VBLT Vascular Biogenics Ltd

VBL Therapeutics (NASDAQ:VBLT), announced financial results for the three and six months ended June 30, 2017 and provided a corporate update.

“VBL made significant advances on clinical and operational fronts during the second quarter of 2017,” said Prof. Dror Harats, Chief Executive Officer of VBL Therapeutics. “We continue to progress in our Phase 3 GLOBE study investigating our lead asset VB-111 in patients with recurrent glioblastoma (rGBM). The trial is proceeding according to plan, following a second positive review by the independent Data Safety Monitoring Committee (DSMC) that took place in April. We expect a final DSMC review in late September, and top-line data in Q1 2018. Based on our interactions with the FDA and the SPA for the trial, the GLOBE study should support a Biologics License Application (BLA)."

“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. Corinne Epperly as our US Chief Operating Officer. Dr. Epperly’s impressive skills and industry track record will be valuable assets to VBL as we continue to advance VB-111 in multiple oncology indications. We welcome her to the team and look forward to the contributions she will make,” concluded Prof. Harats.

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.
• Appointed 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 June 30, 2017 Financial Results:

• Cash Position:  At June 30, 2017, we had cash, cash equivalents and short-term bank deposits totaling $33.8 million and 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, 2017 were approximately $3.2 million, compared to approximately $2.2 million in the same period of 2016.
• G&A Expenses:  General and administrative expenses for the quarter ended June 30, 2017 were approximately $1.9 million, compared to approximately $1.1 million in 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, 2017 of $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 June 30, 2017 Financial Results:

• R&D Expenses:  Research and development expenses (net) were $7.4 million for the six month period of 2017, compared to $6.2 million for 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 million in 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.

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About VBLVascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class biologic agent that uses a dual mechanism to target solid tumors. It utilizes an angiogenesis-specific sensor (VBL's PPE-1-3x proprietary promoter) to specifically target the tumor vasculature, by induction of cell death in angiogenic endothelial cells in the tumor milieu. Moreover, it is an immune-stimulant that triggers a local anti-tumor immune response, which is accompanied by recruitment of CD8 T-cells and apoptosis of tumor cells. Ofranergene obadenovec is positioned to treat a wide range of solid tumors and is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and we have observed its efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).

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 the United States, notwithstanding the positive results seen in prior clinical experience. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

VASCULAR BIOGENICS LTD.CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION(UNAUDITED)
		June 30,				December 31,
		2017				2016
		U.S. dollars in thousands
Assets
CURRENT ASSETS:
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
NON-CURRENT ASSETS:
Property and equipment, net			3,171				687
Long-term prepaid expenses			176				13
TOTAL NON-CURRENT ASSETS			3,347				700
TOTAL ASSETS		$	41,010			$	47,274
Liabilities and equity
CURRENT LIABILITIES—
Accounts payable and accrued expenses:
Trade		$	4,087			$	2,522
Other			1,730				2,266
TOTAL CURRENT LIABILITIES			5,817				4,788
NON-CURRENT LIABILITIES—
Severance pay obligations, net			94				86
TOTAL LIABILITIES			5,911				4,874
EQUITY:
Ordinary shares			50				50
Accumulated other comprehensive income			40				40
Additional paid in capital			200,005				197,400
Warrants			2,960				2,960
Accumulated deficit			(167,956	)			(158,050	)
TOTAL EQUITY			35,099				42,400
TOTAL LIABILITIES AND EQUITY		$	41,010			$	47,274

VASCULAR BIOGENICS LTD.CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS(UNAUDITED)
		Three Months Ended June 30,								Six Months Ended June 30,
		2017				2016				2017				2016
		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
OPERATING LOSS			5,107				3,290				10,356				8,156
FINANCIAL INCOME			(239	)			(22	)			(458	)			(159	)
FINANCIAL EXPENSES			4				6				8				6
FINANCIAL EXPENSES, net			(235	)			(16	)			(450	)			(153	)
COMPREHENSIVE LOSS		$	4,872			$	3,274			$	9,906			$	8,003
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

 

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