VBL Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Update

Rhea-AI Summary

VBL Therapeutics reported financial results for Q2 2021, highlighting a cash position of $57.2 million expected to fund operations until year-end 2023. A public offering raised $26.4 million, allowing for continued development of VB-111, now with an amended primary endpoint including progression-free survival (PFS). Despite increasing R&D expenses rising to $6.6 million, the company’s net loss widened to $8.0 million or ($0.12) per share, compared to ($0.14) per share in 2020. VBL anticipates key data and potential BLA submission for VB-111 in the upcoming year.

Positive

• Net proceeds of $26.4 million from public offering bolster cash reserves.
• Cash position projected to support operations until year-end 2023.
• Amendment of primary endpoint in OVAL study to include PFS expected to enhance trial outcomes.

Negative

• Net loss increased to $8.0 million for Q2 2021, compared to $5.8 million in Q2 2020.
• R&D expenses rose significantly, indicating increased operational costs.

Conference Call and Webcast at 8:30 a.m. EDT Today

	●	Closed public offering raising net proceeds of $26.4 million; cash position is expected to fund operations until year-end 2023, through readout from the OVAL study and potential Biologics License Application (BLA) submission for VB-111 in ovarian cancer
	●	Announced amendment to primary endpoint in OVAL study to include progression free survival (PFS); PFS data expected in second half of 2022; next Data and Safety Monitoring Committee (DSMC) review expected 3Q21
	●	Prepared and submitted requested VB-111 Chemistry, Manufacturing, and Controls (CMC) documentation to the FDA in early August; currently awaiting FDA guidance on use of new batches

TEL AVIV, Israel, Aug. 16, 2021 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.

“With $57.2 million in cash that is projected to fund our operations until year-end 2023, we are excited to advance our OVAL study, with PFS as its additional primary endpoint, towards clinical readout in the second half of 2022,” said Dror Harats, M.D., Chief Executive Officer of VBL. “Following the FDA request for additional technical production data on VB-111, we prepared and submitted the requested information in early August and are currently awaiting agency guidance. With several important milestones anticipated through the rest of 2021, we look forward to keeping investors apprised of our progress.”

Second Quarter and Recent Corporate Highlights

VB-111

	●	In June, VBL presented an update on the progress of the OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation announced an amendment to the primary endpoint in the OVAL study to include a second, separate primary endpoint of PFS in addition to the original primary endpoint of overall survival (OS).
	●	As part of VBL’s discussion with the Chemistry, Manufacturing, and Controls (CMC) group of the FDA on VB-111 production, it was agreed that VBL would provide additional documentation on new batches to be used in the OVAL study. VBL prepared and submitted the requested documentation to the FDA in early August and is currently awaiting agency guidance.
	●	As a precautionary step to preserve supply of FDA-approved batches, in June, VBL voluntarily paused enrollment of new U.S. patients in the OVAL study. Existing patients enrolled in the United States continue on protocol and enrollment continues in Europe, Israel, and in recently opened sites in Japan.

Corporate

	●	In April, VBL closed a public offering raising net proceeds of $26.4 million. The Company’s cash position is expected to fund operations until year-end 2023, through the readout from the OVAL study and potential BLA submission for VB-111 in ovarian cancer.
	●	In July, VBL announced the appointments of Alison Finger and Michael Rice to its Board of Directors.
	●	In July, the planned succession for Chairmanship of VBL’s Board of Directors was completed. Marc Kozin, who joined the Board as Vice Chairman in October 2020 was appointed Chairman. Former Chairman, Dr. Bennett Shapiro, stepped down as Chairman but will remain a Director.

Financial Results for the Second Quarter 2021

	●	As of June 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $57.2 million. In April 2021, VBL raised net proceeds of $26.4 million in a public offering of shares and pre-funded warrants (including partial exercise of the underwriters’ overallotment option). VBL expects that its cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements until year-end 2023.
	●	Revenues for the second quarter 2021 were $188 thousand, as compared to $158 thousand in the comparable period in 2020.
	●	R&D expenses, net, were $6.6 million for the second quarter compared to $4.7 million in the comparable period in 2020. This increase is due to the clinical development activity of VB-111 for ovarian cancer, in addition to the advancement of VB-601 toward Investigational New Drug Application (IND) submission.
	●	G&A expenses were $1.5 million for the second quarter compared to $1.3 million in the comparable period in 2020.
	●	VBL reported a net loss for the quarter ended June 30, 2021, of $8.0 million, or ($0.12) per basic share, compared to a net loss of $5.8 million, or ($0.14) per basic share, in the comparable period in 2020.

