Cisco Cloud Collaboration Solutions exam Dumps

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Enhance Your Capabilities with Cloud Collaboration
Reduce the complexity of your infrastructure.
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a blend of market-leading collaboration solutions, cloud technologies, and Cisco Powered partner services. You can take the best of each approach, combine them, and connect what you have on premises with the cloud. Effectively, you extend the benefits of the Cisco Collaboration portfolio unified communications, customer collaboration, conferencing, and collaboration endpoints across your entire organization.
New Ways to Collaborate, New Opportunities
As collaboration changes, it provides organizations more opportunities to better connect employees, customers, and partners.
Share ideas rapidly across multiple continents.
Make interactions more fulfilling and easier with new tools, such as video and mobile devices.
Deliver results across productivity, innovation, and growth.
How can you capitalize on the potential of this new era of collaboration while helping your organization reduce costs and complexity, boost agility, and better support business priorities- By using the cloud to extend collaboration capabilities across your organization.
Taking Collaboration to the Cloud
With Cisco Cloud Collaboration, you dont have to choose between an on-premises or cloud deployment. You can take advantage of the cloud with complete confidence, and without compromise, because you will get the same enterprise-grade experience and application performance you expect from our on-premises deployments. We make this possible by delivering:
Security: Helps ensure that security remains an integral component of our cloud architectures, and that all Cisco Powered services are certified by Cisco and built using Cisco validated designs.
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Scalability and survivability: Extends the solution to multiple users and geographies with full redundancy.
Exceptional user experience: Gives users the same market-leading Cisco collaboration tools regardless of how their service is enabled.
The portfolio of services we offer with our partners makes these capabilities possible. Together, we deliver customized, Cisco Powered services that help you reduce risks, accelerate time to market, and Boost the collaboration experience.

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Gamida cell Ltd. (GMDA) Q2 2021 revenue name Transcript

a close up of a logo: Gamida Cell Ltd. (GMDA) Q2 2021 Earnings Call Transcript © offered by using The Motley idiot Gamida mobilephone Ltd. (GMDA) Q2 2021 income name Transcript

Gamida cellphone Ltd. (NASDAQ: GMDA)

Q2 2021 revenue name

Aug eleven, 2021, 8:00 a.m. ET

  • prepared Remarks
  • Questions and solutions
  • call contributors
  • prepared Remarks:



    girls and gentlemen, thank you for standing via. Welcome to Gamida mobile's convention demand 2nd-quarter 2021 fiscal effects. My name is Crystal, and that i'll be the operator for ultra-modern call. Please be recommended that this call is being recorded at Gamida cell's request.

    Now, i might now like to introduce your host for contemporary convention, Mr. Josh Hamermesh, chief business officer. Please go ahead.

    Josh Hamermesh -- Chief business Officer

    thank you, Crystal, and good morning, everybody. Welcome to trendy call, during which we can supply an replace on the business and evaluate our economic effects for the 2nd quarter of 2021. earlier this morning, we issued an announcement summarizing our fiscal results and progress throughout the business, which is available on our web page at here with me on our call nowadays are Julian Adams, chief govt officer; Ronit Simantov, chief clinical officer; Michele Korfin, chief operating officer and chief industrial officer; and Shai Lankry, chief monetary officer.

    there will also be a Q&A session following our organized remarks. during this name, we may additionally make ahead-searching statements about our future expectations and plans, together with in admire of the timing and initiation and development of, and records said from the medical trials of our product candidates, predicted regulatory filings, including the submission of the BLA for omidubicel to the FDA, commercialization planning efforts, the potentially lifestyles-saving or healing therapeutic and industrial potential of omidubicel and our expectations regarding our projected money to be used for operating actions and cash runway. Our exact results may additionally differ materially from what we project today due to a couple of essential elements, including the have an effect on of the COVID-19 pandemic on our operations, the scope, development and enlargement of our clinical trials and cost have an effect on thereof, clinical, scientific, regulatory and technical developments and those inherent in the procedure of developing and commercializing product candidates that are protected and advantageous for use as human therapeutic, and within the activity of constructing a enterprise round such product candidates, in addition to these considerations described within the chance elements portion of our most accurate Annual file on kind 20-F and different filings that we make with the SEC occasionally. These ahead-looking statements characterize our views handiest as of nowadays, and we caution you that we can also not replace them in the future, whether on account of new tips, future pursuits or in any other case.


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    this text is a transcript of this conference name produced for The Motley fool. while we strive for our silly finest, there could be errors, omissions, or inaccuracies in this transcript. as with any our articles, The Motley idiot does not assume any accountability for your use of this content, and we strongly motivate you to do your own research, together with listening to the name yourself and practicing the enterprise's SEC filings. Please see our terms and prerequisites for extra details, together with our mandatory Capitalized Disclaimers of liability.

