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Ventyx Biosciences, Inc.
8/10/2023
Good afternoon, ladies and gentlemen, and welcome to the Vintex Biosciences second quarter 2023 earnings conference call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for your questions following the presentation. If you would like to ask a question at that time, please press star 1 on your telephone keypad. If at any point your question has been answered, you may remove yourself from the queue by pressing star two. So others can hear your questions clearly, we ask that you pick up your handset for best sound quality. Lastly, if you should require operator assistance, please press star zero. As a reminder, this conference call is being recorded. I would now like to turn the call over to Dr. Marty Oster, Bintex's Chief Financial Officer. Sir, you may begin.
Thank you, and good afternoon, everyone. Welcome to Ventex Biosciences Conference Call and Webcast, where we'll be discussing our second quarter 2023 financial results and providing a business update for you. As a reminder, the company's most recent investor presentation can be found on our website at www.ventexbio.com in the Investors News and Events section. Before we begin today, I'd like to remind everyone that this conference call and webcast will contain forward-looking statements about the company, including without limitation, statements about the anticipated timing of commencement, enrollment, and completion of clinical trials for our product candidates, anticipated timing of release of clinical trial data, the market opportunity for our product candidates, and the expected timeframe for funding operations with our current cash, cash equivalents, and marketable securities. These statements are subject to risks and uncertainties that could cause actual results to differ. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent periodic reports filed with the SEC, including our Form 10Q for the quarter ended June 30, 2023, which filed just a few minutes ago. Please note that these forward-looking statements reflect our opinions only as of the date of this call, and we undertake no obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events, except as required by law. With that, I'll hand the call over now to Dr. Raju Mohan, Dentix's founder and CEO. Raju, please go ahead.
Thanks, Marty, and good afternoon, everyone. Thank you for joining our second quarter 2023 financial results conference call. It's hard to believe that we're already in August and how the first half has flown by. As you may have recalled from the R&D discussions in January and from our recent press releases, it's been a tremendously productive first half of the year for Rentex, and I am very proud of our team's execution across the entire pipeline. So let me run through this afternoon's agenda. I will begin by providing a high-level business update And then I'll hand the call over to Bill Sanborn, our President and Chief Medical Officer, who will provide updates across our drug development programs. And finally, Marty will present an overview of our second quarter of 2023 financial results before opening the call for Q&A. So let me start by saying at DENTX, we've always believed that novel oral therapies are poised to play a significant long-term role in the treatment of numerous immune diseases indications that are currently dominated by injectable biologics, including indications such as psoriasis, inflammatory bowel disease, psoriatic arthritis, lupus, and others. These large but under-penetrated markets currently exceed over $50 billion in annual sales, and we believe that as clinicians and patients are offered the choice of using a pill, an oral drug, instead of an injectable therapy, there is the potential for a meaningful shift in market share, as well as a general expansion of the treated populations in each of the diseases I referenced earlier. We have seen an overall increase in excitement around the promise of oral therapies, encompassing different targets and indications. And we believe that our portfolio of internally discovered compounds positions us at the forefront of this revolution in oral therapies. And I am proud we are currently conducting five phase two trials across our wholly owned pipeline of novel small molecules. Let me begin with the compounds. As you know, our allosteric TIK2 inhibitor VTX958 is in phase two development for plaque psoriasis, Crohn's disease, and psoriatic arthritis. All diseases where TIK2 plays a direct role in modulating IL-23, a key cytokine implicated in the pathology of disease progression. As previously discussed, We are aiming to achieve sharp coverage of TIK2-IC90 at the highest Phase II dose across all the trials. In June, we announced that we completed patient enrollment in the Phase II serenity trial of PTX958 and moderate to severe plaque psoriasis. This is an important milestone for Ventix, and I'd like to thank our entire team for all their efforts. With enrollment now complete, We look forward to reporting top-line data from the Phase 2 serenity trial in the fourth quarter of this year. On the development of an extended release tablet, ER tablet for VTX958, we continue to make progress towards the target product profile and remain confident that we will have an optimized, once-daily tablet to advance into Phase 3 trials in 2024. As previously discussed, our development strategy incorporates an iterative process that allows us to sequentially evaluate multiple prototype formulations in humans. We look forward to providing a detailed update in the fourth quarter. In June, we announced that we completed enrollment in the ongoing phase two trial of VTX002 in patients with moderate to severely active ulcerative colitis. I'd like to again congratulate the Ventix team on this important milestone. We look forward to reporting top-down results from this trial early in the fourth quarter of this year. We believe we are the first company to demonstrate a greater magnitude of reduction in absolute lymphocyte counts, or ALC, relative to adrazumab and ozonamab in similar Phase II trials. We believe we are exploiting the full potential of this mechanism by a greater reduction of ALC validated by a marker and believe that this may translate into differentiated efficacy relative to other drugs developed for ulcerative colitis. Our aspirations for this asset have always been very clear, which are to demonstrate efficacy in moderate to severe UC patients that is differentiated from both atrazumab and zeposia, and is competitive with or superior to levels achieved by biologics. This efficacy profile, if achieved, should position VTX002 as a potential class-leading safe oral agent in UC. And Bill will provide more color on progress of this trial. Beyond these lead programs, we continue to advance our novel NLRP3 inhibitor portfolio, including our peripheral compound VTX2735, which is now in phase two trials in CAHPS patients, and our CNS penetrant NLRP3 inhibitor VTX3232, for which we recently announced initiation of dosing in phase one trial in healthy volunteers. So in summary, I'm very proud of our team's execution during the first half of the year. and we look forward to generating important Phase II data for both VTX002 and VTX958 in the fourth quarter. So with that, I'll hand the call over to Bill for a more detailed pipeline discussion. Bill?
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