VBL Therapeutics

Greetings and welcome to the VBL Therapeutics full year 2021 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Dan Ferry of LifeSci Advisors. Thank you. You may begin.

Thank you, operator. Good morning, everyone, and thank you for joining the VBL Therapeutics Full Year 2021 Financial Results and Corporate Update Call. Joining me on the call is Professor Jorah Horatz, Chief Executive Officer, and Sam Backenroth, Chief Financial Officer. A press release with the company's financial results was issued earlier this morning and is available on the Investor Relations page of the VBL's website at 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 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, Wednesday, March 23, 2022. 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 Jorah Haratz. Jorah?

Thank you, Dan, and good morning, everyone. 2021 was a very productive year for VBL, and the excellent progress we made both in the clinic and operationally set us up for further success in 2022. Our lead candidate, Ofravec, also known as VP111, recently completed patient enrollment and is now in the late stages of the Oval Phase III Registrational Trial in Platinum-Resistant Ovarian Cancer. Recently, we also announced that the Independent Data Safety Monitoring Committee overseeing this trial made a unanimous recommendation that the oval trial should continue as planned. We are expecting data readout on the progression-free survival primary endpoint from this trial in the second half of this year. If successful, this will be a transformational event for VBL as it would position us to get ready to submit a BLA in ovarian cancer, which we would expect to occur in the first half of 2023. We have a number of other significant catalysts to look forward to this year, including clinical data in two other high-value cancer indications, colorectal cancer and glioblastoma. We have also recently successfully completed toxicology studies for VB601, the first anti-inflammatory candidate from our novel MTT technology targeting monocytes to fight chronic immune inflammatory disease and plan to enter the clinic with this program in the second half of 2022. Beginning with Ofravec, our first-in-class gene-based approach to treating cancer, which is highly differentiated in the oncology space. Ofravec has a unique dual mechanism of action designed to combine the blockage of blood vessels formation that are required for tumor growth with an anti-tumor immune response that recruits T cells into the tumor microenvironment. Therefore, it has a broad potential to change the standard of care in multiple solid tumor indications. In addition to ovarian cancer, our lead indication, it has also shown objective responses in phase two trials in GBM and in thyroid cancer and has been shown to have a good safety profile to date. In more than 300 patients, in completed clinical trials, we have not seen significant bone marrow toxicity or other concerning side effects. Importantly, it has a dosing schedule that is convenient for both the physician and the patient as it is administrated every eight weeks and is not expected to require any special monitoring. We were very pleased to announce earlier in March that Oval, the phase three trial evaluating Ofravec in recurrent platinum resistant ovarian cancer is now fully enrolled with a total of 409 patients. We also announced on the same day that the independent data safety monitoring committee overseeing this trial made a unanimous recommendation that the trial should continue as planned. This pre-planned analysis is particularly important as the committee provided its recommendation following the review of unblinded data from 370 patients, which at the time represented more than 90% of targeted population of the trial. The oval trial is designed with two individual primary endpoints, progression-free survival and overall survival. Based on regulatory guidance, successfully meeting either of these endpoints should be sufficient to support a BLA submission. Readout of the PFS primary endpoint is expected in the second half of this year. With a positive outcome in the PFS endpoint, we would expect to submit a BLA for FDA approval in the first half of 2023. As a reminder, all of the other existing drugs approved for ovarian cancer, including PARP inhibitors and Avastin, were approved based on PFS data, and they have not demonstrated an overall survival benefit to date. As we get ready for success, We had two important senior management hires recently. Matthew Trudeau to the new created position of Chief Commercial Officer earlier this year, and Sam Beckenross as a CFO during the fourth quarter. Matt will be responsible for all commercialization activity around Ofravec. He brings more than 25 years of U.S. and international experience commercializing complex biologic products and has worked on all aspects of commercial practice at both small and large biotech companies. Both Matt and Sam will be based in the U.S. I think it's important to see these appointments in the context of a broader strategic initiative to establish a U.S. presence for VBL and to prepare the company for future success in advance of the Oval readout. As part of our strategy to increase awareness for Ofravec and the company in general, we will be hosting a live in-person KOL event in New York on Monday, April 11th. The event will provide investors with the opportunity to learn more about Ofravec and the ovarian cancer space in general and will feature presentations and panel discussion by three world-renowned experts in the field, Dr. Bradley Monk, Dr. Richard Penson, and Dr. Kathleen Moore. This is a timely event, giving the upcoming PFS readout from Oval and the increasing interest we are seeing in Ofravec from the medical community. This will be our first in-person event for investors in over two years, so we are looking forward to seeing many of you there. You can find a link to register on the investor relations section of our website and also in the earning press release that we issued this morning. I would like to remind the audience that OfraVec is also being evaluated in two other clinical trials that are expected to generate preliminary data in 2022. The first is Phase II clinical trial in combination with Opdivo, an immune checkpoint inhibitor for the treatment of metastatic colorectal cancer. It is being conducted under a cooperative research and development agreement with the National Cancer Institute. The purpose of the trial is to see if Ofravec, can recruit the immune system into the gut environment, which behave quite different than the rest of the body. The result will teach us if simple systemic dosing with Ofravec can turn the colorectal tumor immunologically hot and will help inform the company on whether this is an application we should pursue further in additional studies. The second is a randomized controlled phase two trial investigating Ofravec in neoadjuvant and adjuvant setting in recurrent GBM patients who are undergoing a second surgery. It is sponsored by the Dana-Farber Cancer Institute in collaboration with a group of top neuro-oncology centers and enrollment is ongoing. We expect preliminary data from both the colorectal and GBM study later in 2022. Turning to our pipeline, we continue to make excellent progress with our monocytes targeting program and are on track to initiate the first in human study for our lead candidate, VB601, which aims to offer a novel and differentiated approach to treat prevalent chronic inflammatory diseases such as multiple sclerosis, rheumatoid arthritis, steatohepatitis, inflammatory bowel diseases, and others. BB601 is a monoclonal antibody that targets a receptor known as MOSPD2, the monowalk protein, and is engineered to prevent monocytes from exciting the bloodstream and traveling to inflamed tissue. Monocytes are believed to be one of the key cell types involved in inflammation and have been implicated specifically in the development of chronic diseases. We believe our approach has a broad potential and is differentiated from the majority of current anti-inflammatory agents which work mostly through T and B cells. We have generated preclinical proof of concept showing disease modifying activity in animal models of multiple sclerosis rheumatoid arthritis, steatohepatitis, and inflammatory bowel disease, and demonstrated ex vivo activity of VB601 in monocytes isolated from patients with various chronic inflammatory indications. We had a successful pre-IND meeting with the FDA regarding our development plan for VB601. We have since completed IND-enabling toxicology studies that demonstrated favorable tolerability profile that support moving the product into the clinic. We are now conducting a GMP manufacturing run of VB601 and expect to initiate a clinical trial in the second half of this year. To summarize, with Oval now being fully enrolled and with the DSMC unanimously recommendation to proceed following review of over 90% of the study population, We look forward to the PFS preliminary endpoint top line data readout in the second half of this year and to transformational year for VBL in 2022. I will hand it over now to Sam to discuss the full year financial results. Sam, please go ahead.