VBL Therapeutics

Greetings and welcome to the VBL Therapeutics First Quarter 2022 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 this conference over to your host, Mr. Dan Ferry of Lifestyle Advisors. Please go ahead, Dan.

Thank you, Operator. Good morning, everyone. And thank you for joining the VBL Therapeutics First Quarter 2022 Financial Results and Corporate Update Call. Joining me on the call is Professor Jorah Haratz, 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 Jorah 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 and Form 6K. 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, Tuesday, May 17, 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 Jor Haratz. Jor, please go ahead.

Thank you, Dan, and good morning, everyone. Thank you for joining us on today's call. 2022 is off to a very promising start for VBL with continued progress and important milestones in both our lead clinical program evaluating Ofravec in ovarian cancer as well as in our pipeline. We continue to execute on our strategic plan and remain on track to announce the readout of the progression-free survival primary endpoint from the oval registration enabling trial in the second half of this year, which, if positive, would be a transformative event for VBL. Recently, we were pleased to announce that the FDA has granted fast track registration designation for Ofravec for platinum resistant ovarian cancer, which may help expedite the time to market for our lead candidate, Ofravec. Ofravec is also being evaluated in two other high value cancer indications. colorectal cancer, and glioblastoma, with preliminary data expected from both of these studies in 2022. We are also advancing VB601, the first anti-inflammatory candidate from our novel monocyte targeting technology, toward the clinic. We believe this catalyst set us up to continue to build VBL into a well-positioned company, providing unique and differentiated solutions to patients in need. Beginning with our lead program, Ofravec is a first-in-class gene-based approach to treating cancer, which is highly differentiated in the oncology space. It has a unique dual mechanism of action designed to combine the blockage of blood vessels formation that are required for tumor growth with the anti-tumor immune response that recruit T cells into the tumor microenvironment. In March, we completed enrollment in Oval, our faith-free registration-enabling trial evaluating Ofravec in recurrent platinum-resistant ovarian cancer with a total of 409 patients. We announced that at the same time, that the Independent Data Safety Monitoring Committee overseeing this trial made a unanimous recommendation that the trial should continue as planned. Importantly, the committee provides its recommendation following the review of unblinded data from 370 patients who were on study at the cutoff date of December 31st representing at the time more than 90 percent of targeted population of the trial. We designed the overall trial with two individual independent 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 first of these, the BFS primary endpoint, is expected in the second half of 2022. A positive outcome in the PFS endpoint should set us up to submit a PLA for FDA approval in the first half of 2023. It's important to note that all the other existing drugs approved for ovarian cancer, including the three PARP inhibitors and Avastin, were approved based on PFS data, and they have not demonstrated and overall survival benefits to date. We were pleased to announce in April that the FDA has granted fast-track designation for Ofravec for platinum-resistant ovarian cancer. Fast-track designation, as a reminder, is a process facilitate development and expedite the review of therapies with the potential to treat serious unmet medical needs. There are important benefits that go along with this designation, including eligibility for accelerated approval and priority review, the opportunity for more frequent meetings and written communication with the FDA, as well as opportunity for a rolling BLA submission. Ultimately, having fast track designation may help expedite the time to market for Ofravec. On April 11, we hosted a live KOL event for the investment community in New York to discuss the ovarian cancer space in general, as well as the Ofravec clinical program, the science that support it, and the commercial opportunity. We had the presentation by three world announced experts in the field, Dr. Bradley Monk, Dr. Richard Benson, and Dr. Kathleen Moore. The presentations and discussion reinforce the high level of interest we are seeing in the oncology community about OfraVec and the growing excitement around the upcoming oval top line PFS announcement. The webinar is archived on our corporate website for those of you who have not yet had a chance to listen. We believe Ofravec may have a broad applications in other cancer due to its dual mechanism of function. And part of our strategy is to identify new oncology indications beyond ovarian cancer. There are currently two other ongoing clinical trials that are expected to generate preliminary data in 2022. The first is a phase two clinical trial in combination with Opdivo, an immune checkpoint inhibitor for the treatment of metastatic colorectal cancer. This is being conducted under a cooperative research and development agreement with the National Cancer Institute. In this trial, we are looking to see whether Ofravex immune recurrent mechanism, which has seen in organ throughout the body, also replicate in the gastrointestinal system. The GI system regularly sees viruses, pathogens, and foreign proteins, and therefore it may react differently to Ofravec compared to other organ systems. This study is important to us as it will tell us whether GI cancer should be further explored with Ofravec. The second clinical trial is a randomized control phase two investigating Ofravec in neoadjuvant and adjuvant setting in recurrent GBM patients who are undergoing a second surgery. This trial is sponsored by 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 the GBM studies later on in 2022. Moving on to our pipeline. We are on track to initiate a first in human study for our lead candidate, VB601, which is designed to offer a novel and differentiated approach to treat prevalent chronic inflammatory diseases such as multiple sclerosis, rheumatoid arthritis, non-alcoholic steatohepatitis, ulcerative colitis, IBD, and others. VB601 is a monoclonal antibody that targets MOSPD-2. a surface protein that is expressed on the cell membrane of monocytes and enables them to migrate to inflammatory organs. Monocytes are one of the key cell types involving in inflammation and have been implicated 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 were mostly through targeting T and B lymphocytes. New data from this program, which give insight into the mechanism of our approach, were presented at the Immunology 2022 conference on May 8th. We showed, for the first time, a molecular mechanism explaining how VB61 inhibits the ability of monocytes to walk by changing the dynamic process of adhesion, and detachment from molecule on the blood vessels and the extracellular matrix in the tissue. VB601 acts by fixing monocytes in an adherent state, thereby preventing them from getting into inflamed tissue. In addition to this presentation, we provide a more general overview of our VB601 program last week at the LifeSci Immunology and Inflammation Symposium. A replay of this presentation as well as a copy of the poster we presented at Immunology 2022 can be found on the investor relations section of our website. Regarding our development plan for VB601, we previously had successful pre-IND meeting with FDA. We have since completed INE-enabling toxicology studies that demonstrated a safety profile that support moving the product into the clinic. We expect to initiate a clinical trial in the second half of this year. So, to summarize thus far, we had meaningful progress in 2022, including completing enrollment in the Oval Phase III Registration Enabling Trial, and we are on track for top-line results in the second half of the year. Second, fast-track designation for Ofravec that can facilitate the dialogue with the FDA and potentially expedite time to market for Ofravec. Third, continue progress with the ongoing recurrent GBM and metastatic colorectal cancer clinical trial. And fourth, develop advancement in the VB601 mechanism of action and toxicology studies which support our plan for the first in human trial with this novel candidate later this year. With that, I will hand over to Sam to discuss the quarterly result. Sam, please go ahead.