On August 30, 2023 BioLineRx, a pre-commercial stage biopharmaceutical company pursuing life-changing therapies for certain cancers and rare diseases, reported its unaudited financial results for the second quarter ended June 30, 2023, and provided corporate and portfolio updates (Press release, BioLineRx, AUG 30, 2023, View Source [SID1234634868]).

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"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 in Asia," 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 in Asia, 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 with Columbia University in first line metastatic pancreatic cancer based on promising data from a single-arm pilot phase.

"Finally, our clinical trial collaboration with Washington University School of Medicine in St. Louis to 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.

Corporate Updates

On track for September 9, 2023 PDUFA target action date on NDA for motixafortide in stem cell mobilization for autologous transplantation in multiple myeloma
Signed exclusive license agreement to develop and commercialize motixafortide in Asia with concurrent equity investment; license agreement includes $15 million upfront payment, plus potential development, regulatory and sales milestones, and tiered double-digit royalties, as well as various development obligations for the licensee, including the planned initiation in China of a registrational study in stem-cell mobilization and a randomized Phase 2/3 study in first-line pancreatic cancer; straight common equity investment of $14.6 million in BioLineRx at $2.136 per ADS with no warrants; effectiveness and closing of transactions is contingent upon approval by Israeli Innovation Authority of license agreement within four months of execution, and other closing conditions
Clinical Portfolio Updates

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced publication in Nature Medicine of GENESIS Phase 3 clinical trial data evaluating motixafortide and G-CSF in stem cell mobilization for autologous transplantation in multiple myeloma
Pancreatic Ductal Adenocarcinoma

Announced initiation of randomized, investigator-initiated Phase 2 clinical trial in collaboration with Columbia University, with joint funding of the study by Regeneron and BioLineRx, assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with mPDAC. Anticipate initial patient data in 2023. A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June
Sickle Cell Disease & Gene Therapy

Continued to advance plans for a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate trial initiation later this year
AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Evaluating next development pathways for AGI-134 program in consultation with scientific advisory board. Results from Phase 1/2a first-in-human, single-agent study announced in Q4 2022. Study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
Second Quarter 2023 Financial Results

Research and development expenses for the three months ended June 30, 2023 were $3.0 million, a decrease of $2.4 million, or 44.3%, compared to $5.4 million for the three months ended June 30, 2022. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
Sales and marketing expenses for the three months ended June 30, 2023 were $5.6 million, an increase of $4.4 million, or 383.9% compared to $1.2 million for the three months ended June 30, 2022. The increase resulted primarily from the ramp-up of pre-launch activities related to motixafortide
General and administrative expenses for the three months ended June 30, 2023 were $1.3 million, an increase of $0.3 million, or 24.4% compared to $1.0 million for the three months ended June 30, 2022. The increase resulted primarily from an increase in payroll and related expenses due to a small increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses
Net loss for the three months ended June 30, 2023 was $18.5 million, compared to $7.4 million for the three months ended June 30, 2022. The Company’s net loss for the six months ended June 30, 2023 amounted to $30.7 million, compared to $12.4 million for the six months ended June 30, 2022. The increases in net loss for both the three and six months ended June 30, 2023 were due primarily to a non-operating expense of approximately $7.8 million and $10.8 million respectively, related to the revaluation of outstanding warrants resulting from an increase in the Company’s share price over the preceding three and six months
As of June 30, 2023, the Company held cash, cash equivalents, and short-term bank deposits of $32.8 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024. This amount does not include $29.6 million in total funding from the exclusive license agreement and equity investment announced today, which the Company anticipates closing in Q3 subject to formal transaction approval by the Israeli Innovation Authority and other closing conditions