BLRX: First Quarter Results
NASDAQ:BLRX
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1Q:23 Operational and Financial Results
On May 24, 2023, BioLineRx Ltd. (NASDAQ:BLRX) reported 1Q:23 operational and financial results in a press release concurrent with the filing of Form 6-K. A conference call and webcast were hosted later that morning. Key highlights since the previous earnings update in late March include the publication of GENESIS Phase III clinical trial data in Nature Medicine and a return to compliance with NASDAQ minimum bid requirements. Following the successful completion of the GENESIS trial, BioLineRx has oriented its efforts towards pre-commercialization activities as investors look toward the upcoming target action date for motixafortide (Aphexda) on September 9th, 2023. We provide a thorough discussion of BioLineRx’ plans to commercialize Aphexda in a previous report entitled BLRX: Self-Commercialization in the US. It discusses the company’s plans, reviews Aphexda’s mechanism of action and addresses the real-world benefits of an improved approach to stem cell mobilization.
Below we summarize financial results for the three-month period ended March 31, 2023, compared to the same period ending March 31, 2022:
➢ Research and development expenses totaled $3.7 million, down 17% from $4.4 million, on account of lower expenses related to the new drug application (NDA) supporting activities related to motixafortide and lower expenses associated with the completed AGI-134 study;
➢ Sales and marketing expenses were $3.9 million, up 500% from $0.6 million on account of initiation of pre-commercialization activities related to motixafortide;
➢ General and administrative (G&A) expenses were $1.3 million, up 29% from $1.0 million due to a rise in payroll and related expenses due to a increase in headcount and share-based compensation, as well as small increases in a number of G&A expenses;
➢ Non-operating expense was ($2.9) million reflecting changes in fair-value adjustments of warrant liabilities on the balance sheet;
➢ Net financial expenses amounted to ($0.4) million which was impacted by interest paid on loans partially offset by interest received from cash balances;
➢ Net loss was ($12.2) million compared with ($4.9) million, or ($0.01) and ($0.01) per share respectively.
Cash, equivalents and short-term bank deposits as of March 31, 2023 totaled $43.3 million, down from the year end 2022 balance of $51.1 million. Cash burn during 1Q:23 amounted to ($8.1) million and cash used in financing was ($49,000) related to repayment of lease liabilities. In September 2022, BioLineRx entered into a $40 million loan agreement with Kreos Capital, and $10 million was drawn. The remaining $30 million will be available in two additional tranches upon the achievement of unspecified milestones.
Publication in Nature Medicine
BioLineRx announced that a journal article discussing the Phase III GENESIS trial was published in the April issue of Nature Medicine. The article, entitled Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial,1 examines motixafortide + G-CSF’s ability to produce sufficient CD34+ hematopoietic stem and progenitor cells to conduct stem cell transplantation in multiple myeloma patients. Most patients under approved approaches are unable to collect the target number of cells for stem cell transplantation; however, by adding motixafortide, almost 90% of patients were able to collect sufficient cells in one apheresis session.
The primary endpoint for the trial was to collect greater than 6 x 106 CD34+ cells per kilogram within two apheresis sessions. The secondary endpoint was to achieve the goal in one apheresis session. 122 subjects were enrolled across 18 sites and randomized 2:1 comparing motixafortide + G-CSF or placebo + G-CSF. Motixafortide + G-CSF enabled 92.5% of the subjects to successfully meet the primary endpoint versus 26.2% with placebo + G-CSF. The odds ratio was 53.3, with a 95% confidence interval of 14.12–201.33 and a p-value of less than 0.0001. Motixafortide + G-CSF also enabled 88.8% of subjects to meet the secondary endpoint versus 9.5% with placebo + G-CSF. The odds ratio for the secondary endpoint was 118.0 with a 95% confidence interval of 25.36–549.35 and a p-value of less than 0.0001.
Treatment emergent adverse events (TEAEs) occurred in 93.8% of the motixafortide patients compared with 83.3% of the placebo patients and consisted of pain (local injection site, bone and back), flushing, pruritis, erythema, nausea and hypokalemia. Grade 3 TEAEs were reported in 27.5% of motixafortide patients compared with 4.8% in placebo subjects.