    The Motley idiot has no place in any of the stocks outlined. The Motley fool has a disclosure coverage.

    And now i'd want to flip the call over to Julian.

    Julian Adams -- Chief executive Officer

    thanks, Josh, and due to everybody for joining us this morning. This changed into a productive quarter for Gamida cell. We continue to execute on our plan to launch the first allogeneic stem telephone remedy, omidubicel for cancer sufferers in want of a stem telephone transplant. additionally, in accordance with promising preliminary experiences, we now have accelerated our plans to develop a special NAM-enabled natural killer or NK mobile GDA-201 for patients with follicular lymphoma and diffuse enormous B-mobilephone lymphoma.

    And we're very excited concerning the expansion of our telephone therapy pipeline with four new NAM-enabled genetically modified NK cells focused on cancers. sufferers are on the forefront of our work, and we are committed to turning our NAM-enabled NK product candidates into healing remedies. i may beginning with our most advanced application omidubicel, a probably life-saving medicine for patients with blood cancers who're in want of a stem cellphone transplant. This quarter, we introduced the outcomes of a part 3 medical study of omidubicel, which we published in Blood, the legit Journal of the American Society for Hematology.

    The published effects show that transplantation with omidubicel should fasten neutrophil and platelet recuperation compared with the commonplace of care. moreover, the facts demonstrates that omidubicel consequences in fewer bacterial, fungal, and viral infections and fewer time within the clinic. These results add to the compelling body of facts for the capabilities of omidubicel as a life-saving therapy that can improvement patients in want of a bone marrow transplant and assist in the reduction of the burden on our healthcare gadget. We proceed to execute our plan of motion towards becoming a industrial company in 2022, as we prepare for our BLA submission for omidubicel by using the end of this year, subject to a pre-BLA meeting with the company in the fourth quarter.

    Omidubicel has the abilities to be the first FDA-authorised phone remedy for stem cell transplants. Michele will supply an replace on launch readiness in a while within the name. moving to our NK pipeline. We consider that NK cells dangle colossal skills as a superior-in-type subsequent-technology immunotherapy.

    NK cells, are the physique's first-line of protection in featuring innate immunity. They also have immune-privileged houses, which obviate the requirement for HLA matching. on the grounds that any in shape adult donor can provide an apheresis unit, from which we follow our proprietary NAM know-how to extend and produce a cryopreserved, off-the-shelf allogeneic natural killer mobilephone medication for melanoma sufferers. Our NAM-enabled NK cells display a couple of important mobile floor markers, together with excessive expression of CD16, the Fc-gamma RIII receptor for antibodies, which makes it possible for the combination with monoclonal antibodies to goal tumors via enhanced antibody-based mobile cytotoxicity or ADCC.

    Importantly, NAM also increases CD62L have been L-selectin expression, which leads to in vivo homing and retention in lymphoid tissues. in addition, NAM increases secretion of inflammatory cytokines for activation of host adaptive immune cells. The culmination of these actions effects in multiplied cytotoxicity for more productive tumor phone killing and sturdy responses. The aggregate of NK cells with therapeutic antibodies increased GDA-201's efficiency of killing an enhanced ADCC, each in vitro and in vivo, helping medical remedy with GDA-201 in parallel with selected antibodies for selected malignancies.

    we're advancing the vigour of NK cells to the subsequent stage with our second candidate in medical development, GDA-201, which has established brilliant outcomes in preliminary reviews as a possible treatment for sufferers with follicular and diffuse enormous B-cellphone lymphomas. we now have accomplished the GMP batches with our cryopreserved components of GDA-201 and are on target to post an IND during this quarter to assist a multicentered section 1/2 examine through the conclusion of the yr. these days, we introduced that we are expanding the attain of both the NAM know-how and the vigor of NK cells through the increase of our NK pipeline to now include genetically modified variant and proprietary treatment options using CRISPR-Cas9 and vehicle technologies. Ronit will provide extra element on this entertaining new building shortly.

    And we seem to be ahead to proposing a more exact replace at an R&D Day later this year. i'm extraordinarily pleased with the development our group has made with this expansion, and i consider that our technology, combined with our expertise in NK biology holds remarkable promise for additional -- to extra our vision of bringing curative treatment options to sufferers. I need to conclude my introductory remarks via definitely thanking our employees for their endured dedication to our mission and tough work. And with that, i will be able to turn the name over to Ronit.

    Ronit Simantov -- Chief clinical Officer

    thanks, Julian. i'm very excited to deliver greater detail on our NK pipeline growth, which we announced this morning. We're confident within the potential to leverage our NAM know-how for these newly announced goals in response to the encouraging medical records we demonstrated with GDA-201 for sufferers with lymphoma. These new courses will contain genetic adjustments supposed to direct NK cells in opposition t cancer cells, improving concentrated on and persistence and improving cytotoxicity in opposition t both hematologic malignancies and strong tumors.

