Alaunos Therapeutics, Inc.

Q4 2022 Earnings Conference Call


spk08: Good day and thank you for standing by. Welcome to the Alano Therapeutics 4th Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Danielle Dungeon with Stern IR. Please go ahead.
spk07: Danielle Dungeon Good morning and welcome to the ALONOS Therapeutics fourth quarter and full year 2022 financial results conference call and audio webcast. Earlier this morning, ALONOS issued a press release announcing financial results for the three months and full year ended December 31, 2022. We encourage everyone to read today's press release, as well as the Alanos annual report on Form 10-K for the year ended December 31st, 2022, which was filed with the SEC this morning. The company's press release and annual report will also be available on the Alanos website at In addition, this conference call is being webcast through the investor relations section of the company's website and will be archived there for future reference. Please note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 7, 2023. Actual results could differ materially from those stated or implied by forward-looking statements made today due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filing with the SEC at The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law. With me today are Kevin Boyle Sr., Chief Executive Officer, Drew Deniger, Vice President of Research and Development, Abhi Srivastava, Vice President of Technical Operations, and Mike Long, Vice President of Finance. With that said, I would like to turn the call over to Kevin.
spk03: Thank you, Danielle. Good morning, and thank you for joining us today for an update on the exciting progress we are making here at Alanos. 2022 was a transformational year for Alanos Therapeutics as we achieved several meaningful corporate milestones, including advancing our library TCR T-cell program into the clinic and subsequently achieving our first objective clinical response. We are a highly focused company, committed to leading the scientific development of T-cell receptor therapies to revolutionize solid cancer treatment and improve patient outcomes. I'm extremely proud of our team's work in realizing the promise of our novel technologies and R&D efforts with clinical execution. We believe TCRT, targeting high frequency driver mutations, is potentially the most promising advanced immunotherapy to kill solid tumors. We are proud to be on the leading edge of cell therapy. We are the first company to demonstrate an objective clinical response in a patient with a solid tumor using a non-viral TCRT cell therapy. We are encouraged and motivated by the significant interest these results have since generated among physicians, patients, investors, potential partners, and other key stakeholders. Every day, multiple patients are reaching out to inquire into our clinical study from across the country. This growing momentum provides a tremendous foundation for the year ahead. We have been hard at work to ensure that we can meet our TCRT Library Phase 1-2 program milestones in 2023. In the fourth quarter, we filed an IND amendment for the trial. As part of this amendment, we made several critical enhancements to our enrollment and manufacturing processes. First, We combined our treatment and screening protocols, streamlining enrollment, making it easier for both patients and physicians. Second, we are no longer required to retest the patient's tumor mutation if more than six months has passed between screening and treatment, which will allow for faster accrual. We are confident that these driver mutations will be retained as they are at the core of the cancer. Lastly, we added cryopreservation to our manufacturing process. Cryo reduces the manufacturing process time from 30 days to 26 days, while simultaneously increasing flexibility for patient scheduling and treatment. As we look ahead, cryopreservation also allows us to open additional trial sites outside of Texas. And yes, contrary to the common belief of many Texans, There is a big world outside of this great state. In this expansive IMD amendment, we again added to our industry-leading TCR library for use against solid cancers with two new TCRs targeting frequent mutations and HLAs. This addition effectively doubles our eligible patient pool for the study. with now more than 10% of all patients screened for our trial at MD Anderson matching a library TCR. Taken together, we are confident that these changes will enable us to increase the pace of enrollment in our trial, allowing us to become Phase II ready by the end of the year. I'd like to talk about our TCRT Library Phase I-II trial and what this year will look like. as we move towards phase two readiness. As you will recall, this is a basket trial targeting driver mutations across six solid tumor indications, non-small cell lung, colon, endometrium, pancreas, ovary, and bile duct cancers. We are actively enrolling patients at MD Anderson with any one of these six cancers based on matching both a specific mutation and HLA combination to a TCR that is available in our library. As a result of the most recent IND amendment, our TCR library now consists of 12 TCRs, 5 KRAS, 6 TP53, and 1 EGFR. In December, we successfully dosed the third patient in the trial. This patient was diagnosed with pancreatic cancer with a tumor expressing HLA-A11 and KRAS-G12V mutation, matching one of the TCRs within our TCR library. The patient was treated at the second dose level with 58 billion TCR T-cells. As with the first two patients, patient three had a manageable safety profile with no DLTs or ICANS observed. The flexibility of our platform is astonishing with the first three patients on the study representing three distinct indications being treated with three different TCRs. As we treat additional patients, we believe that presenting safety and efficacy data on multiple patients at the same time is the most credible, clinically meaningful, and industry standard practice. and we look forward to sharing additional Patient 3 data with other patient results later this year. We will remain flexible on what venues we use to provide patient updates, when we provide updates, and how many patients will be included in each update based on what is in the best interest of the company. In total, we anticipate treating between 12 and 15 patients in the Phase 1 portion of the trial. With three patients