BioLineRx Reports Second Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates

- On Track forSeptember 9, 2023PDUFA Target Action Date on NDA for Motixafortide in Stem Cell Mobilization (SCM) for Autologous Transplantation in Multiple Myeloma (MM) -

- Signed Exclusive License Agreement to Motixafortide in Asia Region with Concurrent Equity Investment -

- Announced Initiation of Investigator-Initiated Randomized Phase 2 Combination Trial with Motixafortide in First Line PDAC in Collaboration withColumbia University-

- Management to host conference call today,August 30, at 10:00am EDT -

TEL AVIV, Israel,Aug. 30, 2023/PRNewswire/ -- BioLineRx Ltd. (NASDAQ:BLRX) (TASE: BLRX), a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, today reported its unaudited financial results for the second quarter endedJune 30, 2023, and provided corporate and portfolio updates.

"We had a very productive second quarter across all areas of the company, including our focused pre-launch preparation activities tied to the potential U.S. approval of motixafortide in the next few weeks, as well as the formation of a new strategic partnership, announced today, to develop and commercialize motixafortide inAsia," said Philip Serlin, Chief Executive Officer of BioLineRx. "The partnership, which is subject to certain closing conditions, provides a pathway forward to pursue potential indications for motixafortide in stem cell mobilization and pancreatic cancer inAsia, as well as a source of substantial funding to the company.

Additionally, we advanced our second major development program for motixafortide in pancreatic cancer through the initiation of a randomized Phase 2 clinical trial withColumbia Universityin first line metastatic pancreatic cancer based on promising data from a single-arm pilot phase.

"Finally, our clinical trial collaboration withWashington UniversitySchool of Medicine inSt. Louisto evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress, and we anticipate clinical trial initiation this year. I am extremely pleased with our progress to date and look forward to a fruitful second half of the year, including our potential transition to a commercial stage company," Mr. Serlin concluded.

Multiple Myeloma

Pancreatic Ductal Adenocarcinoma

Sickle Cell Disease & Gene Therapy

Solid Tumor Immunotherapy

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through theevent pageon the Company'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. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available untilSeptember 1, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

BioLineRx Ltd. is a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases.  The company is advancing a pipeline of investigational medicines for patients with multiple myeloma, sickle cell disease, pancreatic cancer, and other solid tumors.  Headquartered inIsrael, and with operations in the U.S., BioLineRx is driving innovative therapeutics with end-to-end expertise in development and commercialization, ensuring life-changing discoveries move beyond the bench to the bedside.

Learn more about who we are, what we do, and how we do it atwww.biolinerx.com, or onTwitterandLinkedIn.

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 include statements regarding management's expectations, beliefs and intentions regarding, among other things, our planned and ongoing clinical trials, the plans and objectives of management for future operations, regulatory filings submitted to the FDA (including potential timing of the FDA's review of the NDA for motixafortide), commercial potential of motixafortide, expectations regarding the announced license agreement, statements relating to the private placement, including, as to the consummation of the private placement and license agreement, and our financial condition and results of operations. 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, including BioLineRx's ability to secure adequate and viable pricing and reimbursement coverage of any marketed product; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate and academic collaborations and licensees, including the collaboration contemplated in the license; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation or characterization 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 inthe United States,Asia, or elsewhere; competitive companies, technologies and BioLineRx's industry, including generic entrants; risks related to unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and statements as to the impact of the political and security situation inIsraelon 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 onMarch 22, 2023. 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 StatesJohn LaceyBioLineRx[email protected]

IsraelMoran MeirLifeSci Advisors, LLC[email protected]