    This pipeline growth stems from research that we now have been conducting here at Gamida phone and in collaboration with key educational researchers and represents important development within the construction of NK remedies for patients. Our new product candidates include GDA-301, a Knockout of CISH or cytokine-inducible SH2 containing protein in NK cells using CRISPR-Cas9 with concomitant insertion of membrane-sure interleukin-15 or IL-15. CISH is a regulator of IL-15 signaling and CISH dilution raises NK sensitivity to IL-15 by using reducing the NK activation threshold. NK cells outfitted with membrane-certain IL-15 are designed for greater persistence and improved antitumor outcomes.

    In preclinical studies, we now have Tested elevation of pro-inflammatory cytokines and more desirable potency and cytotoxic endeavor in these cells. We accept as true with that the CISH goal coupled with membrane-bound IL-15 has abilities across distinctive tumor varieties. additionally, these days, we introduced the development of GDA-401, which is genetically engineered toward an undisclosed goal designed to boost NK mobile survival in an exceptional tumor microenvironment. As with GDA-301, we agree with that GDA-401 has abilities software throughout a extensive latitude of solid tumors.

    The third construction candidate in our NK pipeline is GDA-501, a chimeric antigen receptor or vehicle engineered NK telephone, designed to target HER2-nice solid tumors. This candidate has the potential to enhance homing to and pastime against tumors overexpressing HER2, reminiscent of breast melanoma, ovarian, lung, bladder, and gastric cancers. The NK car is in keeping with a single-chain variable fragment of the everyday humanized monoclonal antibody trastuzumab. GDA-501 automobile changed into selected out of a few constructs which are primarily concentrated on optimizing the intracellular signaling area.

    These had been extra validated in preclinical studies, displaying enhance in cytotoxicity and greater efficiency. The fourth development candidate in our NK pipeline is GDA-601, which is designed to target distinct myeloma. There is robust biological motive for the augmentation of allogeneic NK cells with a motor vehicle to boost myeloma concentrated on. And CD38 is an established immunotherapeutic goal in distinct myeloma.

    youngsters, CD38 expression on NK cells, which is multiplied throughout NK growth, represents a barrier to the building of CD38 automobile NK cellphone remedy. to beat predicted concentrated on our refractory side of NK cells by means of anti CD38, we applied CRISPR-Cas9 genome modifying to disrupt CD38 protein expression in NK. We mixed this with ACD 38 focused on automobile designed to increase killing of CD38 high-quality myeloma cells, and we have validated this in preclinical reviews. We consider that NK cells are a extremely promising new strategy to the medicine of cancers, and we're proud to be on the forefront of the analysis to Boost this effective technology.

    i'll now flip the name over to Michele Korfin, our chief operating officer and chief business officer, who will talk greater about our launch readiness for omidubicel. Michele?

    Michele Korfin -- Chief operating Officer and Chief industrial Officer

    thanks, Ronit, and good morning, everyone. today, i will be able to review our progress on our commercial manufacturing and launch readiness activities. As we proceed to develop our step forward remedy, omidubicel, for sufferers in want of an allogeneic stem cell transplant. As Julian outlined, we are working towards BLA submission for omidubicel in the fourth quarter of this year, and our launch planning and manufacturing actions are underway to support a possible U.S.

    launch in 2022. This quarter, we persevered to make crucial development Preparing each our amenities for industrial manufacturing readiness. CMC qualification activities stepped forward at both the Gamida cell-owned manufacturing facility in Israel and at Lonza. we now have made giant developments in analytical formula validation, analytical comparability and medical manufacturing.

    we're on the right track to finalize the CMC qualification necessities for the BLA submission. furthermore, we are very excited about hiring Vladimir Melnikov as our senior vp, global manufacturing and operations. Vladimir's large and deep event supply key capabilities as we boost our commercial manufacturing readiness. We accept as true with that there's a big opportunity with omidubicel.

    in the U.S. on my own, there are over forty,000 sufferers per yr with hematologic malignancies who accept as true with a bone marrow transplant. regrettably, handiest about 10,000 patients are able to make it to transplant for a lot of explanations. we now have completed wide research and collaboration with the middle for overseas Blood and Marrow Transplant analysis or CIBMTR and unbiased market analysis businesses to thoroughly assess the unmet want.

    This market research has enabled us to strengthen a well-advised launch approach to attain these patients and transplanters. according to our business insights, the probability for omidubicel may also be summarized in two key categories. First is increasing access for sufferers, specifically folks that are eligible for transplant and can't discover a suit. And also improving consequences according to the unmet clinical wants with latest donor sources that will also be addressed by using omidubicel.

