Ventyx Biosciences, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Vintix Biosciences fourth quarter and full year 2022 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 2. 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, FinTech's Chief Financial Officer. You may begin.

Thank you, Chelsea. Good afternoon, everyone. Thanks for joining us today. Welcome to Ventex Biosciences conference call and webcast, where we will be discussing our fourth quarter and full year 2022 financial results and providing a business update. As a reminder, the company's most recent investor presentation can be found on our website at www.ventexbio.com under the Investors tab in the News and Events section. Before we begin today, I'd like to remind everybody 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, the 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 and or implied by such forward-looking statements are discussed in greater detail in our most recent reports filed with the SEC, including our Form 10-K for the year ended December 31, 2022, which we anticipate will be filed this afternoon. 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, and not any information of future events, except as required by law. With that said, I'll hand the call now over to Dr. Rajiv Mohan, Ventex's founder and CEO. Rajiv, please go ahead.

Thanks, Marty, and thanks, everyone, for joining the call this afternoon. So here's... today's agenda, I'm going to provide a high-level business update, and then I'm going to hand the call over to Bill Sanborn, our President and Chief Medical Officer, and Bill will provide a little more color across all our pipeline programs. And finally, Marty will wrap up with a brief overview of our full year 2022 financial results before we open the call up for Q&A. So let me start with reiterating that 2022 was a year of outstanding progress and execution for Ventix. I could not be prouder of our accomplishments as we continue to build an amazing team, strengthen our financial position, and successfully advance our unique portfolio of internally discovered, wholly owned small molecules that target large markets with high unmet medical need. Recapping now, in the third quarter of 2022, We reported positive top-line results from the Phase 1 trial of our novel allosteric TIK2 inhibitor, VTX958. We believe these data demonstrate a potential best-in-class profile, including class-leading IC90 coverage of IL-23 and other TIK2-mediated cytokines. An excellent safety profile across all doses tested in the multiple ascending dose portion of the Phase 1 trial. As we had previously guided, we initiated three Phase II programs with VTX958, beginning with the serenity trial in moderate to severe plaque psoriasis, the harmony trial in moderate to severe active Crohn's disease, and the tranquility trial in active psoriatic arthritis. As I said before, Bill is going to provide additional color on these trials. In June of 2022, we reported positive phase one data for our peripheral NLRP3 inhibitor, VTX2735. With the completion of requisite CMC and toxicology studies, VTX2735 is now a phase two ready program. To that end, we today announced that we have initiated a phase two proof of mechanism trial for VTX2735 in CAHPS patients. Meanwhile, our novel CNS penetrant NLRP3 inhibitor, VTX3232, has completed IND enabling studies, and we look forward to initiating a Phase I trial later in the first half of this year. And we've achieved all of this while continuing to execute on the global Phase II trial of our potential best-in-class S1P1 receptor modulator, VTX002, in ulcerative colitis. We are pleased to report that this trial remains on track to complete enrollment by mid-year, and we remain excited about the potential for VTX002 to differentiate from other S1P1 modulators in ulcerative colitis. And with 2022 behind us, we held our R&D day in New York in January and laid out our vision for what we believe will be a truly transformative year in 2023 for Ventix. With a number of P clinical catalysts in the near-term horizon, the cadence of data will start with top-line Phase II data for VTX002 RS1P1 modulator in ulcerative colitis, which is expected in the second half of the year, likely late Q3 or early Q4. We expect to report top-line data from the Phase II serenity trial of VTX958 in black psoriasis, later in Q4. And finally, we expect the Phase II data readouts for VTX958 in psoriatic arthritis and Crohn's disease in 2024. So as you can see from my brief summary, there's tremendous amount of activity across our entire pipeline, but as always, We remain committed to our mission, which is to bring safe and effective oral medicines to large immunology markets currently dominated by biologics. So we look forward to sharing more updates with you as we progress throughout this year. But with that, I'm going to hand the call over to Bill for a more in-depth update on our pipeline programs. Bill?