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 November 2022
Commission file number: 001-35223
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 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 November 4, 2022, the registrant issued the press
release which is filed as Exhibit 1 to this Report
on Form 6-K.
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.
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BioLineRx Ltd.
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By:
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/s/ Philip A. Serlin |
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| Philip A. Serlin | |||
| Chief Executive Officer | |||
Dated: November 4, 2022
Exhibit 1
For Immediate Release
BioLineRx Announces Receipt of Nasdaq Minimum Bid Price Notification
TEL AVIV, Israel,
November 4, 2022 – (PRNewswire) – BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, today announced that it has received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in
compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market, since the closing bid price for the Company's ADSs listed on Nasdaq was below USD $1.00 for 30 consecutive
trading days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of USD $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if
the deficiency continues for a period of 30 consecutive business days.
The Notice has no immediate effect on the Company’s Nasdaq listing or the trading of its ADSs, and during the grace period, as may be
extended, the Company’s ADSs will continue to trade on Nasdaq under the symbol “BLRX”.
In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or
until May 1, 2023, to regain compliance with the minimum bid price. If at any time before May 1, 2023 the bid price of the Company's ADSs closes at or above USD $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will
provide written notification that the Company has achieved compliance with the minimum bid price requirement.
In the event the Company does not regain compliance by May 1, 2023, the Company may be eligible for an additional 180 days to regain compliance if it meets the continued listing requirement for market value of publicly
held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In this case, the Company will need to provide written notice of its intention to cure the deficiency during
the second compliance period.
The Company will continue to monitor the
closing bid price of its ADSs on Nasdaq between now and May 1, 2023 and seeks to cure the deficiency within the prescribed compliance period. The Company's business operations are not affected by the Notification Letter, and indeed the
Company expects to deliver meaningful regulatory, commercial, and clinical program progress over the next several quarters, including the potential launch of APHEXA® (motixafortide), if approved, in the United States for stem cell mobilization in autologous bone marrow transplantation for
multiple myeloma patients.
If the Company cannot demonstrate compliance by the allotted compliance period(s), Nasdaq’s staff will notify the Company that its
ADSs are subject to delisting.
The Company is also listed on the Tel Aviv Stock Exchange and the notification letter does not affect the Company's compliance status with such listing.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a pre-commercial-stage biopharmaceutical company focused on oncology. The Company's lead program, APHEXDA® (motixafortide), is a cancer therapy platform that was successfully
evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, has reported positive results from a pre-planned pharmacoeconomic study in the U.S., has successfully completed a pre-NDA meeting with the FDA, and has
completed an NDA submission. APHEXDA® was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer (PDAC) in combination with KEYTRUDA® and chemotherapy and is currently being studied in combination with LIBTAYO® and
chemotherapy as a first-line PDAC therapy. A randomized phase 2b study with 200 patients in combination with PD1 and chemotherapy as a first-line PDAC therapy will initiate in 2023. 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.
Forward Looking Statement
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These
forward-looking statements involve known and unknown risks, uncertainties and other factors 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 and ability to access sufficient 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; statements as to the impact of the political and security situation in Israel on BioLineRx's business; and the impact of the COVID-19 pandemic and the Russian invasion of
Ukraine, which may exacerbate the magnitude of the factors discussed above. 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 16, 2022. 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.
Contacts:
United States
John Lacey
BioLineRx
+1-781-392-5514
johnl@biolinerx.com
Tim McCarthy
LifeSci Advisors, LLC
tim@lifesciadvisors.com
Israel
Moran Meir
LifeSci Advisors, LLC
+972-54-476-4945
moran@lifesciadvisors.com