Q4 2021 Gamida Cell Ltd Earnings Call
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Ladies and gentlemen, please stand by. Your conference call will begin momentarily. Once again, ladies and gentlemen, thank you for calling. Please remain on your lines. Your conference call will begin momentarily. Thank you for your patience.
Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, thank you for calling please remain on your lines. Your conference call will begin momentarily. Thank you for your patience.
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Speaker Change: Thank you.
Speaker Change: .
Speaker Change: Ladies and gentlemen, thank you for standing by. Welcome to the Gamita Sales conference call for the fourth quarter and full year 2021 financial results. My name is Howard, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gamita Sales request. Now, I would like to introduce your host for today's conference, Heather DeVecchia, Gamita Sales Chief of Staff. Please go ahead. Thank you, Howard.
Ladies and gentlemen, thank you for standing by welcome to Gamete of sales conference call for the fourth quarter and full year 2021 financial results. My name is Howard and I'll be your operator for todays call. Please be advised that this call is being recorded at gamete of sales request now I would like to introduce.
Your host for today's conference Heather direct you to meet our sales chief of staff. Please go ahead.
Thank you Howard and good morning, everyone welcome to today's call during which well provide an update on the company and review our financial results for the fourth quarter and full year of 2021.
Heather DeVecchia: Welcome to today's call, during which we will provide an update on the company and review our financial results for the fourth quarter and full year of 2021.
Heather DeVecchia: Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www.comedicel.com.
Earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www Dot dot.
Dot com.
Speaker Change: Here with me on our call today are Julian Adams, Chief Executive Officer, Renit Simantop, our Chief Medical Officer, and Chief Scientific Officer.
Here with me on our call today are Julian Adams, Chief Executive Officer, when he came on top our Chief Medical Officer, and Chief Scientific Officer, Michele <unk>, Our Chief operating officer, and Chief Commercial Officer, and Shine Landry Chief Financial Officer.
Speaker Change: Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Shai Langry, Chief Financial Officer.
Speaker Change: During this call, we may make forward-looking statements about our future expectations and plans, including in respect to the timing of initiation and progress of, and data reported from, the clinical trials of our product.
During this call we may make forward looking statements about our future expectations and plans, including in respect to the timing of initiation and progress.
And data reported from the clinical trials of our product candidates anticipated regulatory filings, including the submission of the BLA for them or do they sell to the F. D. A commercialization planning efforts, but potentially lifesaving or curative therapeutic and commercial potential of I'm gonna do Michelle and our expectations regarding.
Speaker Change: candidates, anticipated regulatory filings, including the submission of the BLA for Amadoubicel to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Amadoubicel, and our expectations regarding our projected cash to be used for operating activities and cash runway.
Our projected cash to be used for operating activities and cash runway.
Speaker Change: Our actual results may differ materially from what we project today due to a number of important factors.
Our actual results may differ materially from what we project today due to a number of important factors, including the impact of COVID-19 pandemic on our operations the scope progress and expansion of our clinical trials and cost impacts thereof, clinical scientific regulatory and technical development and those inherent in.
Speaker Change: including the impact of COVID-19 pandemic on our operations, the scope, progress and expansion of our clinical trials and cost impact thereof, clinical, scientific, regulatory, and technical developments, and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapy.
The process of developing and commercializing product candidates that are safe and effective for use as human therapeutics and the endeavor of building a business around such product candidates as well as those considerations described in the risk factors section of our most recent annual report on form 20-F, and other filings that we make.
Speaker Change: and the endeavor of building a business around such product candidates as well as those considerations described in the risk factor section of our most recent annual report on Form 20-F and other filings that we make.
And in other filings that we make with the SEC from time to time.
Speaker Change: These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise. Now I'd like to
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future while the rest of the result of new information future events or otherwise.
Now I'd like to turn the call over to Julian.
Speaker Change: Thank you, Heather, and thanks to everyone for joining us.
Thank you Heather and thanks to everyone for joining us this morning.
Speaker Change: Before I begin, I want to take a moment to acknowledge the major events in the Ukraine that are impacting the world globally.
Before I begin I wanted to take a moment to acknowledge the major events in the Ukraine that are impacting the world globally over the past few weeks.
Speaker Change: while we don't have any operations in the Ukraine or Russia.
While we don't have any operations in the Ukraine, or Russia, and expect minimal impact to our operations as global citizens. Our thoughts are with all those affected.
Speaker Change: and expect minimal impact to our operations. As global citizens, our thoughts are with you.
Speaker Change: At Kamita Cell, we are incredibly proud to be part of the significant advancements occurring in the field of cell therapy as it continues to grow and progress.
At Camino cell, we are incredibly proud to be part of the significant advancements occurring in the field of cell therapy.
As it continues to grow and progress.
Progress towards cures for patients in need.
Speaker Change: 2021 was an important year for us as we progressed our two clinical stage NAM-enabled cell therapy programs, Omidubicel and...