having been dosed in 2022, we are confident that our growing patient pipeline and manufacturing capacity will support treating the remaining balance of patients this year. Our resolve and commitment to developing the best-in-class TCRT cell therapies has been strengthened by the growing momentum we are seeing in the patient and physician interest in our trial. Now before I hand the call over to Drew, I'll briefly speak to our financial position. In December, we completed a follow-on offering where we raised approximately $15 million in gross proceeds despite the most challenging market conditions facing the biotech industry over the past five years. As responsible stewards of the company, the Board carefully evaluated all available financing options and firmly believes that this was the right decision to allow the company to continue to advance our pioneering science. For perspective, in 2022, only 58 follow-on financings were completed compared to over 200 in the years prior. As one of the few companies to close a financing at market terms without issuing warrants, the promise of our science and technology was recognized by investors. The additional cash has allowed us to extend our runway into the fourth quarter and should enable us to accelerate the enrollment of patients and the manufacturing of clinical products to generate additional, meaningful clinical data this year. Now let me hand the call over to Drew to highlight our ongoing R&D efforts and discuss where we see opportunities to explore next-generation TCR T-cell therapies to further deepen clinical responses. Drew?
spk05: Thank you, Kevin. I'm excited to share today that we were pushing full speed ahead in our R&D efforts. We continue to ramp up our Hunter TCR discovery platform to increase the number of patients who can benefit from TCR T-cell therapy. We are generating foundational data from the translational assessments in our treated patients. And we are using the translational data to guide our next generation TCR T cell endeavors that will fuel our pipeline for the long term. Let me start with Hunter. We continue to strongly believe that Hunter is at the cutting edge of innovation and has significant advantages over traditional TCR discovery methods. We have been very successful in identifying novel, exclusively owned mutation reactive TCRs and are emboldened to increase throughput and focus on high-value targets. Our TCRs are sourced from T cells infiltrating a tumor, expressing the driver mutation in the natural context of HLA. We can then use the TCR to add to the library for the benefits of another patient who has the same target. At the 2022 CITSE conference, we presented proof of concept data supporting Hunter's ability to evaluate hundreds of thousands of HLAs, mutations, and TCR combinations in a high throughput setting with our proprietary technology. As Kevin referenced, In the fourth quarter, we added two new TCRs to our library, targeting frequent driver mutations and HLAs. The addition of these two TCRs has had a major impact on the potential addressable market for our TCR-T program, effectively doubling. We are pleased to show now a greater than a 10% match rate in the patient pre-screening process. The addition of these New TCRs is a prime example of our two-pronged library expansion strategy. On one hand, we are working to add more HLAs to the existing KRAS TP53 and EGFR mutations in the library, which we did by adding DR07 to KRAS G12V. On the other hand, we're adding new mutations within our targeted gene families, which we did with TP53R273C. This year, we expect to grow the library to 15 TCRs. And over time, we imagine that the library could be above 40 TCRs to expand the number of patients that could potentially benefit from our TCR T cell therapy. We believe Alanos is uniquely situated to effectively deliver more than one PCR to a patient on a commercial scale, which we call multiplexing. From a therapeutic perspective, multiplexing is advantageous because the more targets we attack, the better chances we have of achieving long-term durable remissions of cancer. We are highly encouraged that roughly one in five of our patients match to more than one TCR in our library right now. Multiplexing TCRT is therefore a unique opportunity for us in the near term. We expect the number of patients with single and multiple matches to continue to grow as we expand the library. And given the pace of our hunter successes, we believe we can further weaponize TCR T-cells to benefit patients with driver mutations. Our non-viral sleeping beauty system enables us to build the library of TCRs quickly and cost-effectively in a way that we believe no other company can. In addition to expanding the addressable market and reach of our TCR T cell therapy through the TCR library, we are also using our translational data from the clinical trial to help guide our next generation TCR T efforts. We will make data-driven decisions to address factors relevant for limiting exhaustion and maximizing the therapeutic potential of our TCR T cells. We are delighted to say that we have detected persistence of our TCR T cells in the peripheral blood without exhaustion markers such as PD-1. Further, we have observed effector cells and a diverse group of T cell memory subsets, including T memory stem cells. Post-treatment biopsies have retained the targeted HLA mutation. T cells grown from post-treatment biopsies contain TCRT cells capable of responding to the appropriate driver mutation, and therefore our cells are making it to the tumor microenvironment and are functional. This is what we were hoping to see and are thrilled to have these translational data with the Sleeping Beauty TCRT experience. We continue to develop novel strategies that generate IP for the company and build upon our early successes while being supported by the translational assessments. We routinely engage with our scientific advisory board chaired by Dr. Carl June. leading experts at MD Anderson, and a host of other advisors, consultants, and key opinion leaders on these topics who believe in the promise of our platform and support our trailblazing path. Given our demonstration of proof of concept, we are marching towards commercialization of the first-ever driver mutation TCR T-cell therapy. Now let me turn the call over to Abhi to highlight the tremendous progress this team has been making in our manufacturing process. Abhi?