Another important observation from the trial was the improvement in healthcare resource utilization, as fewer apheresis days and procedures were required. Based on these data reported in the article, a single injection of motixafortide added to G-CSF substantially improves upon approved mobilization regimens. Favorable aspects include the rapidity, robustness and reliability of hematopoietic stem and progenitor cell mobilization for autologous hematopoietic stem cell transplantation in patients newly diagnosed with multiple myeloma following modern induction therapy.
Opportunities for Gene Therapy
In a March 6th press release, BioLineRx announced a collaboration with Washington University School of Medicine to evaluate motixafortide for CD34+ hematopoietic stem cell mobilization for gene therapy in sickle cell disease. The study opens up a door to enter into the gene therapy space which in many cases relies on the collection of stem cells for ex vivo modification. Stem cell mobilization is important for gene therapy because it can increase the number of stem cells available for gene modification, which can improve gene therapy’s efficiency and effectiveness. In the case of sickle cell disease, the use of G-CSF is contraindicated which demands an alternative that can reliably generate sufficient cells in a safe manner.
The proposed study is a Phase I clinical trial that will evaluate the safety and feasibility of motixafortide to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease. Dr. John Dipersio, who we know from last year’s key opinion leader event, is the principal investigator for the trial and sees motixafortide as a candidate for a gene therapy stem cell mobilization agent. BioLineRx management sees other lentiviral gene therapy approaches, particularly those that are ex vivo as being well aligned with using motixafortide.
AGI-134
In January 2022, the AGI-134 trial completed enrollment and by year end, results were announced. The study met its primary safety and tolerability endpoint. An immune response and markers of clinical efficacy were assessed as secondary endpoints. Most patients analyzed showed an increase in Alpha-Gal antibodies, indicating increased overall immune activity. Additionally, increases in antigen presenting cells were observed in most tissue samples analyzed. T cell and macrophage tumor infiltration was seen in approximately one-third of evaluable patients’ injected tumors and in approximately half of evaluable patients’ lesions not injected. Radiological assessments found that 29% (11/38) of patients in the trial achieved best overall response of stable disease. BioLineRx plans to seek publication of the data at a medical congress in 2023, and in consultation with its scientific advisory board, it will determine the next steps for the program in the 1H:23.
Upcoming Milestones
➢ Motixafortide, Phase II (Columbia) PDAC study data release – 2023
➢ Presentation of GENESIS data at medical meetings & conferences – 2023
➢ Initiate Phase II combination study of motixafortide with GenFleet – 2H:23
➢ Data published for Phase II PDAC trial – 2H:23
➢ Motixafortide, Phase I in Sickle Cell Disease – 2H:23
➢ Motixafortide in SCM target action (PDUFA) date – September 2023
➢ US launch of motixafortide in SCM – 3Q:23
➢ Potential initiation of randomized Phase 2 study of AGI-134 – 2023
Summary
BioLineRx reported financial and operational results for 1Q:23 on May 24th. The highlight since our previous update is the publication in Nature Medicine outlining the results of the GENESIS trial. All eyes are on September, when we expect to hear from the FDA regarding Aphexda’s PDUFA date. The US commercialization team is hard at work preparing for a launch and is ahead of the game, ready to spring out of the gate once FDA approval is granted. Other ongoing work includes programs with its partners including Washington University School of Medicine, GenFleet Therapeutics and Columbia University for the advancement in its gene therapy and pancreatic oncology programs respectively.
The market for Aphexda is sizable with approximately 23,000 stem cell transplants taking place per year in the United States. About 59% of these are autologous and 90% are in multiple myeloma (MM) and lymphomas with about 65% of the autologous MM and lymphoma patients appropriate for the therapy. BioLineRx’ second indication for motixafortide is in pancreatic cancer which is being developed in Phase II trials. There is also a substantial opportunity to support collection of stem cells for gene therapy. We maintain a valuation of $6.00 per share.
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1. Crees, Z.D., Rettig, M.P., Jayasinghe, R.G. et al. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nat Med 29, 869–879 (2023).
2. BioLineRx May 2023 Corporate Presentation.
3. BioLineRx May 2023 Corporate Presentation.
