BioLineRx Ltd. (NASDAQ: BLRX) is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

 

The company’ shares continue to zoom backed by the favorable impact of its recent announcements, and many high-potential near-term catalysts that are lined up for 2018/2019. In fact, the positive outcomes of its clinical developments, that continue to support the therapeutic potential of its drug candidates, have also made BLRX a lucrative takeover play for some larger participants in the industry.

Furthermore, from a liquidity and financial standpoint, BLRX’ financial footing continues to remain stable and provides it with resources necessary to fully execute on its operational plan towards the first half of 2020.

 

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On October 3rd, the company announced an agreement with Biokine Therapeutics to increase BioLineRx’s stake in its lead oncology platform, BL-8040, a CXCR4 antagonist currently in late stage clinical development in both solid tumor and hematological indications, including stem cell mobilization (SCM), acute myeloid leukemia (AML) and immunotherapy for multiple types of solid tumors. As a result of the transaction, BioLineRx will increase its economic stake in the program to 80% from the previous level of 60%. BioLineRx licensed the exclusive worldwide rights to BL-8040 from Biokine Therapeutics in 2012.

 

Under the terms of the agreement, upon closing of the transaction, BioLineRx will pay Biokine Therapeutics an upfront payment of $10 million in cash plus $5 million in restricted BioLineRx shares. Biokine is also eligible to receive up to a total of $5 million in future milestone payments. The $10 million upfront payment is being financed in full via the receipt of $10 million in debt financing from Kreos Capital.

 

As the company works to bring novel cancer treatments to patients in need, the management believes that this transaction reflects their strong commitment to this program and better positions BLRX to create significant long-term value for its stakeholders.

 

Before this, on August 13, 2018, the company reported its financial results and business updates for the second quarter ended June 30, 2018.

 

Highlights and achievements during the second quarter of 2018 and to date: BLRX Continued to make progress on multiple clinical trials and its lead oncology program, BL-8040:

• Positive data from successful completion of the first lead-in patient cohort of the GENESIS trial, 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.
• Expansion of immuno-oncology collaboration with Merck & Co., Inc., Kenilworth, N.J. (Merck), supporting a Phase 2a program investigating BL-8040 in combination with KEYTRUDA in pancreatic cancer patients.
• Presentation at the 2018 European Hematology Association (EHA) Conference of very encouraging long-term overall survival results in Phase 2a trial in relapsed/refractory AML, demonstrating that the combination of BL-8040 with high-dose Cytarabine (HiDAC) significantly improved overall survival, compared with historical data for HiDAC monotherapy;
• Grant of European patent covering the use of BL-8040 with Cytarabine for treating AML; valid through March 2034 with up to five years’ patent term extension.

 

The Company also announced advancements made in its 2^nd immuno-oncology compound, AGI-134   

• Initiation of multicenter, open-label Phase 1/2a study in the UK and Israel, with possible expansion to the US and additional countries in Europe in 2019; study will evaluate the safety and tolerability of AGI-134, as a monotherapy and in combination with an immune checkpoint inhibitor, in unresectable metastatic solid tumors.

 

Over the next few quarters, the company has promising milestones/Catalysts in the next 18 months:

• Top-line results in immuno-oncology Phase 2a COMBAT study in pancreatic cancer for BL-8040 in combination with KEYTRUDA, under collaboration with Merck, to be presented at the European Society for Medical Oncology (ESMO) Congress in October 2018;
• Partial results in Phase 1b/2 study in pancreatic cancer under Genentech immuno-oncology collaboration, investigating BL-8040 in combination with Genentech’s atezolizumab, expected in H2 2018;
• Potential interim analysis of Phase 2b BLAST study in AML consolidation in mid-2019:
• Results from the additional cohort in Phase 2a COMBAT study under the expansion of Merck collaboration, investigating a triple combination of BL-8040, KEYTRUDA and chemotherapy in pancreatic cancer, by the end of 2019

 

Upcoming events:

• October 19, 2018 – ESMO 2018 Congress
• January 7, 2018 – JPM/Biotech Showcase

 

Investment highlights and target price.

 

Analyst tracking the stock believes that the company business profile is marked by significant revenue potential & the company’ strong fundamentals are well poised for value creation. Per www.marketbeat.com, their average twelve-month price target is $3.00, suggesting that the stock has a possible upside of 117.39%. The high price target for BLRX is $4.00, and the low-price target for BLRX is $2.00. Considering all this, the company is in an extremely favorable risk-reward position, and value investors should consider exposure in this sector as the backdrop remains favorable.

 

Below are the excerpts of recent analyst rating on the script:

As per marketbeat.com

 

About the Product: BioLineRx’s leading therapeutic candidates are: BL-8040, a multi-therapy platform, which has completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment and has initiated a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which has recently initiated a Phase 1/2a study.

 

Strategic collaboration: In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®; and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications and AML.

 

Pipeline:

Recent accomplishments and upcoming opportunities at a glance:

Second Quarter 2018 Highlights:

• R&D: Research and development expenses for the three months ended June 30, 2018, were $4.5 million, an increase of $0.4 million, or 10.4%, compared to $4.1 million for the three months ended June 30, 2017.

 

• Operating Loss: The Company’s operating loss for the three months ended June 30, 2018, amounted to $5.7 million, compared with an operating loss of $5.2 million for the corresponding 2017 period.
• Net Loss: The Company’s net loss for the three months ended June 30, 2018, amounted to $4.8 million, compared with a net loss of $4.9 million for the corresponding period. The Company’s net loss for the six months ended June 30, 2018, amounted to $11.0 million, compared with a net loss of $9.8 million for the corresponding 2017 period.
• Liquidity and financial flexibility: The Company held $41.1 million in cash, cash equivalents, and short-term bank deposits as of June 30, 2018.

 

Key risk factors and potential stock drivers:

• Successful completion of the upcoming milestones would lead future direction for the company. Any adversities might adversely impact the overall investor sentiments.
• The company operation is still in the clinical development stage. Therefore, its ability to maintain its present strong liquidity and financial flexibility and to fund its incremental capital requirements without any major cost or time overruns would remain a critical challenge for the company.
• BLRX operates in a competitive and dynamic space and only time would differentiate between real winners and laggards. Some of its competitors may have longer operating histories and greater resources than BLRX.
• As far as choosing an option with a relative advantage is concerned, BLRX is preferred choice with upside potential.

 

Stock Performance

Comments:

• On Tuesday, Oct 16th, 2018, BLRX was at $1.45, on traded volume of 1.9 million shares exchanging hands. Market capitalization is $146.181 million. The current RSI is 71.49
• In the past 52 weeks, shares of BLRX have traded as low as $0.78 and as high as $1.84
• At $1.45, shares of BLRX are trading above its 50-day moving average (MA) at $1.02 and above its 200-day moving average (MA) at $0.96
• The present support and resistance levels for the stock are at $1.26 & $1.50 respectively.

 

 

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