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| So as we saw at AACR, we do see very nice expansion, in fact, very impressive expansion with Fc alone |
| And lastly, we are proud that we have been and continue to be very thoughtful about how we deploy our resources |
| One feature of ALLO-316 that we are particularly excited about is the expansion of persistence of ALLO-316, which we believe compares favorably with what has been reported for autologous CAR T therapies |
| AlloCAR T is unique in its ability to potentially provide a onetime off-the-shelf product capable of achieving long-term remissions |
| The preponderance of data we’ve already presented from our CD19 program point to improved clinical performance with ALLO-647 in terms of depth and durability of response |
| The unique experience and track record we have across our teams derived from previous success developing autologous CAR T therapies that led to approvals in late- and earlier-line disease gives us the confidence in our approach in clinical data |
| When you combine that history with the nearly 200 patients we have treated with our AlloCAR T investigational products, including nearly 50 patients alone with LBCL, we are in an unparalleled position when it comes to depth of understanding |
| So we’re going to run ALPHA2 the way that we’re treating patients and we’re very confident in that study’s ability to demonstrate a benefit for patients who meet the eligibility criteria |
| Our balance sheet remains strong as we ended the quarter with $514 million in cash, cash equivalents and investments |
| More importantly, he successfully navigated the complex CMC processes for the BLA submission of YESCARTA that led to an on-time approval of YESCARTA and Kite’s commercial manufacturing facility |
| We also continue to execute cost savings measures directed at preserving our balance sheet strength |
| But the fact that we did see preliminary evidence that the higher the expression of CD70 the deeper the response gave us a lot of enthusiasm that this is a truly active agent in this disease |
| We’ve seen good durability, obviously, with the early patients and the majority of Alloy patients have made it past 12 months |
| The two patients I met earlier this week are living proof of Allogene’s success |
| But I’m pleased to report that the majority of centers now have that protocol amendment in hand and we are seeing a significant increase in the pace of enrollment |
| Based on our emerging product profile, you can understand why we remain very confident in the potential outcome of both of our ongoing Phase II trials |
| Dagger technology, as we review more data, we get more excited about what we’re seeing with the Dagger |
| In an effort to increase awareness of our programs to an even broader set of physicians, we are very pleased to be presenting updated Phase I data from our trials with ALLO-501 and ALLO-501A at the upcoming American Society of Clinical Oncology Annual Meeting in Chicago |
| So there are many out there who see the value and the scientific merit of this trial and so we’re obviously very excited to participate with those studies -- with those investigators in those sites |
| We at Allogene not only have the confidence in the clinical data sets that we have delivered, but know that we are on the right path by having look into the eyes of patients who are with us today because of our investigational products |
| Our scientific innovation is proving itself in the clinic |
| We continue to believe that our success across multiple clinical programs, ability to attract top tier talent and financial stewardship to weather the challenging external market environment paves the way towards to bringing a new generation of CAR T products to patients and we look forward to seeing you next at ASCO |
| As our clinical safety and efficacy data continue to mature, the more excited our investigators are of the potential of allogeneic CAR T |
| Another important benefit of our experience in the field is our longstanding relationships with investigators |
| We believe these efforts have extended our cash runway into Q2 of 2025, long enough to complete our pivotal trials for ALLO-501A and prepare for a potential BLA submission |
| We are excited by the possibility to deploy Dagger alongside CARs directed at other antigen targets in the same cell for the purpose of creating a novel allogeneic CAR T platform for a suite of next-generation products that are less dependent on traditional chemotherapy-based lymphodepletion |
| We are keenly aware that shareholder interest is best served by bringing AlloCAR T products to the market as soon as possible, but the real sense of urgency that we feel originates from many patients who are on the sidelines today waiting their turn |
| In fact, it really kind of drills down on exactly what we’re so excited about with the Dagger technology |
| As we march towards our goal of a BLA submission for ALLO-501A upon completion of the ALPHA2 trial and evaluate manufacturing process across our BCMA candidates to achieve optimal clinical performance, I am particularly excited to welcome Tim Moore to Allogene as our new Chief Technical Officer |
| But year-end-ish of 2024 is a good time line to think about |
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| And yes, many of us in the industry find it frustrating that progress is not always rewarded in real time |
| You’re lowering your cash flow guidance for the year, I think, about $20 million, if I’m not mistaken |
| We’ve lowered our cash burn target from $250 million to $230 million |
| You’re lowering your cash burn guidance for the year by $20 million |
| Yes, the market is challenging |
| David Chang Luca, we’re losing you again |
| As we hear their stories, we also hear the growing rumble of this content around the inability of autologous CAR T therapies to satisfy patient demand |
| Why do I mention this? We often get questions about our stock price weakness |
| Like other industry pioneers, we knew that along our journey, we might face many obstacles that our progress would be marked by several first-in-class milestones and that a scientific approach to decision-making would guide us on the best path to success |
| Treatment consists of a onetime infusion of cells, free of hassle and inconvenience of having to return to the clinic for treatment again and again, and would ask the cumulative toxicities that often comes with lengthy chronic therapy |
| Last year, based on the reported sales, 6,000 to 7,000 runs were required, which along strained the system |
| While the market environment for biotech companies continues to present challenges, one thing remains certain, success will ultimately be driven by a combination of scientific innovation, experience and financial stewardship |
| You can imagine that any dollar spend going down to relatively low dollar amounts, gets the second look these days given the nature of the capital markets raising environment and our need to focus on our highest priority items |
| Our net loss for the first quarter of 2023 was $98.7 million or $0.68 per share, including non-cash stock-based compensation expense of $18.8 million |
| You’ve also commented previously that the percentage of patients that are actually receiving autologous CAR T is actually quite low |
| Yes, cell therapy stocks are temporarily out of favor |
| So I wonder if [Technical Difficulty] Dr |
| I noticed that in your 10-Q, it stated that a couple of the clinical trial sites have declined to participate, because of its randomized design |
| Most of all, we knew that our compass has to be standard on doing right for patients |
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