spk01: Thank you, Drew. As Kevin and Drew have discussed, we continue to be very excited about the progress we are making in our TCRT library trial. Last year was a critical year for us as we initiated several efforts to advance and accelerate our clinical program. I'd like to highlight three major efforts. First, we have successfully manufactured at the LONUS GMP suite three patient's product using three different TCRs in three different tumor indications. All three manufactured products had fantastic characteristics relating to viability, purity, and TCR positivity. Our manufacturing process works consistently for the TCR in our library, irrespective of mutations or HLAs. Second, we have doubled our manufacturing capacity by implementing new SOPs that allow for simultaneous production of multiple products in our GMP suite. And third, we continue to invest to improve process development, further refining our manufacturing platform. In the fourth quarter of 2022, we work to further optimize our manufacturing process through an INV amendment to move from fresh to cryopreserved cell products. Cryo enabled us to reduce the manufacturing process time from 30 to 26 days, representing a 13% decrease. I'm happy to report that we have already implemented the Cryo manufacturing process this year. This new process now provides us with greater flexibility for patient scheduling and treatment. with the possibility to collect the patient's apheresis earlier in their treatment journey. We can then manufacture the drug product and cryopreserve it until the patient is ready for the infusion. This is a good start, and our long-term goal is to further reduce the manufacturing time to 15 days. I'm so proud of our fully committed technical operations team and our universal TCR manufacturing platform. And I remain excited about the investment we are making in process development that will close the system, automate the process, and decrease the cost while preparing us for phase two. I would now like to turn the call over to Mike Wong to review the financial results for the fourth quarter and full year.
spk02: Mike? Thank you, Avi. Allow me to review our financials for the three months ended December 31st, 2022. For the fourth quarter of 2022, we reported a net loss of approximately $9.2 million, or a four cent net loss per share. compared to a net loss of approximately $11.8 million, or a 5 cent net loss per share for the same period in 2021. Research and development expenses were approximately $5.6 million for the fourth quarter of 2022, compared to approximately $8.2 million for the fourth quarter of 2021, a decrease of 32%. The decrease was primarily due to reduced program-related costs and lower employee-related and consulting expenses. General and administrative expenses were approximately $2.9 million for the fourth quarter of 2022, compared to approximately $2.1 million for the fourth quarter of 2021, an increase of approximately $800,000 which was primarily due to higher legal and accounting expenses. Our operating cash burn for the fourth quarter of 2022 was approximately $7.1 million compared to approximately $15.1 million in the fourth quarter of 2021, a decrease of approximately $8 million or 53%. And now I will review the results for the full year ended December 31st, 2022. For the year ended December 31st, 2022, we reported a net loss of approximately $37.7 million or a 17 cent net loss per share compared to a net loss of approximately $78.8 million or a 37 cent net loss per share for the year ended December 31st, 2021, an impressive year over year reduction of 52%. Collaboration revenue was approximately $2.9 million for the year ended December 31st, 2022, compared to approximately $400,000 for the year ended December 31st, 2021. The increase in collaboration revenue was primarily due to the achievement of sales-based milestones of Derina Parson in Japan, which was largely offset by a one-time research and development expense that I'll touch on shortly. Research and development expenses were approximately $25 million for the year ended December 31st, 2022. compared to approximately $49.6 million at the year-ended December 31, 2021, a decrease of 50%. The decrease in research and development expenses was primarily due to reduced program-related costs and lower employee-related and consulting expenses. These decreases were partially offset by a one-time $2.5 million milestone payments to MD Anderson for Darinah Parson. For the year 2022, general and administrative expenses were approximately $13.1 million, compared to approximately $27.6 million for the year ended December 31, 2021, a decrease of 52%. The decrease in general and administrative expenses primarily due to lower employee-related and professional services expenses. As of December 31st, 2022, Elanos had approximately $53 million in cash balances, which includes restricted cash of approximately $13.9 million, serving as collateral for our outstanding debt. Our operating cash burn for the year ended December 31st, 2022 was approximately $29.2 million compared to approximately $61.5 million for the year ended December 31st, 2021. A decrease of approximately $32.2 million or 52%. Reflecting the full year impact of our cost reduction efforts, and our focus on being good stewards of capital. Based on our current operating plans, we expect our operating cash flows, excluding debt service costs for 2023, to be between approximately $35 to $40 million. We expect to have sufficient cash resources to fund research and development programs and operations into Q4 of 2023. I want to highlight some of the work we are doing on the corporate side to further build upon our growing momentum. Alanos is the leader in TCRT targeting driver mutations, and as we look to further solidify this presence and raise our profile among the industry and media, we recently engaged Six Degrees, an established public relations firm specializing in and serving the biotech industry. Our innovative technology and exciting clinical program remain on the cutting edge of research in the TCR and solid tumor space, and we look forward to engaging with and building relationships with media audiences. In addition to Six Degrees, we recently engaged additional investor relations resources to cultivate existing and develop new investor relationships. I would now like to turn the call to Kevin for closing remarks.
spk03: Thank you, Mike. As we look to the year ahead, we are dedicated to revolutionizing how solid tumors are being treated using our disruptive technology, and the clinical, manufacturing, and research teams are committed to this objective. Through the groundwork we have laid in our recent IND amendment, where we added additional TCRs and transitioned to cryopreservation, we will greatly enhance patient throughput, and treatment flexibility for our TCRT Library Phase 1-2 trial. We remain confident the positive momentum we have built among patients and physicians will lead to even greater accomplishments as we expect to treat the remaining balance of patients in the Phase 1 portion of our TCRT Library trial, share additional patient data, and become Phase 2 ready by the end of the year. Looking beyond 2023, we envision being in the Phase II stage of our existing IND. Our IND enables us to conduct multiple, independent, indication-specific Phase II trials simultaneously. Oftentimes, certain TCRs may be associated with specific cancer types. For instance, non-small cell lung cancer commonly has EGFR and KRAS mutations. so we may expect to enroll lung cancer patients with predominantly these TCRs. Colon cancer, on the other hand, is associated with KRAS and TP53 mutations, which could be a second Phase II trial. Over time, we expect to initiate multiple Phase II trials across several solid tumor indications, as we believe our TCR T-cell therapy has applicability across a broad range of solid tumor types. To our knowledge, we are the only company taking this type of unique approach utilizing a TCR library targeting driver mutations against solid tumors. As we continue to build the long-term potential of TCR-T cell therapies from Elanos, we are actively developing next-generation treatments which hold the potential to deepen clinical responses through combination approaches and multiplexed TCR-T cell therapies. We are working to conduct translational assessments of treated patients to guide these next-gen approaches. In the near term, our membrane-bound IL-15 TCR-T cell therapy program is advancing towards an IMD, which we anticipate submitting later this year. We remain very optimistic about our Hunter TCR discovery platform. which is firing on all cylinders. By expanding the library with proprietary TCRs, we increase the addressable market and the number of patients that might benefit from our single or multiplex TCR-T cell therapies. It is truly astonishing what this platform is capable of, and I look forward to what the future holds for Hunter. In sum, bolstered by the early and encouraging clinical results, We believe 2023 will prove to be an exciting year filled with promise and progress for Alano's as we advance our pipeline of innovative TCR therapies. I want to express my deepest gratitude to our patients, shareholders, and employees for their support as we continue our mission to improve the lives of patients with solid tumors. We will now open the call to questions. Michelle?
spk08: Thank you. As a reminder, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment while we compile the Q&A roster. Our first question comes from the line of Parker Agarwal with Cantor. Your line is open, please go ahead.
spk00: Hi, thanks for taking my questions and congrats on 4Q. So, Kevin and team, my first question Have there been additional patients' dose since patient number three and key four given enrollment progress as a key focus for the company? So I appreciate any color here. And just to confirm that you have the green light from DFDA on the specific enhancements to the IND, and there are no further regulatory approvals required. And I had a couple of follow-ups.