    One selected enviornment of capabilities for omidubicel is that it has less stringent matching criteria for patients as compared to graft sources from fit connected or unrelated donors. here's certainly important for patients of non-Caucasian descent who are likely to have a greater challenging time finding an appropriate in shape donor. truly, in the omidubicel section 3 trial, over forty% of the patients enrolled have been non-Caucasian, illustrating the crucial want for an appropriate graft source during this affected person inhabitants. If authorized, we trust omidubicel will provide a timely and engaging option for an appropriate graft source to sufferers in need of a bone marrow transplant who would otherwise undergo a look for a matched donor that may take several months, causing high degrees of nervousness and also uncertainty for sufferers who are at high-quality chance or high-chance for relapse.

    Upon FDA approval, we agree with omidubicel may be a vital therapy option for patients within the U.S. in need of an allogeneic stem telephone transplant and we're concentrated on establishing a powerful launch method. especially, we have employed a extremely skilled industrial leadership team within the U.S. and continue to augment the capabilities of our group.

    moreover, we proceed to have energetic speak with physicians and payers and remarks on the price proposition of omidubicel has been particularly encouraging. above all, payers are encouraged by means of the talents for sooner time to neutrophil engraftment, lowered infections, decrease in hospitalizations, and fewer graft-versus-host disorder as compared to posted literature for different graft sources. In preparation for the skills approval of omidubicel in the U.S., the construction of Gamida phone support continues to growth, which might be an important source of support to sufferers, caregivers, and transplant groups all over every affected person's event with omidubicel. this is a application like no other for patients present process a transplant.

    we've hired the Gamida telephone support management group that could be focused on assisting the patients' journey with omidubicel. The Gamida cellphone help team will consist of an skilled case administration group that could be focused on making certain affected person entry and offering guide to patients, their caregivers, and the transplant group at the health center all through every step of the procedure. Gamida phone help could have a few key roles. one of the crucial important roles is compliance with the FDA's chain of id requirements.

    Gamida mobile aid will delivery our chain of identification, which is a distinct patient identifier if you want to comply with the affected person in the course of the total procedure. in addition, we can be able to give the hospitals and patients with information to guide entry to omidubicel, reminiscent of advantage verifications or travel and lodging wants. Gamida telephone is committed to supporting a positive adventure for sufferers and their transplant centers in order that they might center of attention on what matters most, the patient journey and a hit clinical results. In abstract, we're excited through the abilities of omidubicel to be the first FDA-approved mobilephone remedy for bone marrow transplant, and we're encouraged by way of the medical statistics and comments from physicians, payers and patients.

    we're progressing our launch preparations and continue to be on target for product launch in 2022, with a focus on assuring a favorable patient and transplant middle event. i'll now turn the call over to Shai to assessment our financial outcomes. Shai?

    Shai Lankry -- Chief fiscal Officer

    thank you, Michele, and good morning, everyone. nowadays, i will summarize our financial consequences for the 2d quarter of 2021. As of June 30, 2021, our complete cash position will $one hundred fifty.2 million, in comparison to $127.2 million as of December thirty first of last year. analysis and development prices for the quarter had been $13.5 million, compared to $9.3 million for the same period in 2020.

    The increase turned into certainly because of omidubicel industrial manufacturing readiness activities as neatly because the developments of GDA-201 and our rising NK pipeline, including broadening our scientific capabilities and talent. commercial charges within the quarter had been $5.2 million, in comparison to $1 million for the same duration closing 12 months. The enhance changed into specifically attributed to growth with omidubicel commercial readiness activities, which comprises, amongst different issues the hiring of an skilled business management team. typical and administrative fees have been $three.8 million for the 2d quarter of 2021, compared to $2.5 million for a similar length in 2020.

    The enhance was notably as a result of hiring key administration place to support the company increase. Finance salary internet changed into $1.2 million for the quarter, in comparison to finance price internet of $2.2 million in the equal length closing 12 months. The enhance become essentially as a result of non-cash earnings resulting from revaluation of warrants, offset by way of activity fees from the $75 million convertible word financing we did prior this yr. web loss for the quarter was $21.3 million, compared to a net lack of $15.1 million for the same duration closing 12 months.

    We continue to expect cash use for ongoing operating actions this yr to range from $one hundred ten million to $one hundred twenty million. We expect that our present total cash position will help our ongoing operating activities into the second half of 2022. This cash runway tips is in response to our current operational plan and exclude any extra funding that could be bought, or enterprise building activities that can be undertaken. With that, i'll flip the call returned over to Julian.

    Julian Adams -- Chief govt Officer

    Thanks, Shai. Our imaginative and prescient has at all times been to discover remedies for sufferers with hematologic malignancies and blood issues and we are excited at the many opportunities ahead. Our accomplishments in 2021 will construct awesome momentum and create a foundation for success in 2022. With omidubicel, we expect to put up the BLA within the fourth quarter of this year, and we are committed to being launch-able on the time of approval.

