– Final results from motixafortide’s Phase 2 clinical trial, COMBAT-KEYNOTE-202, for the treatment of metastatic pancreatic cancer, showed significant improvement in all trial objectives compared to historical data –
Bioline R. Ex. (NASDAQ / Tel Aviv BLRX), A biopharmaceutical company in advanced clinical development stages focusing on oncology, today released its financial results for the year ended December 31, 2020.
Landmarks and achievements during the fourth quarter of 2020 to date:
Reporting of positive intermediate results from the Phase 3 clinical trial, GENESIS, for the test of motixafortide in stem cell mobility. The intermediate results of the main target of the experiment showed statistical significance in favor of treatment with motixafortide; Accordingly, the Data Monitoring Committee recommended to immediately discontinue the recruitment of patients and therefore, the recruitment of patients for the trial was completed and stands at 122 patients (instead of the 177 patients originally planned). Final results, including the primary and secondary efficiencies targets, are expected early in the second quarter of 2021. At the same time, the Company continues all activities leading up to the submission of NDA (US Product Registration) in this indication, expected in the first half of 2022, including a preliminary meeting with -FDA expected in the second half of the year.
Reporting of positive end results from the triple therapy arm in the COMBAT / KEYNOTE-202 clinical trial to evaluate motixafortide in combination with KEYTRUDA® and chemotherapy for patients with stage 4 metastatic pancreatic cancer. The results of the experiment showed a significant improvement across all the objectives of the experiment compared to historical data. The company is currently planning the further development of this program, including discussions with potential partners and writing a protocol for a randomized and controlled trial.
• Reporting the start of a Phase 2 clinical trial, led by Columbia University, to evaluate motixafortide in combination with LIBTAYO® and chemotherapy in patients with metastatic pancreatic cancer in the first line of treatment.
• Reporting the initiation of a Phase 1b clinical trial, led by Wolfson Medical Center, to evaluate motixafortide in patients with acute respiratory distress syndrome (ARDS) as a result of COVID-19 and other respiratory viral infections.
• Completion of a public offering of $ 34.5 million gross.
Philip Serlin, CEO of Bioline R., ex, “The fourth quarter of 2020, was the company’s most significant quarter to date, during which positive results were published from two trials in areas where there is a significant medical need – stem cell mobility and metastatic pancreatic cancer. Intermediate results from the Phase 3 clinical trial for stem cell mobility reported In October, there were significant positives and in accordance with the recommendation of the Data Monitoring Committee, the recruitment of patients in 122 patients was stopped, without the need to complete the recruitment of the 177 patients originally planned.
We now look forward to presenting full results from the trial, including results related to the completion of 100 days of transplant follow-up, early in the second quarter of the year. This stem cell mobility program is the most advanced towards registration and therefore we anticipate that these results will bring about a significant change for society. At the same time, we are making steady progress in all activities related to NDA filing, which is expected in the first half of next year. “
We are also excited about the final results of the Phase 2a, COMBAT / KEYNOTE-202 clinical trial in pancreatic cancer, which we reported in December 2020. The results of the triple treatment of motixafortide, KEYTRUDA and chemotherapy, showed a significant improvement throughout the trial goals including Median overall survival, median survival without disease progression, objective response rate and confirmed objective response rate as well as disease control rate.
These results are very encouraging, in light of this population of patients with metastatic pancreatic cancer in the second line of treatment, and moreover in light of the fact that these are patients who were first diagnosed with metastatic pancreatic cancer stage 4, and we plan to further develop this program, probably in collaboration with a biopharmaceutical company. .
Finally, in January 2021, we strengthened our balance sheet with a gross fundraising of $ 34.5 million. This amount will allow us to continue to implement our strategy for motixafortide in both stem cell and pancreatic cancer, while promoting the development of our additional clinical product, the treatment. “In summary, the immunotherapeutic agent, AGI-134. In conclusion, we ended 2020 very positively, with results from 2 trials. These results indicate the effectiveness and versatility of motixafortide in a variety of indications, and we intend to leverage these successes this year,” Mr. Serlin concluded.