spk03: Rekhar, good morning. Good to hear from you. With regards to patient enrollment, as we said, we are very excited about the progress that is being made and the interest in this trial stemming from our first objective clinical response we are not going to report on a patient by patient basis but we're going to look for the right venue to provide further updates on number of patients treated and the data associated with that but we're feeling quite confident based on the interest that has grown and the excitement around the response and the data that we've seen thus far out of the first three patients And with regards to the IND amendment in the fourth quarter where we added two additional TCRs and made certain enhancements in the clinical trial design to further facilitate and accelerate the enrollment, there are no outstanding questions from the IND, which is really shown our unique trial design and the relationship with the agency, the fact that we have had multiple IND amendments with very minimal comments. So this is a unique trial design. for sure, one that we believe is a differentiator for this company in quite a positive way and very excited about these driver mutations benefiting cancer patients.
spk00: Got it. Thank you. And the second question, the opportunity for multiplexed TCR was noted in the press release and the comments for patients who are matching for more than one TCR. So maybe if you can expand on how this will be, this could be implemented in the trial. Will it be a separate IND? And if you can expand on the scientific rationale for a multiplexed TCR. Thank you.
spk03: Absolutely. I'll let Drew comment on that.
spk05: Yeah, Prakhar, good morning. Thanks for the question. We're very excited about the potential for multiplexings. A lot of it's TBD for now, but we're excited to see that roughly one in five of our patients have matched one of the TCRs. on our pre-training process have more than one match. So we do think that this is something that's feasible for us. We think that through our sleeping beauty non-viral system, we have a unique position to deliver more than one TCR. And to your point about the rationale, just going back to more than one target at a given time has more than one chance to affect the cancer. So we're excited about that. And we're looking forward to bringing in IL-15 in the second half of this year for an I&D amendment, maybe even potentially adding that to multiplexing in the long term.
spk00: Thank you.
spk08: Thank you. And one moment for our next question. Our next question comes from the line of Yelgin with Laidlaw. Your line is open. Please go ahead.
spk04: Good morning, and thanks for taking the questions. My first question is that in terms of you characterize the TCR cells that have certain characteristics, could you elaborate more in terms of whether those aspects are functional, and then I have a follow-up as well?
spk05: Morning, Yale. Yes, great question. Thank you for the question. We're very excited about what we're seeing in the translational assessments and all, and then specifically in regards to the cells that are persisting in the blood of our patients that have been treated are showing limited exhaustion. We're seeing T-memory stem cells, and then within the Tumor biopsies that have happened post-treatment, we've seen retention of the HLA and the mutation by the tumor, and T cells that we've grown from those tumors, so TILs, have had TCR T cells, and those are indeed functional against the driver mutations. So, really encourage that our cells are getting there. They look to be functional, and they look to have limited exhaustion.
spk04: Okay, great. That's very helpful. Maybe a follow-up here, which is that given you guys start to progress a little bit more into, you know, more patients and goals, are you guys thinking about any potential big business development opportunities? And if so, how would those things could be, you know, defined or characterized that you would – still retain a good portion of the assets in-house.
spk03: Sure, Yale. Like all biotechs, we're always in active discussion with potential partners and business development opportunities. We're very excited about the interest that our TCRT platform targeting driver mutation has generated within discussions with other folks, and we're also very motivated by the potential of our Hunter platform. We really believe that is quite interesting and novel because we can develop through this very high throughput of single-cell sequencing that Drew has mentioned, identify novel targets with proprietary IP, so a very strong patent position, both to bolster our own TCR library of KRAS TP53 and EGFR mutations, But at the same time, Hunter identifies and has the capability of identifying other novel targets that would be of interest to potential partners. So we really have something special here, and I believe strongly that others see that very opportunity and potential as well.
spk04: Okay, great. That's very, very helpful. Maybe just tweeting one more. You currently assume you have a certain level of debt. What's your thought in managing that? And thanks.
spk02: Thanks for the question. As of year end, our outstanding debt balance was approximately $16.7 million. And we started principal repayments in September of 2022. And we expect to have that fully repaid by August of this year.
spk04: Okay, great. Thanks a lot, Rudy. Appreciate it.
spk08: Thank you. And one moment for our next question. Our next question comes from the line of Thomas Flatton with Lake Street. Your line is open. Please go ahead.