    The GDA-201 on its heels with compelling statistics, we're planning to initiate a Gamida cellphone-sponsored medical study in lymphoma earlier than the end of the yr. We plan to share records on the mechanism of motion of our NAM platform, translational statistics, and greater mature clinical facts at principal medical meetings and in peer-reviewed publications this year. finally, we're excited about our NK pipeline expansion introduced these days and appear forward to updating you as we've extra growth to record later this year. Now, we can open the call for your questions.

    Krystal, operator.

    Questions & answers:


    [Operator instructions] Your first question comes from the line of Ted Tenthoff from Piper Sandler. [Operator instructions]

    Julian Adams -- Chief govt Officer

    Crystal, let's perhaps simply go to the next caller. we are going to give Ted a different opportunity.


    Your subsequent question comes from the road of Jonathan Miller from Evercore ISI.

    Jonathan Miller -- Evercore ISI -- Analyst

    Congrats on the entire new programs that you just just announced. Couple of things throughout the pipeline. are you able to consult with us about spending ramp for OMI business launch? How massive a crew you anticipate desiring? And what the time line of that ramp is going to be as we count on both the BLA and the subsequent approval? Secondly, on OMI, you've gotten outlined this huge skills market question in the states, but what quantity do you expect current manufacturing being capable of fill -- again, so perhaps coming from the different aspect, the provide facet of that curve. Then speaking about the pipeline possibly a little bit, i'm curious concerning the timing of medical initiation of these pipeline classes.

    Are any of these predicted to have an IND before the meditated latest cash runway is up? and what is the time line for getting extra readability on the specifics of these classes, particularly the target of the 401 asset?

    Julian Adams -- Chief executive Officer

    thank you, Jon. Michele, let me ask you to respond to the industrial growth and the capacity query.

    Michele Korfin -- Chief working Officer and Chief commercial Officer

    fully. So with reference to your question about omidubicel container crew and timing. So in the event you look on the benchmarks within the telephone therapy house, certainly, if you appear on the core key groups that are additionally concentrated on the transplant facilities within the U.S., their range for personnel is about 25 to 30 business account managers and approximately 10 to 15 scientific science liaisons that would fall under Ronit's crew. We do recognize that within the U.S., 70 transplant centers make up approximately 80% or account for 80% of the transplant.

    So we definitely do think we may be on the reduce end of these degrees and have a very thorough, but efficient footprint in the container. So we're searching on the lessen end of those tiers that I've outlined. So the industrial cap managers closer to the 25 and the clinical science liaisons nearer to the 10, the decrease end of that latitude. when it comes to ramp-up, so on the industrial side, we have hired Linda Stamler, who changed into our vice president for both marketing and account administration.

    So we've the leader of both the marketing and account administration team in area already, and Linda is now in the process of mapping up the -- hiring the account manager side. And Ronit and her crew have made fantastic progress in bringing in strong leaders on the scientific affairs side also. So the management team and additionally one of the crucial field hiring is already in location. So that's the question on the industrial footprint.

    with reference to manufacturing, the team at our industrial manufacturing facility in Israel has in fact made amazing progress, now not most effective with Preparing for the qualification requirements for BLA, but also getting able for commercialization. When the power changed into designed in Israel it was designed as a modular facility. in order we're seeing this encouraging records are available for our forecast going forward upon potential FDA approval, we have the means so as to add further modules at our facility in Israel in Kiryat Gat. So we suppose very assured that we now not handiest have already got the facility in region for launch readiness for industrial wants, however additionally, we know what the lengthy-time period appears like for adding additional cores or extra modules.

    So let me cease there, Jon, and see when you have any questions on what I simply mentioned, after which I might turn to Ronit for the NK query.

    Jonathan Miller -- Evercore ISI -- Analyst

    No. That changed into a fabulous response. I wager while we're talking about -- what we're talking to you concerning the industrial launches and what the opportunities are, do you have any up to date color on the ecu market? How the possibility is diverse there and any update on BD for ex U.S.?

    Michele Korfin -- Chief operating Officer and Chief business Officer

    sure. So let me speak in regards to the eu market, and that i'll also mention other markets. So we've undertaken commercial assessments in both Europe and other constituents of the world, together with Asia. We're encouraged by using the alternatives.

    there's definitely the superb need for different expertise graft sources, different mobile healing procedures for allogeneic stem mobilephone transplant sufferers in Europe and additionally in certain areas throughout the area, together with Asia. So we're certainly very concentrated on launching omidubicel within the U.S., we suppose very assured in our approach and our execution plans to do it, and we're at the moment assessing what a possible direction to launch may well be in Europe and in Asia. The scientific analyze changed into designed as a head-to-head comparator. So we do respect the applicability of that study in definite components of the world, specifically in Europe.

