VBL Therapeutics

everyone, and thank you for joining the VBL Therapeutics Third Quarter 2021 Financial Results and Corporate Update Call. Joining me on the call is Professor Bo Harad, Chief Executive Officer, and Sam Backenroth, 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 VBL's website at ir.vblrx.com. Before turning the call over to Dror and Sam, 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 of the Private Security 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 filing with the SEC, which includes, among other things, our annual report on Form 20-F. 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, November 15th, 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 our 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 Loharat. Loharat, please go ahead.

Thank you, Erez, and good morning, everyone. Joining me on today's call is Sam Beckinross, our new chief financial officer, who will discuss the third quarter financial results for 2021. We continue to execute on our development programs and strategic objectives and look forward to 2022, which we believe is going to be a transformational year for VBL. We expect to have data from multiple VB111 clinical trials in high-value indications, including the progression-free survival co-primary endpoint from the phase III oval study in ovarian cancer. We also anticipate beginning first in human studies, evaluating VB601, our monocytes targeting antibody, for the treatment of chronic immune inflammatory diseases. Our Oval Clinical Trial, a registration-enabling phase three study of VB111 in ovarian cancer, has now enrolled over 85% of the targeted study patient population. and we expect to complete enrollment in the first quarter of 2022. Also, in the first quarter of next year, we expect to have another DSMC review, which will include a data set of almost 100%, if not a 100%, of the total study population. The next milestone in the overall trial we are looking forward to is a readout of the progression-free survival co-primary endpoint in the second half of 2022. This is particularly important as successfully meeting the PFS endpoint has the potential to enable us to submit a BLA one year ahead of plan compared to our original projections, which were based on the readout of the overall survival primary endpoint, which remain anticipated in 2023. In addition to the readout in ovarian cancer, in 2022 we also expect preliminary data from the investigator-sponsored clinical trial of VB111 in colorectal cancer in the first half of 2022 and from the recurrent GBM trial in the second half of 2022. We believe that VB111, based on its dual mechanism of action targeting tumor vasculature and immune recruitment, has a potential to change the standard of care in multiple solid tumor indications. As for our pipeline, we continue to advance our monocytes targeting program and expect to initiate a first in human study for our lead candidate VB601 in 2022. We believe that VB601 has a new and differentiated approach in the landscape of anti-inflammatory agents by specifically targeting monocytes, which are crucial for the development of chronic immune inflammatory diseases. Based on our promising preclinical data, VB601 may have applicability for a range of high-value immune inflammatory indications. To prepare the company for the continued growth and the commercialization of VB111, We recently strengthened our management and board and opened a U.S. office. In addition to the appointment of Sam Beckenrose as CFO, we also added Mike Rice and Alison Finger to the board. Mike has many years of capital markets and IR experience with particular expertise in helping emerging biopharma companies attack high-quality investors. Alison brings nearly three decades of leadership experience in biotech and pharma. She was previously chief commercial officer at Bluebird Bio, where she built the commercial infrastructure in Europe and the US in advance of Bluebird's first gene and cell therapy product launches. VBL is well capitalized. with the expected cash runway into the fourth quarter of 2023, significantly beyond the BFS readout and potential BLA filing. And we are excited to be building momentum as we head into 2022, a year with a number of potential catalysts and multiple opportunities to create value. At this point, I would like to introduce Sam Beckenrose, our Chief Financial Officer to the audience. Sam has proven track record in corporate, finance, strategy, operations, and business development. And I'm confident that his leadership and strong investor and banking relationships will help VBL as we enter a new era of innovation and growth. With that, I will hand over to Sam to discuss the third quarter 2021 financial results. Sam, please go ahead.

Thank you, Gerard, and good morning, everyone. First of all, I would like to say how thrilled I am to be working with VBL's management team and board of directors to capitalize on our tremendous potential to bring novel therapies to people with cancer and immune inflammatory disorders. What drew me to VBL was the company's cutting-edge science and deep understanding of biology, coupled with an experienced and driven team with the ability to develop highly differentiated therapeutics. I am especially impressed by the corporate culture at VBL and commitment of the entire team to help cancer patients in need and improve the standard of care. I'm excited to be leading the build out of VBL's U.S. operations as we head towards significant inflection points in 2022 and begin preparing for a potential commercial launch of VB111. My appointment is consistent with the company's plan to raise awareness with investors, and I look forward to meeting some of you in person in the coming months. Now on to the third quarter financial results. As of September 30, 2021, we had cash, cash equivalents, short-term bank deposits, and restricted bank deposits totaling $50.8 million. After the quarter ended, we received an additional $9.6 million in proceeds from warrant exercises. We expect that our cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023. Revenues for the third quarter were $0.2 million as compared to $0.2 million for the comparable period in 2020. R&D expenses net was $5 million for the third quarter as compared to $4.6 million in the same period of 2020. For general and administrative expenses, it was $1.6 million for the third quarter as compared to $1.3 million in the same period for 2020. And finally, comprehensive loss for the third quarter was $6.5 million or $0.09 per ordinary share compared to $5.8 million or $0.12 per basic share in the comparable period in 2020. With that, I would like to return the call back to the operator for the question and answer portion of this morning's call. Thank you.