Conference Call and Webcast:
Monday, August 16 at 8:30 a.m. EDT
Conference ID: 13721456
From the US: 1 877 407 9208
Israel Local: 1 809 406 247
International: 1 201 493 6784
Webcast: https://edge.media-server.com/mmc/p/9trg9snq

The live webcast will be available online and may be accessed from the “Events and Presentation” page of VBL's website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

About VBL Therapeutics

Vascular 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 areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111; `ofra-vec`), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is currently being studied in a VBL-sponsored Phase 3 registration enabling trial for platinum-resistant ovarian cancer.

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 may include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, therapeutic potential and clinical results. 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, the risk that historical clinical trial results may not be predictive of future trial results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. In particular, the DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint of overall survival once completed, or that we will obtain positive results to support further development of this candidate. A further list and description of these risks, uncertainties and other risks can be found in our regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2020, and subsequent filings with the SEC. 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.

CONTACT:
Burns McClellan for VBL Therapeutics
Lee Roth & Eric Ando (Investors)
LRoth@burnsmc.com & EAndo@burnsmc.com
+1-212-213-0006
Robert Flamm & Harrison Wong (Media)
RFlamm@burnsmc.com & HWong@burnsmc.com
+1-212-213-0006

VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(UNAUDITED)

		June 30, 2021				December 31, 2020
		U.S. dollars in thousands
ASSETS
Current assets:
Cash and cash equivalents		$	31,660			$	13,184
Restricted bank deposits			-				151
Short-term bank deposits			25,131				17,110
Trade receivables			-				129
Other current assets			1,017				1,419
Total current assets			57,808				31,993
Non-current assets:
Restricted bank deposits			361				362
Long-term prepaid expenses			222				241
Funds in respect of employee rights upon retirement			337				354
Property, plant and equipment, net			6,439				6,632
Operating lease right-of-use assets			2,173				2,124
Total non-current assets			9,532				9,713
Total assets		$	67,340			$	41,706
LIABILITIES, ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND
SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable:
Trade		$	2,487			$	1,960
Other			4,864				4,275
Deferred revenue			752				725
Current maturity of operating leases liability			477				393
Current maturity of finance lease liability			-				106
Total current liabilities		$	8,580			$	7,459
Non-current liabilities:
Liability for employee rights upon retirement			452				474
Deferred revenue			352				704
Operating lease liability			1,946				2,029
Other non-current liability			155				123
Total non-current liabilities			2,905				3,330
Commitments
Total liabilities		$	11,485			$	10,789
Ordinary shares subject to possible redemption, 615,366 shares at redemption value (see note 4b)			1,598				-
Shareholders’ equity:
Ordinary shares, NIS 0.01 par value; Authorized as of June 30, 2021 and December 31, 2020, 150,000,000 shares; issued and outstanding as of June 30, 2021 and December 31, 2020 61,421,159 and 48,187,463 shares, respectively (excluding 615,366 and -0- shares subject to possible redemption, as of June 30, 2021 and December 31, 2020, respectively)			148				108
Additional paid in capital			292,017				252,561
Warrants			8,556				10,401
Accumulated deficit			(246,464	)			(232,153	)
Total equity			54,257				30,917
Total liabilities, ordinary shares subject to possible redemption and shareholders’ equity		$	67,340			$	41,706

The accompanying notes are an integral part of the financial statements.

VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(UNAUDITED)

		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2021				2020				2021				2020
		U.S. dollars in thousands
Revenues		$	188			$	158			$	373			$	524
Cost of revenues			(89	)			(21	)			(179	)			(166	)
Gross profit			99				137				194				358
Research and development expenses, net		$	6,642			$	4,664			$	11,411			$	9,173
General and administrative expenses			1,481				1,338				3,154				2,677
Operating loss			8,024				5,865				14,371				11,492
Financial income			(3	)			(45	)			(87	)			(335	)
Financial expenses			7				11				27				26
Financial income, net			4				(34	)			(60	)			(309	)
Net loss and comprehensive loss		$	8,028			$	5,831			$	14,311			$	11,183

		U.S. dollars
Loss per share (see note 3)
Basic and diluted		$	0.12			$	0.14			$	0.24			$	0.28

		Number of shares
Weighted average shares outstanding
Basic and diluted			68,092,953				42,674,526				60,075,863				39,354,355

The accompanying notes are an integral part of the financial statements.

FAQ

What were VBL Therapeutics' Q2 2021 financial results?

In Q2 2021, VBL reported revenues of $188 thousand and a net loss of $8.0 million, or ($0.12) per share.

What is the current cash position of VBL Therapeutics?

VBL has a cash position of $57.2 million, sufficient to fund operations until the end of 2023.

When is the next major data readout expected for VB-111?

The next data readout for the OVAL study of VB-111 is expected in the second half of 2022.

What changes were made to the OVAL study protocol?

The primary endpoint of the OVAL study was amended to include progression-free survival (PFS) along with overall survival (OS).

How did the public offering affect VBL Therapeutics' finances?

The recent public offering raised $26.4 million, enhancing the company's financial stability.