    Let me flip --

    Julian Adams -- Chief government Officer

    i'm just announcing in regards to the additional pipeline in our NK 301, 401, Ronit, do you wish to touch upon timing? and i'll just cover the everyday cash place as smartly.

    Ronit Simantov -- Chief clinical Officer

    sure. fully. So we're in the midst of preclinical stories for each and every of the classes that I've outlined, including in vitro and in vivo reports. And as we build the facts and put together the assistance, we can advance those via IND.

    We're not providing certain element about the IND timing at this time. however what i will say is that we are going to have an opportunity later this yr in an R&D Day to supply greater colour and element about all the features of that program. So we appear forward to sharing more aspect later.

    Julian Adams -- Chief government Officer

    or not it's clear that we now have been able to repurpose loads of our capabilities, together with cryopreservation and phone growth. but couple that with the applied sciences for CRISPR-Cas9 and vehicle applied sciences to be able to enhance our pipeline so without delay. surely, we are able to deserve to raise additional capital to prosecute all these classes. however presently, I see this as an embarrassment of ridges in our pipeline.Julian AdamsSo I certainly look forward to seeing what you should share with us in the R&D Day.


    Your subsequent question comes from the line of Ted Tenthoff from Piper Sandler.

    Ted Tenthoff -- Piper Sander -- Analyst

    Congrats on all the growth. i am simply wondering, listening to your prepared remarks and additionally one of the query-reply. i'm wondering if you are at all thinking of -- NK cells are my favourite too, but are you thinking of evaluating other cell kinds that may well be processed from umbilical twine NK cells and from donors?

    Julian Adams -- Chief executive Officer

    yes. Ted, thanks for your query. in fact, the NAM know-how has extensive applicability, we've been capable of extend dendritic cells, we've been able to extend gamma delta T cells. it be basically just a query of bandwidth and prioritization and we've had some very, very first rate success with the NK mobilephone program.

    and obviously, a lot of consideration in the container is being paid to the NK box. That spoke of, it does not preclude us from expanding different mobilephone forms with therapeutic capabilities.

    Ted Tenthoff -- Piper Sander -- Analyst

    terrific. it truly is in reality interesting. eager for the BLA and additionally 201 getting into the hospital.

    Julian Adams -- Chief executive Officer

    Thanks, Ted.


    Your subsequent query comes from the line of Jason Butler from JMP Securities.

    Jason Butler -- JMP Securities -- Analyst

    Thanks for taking the questions, and congrats on the progress. First one, simply questioning if you might give us an update on the elevated entry software for omidubicel. and should we see any statistics from the EAP earlier than the pre-BLA assembly or the BLA submission this year? and then 2nd query on the NK courses. You outlined, Julian, leveraging your journey with the cryopreservation of 201.

    are you able to just probably speak to your plans for manufacturing for the brand new classes? Will they be cryopreserved items from the birth within the scientific development? Or how will you integrate these into your manufacturing amenities?

    Julian Adams -- Chief govt Officer

    So let me flip the primary query to Ronit to speak in regards to the EAP, and then i could answer your NK question.

    Ronit Simantov -- Chief clinical Officer

    completely. So our increased access software is presently operating, and we're the usage of it in -- as a way for serving as our medical bridging cohorts for each the Lonza, Netherlands, and Kiryat Gat facilities for our commercial manufacturing classes, and we now have been capable of do that as the expanded entry look at has been open and enrolled patients so as to do this. we now have some effects from these -- from that look at. And we should be chuffed to share those in collaboration with our academic collaborators when we all feel that those information mature and able for ebook or presentation.

    So we are also very excited about other records that we might be sharing, extra records on our phase 3 examine and other talents information that have been submitted and hope to make these obtainable by using the conclusion of the 12 months in medical conferences as well.

    Julian Adams -- Chief govt Officer

    And, Jason, let me reply in regards to the NK application. We intend to simplest use cryopreserved off-the-shelf products going ahead. So our pipeline is so designed that we will both manufacture the cells from apheresis instruments after which genetically manipulate them and cryopreserve them, and that could be our playbook going forward.


    Your next query comes from the road of Gregory Renza from RBC Capital Markets.

    Yinglu Zhang -- RBC Capital Markets -- Analyst

    this is Yinglu on for Greg. First, perhaps a follow-up on the EAP. i used to be questioning how should we believe concerning the time line for manufacturing and records collection for medical comparability for the web page in Israel? and how does that align along with your expectation for a pre-BLA meeting and submission within the fourth quarter? after which a different one on the NK application now that you have dissimilar in the pipeline. How do you feel about choice and execution throughout the five classes?

    Julian Adams -- Chief government Officer

    So, Ronit, would you remark once more on the EAP?

