On May 14, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, VBL Therapeutics, MAY 14, 2020, View Source [SID1234558005]).
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"We reached an important milestone in our development of VB-111 in ovarian cancer with the recent positive outcome of the interim analysis of the ongoing Phase 3 OVAL study, which demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "A second planned interim analysis which will assess overall survival in the two treatment arms, is expected in the third quarter this year. We are pleased to be making progress also in our MOSPD2 antibody programs. We recently presented promising new data in NASH and colitis models in a Poster of Distinction at Digestive Disease Week, and also published a peer review manuscript on the potential of MOSPD2 antibodies to treat multiple sclerosis (MS). New data on our MOSPD2 bi-specific antibodies will be presented in a late breaking session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in June. Based on these positive developments, we successfully raised additional $18.1 million in gross proceeds, in spite of the COVID-19 pandemic complexities. Our current cash position is expected to fund our operations into the third quarter of 2022."
First Quarter and Key Corporate Highlights:
VB-111:
●The independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data from the ongoing OVAL study in ovarian cancer and determined that the study has met the interim pre-specified criterion, of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification.
●The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.
●The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in Phase 2, which enrolled similar population of patients with platinum-resistant ovarian cancer. The results will be presented at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.
●The OVAL interim analysis results were discussed by Dr. Bradley J. Monk of Arizona Oncology on a KOL call hosted by the Company on March 26.
●NanoCarrier Co., Ltd., the Japanese licensee for VB-111, announced its intention to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan.
●The Israel Innovation Authority (IIA) awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) to fund development of VB-111.
●The planned studies of VB-111 in metastatic colorectal cancer and GBM are expected to start patient recruitment as soon as the COVID-19 situation allows.
MOSPD2:
●Published a new peer review manuscript demonstrating the potential of MOSPD2 antibodies for multiple sclerosis (MS).
○VBL’s data offer a differentiated approach to potential treatment of relapsing as well as progressive MS disease
●New preclinical data on MOSPD2 antibodies for treatment of NASH and colitis were presented at Digestive Disease Week (DDW).
○Data demonstrate the potential of VBL’s proprietary MOSPD2 mAbs for chronic inflammatory indications, via a novel and distinct mechanism targeting monocyte migration
○The study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction
VB-201:
●A milestone event was reached under VBL’s collaborative agreement with a world-leading European animal health company, evaluating use of VB-201 for veterinary applications.
Quarter Ended March 31, 2020 Financial Results:
●Cash Position: At March 31, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $31.6 million and working capital of $24.6 million. VBL expects that its cash and cash equivalents and short-term bank deposits with the addition approximately $16.7 million from the net proceeds of the Registered Direct Offerings of which we have announced on May 7, 2020 and on May 11, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.
●Revenues: Revenues for the three-month period ended March 31, 2020 were $366 thousand, compared to $219 thousand in the same period of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, in the three-month period ended March 31, 2020, were $4.8 million, compared to $3.3 million in the same period in 2019.
●G&A Expenses: General, administrative and marketing expenses for the three-month period ended March 31, 2020, were $1.2 million, compared to the $1.3 million in the same period in 2019.
●Comprehensive Loss: VBL reported a net loss for three-month period ended March 31, 2020 of $5.4 million, or ($0.15) per diluted share, compared to a net loss of $4.2 million, or ($0.12) per diluted share, in the same period of 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.
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