Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
Please consider a small donation if you think this website provides you with relevant information
| Statement |
|---|
| We believe that CD40 activation and the resulting involvement of the adaptive immune system is important in the heme indications and may provide significant improvement to CD47 blockade in terms of both improved response rates and durability of response |
| And clearly in patients like this, improved CR rates, not just over the expectations of azacitidine alone, but over prior benchmarks with AZA plus, drugs like magrolimab are important to exceed |
| Taken together, I believe the combination of our experienced team, transformational science and protein engineering, as well as financial resources, puts us in a strong position to move beyond our next set of milestones and into 2024 |
| Regardless, SL-172154 has to stand on its own two feet in syndication, and clearly we're encouraged by the differentiated safety profile, the lack of destructive anemia |
| Overall, we are encouraged by the growing body of data that validates the unique mechanism of action of SL-172154 and its therapeutic potential to address the unmet needs of patients with AML and higher-risk MDS |
| And in pre-clinical models, the activity of CD40 agonism translated to both improved response rates and improved response durability |
| We are very pleased that our lead clinical stage product candidate, SL-172154, has advanced to a stage where we are able to begin sharing clinical data from both our hematologic and solid tumor programs |
| I’m grateful for the relentless efforts of our team, our participating investigators and most importantly, the patients themselves that have enabled this progress |
| We continue to be well positioned financially |
| We are very pleased with the momentum in this trial |
| And if and only if you exceed those CR rates, you then have an opportunity of seeing an improved duration of response and improved overall survival |
| At a high level, our confidence is bolstered by the interim results of SL-172154 in combination with pegylated liposomal doxorubicin, which we will call PLD in patients with PROC |
| This attribute of SL-172154 has already led to a differentiated pharmacodynamic profile and dose escalation studies and may contribute to improved response rates, accelerated kinetics of response and durability of responses in our [Technical Difficulty] Dr |
| We remain encouraged by the safety and tolerability profile of SL-172154 to date |
| In the third quarter of 2023, we made excellent progress across the four different ongoing expansion cohorts in our PROC, AML and higher-risk MDS trials |
| Importantly, we are also pleased to have observed our first responses and efficacy data across our clinical trials, including our Phase 1B clinical trial in platinum-resistant ovarian cancer and our Phase 1A/B clinical trial in acute myeloid leukemia or high-risk myelodysplastic syndromes |
| And again, we'll look to exceed that by a substantial margin |
| Consequently, we were particularly encouraged by a monotherapy response in a heavily pre-treated relapsed refractory TP53 mutant AML patient |
| And enrollment has proceeded very quickly, which we attribute to the high unmet need for these patients and our investigators’ enthusiasm regarding the differentiated profile of SL-172154 |
| SL-172154 plus PLD had an acceptable safety profile, which was consistent with the safety profile of the individual agents |
| Gil Blum All right, excellent |
| And what I can say is that it's always been a little bit of a mystery why the TP53 mutant AML patients with some prior studies seem to do a bit better than the TP53 wild-type patients because otherwise, those are quite similar diseases |
| Overall, we are encouraged by the emerging data from this combination cohort and look forward to update with more patients and longer follow-up |
| Gil Blum Excellent |
| Thanks for taking the question and nice to see the early data |
| Enrollment and dosing are progressing quickly |
| And there certainly would be an opportunity for an accelerated path there if we were to first hit the CR rate in excess of 40% or so |
| In this trial, SL-172154 had an acceptable safety profile as a monotherapy and in combination |
| But I do agree that there is a potential accelerated opportunity |
| Should the initial results gathered in our heme and solid tumor studies hold as the size and maturity of these cohorts increase, SL-172154 would have first-to-market potential among CD47 agents and PROC, as well as both AML and higher-risk MDS |
| Statement |
|---|
| What would you gauge as a go/no-go decision on PLD plus SL-172154? And – how relevant is PLD these days and PROC? I mean you faced some enrollment challenges here |
| Additionally, to date, a higher proportion of patients enrolled in our trial have bulky disease measuring over 5 cm in diameter and pre-treatment with bevacizumab, both of which are poor prognostic factors |
| These safety issues and the related clinical challenges have led to significant skepticism regarding the potential clinical utility of the CD47 pathway |
| And so this is a fairly homogeneous poor prognosis group with rapid kinetics of disease |
| Several advanced programs have encountered significant challenges with toxicity, including destructive anemia |
| They've failed 7+3, they've failed FLAG, they've failed VEN-AZA |
| It seems, however, as though many of these patients enrolled to the magrolimab arms, may have discontinued earlier or may have had dose interruptions in a way that could have impacted the top line readouts of that study |
| And, pardon me, with regard to how SL-172154 needs to show in these patients and how that compares to what's evolved in the AML and higher-risk MDS space with other CD47 inhibitors, as most of the audience probably knows, this has been an evolving space over the last three years and certain agents might have been discontinued in the AML and higher-risk MDS space early on purely for competitive reasons under the assumption that magrolimab would be first-to-market and therefore, the commercial opportunity might have dwindled |
| We believe, however, that these safety issues are the result of the design of some CD47 targeted agents and are not inherent to the CD47 target itself |
| And certainly, and – people always seem to shy away from the word synergy, and we can't say that quite yet |
| So SL-172154, the most common drug-related adverse event was infusion-related reaction, mostly Grade 1 or Grade 2 |
| Our net loss for the third quarter of 2023 was $27.5 million or $0.65 per basic and diluted share, as compared to a net loss of $24.6 million or $0.58 per basic and diluted share for the third quarter of 2022 |
| For SL-172154, the most common drug-related adverse events was infusion-related reactions, mostly Grade 1 or 2 |
Please consider a small donation if you think this website provides you with relevant information