VBL Therapeutics

Good morning, everyone, and thank you for joining today's VBL Therapeutics Second Quarter 2021 Financial Results and Corporate Updates. Leading the call will be Professor Dror Haras, Chief Executive Officer, and Amos Ron, Chief Financial Officer. A press release of the company's financial results was issued earlier this morning and is available on the Investor Relations page of the company's website at vblrx.com. Before turning the call over to management, I would like to remind everyone that during this conference call, Forward-looking statements made by management are intended to fall within the Safe Harbor Provisions Act of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934 as amended. As set forth in our press release, forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which include, among other things, our annual report on Form 20F. These filings are available from the SEC or on our website. Any forward-looking statements made on today's conference call speak only as of today's date, Monday, August 16, 2021, and the company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date. As a reminder, this call is being recorded and will be available for audio rebroadcast on the company's website. There will be a Q&A session following the company's prepared remarks. With that, I'd like to turn the call over to Professor Harath. Please go ahead.

Thank you, Eric, and good morning, everyone. Joining me on today's call is Amos Ron, our chief financial officer, who will discuss the second quarter financial results for 2021. We continue to make progress in our Oval Clinical Trial, a registration-enabling phase three study of VB111 in ovarian cancer. The most significant event of the second quarter was the overall protocol change agreed upon with the US FDA. Progression-free survival was added as a primary endpoint to the original overall survival endpoint. Successfully meeting either endpoint is expected to be sufficient to support a BLA submission. The details of the change were described in a presentation at this year's ASCO Annual Meeting in early June and the accompanying press release. Successful meeting of the progression-free survival endpoint with the readout anticipated in the second half 2022 has the potential to accelerate the BLA submission by approximately one year compared to original projections based on the readout of the overall survival primary endpoint, which remains anticipated in 2023. In addition to potentially shortening the time for the anticipated BLA submission, the protocol changes have several positive implications for the Oval Trial and VP111's potential use as a treatment for platinum resistant ovarian cancer. First, including a second independent endpoint, de-risks the trial, as we now have two shots on goal to obtain a result that will enable us to submit a BLA. Second, keeping the overall survival endpoint preserved the opportunity to differentiate VB111 from currently available ovarian cancer treatments, which were approved based on progression-free survival data so far, and did not show an overall survival benefit. As part of our discussion with the U.S. FDA's CMC, the Chemistry Manufacturing and Controls Group, it was agreed that VBL would provide additional data and documentation on new batches to be used in the oval study in the U.S. We submitted all requested material to the agency in early August. and the CMC group is evaluating the data we sent them. At this point, we do not have an estimated timetable on when we will hear back from the agency regarding their review. In the meantime, we took a precautionary step to reserve supply of FDA-approved batches of VB111 for U.S. patients who are being actively treated in the oval study And in June, we voluntarily paused enrollment of new U.S. patients. Existing patients enrolled in the U.S. continue on protocol, and enrollment continues in Europe, Israel, and Japan. Despite the temporary pause in U.S. enrollment, we maintain our expectations with respect to the timing of the PFS data readout in the second half of 2022. Our next milestone for Oval is the upcoming DSMC review expected this quarter. This time, it will include review of 75% of the study population. That is about 300 patients. To date, we have had three successful DSMC reviews of the study. The most recent one was in February of this year. Following the review, which looked at 200 patients, the DSMC again gave us a green light to proceed as planned. In the second quarter, we also significantly strengthened our cash position. Earlier in the quarter, we closed a public equity offering at market price to raise net proceeds of $26.4 million from existing shareholders as well as institutional funds from the U.S. and Israel. Together with the additional of $12.3 million that was injected into the company during the first quarter, mostly through the existing of warrants that were issued in 2020, we now have more than $57 million on hand. These funds are expected to cover the company until the year end 2023, which is beyond clinical readout in Oval and the potential BLA submission of the VB111 in ovarian cancer. As VBL prepares for success and potential commercialization of VB111, we had a few changes to our board of directors. We are happy to welcome Alison Finger and Michael Rice to our board. Alison was previously the chief commercial officer at Bluebird Bio and has extensive experience in global product commercialization, including commercialization of gene and cell therapy products at Bluebird. Michael's experience in healthcare capital markets will be critical to VBL as we approach the disclosure of top-line data from Oval and as we plan to execute our strategic and operational objectives in bringing VB111 to patients. Finally, our planned succession for the chairmanship of our board was recently completed. Mark Ozin, who joined our board as vice chairman last October, is now our chairman. Dr. Bennett Shapiro stepped down as a chairman but will continue to contribute to VBL as a member of our board. Before I hand the call over to our Chief Financial Officer Amos Rohn, I would like to say that we have continued our momentum from 2020 into the first half of 2021 and are optimistic about the second half of this year. We are encouraged by the significant investments of VB111 and I look forward to sharing updates on our ongoing programs through the rest of the year. With that, I will hand off the call to Amos, who will discuss the financial results for the second quarter. Thank you.

Thank you, George, and good morning, everyone. As of June 30, 2021, we had cash, cash equivalents, short-term bank deposits, and restricted bank deposits totaling $57.2 million. and working capital of $49.2 million. We expect that our cash and cash equivalent 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 were $188,000 as compared to $158,000 for the comparable period in 2020. R&D expenses net was $6.6 million for the fiscal year compared to $4.7 million in the same period in 2020. General and administrative expenses was $1.5 million for the second quarter compared to $1.3 million in the same period in 2020. And finally, comprehensive loss for the second quarter was $8 million or 12 cents per basic share compared to $5.8 million or 14 cents per basic share in the comparable period in 2020. With that, I will return the call back to the operator for the Q&A portion of this morning call. Thank you.