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| Statement |
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| I'm confident that Selecta is well positioned to execute on the priorities I've outlined today |
| So I think we are -- as I mentioned earlier, we're quite confident that we can move this forward ourselves in autoimmune diseases of the liver |
| But we still -- as I said earlier, we remain excited about IgAN, and we think it's a valuable indication and we'll explore the best path forward for the program |
| We're also very encouraged by the safety profile of SEL-212 observed in the trials |
| We're very excited about these results, which support that SEL-212 could potentially serve as a meaningful new therapeutic option, notably with a convenient once-monthly dosing schedule for patients suffering from chronic refractory gout |
| So as you can tell, we're extremely excited by moving ImmTOR IL forward |
| So on the cash runway piece, we feel very confident in our ability to achieve the milestone payment that we mentioned in the cash runway guidance |
| That's very attractive |
| This is an achievement that many biotech companies never realized, and I'm very proud of the team at Selecta that help us reach that important milestone |
| Carsten Brunn Over the past few months, we delivered 2 successful Phase III studies that could potentially pave the way for our lead asset to reach the market and offer a meaningful new treatment option to patients |
| I think we've just delivered a very positive and successful Phase III program |
| The only thing I can say they're extremely excited about this and they've publicly stated, this is one of their top priorities |
| So we remain very excited, but something we're looking at right now and see what the best path forward is for the asset |
| The first quarter of 2023 was marked by a significant milestone with the announcement of positive results from 2 Phase III studies of SEL-212 in chronic refractory gout, DISSOLVE I and II, both of which met their primary endpoints |
| And the -- we think that collectively, the autoimmune liver diseases, which are PBC, PSC and autoimmune hepatitis, represent a very good target for our therapy, primarily because they are all known to be T cell-mediated diseases |
| Sobi is excited about this |
| So that expands the market opportunity for a new therapy that addresses the underlying immunologic aspect |
| But also, we believe that in ImmTOR alone also will have an impact -- a positive impact on liver diseases as well as it accumulates in the liver, and we've shown this in a couple of various animal models |
| ImmTOR IL, which combines our proprietary Trex selective IL-2 candidate with ImmTOR represents the evolution of our precision immune tolerance platform and has potential to further enhance the magnitude and duration of immune tolerance in patients treated for autoimmune diseases |
| We definitely think that ImmTOR is well suited in gene therapy |
| And we're also doing this in a relatively -- in a position of strength really |
| As we now sharpen our focus on ImmTOR IL, while supporting our ongoing partnership with Sobi and Astellas, we believe we have the right strategy in place to add value for all of our stakeholders |
| We haven't incorporated additional milestones, right? So we think it's a very achievable milestone that we anticipate |
| Xork is differentiated by its low cross-reactivity to preexisting antibodies in human serum |
| So just elaborating a bit on the IgAN decision, we remain very excited, but we had to make resource decisions on where we allocate our investment |
| Due to selective protease activity against anti-AAV Nabs, we believe Xork has the potential to expand access to life-changing gene therapies by addressing preexisting immunity to AAV |
| So we think that the approach is likely to yield results with individual agents as well are collectively better results with multiple agents |
| So we think that targeting liver diseases gives us one of the greatest opportunities to show efficacy of the various components, but will then set the stage for autoimmune diseases more broadly |
| And we believe pausing the reimagine trial will allow any potential partners to help inform the clinical and regulatory path forward for this program, while also preserving Selecta's cash resources in the near term |
| But just as a reminder, we have the opportunity to receive an additional $65 million in kind of development and regulatory milestones associated with the Sobi deal as well as up to $550 million in commercial milestones |
| Statement |
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| As we've demonstrated with our empty Capsids study, actually, where we clearly demonstrated that even a single dose of ImmTOR meaningfully reduces NAb titers and redosing is a key challenge |
| We both have some difficult decisions about how to advance our mission and position Selecta for continued success |
| Our basic net loss per share of $0.14 |
| For the first quarter of 2023, we reported net loss of $21.7 million |
| In light of the strategic initiatives announced today, as well as our expectation that we will receive a milestone payment related to SEL-212 development activities, we believe that our cash position will not be sufficient to meet our operating requirements into the second half of 2025 |
| In connection with this capital privatization initiative, we've undertaken the difficult decision to reduce our headcount by approximately 25% in order to align our workforce with our priorities and streamline our operations |
| Gil Blum So it's never great to have to reduce headcount |
| But as we've gone through the prioritization, as we laid out in the call and in the press release, you should expect to see a decrease in the subsequent quarters, specifically on the R&D side |
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