VBL Therapeutics Announces Second Quarter 2017 Financial Results
“VBL made significant advances on clinical and operational fronts during the second quarter of 2017,” said Prof.
“VB-111 continues to generate positive clinical results and we recently provided follow-up data demonstrating that more than 50% of patients achieved long-term survival following treatment with VB-111 in our three completed Phase 2 trials, in rGBM, platinum-resistant ovarian cancer and radioiodine refractory differentiated thyroid cancer. VBL is also following up on patients who remain alive for up to 7 years after enrolling into VB-111 Phase 1 study,” continued Prof. Harats. "We are on track to initiate a Phase 3 study of VB-111 in ovarian cancer by year-end 2017 and an exploratory clinical study in combination with a checkpoint inhibitor in lung cancer in Q1 2018.”
“As we are planning for commercialization of VB-111 in rGBM and preparing to launch our new manufacturing facility, we also made an important senior management addition during the quarter, with the appointment of Dr.
Second Quarter and Recent Corporate Highlights:
- Long-term survival update on VB-111: In addition to long-term survival for some Phase 1 patients being followed up to 7 years, the Company provided an update on long-term survival from VB-111 Phase 2 trials of patients with multiple tumor types, at the
BIO International Convention.
• rGBM: In the Phase 2 rGBM study, 12-month survival was 54% in patients who were treated with VB-111 through progression, including an rGBM patient who remains alive with complete response after 38 months, compared to 23% of patients who had limited exposure of a therapeutic dose of VB-111. According to a meta-analysis, the 12-month survival on Avastin® (bevacizumab) is only 24%.
• Ovarian cancer: In the Phase 2 recurrent platinum-resistant and refractory ovarian cancer study, 53% of patients treated with a therapeutic dose of VB-111 in combination with paclitaxel were alive at 15 months. No patients in the sub-therapeutic dose were alive at the 15-month time point.
• Thyroid cancer: In the Phase 2 radioiodine refractory differentiated thyroid cancer study, 53% of those who received multiple therapeutic doses of VB-111 were alive at 24 months, compared to 33% of those who received a single, sub-therapeutic dose of VB-111. 35% of patients on the therapeutic dose cohort remain alive at 39 to 46 months.
- Presented new data at the
American Society of Clinical Oncology( ASCO) annual meeting that strengthen the evidence for the anti-tumor activity of VB-111 in rGBM.
• The data, from patients in the completed Phase 2 study of VB-111 in rGBM, demonstrate that longer exposure of VB-111 significantly attenuated tumor growth kinetics and was associated with more frequent tumor regression, compared with limited exposure.
• Full data analysis of our Phase 2 study in rGBM shows statistically-significant benefit of VB-111 not just on Overall Survival (OS) (p=0.043), but also on Progression-Free Survival (PFS) (p=0.01).
- Published research on MOSPD2, a novel immune-oncology target at the annual American Association of Cancer Research (AACR) meeting.
• Targeting of MOSPD2 may have several therapeutic applications, including inhibition of monocyte migration in chronic inflammatory conditions, inhibition of tumor cell metastases and targeting of MOSPD2 tumor cells.
• VBL’s “VB-600 series” of pipeline candidates is being developed toward these applications.
Corinne Epperly, MD, MPH, as US Chief Operating Officer.
• Dr. Epperly is an oncology expert with industry background in drug development, strategy, commercialization and operations. Her experience includes seven years at Bristol-Myers Squibb, where most recently she was involved in leading the preparation for the commercial launches of OPDIVO® (nivolumab) in hepatocellular carcinoma, glioblastoma and metastatic melanoma.
• Dr. Epperly will have key responsibilities in forming VBL's marketing strategy and commercialization plans for VB-111.
- Awarded a grant of 8.75 million New Israeli Shekels (approximately
$2.5 million) by the Israel Innovation Authority. The grant will support clinical trials and development activities for calendar year 2017 and beyond.
