Bioline RX Ltd (NASDAQ:BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reports its financial results for the first quarter ended March 31, 2015.
Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “During the first quarter of 2015, we continued to focus on advancing our lead programs through value-driving clinical and regulatory milestones. We recently completed the dose escalation stage of our ongoing BL-8040 Phase 2 clinical study for treating relapsed and refractory acute myeloid leukemia (AML), which continues to show excellent safety and tolerability, as well as robust mobilization and apoptosis of the cancer cells. We have begun to enroll patients in the expansion stage of the study at the optimal chosen dose of 1.5 mg/kg. In addition, we announced successful top-line safety and efficacy results from our Phase 1 study of BL-8040 as a novel, single-agent stem cell mobilization treatment, where we met all safety and efficacy endpoints. We plan to meet with the FDA as soon as possible to discuss the results of the study and obtain more clarity on the next steps in clinical development for this indication. We intend to present the full Phase 1 study results at the European Hematology Association Conference in June, which we expect will garner significant interest from the transplant community.”
Dr. Savitsky continued, “BioLineRx has significant milestones upcoming in the near term and over the next twelve months. In the fourth quarter of 2015, we anticipate reporting top-line results from the complete Phase 2 AML study, including the current expansion phase. Over the next few months, we are also preparing to initiate several additional clinical studies for BL-8040 that will expand the potential indications for our lead platform. The required regulatory submissions have been made for the first of these studies, a large Phase 2b study to evaluate BL-8040 as a consolidation AML therapy. In addition, we plan to assess BL-8040 as a novel treatment for hypoplastic myelodysplastic syndrome and aplastic anemia with the initiation of a Phase 2 trial. Following that, we expect to initiate a third AML trial for BL-8040, a Phase 2 study in combination with a FLT3 inhibitor agent, for patients with FLT3-ITD-mutated AML. We are very excited to explore the expanded potential for BL-8040, which we believe is poised to become a market-leading hematological platform.”
“Beyond our BL-8040 platform, we are awaiting formal approval of the device regulatory pathway by the EU Notified Body with regard to BL-7010, our novel polymer for treating celiac disease. In addition, we are finalizing additional non-clinical studies and formulation work to support potential initiation of a pivotal CE Mark registration study in the fourth quarter of this year.”
“Finally, at the beginning of the year, we announced that our partner Bellerophon had completed enrollment for BL-1040, our most advanced partnered program, in the PRESERVATION 1 pivotal CE Mark registration study. The enrolled patients are completing the six-month follow up period and we expect to report top-line results in mid-2015. In parallel to the study in Europe, Bellerophon is preparing to commence a U.S. pivotal study in the first half of 2016.”
Dr. Savitsky concluded, “From a corporate perspective, we recently announced our intention to carry out a 1:10 reverse split of our ordinary shares traded in Tel Aviv. The purpose of this reverse share split is to provide for a 1:1 ratio of our ordinary shares traded in Tel Aviv with our American Depositary Shares traded on NASDAQ, thus preventing any confusion in the market due to the current 10:1 ratio. In addition, we would also like to emphasize our strong balance sheet following the successful completion of a $29 million secondary public offering of our ADSs this quarter, which allows us to aggressively progress the clinical development of BL-8040 and BL-7010, and continue to screen for opportunities we hope to realize under our strategic collaboration with Novartis. We believe we have a sufficient cash runway to pursue all planned clinical activities for the next three years.”
Financial Results for First Quarter Ended March 31, 2015
Research and development expenses for the three months ended March 31, 2015 were $3.2 million, an increase of $0.5 million, or 18%, compared to $2.7 million for the corresponding 2014 period. The increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-9020 and BL-5010.
Sales and marketing expenses for the three months ended March 31, 2015 were $0.3 million, a decrease of $0.1 million, or 29%, compared to $0.4 million for the three months endedMarch 31, 2014. The decrease resulted primarily from professional fees related to a number of significant business development activities carried out during the 2014 period, which resulted in collaboration and outlicensing agreements later in the year.
General and administrative expenses for the three months ended March 31, 2015 were $0.9 million, a decrease of $0.1 million, or 14%, compared to $1.0 million for the three months ended March 31, 2014. The small decrease resulted primarily from exchange rate differences.
The Company’s operating loss for the three months ended March 31, 2015 amounted to $4.3 million, compared with an operating loss of $4.1 million for the corresponding 2014 period.
The Company recognized an immaterial amount of net non-operating expenses for the three months ended March 31, 2015, compared to net non-operating income of $1.7 million for the corresponding period in 2014. Non-operating income (expenses) for both periods primarily relates to fair-value adjustments of liabilities on account of the warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date).
The Company recognized an immaterial amount of net ﬁnancial income for the three months ended March 31, 2015, compared to net ﬁnancial income of $0.3 million for the corresponding period in 2014. Net financial income (expenses) for the 2015 period primarily relates to investment income earned on bank deposits, as well as banking fees. The 2014 period also includes exchange rate differences primarily relating to changes in the USD/NIS exchange rate.
The Company’s net loss for the three months ended March 31, 2015 amounted to $4.3 million, compared with a net loss of $2.1 million for the corresponding 2014 period.
The Company held $57.5 million in cash, cash equivalents and short-term bank deposits as of March 31, 2015.
Net cash used in operating activities was $3.5 million for the three months ended March 31, 2015, compared with net cash used in operating activities of $3.4 million for the three months ended March 31, 2014. The $0.1 million increase in net cash used in operating activities during the three-month period in 2015, compared to the three-month period in 2014, was primarily the result of increased research and development spending, partially offset by an increase in trade payables and accruals.
Net cash used in investing activities for the three months ended March 31, 2015 was $20.7 million, compared to net cash used in investing activities of $19.1 million for the three months ended March 31, 2014. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.
Net cash provided by financing activities for the three months ended March 31, 2015 was$26.5 million, compared to net cash provided by financing activities of $22.6 million for the three months ended March 31, 2014. The cash flows from financing activities primarily reflect underwritten public offerings of our ADSs in March 2015 and 2014. (Original Source)
Shares of Biolinerx closed last Friday at $1.99 . BLRX has a 1-year high of $3.28 and a 1-year low of $1.20. The stock’s 50-day moving average is $2.08 and its 200-day moving average is $1.87.
On the ratings front, Biolinerx has been the subject of a number of recent research reports. In a report issued on May 4, Roth Capital analyst Joseph Pantginis maintained a Buy rating on BLRX, with a price target of $10.50, which implies an upside of 427.6% from current levels. Separately, on the same day, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $8.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of 6.3% and -0.6% respectively. Pantginis has a success rate of 48.5% and is ranked #454 out of 3604 analysts, while Kolbert has a success rate of 39.4% and is ranked #2967.
Bioline Rx Ltd is a clinical stage biopharmaceutical development company engaged in identifying, in-licensing & developing therapeutic compounds.