3/23/2023

speaker
Josh
Conference Call Manager

Good afternoon and welcome to the Sarozen corporate update conference call. My name is Josh and I will be your manager for this call. I will now turn the call over to Craig Parker, CEO of Sarozen to begin the call.

speaker
Craig Parker
Chief Executive Officer

Thanks, Josh. And thank all of you for joining us today for this important corporate update. As Josh said, I'm Craig Parker, CEO of Sarozen. And with me today is Chuck Williams, the chief financial officer at Sarozen. We'll be providing corporate and R&D pipeline updates today, and we'll then address questions. Slide two. I'll be making forward-looking statements. Please consult our SEC filings, in particular our 2022 annual report on Form 10-K for a full discussion of our risk factors. Slide three. As some of you know, Surizin is the preeminent innovator in using the Wnt pathway, the body's own physiologic mechanism for tissue repair, to selectively stimulate tissue regeneration in a broad range of diseases. We do this through our proprietary platform and technologies that combine an understanding of Wnt pathway biology in specific disease settings with advanced antibody engineering techniques and proprietary antibody technologies. Our vision is to design and develop tissue-selective antibodies that have the potential to regenerate tissue in many severe diseases. It's this targeted approach to Wnt modulation and the extremely broad potential therapeutic applications that distinguish our approach and our technologies. The ultimate clinical promise of our approach is disease-modifying benefit. Wnt signaling plays an essential role in regulating many biological processes, including regenerative responses to tissue injury, and we see myriad opportunities to regenerate tissue for clinical benefit. We've invented several novel multivalent antibody-based approaches to selectively modulating Wnt signaling and have advanced two into the clinic. We believe that the Wnt pathway's broad physiologic role portends a role for Wnt therapeutics in a wide range of severe and acute diseases. Our approach overcomes a significant limitation to most regenerative medicine approaches that are limited by availability of donor tissue or long-term viability. We're currently focused on two key clinical areas. severe alcoholic hepatitis with our candidate SCN043, and inflammatory bowel disease with our candidate SCN1326. Today we'll provide you with corporate and pipeline updates, including anticipated timelines for our lead clinical programs, our prioritization efforts for the research pipeline, updates on our partnered program with Boehringer Ingelheim, and our expectations around cash runway as we look toward key inflection points in our lead programs. We'll also provide an overview of our initial evaluation of the Transaminase elevations observed in the Phase Ia studies and our approach to advancing both lead programs. In November, we disclosed several adverse events observed in clinical trials that had commenced in 2022. One of the studies, the phase one single ascending dose study for SCN1326, was voluntarily paused pending further evaluation of grade three transaminase or liver enzyme elevations. We're excited to be able to update you on progress for both SCN043 and SCN1326 phase one clinical trials. Both are currently open to enrollment. For SCN043, we've enrolled our first patient. and we'll provide more information later in the call. Slide four. If Wnt biology is so promising, why has it taken decades to drug this pathway? There are many technical impediments. Wnt proteins themselves are insoluble, promiscuous, and not manufacturable, so a typical recombinant native protein strategy is just not possible. Surazin's platform technologies and strategies have helped us overcome all of these limitations. Our candidate molecules are full-length by specific antibodies that have desirable drug-like properties such as solubility, stability, and manufacturability. They're also highly targeted to tissue-specific receptors. Importantly, we're mimicking a normal physiologic response, so our antibodies in a selective way are able to do what Wnt pathway proteins do in all of our bodies in many tissues, either to maintain the tissue or respond to injury. The novelty and breakthrough nature of our work is validated by our strong publication record and high-impact peer-reviewed journals, including Science, Nature, cell chemical biology, nature scientific reports, and nature communications. We have filed or licensed over 20 patent families related to our key discoveries involving the wind pathway and its modulation. We recently received notices of allowance from the United States Patent and Trademark Office for two patent families assigned to CSRSN related to the SCN 1326 program. We think the breadth of our scientific discoveries and related patent application and claims can establish a dominant position for us in the use of antibody therapeutics to modulate Wnt signaling. Slide five. Our proprietary technologies have led to two different lead programs that entered the clinic in 2022. the licensing of the lead development candidate SCN413 for treatment of retinal diseases to Beringer-Ingelheim in the fourth quarter of 2022, and a focus on two discovery pipeline programs for cornea and lacrimal gland. Our research programs focus on indications of high unmet need with no or few available treatments, including a group of ophthalmologic indications that we'll tell you more about. We're excited today to provide an update on advancing both of our clinical programs, SCN043 and SCN1326. Since our announcement in the fourth quarter of 2022 regarding transaminase elevations, we've completed numerous studies to understand the mechanism of transaminase elevation seen in the SCN1326 programs and also at a lower grade in the SCN043 program. We'll provide you with an overview of our efforts to date and clinical program plans. For SCN043, we're really excited we've advanced to the second phase of the study in chronic liver disease patients following completion of dosing at two dose levels in healthy volunteers. For SCN1326, we will progress our phase one single ascending dose study at lower doses pursuing a dosing strategy frequently applied to first-in-class antibodies referred to as a MABEL, or Minimal Anticipated Biological Effect Level. Additionally, we look forward to the opportunity to advance another development candidate in 2023 in collaboration with our partner, Beringer Ingelheim, with the potential to identify the final Frizzled 4 targeted development candidate by year-end, a milestone that would trigger a payment to CERZIN. Finally, we anticipate that our prioritization and restructuring will result in a cash runway into the second half of 2024, allowing us to achieve multiple key milestones and catalysts.

speaker
Josh

Slide seven.

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