    Ronit Simantov -- Chief scientific Officer

    fully. So we now have six websites for the EAP open within the U.S. with investigators who've labored with us earlier than and are extremely captivated with enrolling patients. And in order we enhance our manufacturing, we have been capable of slot in sufferers for the application and treat them.

    And we can continue to try this as we enhance ahead towards submitting the BLA the usage of the ability in Kiryat Gat to deal with sufferers within the coming months.

    Julian Adams -- Chief govt Officer

    And concerning the NK, the alternative method could be all statistics-driven. we've created a number of very, very entertaining aims. We're looking at mobilephone traces, however we are going to ultimately increase these to mouse models the usage of PDX fashions in addition to other subtle fashions to make the optimal decisions of product -- for product development. And this may even be informed by way of our business colleagues, who will go cautious market assessments and unmet need assessments for the a lot of courses that we are developing.

    Yinglu Zhang -- RBC Capital Markets -- Analyst

    extraordinary. thank you, and congrats on the growth.


    Your subsequent query comes from the line of Vernon Bernardino from H. C. Wainwright.

    Vernon Bernardino -- H.C. Wainwright & Co. -- Analyst

    Very excited on your development with the omidubicel, BLA and appear forward to its submitting later this yr and extra growth on the new programs. i used to be questioning in case you might deliver some insight related to the market research you will have carried out. chiefly, i used to be questioning if the market analysis covered a part concerning what effects the pandemic has had on transplantation approaches, specially the capability to conduct these strategies during surges of COVID circumstances. however additionally whether the market researches has induced any adjustments in your approach and concentrated on that the corporations that you simply identified as a a considerable number of alternatives?

    Julian Adams -- Chief executive Officer

    Michele, let me invite you to answer in the marketplace research actions.

    Michele Korfin -- Chief working Officer and Chief commercial Officer

    So we performed a couple of several types of market analysis. And what we're very inspired by is that the consistency of the research. So this existing circular of market research that we conducted, it changed into over one hundred transplanters in the U.S., and it changed into with the precise medical facts from the phase 3 examine. Prior analysis before the study had been completed or all of the data set became in was with what we'd consult with as a centered product profile.

    Now we had been getting health care provider transplanter feedback on the exact medical data. They were very encouraged with the aid of a couple of factors, the primary endpoint, the secondary endpoints and the exploratory endpoints. Payers also that we spoke to, we're encouraged with the aid of the medical facts and additionally appreciate the significance of reduction in healthcare useful resource utilization, chiefly round reduction in time in hospital, reduction for interventions because of less infections. So the takeaway from the analysis remains very encouraging.

    So it has not modified our approach. What it has done is basically aid to more desirable inform our method and provides us extra encouragement and self belief within the probability. Now, Vernon, the question round COVID has been very, very difficult for patients. And we certainly hope that we see this pandemic start to get to a extra reliable vicinity for patients.

    What we can say that comes out within the research is it became very elaborate to align donors with sufferers all over the pandemic. Unrelated donors changed into very problematic since you needed to align the donor with the affected person. And we be aware of even in normal times, that may take two to 3 months. And what we were being advised throughout COVID is from time to time it was simply not feasible to align the donor with the affected person.

    one of the crucial benefits of omidubicel with our starting fabric being twine blood this is banked on the cord blood banks. right through our phase 3 analyze, we were nonetheless capable of entry that the cord blood that changed into required for manufacturing, have our proprietary NAM know-how expand the cells as it should be and return them to the center. in order that became something that came out in the course of the market research as a benefit from omidubicel due to the fact we wouldn't have to bring a donor into health facility atmosphere as you see with different graft sources. So Vernon, let me stop there and notice you probably have any questions.

    Vernon Bernardino -- H.C. Wainwright & Co. -- Analyst

    No. it's ultimate. it's exactly the insight i used to be hunting for.


    Your subsequent question comes from the road of Mark Breidenbach from Oppenheimer.

    Mark Breidenbach -- Oppenheimer & Co. Inc. -- Analyst

    simply a couple of for me, all variety of geared toward the NK courses. First, now that the phase 1/2 protocol for GDA-201 has been finalized. are you able to provide us a bit color on the study aspect and the specifics doses that will be validated in part 1. how many websites you intend to spark off that kind of component.

    after which i was hoping Ronit may describe the intracellular signaling domains of the HER2 and CD38 car constructs for the -- which are being used in probably the most new products? Are they both the identical? and perhaps that you can aspect to any key alterations between these and competing motor vehicle NK constructs? and finally, with appreciate to the use of membrane-sure IL-15, i am simply questioning if you see any IT barriers to this class of -- to putting this category of construct in GDA-301, due to the fact that other NK developers are additionally pursuing identical approaches.

    Julian Adams -- Chief government Officer

    So, Ronit, would you comment on the GDA-201 section 1/2?

