For traders interested in undervalued speculative biotech opportunities, BioLineRX Ltd/S ADR (NASDAQ: BLRX) may be worth a close look. The stock has been trading in a lateral range with key support repeatedly defended in the $0.80/share area. According to the 14-day RSI indicator, shares of BLRX are coming off a pivot low and remain poised for potential upside.
As far as key catalysts, the company just put out its quarterly report. With a clinical stage biotech, we generally want to focus on clinical data trends and how aggressively the company is set to reveal more research results in the near future, rather than pure financial data – though the balance sheet does appear to be in great shape. Moreover, the catalyst for this type of stock is usually about anticipation of important data breakthroughs. And there’s a ton to chew on here, which we will cover below. But first, let’s get a better overall sense of who this company is.
BioLineRX Ltd/S ADR (NASDAQ:BLRX) is a clinical stage biopharmaceutical development company focused on oncology and immunology.
Currently trading at a market capitalization of $99.69M, BLRX has a significant war chest ($27.4M) of cash on the books, which stands against about $327K in total current liabilities. The company is pre-revenue at this point, but has an impressive development pipeline in the works.
At this point, the pipeline consists of clinical-stage therapeutic candidates, which include BL-8040, a peptide for the treatment of multiple cancer and hematological indications; AGI-134, an immuno-oncology agent in development for solid tumors; and BL-5010, a customized, proprietary, pen-like applicator for the non-surgical removal of benign skin lesions.
The company’s other therapeutic candidates comprise BL-1040, a resorbable polymer solution for use in the prevention of ventricular remodeling; BL-9020, which is a monoclonal antibody treatment designed to prevent immune-mediated destruction of insulin-producing beta cells in the pancreas; and BL-1230, a cannabinoid receptor type 2 intended as an anti-inflammatory treatment for dry eye syndrome.
The company has collaboration agreement with Novartis Pharma AG to facilitate development and commercialization of Israeli-sourced drug candidates; MSD for the cancer immunotherapy field; MD Anderson Cancer Center to investigate the combination of BL-8040 with Keytruda (pembrolizumab) in pancreatic cancer; and Genentech Inc. to investigate the combination of BL-8040 and Genentech’s Atezolizumab in various Phase 1b/2 studies for in various solid tumors and hematologic malignancies. BioLineRx Ltd. was founded in 2003 and is headquartered in Modi’in, Israel.
Where Things are Headed
As stated above, the stock is coming off key support and may have significant room to run to the upside. BLRX just came out with key data to possibly fuel that type of action.
Perhaps most significantly, the company just announced positive data from successful completion of first lead-in patient cohort of the GENESIS trial, which is a double-blind, placebo-controlled, Phase 3 trial comparing BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobilization of hematopoietic stem cells (HSCs) used for autologous transplantation in multiple myeloma patients.
According to the release, “Results from first 11 patients prompted Data Monitoring Committee (DMC) to recommend early continuation to randomized placebo-controlled part 2 of trial; data show that 9/11 patients (82%) reached primary endpoint threshold of ≥ 6×106 CD34 cells/kg with only one dose of BL-8040 and in up to 2 apheresis sessions.”
As also noted above, perhaps the most important point to make here is that the company has stated that it expects to present major data over coming months. This is dangling the carrot above the stock for speculators, which can really power the action for a stock like this.
Looking ahead, the company expects to present top-line results in immuno-oncology Phase 2a COMBAT study in pancreatic cancer for BL-8040 in combination with KEYTRUDA, under collaboration with Merck, at the European Society for Medical Oncology (ESMO) Congress in October 2018. In addition, we should get partial results in Phase 1b/2 study in pancreatic cancer under Genentech immuno-oncology collaboration, investigating BL-8040 in combination with Genentech’s atezolizumab, sometime before the end of this year.
“We are very encouraged by the clinical results achieved to-date in the major indications being developed under our BL-8040 platform, as we continue to advance the asset towards registration,” stated Philip A. Serlin, Chief Executive Officer of BioLineRx. “Specifically, positive results from the initial lead-in cohort in the Phase 3 GENESIS trial, and the resulting DMC recommendation for an early continuation to the randomized, double-blind, placebo-controlled part of the trial, is an important clinical achievement for BL-8040. The data continue to demonstrate BL-8040’s robust efficacy in stem-cell mobilization for autologous transplantation, including the potential to reduce the number of required apheresis sessions to one session in the majority of patients, versus multiple sessions under current practice. Building on this success, data from our ongoing COMBAT Phase 2a immuno-oncology trial support continued development in pancreatic cancer, as we expand our collaboration with Merck, with the addition to the existing study of a new cohort with 30-50 patients investigating the triple combination of BL-8040, KEYTRUDA and chemotherapy. The new cohort will focus on second-line pancreatic cancer patients and we are hopeful for significant synergies from the triple drug combination in this very difficult-to-treat population.”