spk06: Good morning. Thanks for taking the questions. Kevin, I was wondering if you could expand a little bit more on what qualifies you as Phase II ready aside from the patient number. Any other things we should be looking for there?
spk03: Thomas, good morning. When we look towards what we want to accomplish in the phase one, first and foremost, it's about safety. It's identifying a maximum tolerated dose, and then it's also identifying the recommended phase two dose. So those are going to be the three items that we look for, safety, maximum tolerated dose, recommended phase two dose. And what's really nice is this Bayesian design allows us to accelerate achieving this objective. And that is why a relatively low patient number in phase one is all that's required to achieve these objectives. So as you may recall, Thomas, we only had to dose one patient at the first dose level. And because of the favorable safety profile that we've seen, we were able to accelerate that to the second dose level. So we're very excited. We also have a higher dose level, you may recall, because of the safety profile should be rather favorable. The targets we're going after, these driver mutations by definition, are at the core of the heart of the cancer and do not appear on healthy tissue cells like some of our other TCR competitors that are targeting different targets. So we believe we have a superior target in our driver mutation with our TCRs going after these targets that are only in the cells of the cancer. And therefore, we can use higher doses, and we believe that will lead to greater efficacy.
spk06: That's great. I appreciate the color. And the enrollment target that you have of 12 to 15, can we assume that that would be achievable with the current stable of TCR? So the 12, or does that imply that you're going to add a few more during the year in order to hit that enrollment goal?
spk03: Oh, I tell you, we feel very confident with the number of patients that we're seeing in our pipeline. Any additional TCRs are just building towards the future, building towards our goal of multiplexing. So as a reminder, any time we add a TCR, we can absolutely use it to start treating patients right away. But we're very confident with what we see right now with the engagement of our PIs at MD Anderson. that with our phase one, we will be successful in treating the required number of patients, and we'll do so in a very expeditious manner. And we have our own manufacturing capacity with our own employees being able to execute on that, being able to manufacture multiple products at the same time. And what's nice with this as well with the cryopreservation, Thomas, is we're able to start manufacturing now earlier in the patient's journey. So we can manufacture products. It can be waiting in the freezer for when, unfortunately, if a treatment fails a patient, we can then take that product that we made early in 2023 and infuse that patient when they're ready. So it's really a very important enhancement that we made. We believe we're going to end up with more fit cells by taking the apheresis earlier in the patient's journey. We can manufacture that product, cryopreserve the cells, and then be ready for that patient when, unfortunately, if their current therapy fails them.
spk06: Excellent. And then just one final one, just to segue off of manufacturing. I believe that Avi said during the call that the goal was to reduce the manufacturing timeline from 26 to 15 days. I was just wondering if you could comment on what's required to hit that goal and over what timeframe we might expect to see you guys kind of whittle that timing down.
spk03: Sure. And I do think Avi hits some of the aspects, the kind of three aspects within that we're working on in addition to reducing costs. But Avi, why don't you go ahead and talk to Thomas?
spk01: Yeah, Tom. So we are investing in multi-pronged manufacturing strategy to really cut down our manufacturing time. We are constantly investing in process development, closing the system, providing the automation in our manufacturing platform. And by doing so, we are very confident that we'll be able to reduce the manufacturing time to the 15 days as we reach to the commercialization stage. Excellent.
spk06: Thanks for taking the question. Oh, sorry. Sorry. Sorry. Go ahead.
spk01: And just wanted to highlight how much cryopreservation has provided us the power of flexibility. By utilizing that cryopreservation, we'll be able to manufacture the better products and overall efficacy of the, overall quality of the product.
spk03: Yeah, Thomas, just important, I think, to highlight here is one of the things that cryopreservation does, when fresh cells, you had a patient that was ready to be infused immediately, so timing really mattered, right? Now, the fact that we're able to manufacture the cells ahead of time in this phase one portion of the trial with the cryopreservation, Whether it's 26 days or 15 days, it's still earlier in the patient's journey where they're not quite ready to be infused yet. So the time is less relevant at this stage. So we have the time to be able, by the time, as Avi said, when we hit commercial, it'll be reduced. That will be very important. But as of right now, the timeframe taking to manufacturing the cells is less relevant because the cells will be frozen down and be available immediately when the patient is ready.
spk06: Excellent. Appreciate it. Thank you, guys.
spk03: Thank you, Thomas.
spk08: Thank you. And this does conclude today's question and answer session. Ladies and gentlemen, this also does conclude today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.
spk06: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1-1

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