Significant milestones expected:
• Final results from the Phase 3 clinical trial, GENESIS, in stem cell mobility are expected early in the second quarter of 2021;
Preliminary results of the second part of the Phase 1 / 2a clinical trial for AGI-134, in solid tumors, are expected in the second half of 2021;
• Preliminary meeting with the FDA for an indication of stem cell mobility is expected in the second half of 2021;
• NDA filing for stem cell mobility indication is expected in the first half of 2022;
Financial results for the year ended December 31, 2020
Research and development expenses in the year ended December 31, 2020 amounted to $ 18.2 million, a decrease of $ 5.2 million, or 22.5%, compared to $ 23.4 million in the year ended December 31, 2019. The decrease is mainly due to the closure of motixafortide’s BATTLE clinical trial in 2019. , From lower expenses related to the COMBAT trial and the AGI-134 trial, as well as from a decrease in benefit options and salary expenses due to a reduction in cross-company wages following the Corona plague.
Marketing and sales expenses for the year ended December 31, 2020 amounted to $ 0.8 million, similar to the corresponding year last year.
General and administrative expenses for the year ended December 31, 2020 amounted to $ 3.9 million, an increase of $ 0.1 million, or 2.6%, compared to $ 3.8 million for the year ended December 31, 2019. The increase is mainly due to an increase in expenses for directors ‘and officers’ insurance and From the benefit of options, offsetting a low decrease in the number of items of administrative and general expenses.
The Company’s operating loss for the year ended December 31, 2020 amounted to $ 22.9 million, compared to an operating loss of $ 28.1 million for the year ended December 31, 2019.
Other expenses in the year ended December 31, 2020 amounted to $ 5.7 million, compared to other expenses in the amount of $ 4.2 million in the year ended December 31, 2019. Other expenses in the year ended December 31, 2020 are mainly due to revaluation of financial liabilities measured at fair value. From expenses for the issuance of warrants and from expenses for the issuance of the ATM plan. Other income for the year ended December 31, 2019 is mainly due to the revaluation of financial liabilities measured at fair value in respect of warrants offsetting expenses in respect of the issuance of warrants.
Net financing expenses in the year ended December 31, 2020 amounted to $ 1.4 million, compared to net financing expenses of $ 1.5 million in the year ended December 31, 2019. Net financing expenses in both periods are mainly due to interest expenses offsetting interest income on bank deposits.
The Company’s net loss for the year ended December 31, 2020 amounted to $ 30.0 million, compared to a net loss of $ 25.5 million for the year ended December 31, 2019.
Cash, cash equivalents and short-term deposits as of December 31, 2020 amounted to $ 22.6 million. At the end of the year, the company completed a public offering of $ 34.5 million and received an additional $ 9.8 million as a result of the exercise of options.
Cash flow from operating activities in the year ended December 31, 2020 amounted to $ 23.2 million, compared to cash flow of $ 22.7 million in the year ended December 31, 2019. The increase of $ 0.5 million in cash flow used for operating activities in 2020 compared to the corresponding year last year , Is mainly due to a decrease in the balances of suppliers and eligible persons in the period of 2020.
Cash flow from investing activities in the year ended December 31, 2020 amounted to $ 16.7 million, compared to cash flow of $ 5.3 million in the year ended December 31, 2019. Cash flows related to investing activities are mainly attributed to investments and short-term withdrawals from deposits.
Cash flow from financing activities in the year ended December 31, 2020 amounted to $ 17.9 million, compared to cash flow of $ 19.2 million in the year ended December 31, 2019. Cash flow in 2020 mainly reflects the raising made in May and June as well as the proceeds from the plan. The ATM, offsetting the repayments for the loan received from Kreos Capital. The cash flow in 2019 mainly reflects the public offering completed in February 2019 as well as the consideration received from the ATM plan.