    Ronit Simantov -- Chief scientific Officer

    sure. So in terms of the GDA-201 part 1/2, we are going to be conducting it as a section 1 first at a constrained number of sites within the united states, applicable to a section 1. we're the use of doses in accordance with our experience using the items that we validated with the tuition of Minnesota. So we now have event there in terms of the number of cells, and we are going to be the use of equivalent dosing based on that adventure.

    After we finished the part 1, which might be used to consider safeguard, as phase 1s are, we'll be transferring the study over to a bigger variety of sites to conduct the phase 2. and we've not introduced yet the number of patients that could be demonstrated within the phase 2 nor the variety of sites, however i will share that the operational activities are underway. there may be enthusiasm and pleasure by using capabilities investigators and the -- the entire executional activities when it comes to getting the websites and the investigators lined up for the look at are going on at the moment in coaching for initiating the analyze later this year.

    Julian Adams -- Chief executive Officer

    And once we file the IND and are cleared to open the analyze, we'll deliver more particulars on the study design, variety of patients and some of your different observe-up questions.

    Ronit Simantov -- Chief scientific Officer


    Julian Adams -- Chief executive Officer

    in regards to the pipeline, we're staying silent on the details of the intracellular signaling these days. but at an R&D Day later this year, we planned to go into a lot more aspect and leisure assured that we've got filed all the appropriate intellectual property submissions. and that i'm quite confident that we are going to have latest to operate with this -- the special genetic manipulations that are underway, each for the automobile and for the knockout pathways. Mark, are you there?

    Mark Breidenbach -- Oppenheimer & Co. Inc. -- Analyst

    yes. So right here -- and i assume that that covers the member-certain IL-15 as smartly?

    Julian Adams -- Chief government Officer


    Mark Breidenbach -- Oppenheimer & Co. Inc. -- Analyst

    All correct. thank you.

    Julian Adams -- Chief govt Officer

    now we have checked out a couple of distinct constructs and definitely are doing head-to-head comparisons and really just picking out the better of the most fulfilling within the lab.


    [Operator instructions] Your subsequent query comes from the line of Chad Messer from Needham and enterprise.

    Chad Messer -- Needham & company -- Analyst

    Between NDAs and INDs and pipeline expansions, it sounds such as you guys certainly are busy over there. we have now covered a lot of floor, but probably just on the pipelines. i used to be questioning if I may get your strategies on the HER2 target? you may have received lots of actually slicing-part technologies you are thrown at NAM, which is interesting to see. this is an exceptionally smartly-balanced goal can be one of the vital in oncology with antibodies and small molecules after which in construction, any variety of alternative routes are going at it.

    simply questioning what specific advantages you believe you usher in HER focused on notably and strong tumor target too, by the way very unique to peer that. And the place you could believe the unmet need is, where you suppose you might enhance this? I imply, most likely in some noncellular disasters to targeted treatments. but if there's a selected region you see the need?

    Julian Adams -- Chief executive Officer

    it be a superb question. without doubt, we suppose that the HER2 automobile has the advantage to be as helpful, if not a whole lot more constructive than combining it with Herceptin, the monoclonal antibody. and that's a part of our engineering strategy is to make the automobiles advantageous to be able to be used in solid tumors. As you comprehend, strong tumors have a very immunosuppressive microenvironment.

    And so there are a lot of limitations. And so far, truly nobody has stated information in solid tumors with any incredible efficacy, but it's nevertheless early days. And what became mentioned within the prepared remarks is that there are a number of HER2-superb cancers. however in certain, I believe plenty about gastric melanoma and some of the lesser-everyday cancers that aren't as smartly served through Herceptin or Perjeta.

    So we're thinking a great deal in regards to the a lot of tumor models that we are going to increase and the medical software could be a basket trial allowing all HER2 patients that are refractory, obviously, to enter the trial.


    There are not any further questions at present. Mr. Julian, please proceed.

    Julian Adams -- Chief government Officer

    well, it just remains for me to thank all and sundry for becoming a member of us on trendy call. And we seem to be forward to updating you in the future. Bye for now.


    [Operator signoff]

    duration: 50 minutes

    name members:

    Josh Hamermesh -- Chief company Officer

    Julian Adams -- Chief govt Officer

    Ronit Simantov -- Chief scientific Officer

    Michele Korfin -- Chief working Officer and Chief industrial Officer

    Shai Lankry -- Chief economic Officer

    Jonathan Miller -- Evercore ISI -- Analyst

    Ted Tenthoff -- Piper Sander -- Analyst

    Jason Butler -- JMP Securities -- Analyst

    Yinglu Zhang -- RBC Capital Markets -- Analyst

    Vernon Bernardino -- H.C. Wainwright & Co. -- Analyst

    Mark Breidenbach -- Oppenheimer & Co. Inc. -- Analyst

    Chad Messer -- Needham & business -- Analyst

    greater GMDA analysis

    All profits call transcripts


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