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| And we are really excited about that |
| With pivotal Phase 2 data underway and the plans to submit a BLA in the second half of this year, we are poised to deliver health to patient population with no alternative and drive shareholder value |
| So as you can imagine, this platform, with the differentiation that it has from all the other platforms, with the efficacy that has shown and in our lead PRGN-2012 were based on its safety, clinical efficacy and also in discussions with the KOL and investigators, they have high excitement about this molecule for this rare disease because of ease of administration, because of efficacy of clinical response and the durability of response has generated a lot of excitement and really has positioned us to become a leader in treatment for this rare disease |
| This is due in part to the positive guidance and pathway provided by the FDA and to the tireless work done by our team over the last several years, starting from discovery in 2020 all the way to the potential filings in 2024 |
| And this is quite exciting |
| So as you can imagine, this is quite exciting and also a proof-of-concept for this platform |
| So we are really excited about that |
| And I think this is the advantage that, currently, our CAR-T and the combination of those two factors, obviously, have created a lot of excitement and also attention |
| In addition, we are continuing to evaluate various opportunities in our current -- and are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRGN-2012 and transitioning from a clinical to a commercial stage company |
| I will go back to my prepared remarks and reiterate that we're continuing to evaluate various opportunities and we are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRGN-2012 |
| In a single-arm Phase 1 pivotal trial that we run originally, what we observed was, first of all, from a safety perspective, these patients have a very favorable safety, mainly Grade 1, Grade 2, which is some rashes at the site of injection or some fever and then it resolves within a day or 2, very similar to the flu shots that you get |
| So now positioning PRGN-2009 in a head and neck in combination with the pembro, in early onset, it's quite exciting |
| However, this is an umbrella trial, as we have mentioned before that basically means we are addressing a number of indications, both hematological as well as solid tumor, especially triple-negative breast cancer, this can be very exciting |
| So we are confident that we can meet the needs of the commercial, basically forced and there are patients, as we move forward |
| So we will be able to create, hire and train a specialty sales team focused in the major metropolitan areas and very efficiently be able to increase awareness, launch and then promote our product once approved |
| So we will be updating as we move forward in regard to our basically partnership activity, but this is going to be a very exciting year |
| As you can see, 2024 is poised to be a transformative year for us at Precigen, especially as we transition from a clinical to a commercial company |
| So I think we are really excited about that and our CAR-T and the results that have been showing, and then we will be -- as we have given the guidance, by the end of 2024, we will present the data on expansion |
| In regard to our -- as Harry mentioned, we are looking at the various strategies for basically supplementing our financial balance sheet and we are confident that we -- as we move forward, we have that ability |
| For those of you who might not be familiar with this platform, this is a very differentiated platform from the rest of the viral platform |
| And currently, as we speak, we are recruiting to this trial and this is quite exciting |
| So as we have mentioned, last year, we finished the enrollment to our Phase 2, and we are really excited that we will be presenting the full dataset of our Phase 2 by the end of Q2 |
| 2024 is poised to be a transformational year for Precigen |
| So for today, let me just jump into our AdenoVerse platform, why we are excited about this platform and our lead assets that it pays off |
| But I think we are going through a very, very transformative year |
| On the other hand, when you are looking at the chronic diseases such as lupus or autoimmunity clearly, now you have to have a very, very safe drug |
| As we approached the end of the first quarter of fiscal '24, we're continuing to exercise sound financial management preparing for the planned launch of PRGN-2012 in 2025 and continuing to move our other programs rapidly through the clinic, all while maintaining efficient SG&A operations |
| As Helen mentioned earlier, 2024 is shaping up to be a transformative year for Precigen |
| This is additional to expand our label and as well expand the patient population that they can benefit from repeat dosing, especially with the durability that we see currently, which is more than two years |
| This was due primarily to reduced legal and insurance costs and was achieved while we began to build out our commercial group |
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| And as a result, the patient, first of all, it gets worse the situation, there is a danger and there is a continuous problem that you have not solved |
| And, again, apologies for this little bit of technical problems |
| Our continued focus on SG&A costs resulted in a decrease of 16% or $7.6 million from the prior year to $40.4 million for the full year of 2023 |
| And as you are aware, other CAR-Ts and TCRs have not been able or even the off-the-shelf have not been able to enter into that arena |
| That's one of the major issues in the vectors, other vectors and other platforms that exist |
| So as we've mentioned, this is truly a devastating disease with no current treatment |
| These patients for decades have gone through this devastating disease with really no treatment except surgery |
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