– On track to submit New Drug Application to FDA for Motixafortide in stem cell mobilization (SCM) for autologous stem cell transplantation




in mid-2022, consistent with prior guidance –

– Progressing critical Motixafortide pre-launch activities while maintaining full optionality on commercialization strategies –

– Cash and cash equivalents at

March 31, 2022

of

$50.6 million

, sufficient to fund operations, as currently planned, into first half of 2024 –

– Management to hold conference call today,

May 11

, at 10:




00 am EDT –

TEL AVIV, Israel


,


May 11, 2022


/PRNewswire/ — BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the first quarter ended

March 31, 2022

and provides a corporate update.

Significant events and achievements during the first quarter 2022 and subsequent period:

• Progressed the New Drug Application (NDA) for Motixafortide in stem cell mobilization, remaining on track to submit mid-year;
• Advanced critical pre-launch activities while maintaining full optionality with respect to Motixafortide commercialization plans in the U.S., if approved;
• Commissioned a comprehensive third-party market assessment of the US stem cell mobilization market, which identified a commercial opportunity of
  
  ~$360 million
  
  annually in the U.S. alone;
• Announced significantly positive and commercially relevant results from a pharmacoeconomic cost effectiveness study comparing Motixafortide + G-CSF versus G-CSF alone and indirectly comparing Motixafortide + G-CSF versus plerixafor + G-CSF:

– Versus plerixafor + G-CSF, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of

~$30,000

per patient (not including the cost of Motixafortide).

– Versus G-CSF alone, the study found that the addition of Motixafortide to G-CSF is associated with a net cost savings of

~$19,000

per patient (not including the cost of Motixafortide).

• Completed recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors;
• Ended the first quarter on solid financial footing, with cash and cash equivalents of
  
  $50.6 million
  
  , sufficient to fund operations, as currently planned, into the first half of 2024.

“During the first quarter and subsequent period, we continued to prepare our New Drug Application for Motixafortide in stem cell mobilization, and we remain on track for submission to the FDA mid-year, consistent with our prior guidance,” stated

Philip Serlin

, Chief Executive Officer of BioLineRx. “In parallel, we are advancing a range of critical pre-launch activities, should Motixafortide be approved, while maintaining full optionality with respect to our commercialization plans, in light of the highly concentrated end market in the U.S., in which 80 transplant centers conduct the vast majority of stem cell transplant procedures.

“The third-party commercial market assessment that we recently commissioned estimates the size of the stem cell mobilization market to be

$360 million

annually in the U.S. alone and growing. In this respect, the overwhelmingly positive results from our GENESIS Phase 3 study, together with the very compelling cost savings identified through our pharmacoeconomic cost effectiveness studies, give us optimism that Motixafortide, if approved, can quickly become a core component of a new mobilization paradigm in multiple myeloma patients, and in potential other indications as well.

“With over

$50 million

in cash, we believe we are well financed to extract maximum value from Motixafortide in stem cell mobilization while at the same time advancing our other pipeline programs, allowing us to achieve notable corporate and clinical milestones into the first half of 2024,” concluded Mr. Serlin.

Upcoming Expected Milestones:

• Submission of NDA to FDA for Motixafortide as novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022;
• Initial results from Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in H2 2022;
• Initiate Phase 2 study of AGI-134 in 2023;
• Potential FDA approval of Motixafortide in 2023;
• Potential US launch of Motixafortide in SCM in 2023.

Financial Results for the Quarter Ended

March 31, 2022

:

Research and development expenses for the quarter ended

March 31, 2022

were

$4.4 million

, an increase of

$0.1 million

, or 3.7%, compared to

$4.3 million

for the quarter ended

March 31, 2021

. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the quarter ended

March 31, 2022

were

$0.7 million

, an increase of

$0.5 million

, or 313% compared to

$0.2 million

for the quarter ended

March 31, 2021

. The increase resulted primarily from an increase in market research and consultancy services, as well as initiation of pre-launch activities related to Motixafortide.

General and administrative expenses for the quarter ended

March 31, 2022

were

$1.0 million

, similar to the comparable period in 2021.

The Company’s operating loss for the quarter ended

March 31, 2022

amounted to

$6.1 million

, compared to an operating loss of

$5.4 million

for the quarter ended

March 31, 2021

.

Non-operating income amounted to

$1.3 million

for the quarter ended

March 31, 2022

, compared to non-operating expenses of

$4.6 million

for the quarter ended

March 31, 2021

. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Net financial expenses amounted to

$0.1 million

for the quarter ended

March 31, 2022

, compared to net financial expenses of

$0.2 million

for the quarter ended

March 31, 2021

. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the quarter ended

March 31, 2022

amounted to

$4.9 million

, compared with a net loss of

$10.2 million

for the quarter ended

March 31, 2021

.

The Company held

$50.6 million

in cash, cash equivalents and short-term bank deposits as of

March 31, 2022

, compared with

$57.1 million

as of

December 31, 2021

.

Net cash used in operating activities was

$5.6 million

for the quarter ended

March 31, 2022

, compared with net cash used in operating activities of

$6.2 million

for the quarter ended

March 31, 2021

. The

$0.6 million

decrease 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 smaller increase in prepaid expenses and other receivables in 2022 versus 2021, as well as increase in accounts payable and accruals in 2022, versus a decrease in the 2021 period.

Net cash provided by investing activities was

$5.0 million

for the quarter ended March 31, 2022, compared to net cash used in investing activities of

$36.3 million

for the quarter ended

March 31, 2021

. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash used in financing activities was

$1.0 million

for the quarter ended

March 31, 2022

, compared to net cash provided by financing activities of

$41.9 million

for the quarter ended

March 31, 2021

. The cash flows in 2022 primarily reflect repayments of the loan from Kreos Capital. The cash flows in 2021 primarily reflect the underwritten public offering of ADSs in

January 2021

, warrant exercises, and net proceeds from an ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today,

Wednesday, May 11

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.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the

Investor Relations

page of BioLineRx’s website. A dial-in replay of the call will be available until

May 13, 2022

; 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 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, has reported positive results from a pre-planned pharmacoeconomic study, has successfully completed a pre-NDA meeting with the FDA, 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, 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 “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.

Contact:



Tim McCarthy


LifeSci Advisors, LLC

+1-917-679-9282


[email protected]

or

Moran Meir


LifeSci Advisors, LLC

+972-54-476-4945


[email protected]

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SOURCE BioLineRx Ltd.