Second Quarter Ended
- Cash Position: At
June 30, 2017, we had cash, cash equivalents and short-term bank deposits totaling $33.8 millionand working capital of $31.8 million. We expect that our cash, cash equivalents and short-term bank deposits will enable us to fund our operating expenses and capital expenditure requirements into 2019 and is expected to be sufficient to enable us to complete our on-going Phase 3 clinical trial of VB-111 in rGBM, to support our planned potential registrational trial in ovarian cancer and an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor in lung cancer, as well as to support the launch of our new Modiin facility.
- R&D Expenses: Research and development expenses for the quarter ended
June 30, 2017were approximately $3.2 million, compared to approximately $2.2 millionin the same period of 2016.
- G&A Expenses: General and administrative expenses for the quarter ended
June 30, 2017were approximately $1.9 million, compared to approximately $1.1 millionin the same period of 2016. The bulk of this increase is attributed to a one-time non-cash cost for management share-based compensation expense.
- Net Loss: The Company reported a net loss for the quarter ended
June 30, 2017of $4.9 million, or ($0.18)per share, compared to a net loss of $3.3 million, or ($0.14)per share in the quarter ended June 30, 2016.
Six Months Ended
- R&D Expenses: Research and development expenses (net) were
$7.4 millionfor the six month period of 2017, compared to $6.2 millionfor the six month period of 2016.
- G&A Expenses: General and administrative expenses for the six month period of 2017 were
$3.0 million, compared to $1.9 millionin the same period of 2016. See related comment for second quarter above.
- Net Loss: Net loss for the six months of 2017 was
$9.9 million, or ($0.37)per share, compared to a net loss of $8.0 million, or ($0.35)per share in the first six months of 2016.
Replays, Available through
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of ofranergene obadenovec (VB-111) and its therapeutic potential, ongoing and planned clinical trials and clinical results, including the timing thereof, our other pipeline candidates, including the clinical development and therapeutic potential of our VB-600 series of pipeline candidates and Lecinoxoids in NASH, our new Modiin facility and our cash position and financial outlook. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our pivotal Phase 3 clinical trial of ofranergene obadenovec (VB-111) in rGBM may not support approval of ofranergene obadenovec for marketing in
|VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
|June 30,||December 31,|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||11,064||$||11,585|
|Short-term bank deposits||22,724||33,669|
|Other current assets||3,875||1,320|
|TOTAL CURRENT ASSETS||37,663||46,574|
|Property and equipment, net||3,171||687|
|Long-term prepaid expenses||176||13|
|TOTAL NON-CURRENT ASSETS||3,347||700|
|Liabilities and equity|
|Accounts payable and accrued expenses:|
|TOTAL CURRENT LIABILITIES||5,817||4,788|
|Severance pay obligations, net||94||86|
|Accumulated other comprehensive income||40||40|
|Additional paid in capital||200,005||197,400|
|TOTAL LIABILITIES AND EQUITY||$||41,010||$||47,274|
|VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|Three Months Ended June 30,||Six Months Ended June 30,|
|U.S. dollars in thousands|
|RESEARCH AND DEVELOPMENT EXPENSES, net||$||3,209||$||2,230||$||7,353||$||6,233|
|GENERAL AND ADMINISTRATIVE EXPENSES||1,898||1,060||3,003||1,923|
|FINANCIAL EXPENSES, net||(235||)||(16||)||(450||)||(153||)|
|LOSS PER ORDINARY SHARE||U.S. dollars|
|Basic and diluted||$||0.18||$||0.14||$||0.37||$||0.35|
|Number of shares|
|WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING—|
|Basic and diluted||27,009,719||23,602,333||26,957,719||23,033,339|
Michael Rice LifeSci Advisors, LLC(646) 597-6979 MEDIA CONTACT: Matt MiddlemanLifeSci Public Relations (646) 627-8384