effects on the financial markets. All estimates made by the Company related to the impact of COVID-19 in its financial statements may change in future periods. Actual results could differ from those estimates.
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, 2020 and for the year then ended.
F - 8
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 4 – AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW
In September 2020, the Company entered into an ATM sales agreement with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as sales agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remains in effect. The Company agreed to pay HCW a commission of 3.0 % of the gross proceeds from the sale of ADSs under the facility.
During the six months period ended June 30, 2021, the Company issued a total of 3,920,539 ADSs for total gross proceeds of $16 .0 million. From the effective date of the agreement through the issuance date of this report, 7,381,101 ADSs were sold under the program for total gross proceeds of approximately $24.5 million, leaving an available balance under the facility of approximately $0.5 million as of the issuance date of this report.
NOTE 5 – UNDERWRITTEN PUBLIC OFFERING
In January 2021, the Company completed an underwritten public offering of 14,375,000 of its ADSs at a public offering price of $2.40 per ADS. The offering raised total gross proceeds of $34.5 million, with net proceeds of $31.4 million after deducting fees and expenses. In addition, warrants to purchase 718,750 ADSs were granted to the underwriters. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $3.00 per ADS.
The warrants have been classified as shareholders’ equity, with initial recognition at fair value on the date issued. The total issuance costs initially allocated to the warrants were recorded as an offset to share premium.
The fair value of the warrants on the issuance date was approximately $1.0 million, which was recorded as issuance costs, and computed using the Black and Scholes option pricing model, based upon the then current price of an ADS, a risk-free interest rate of approximately 0.45 % and an average standard deviation of approximately 73.8 %.
F - 9
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 6 – SHAREHOLDERS’ EQUITY
As of December 31, 2020 and June 30, 2021, share capital is composed of ordinary shares, as follows:
|
Number of ordinary shares
|
||||||||
|
December 31,
|
June 30,
|
|||||||
|
2020
|
2021
|
|||||||
|
Authorized share capital
|
|
|
||||||
|
Issued and paid-up share capital
|
|
|
||||||
|
In USD and NIS
|
||||||||
|
December 31,
|
June 30,
|
|||||||
|
2020
|
2021
|
|||||||
|
Authorized share capital (in NIS)
|
|
|
||||||
|
Issued and paid-up share capital (in NIS)
|
|
|
||||||
|
Issued and paid-up share capital (in USD)
|
|
|
||||||
F - 10
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 February 23, 2021 (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
forward-looking 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;
|
| • |
the impact of the COVID-19 pandemic on our operations;
|
| • |
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;
|