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| Statement |
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| Improved efficacy, especially histologic remission as anti-inflammatory biologics achieved clinical remission in less than 50% of patients at 52 weeks, and low rates of histologic remission as low as 20% |
| We're excited with the multiple opportunities that lie ahead of Surrozen in 2023 and 2024 |
| We think the biological rationale and preclinical data that support the concept of activating Wnt signaling for the treatment of liver disease -- severe liver disease is compelling |
| And I wanted to highlight a few, the things that we've accomplished from a corporate and capital structure perspective to establish an even stronger foundation for continued future success |
| 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 |
| Because of the disease severity and unmet medical need, we believe there's an opportunity for favorable regulatory treatment such as breakthrough designation and a potentially rapid approval pathway as seen in other grievous diseases |
| 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 |
| For SZN-043, we're really excited we've advanced to the second phase of the study in chronic liver disease patients following completion of dosing at 2 dose levels in healthy volunteers |
| Surrozen's platform technologies and strategies have helped us overcome all of these limitations |
| In summary, we believe that SZN-043's mechanism and preclinical data are ideally aligned with our initial target indication, and that SZN-043 has a well-defined clinical development and regulatory pathway |
| We've also shown that this activity in preclinical models of colitis compares favorably to approved biologics and immunosuppressants |
| Histologic remission has been associated with a better clinical course |
| 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 |
| In vivo Surrozen Wnt activating molecules are efficacious in reducing corneal thickness and improving opacity |
| 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 |
| As I've emphasized, I think the robust nature of the response in multiple different animal models for both molecules, the consistency of that response across experiments and across different types of injury, I think is very compelling evidence of the pharmacology and the biological rationale, but I wouldn't get too focused on the exact doses that we tested in animals |
| So as Craig outlined, we've made significant progress with our programs over the last few months |
| Short-term mortality of severe AH remains very high |
| It's this targeted approach to Wnt modulation and the extremely broad potential therapeutic applications that distinguish our approach and our technologies |
| Our efforts were focused on maximizing shareholder value by: one, aligning resources and R&D investments for the 2 lead clinical development programs with a focus on obtaining proof-of-concept data; two, prioritizing investment in the most advanced discovery preclinical programs, lacrimal and cornea; and thirdly, reducing operating expenses with the goal of maintaining a strong balance sheet |
| Well, let me tell you about another ophthalmologic program that we're excited about |
| We've published data from multiple rodent liver injury models demonstrating that SZN-043 rapidly proliferates mature hepatocytes resulting in functional improvements and a reduction in fibrosis |
| We're excited today to provide an update on advancing both of our clinical programs, SZN-043 and SZN-1326 |
| So this is an identifiable population with an extremely high unmet need |
| We're excited to have completed 2 cohorts of patients in the Phase I single ascending dose study in healthy volunteers, and we've enrolled our first patient with chronic liver disease |
| Importantly, hepatocyte regeneration is known to correlate with improved survival |
| The ultimate clinical promise of our approach is disease-modifying benefit |
| SZN-043 specifically activates Wnt signaling in the liver, resulting in hepatocyte proliferation, liver regeneration, improvement in liver function and reduction in fibrosis |
| In preclinical studies, we've demonstrated that 1326 restores Wnt signaling in the damaged intestine, repairs the damage colon epithelium, reduces inflammatory cytokines and reduces disease activity |
| We're excited to be able to update you on progress for both SZN-043 and SZN-1326 Phase I clinical trials |
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| And again, I think we have to be cautious about extrapolating too much from the animal models |
| 20% of patients with AH die within 30 days of admission to the hospital, and 30% die within 90 days due to hepatocyte loss and lack of sufficient regeneration to overcome that loss |
| Additional mechanisms of action -- as an additional unmet need as many patients fail first-line anti-inflammatory biologics and subsequently fail second and third-line therapies |
| But whether they have frank cirrhosis, I think we'll just have to see |
| and EU are affected |
| But again, it's possible that at quite low doses, there's a regenerative response that doesn't bring with it some hepatocellular injury |
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