2021 was an important year for us as we progressed, our two clinical stage Nam enabled cell therapy programs.
<unk> and GDA 201.
Speaker Change: both of which hold significant potential to benefit patients suffering from hematologic malignancies.
Both of which holds significant potential to benefit patients suffering from hematologic malignancies and serious blood disorders.
Speaker Change: Additionally, we further expanded our NAM-enabled platform with the addition of genetically-modified NAM-enabled NK-cell condoms.
Additionally, we further expanded our Nam enabled platform with the addition of genetically modified Nan enabled NK cell constructs, allowing us to leverage our expertise in NK cells to potentially treat various hematologic malignancies and solid tumors.
Speaker Change: allowing us to leverage our expertise in NK cells to potentially treat various hematologic malignancies.
Speaker Change: I will start today's call by commenting on our lead program, Omaduba.
I will start today's call by commenting on our lead program <unk>, which has breakthrough therapy designation and the potential to be the first FDA approved cell therapy for stem cell transplant.
Speaker Change: has breakthrough therapy designation and the potential to be the first FDA-approved cell therapy for STEM patients.
Speaker Change: Throughout 2021, we announced several data presentations.
Throughout 2021, we announced several data presentations, which contribute to the evidence for <unk> potential efficacy.
Speaker Change: contribute to the evidence for Omoduba cells potential efficacy.
Speaker Change: and also the positive health economic impact of.
And also the positive health economic impact of on the <unk> with data demonstrating a reduction in health care resource utilization.
Speaker Change: with data demonstrating a reduction in health care resource utilization. As Ronit will describe.
As Ronnie will describe later on in this call.
Speaker Change: This reduction in health care resource utilization is very important for patients, hospitals.
This reduction in health care resource utilization is very important for patients hospitals and payers.
Speaker Change: The robust data that we have generated in support of the potential for Omoduba's...
The robust data that we have generated in support of the potential for <unk> led us to our most recent and exciting milestone last month.
Speaker Change: led us to our most recent and exciting milestone last
Speaker Change: namely the initiation of the rolling BLA.
Mainly the initiation of the rolling BLA.
Oh Madhu the cell.
Speaker Change: with the submission of our non-clinical module following the receipt, the recent receipt of positive CMC-focused type B.
With the submission of our non clinical module following the receipt.
The recent receipt of positive CMC focused type B meeting correspondence from the FDA.
Speaker Change: In this correspondence, the FDA confirmed analytical comparability.
In this correspondence the SBA confirmed analytical comparability between our wholly owned commercial manufacturing facility in Israel.
Speaker Change: between our wholly owned commercial manufacturing facility in Israel.
Speaker Change: to the Omoduba cell batches that were produced at the clinical manufacturing sites for the phase three study. This month, we
The <unk> batches that were produced at the clinical manufacturing sites for the Phase III study.
This month, we also submitted our clinical module to the FDA.
Speaker Change: We are on track to submit the remaining modules and a complete
We are on track to submit the remaining modules and are complete.
Speaker Change: and complete the full BLA submission by the end of the second
And complete the full BLA submission by the end of the second quarter.
Speaker Change: We are thrilled to have reached this inflection point and look forward to working with the FDA to bring omiduba cell to patients as soon as possible.
We are thrilled to have reached this inflection point and look forward to working with the FDA to bring <unk> to patients as soon as possible.
Speaker Change: Beyond Omiduba cell, we are also developing our NAM-enabled NK cell pipeline, which is led by GDA-201.
Beyond <unk>. We are also developing our Nam enabled NK cell pipeline, which is led by GDA 201.
Speaker Change: GDA-201 leverages our proprietary NAM technology platform to expand natural killer cells.
GDA 201, Leverages, our proprietary NAV technology platform to expand natural killer cells.
Speaker Change: to enhance their functionality, direct tumor cell killing properties, and antibody-dependent cellular cytotoxicity.
To enhance their functionality direct tumor cell, killing properties and antibody dependent cellular cytotoxicity or <unk>.
Speaker Change: We are highly encouraged by the potential of GDA-201, which has produced truly remarkable results in a phase one investigator-sponsored study where we have seen very high and complete durable results.
We are highly encouraged by the potential of GDA 201, which has produced truly remarkable results in our phase one investigator sponsored study, where we have seen very high and complete.
Durable responses.
In both Follicular lymphoma, and diffuse large b cell lymphoma.
Speaker Change: In September 2021, we submitted an IND application to the FDA for a Phase I-II trial with a cryopreserved formulation of GDA-201 in patients with diffuse large B cell lymphoma and folliculitis.
In September 2021, we submitted in India implication to the FDA for a phase one two trial with a cryopreserved formulation of GDA 201 in patients with diffuse large b cell lymphoma, and Follicular lymphoma.
Speaker Change: Following this submission, we were placed on clinical hold in November of 21.
Following this submission we were placed on clinical hold in November of 'twenty one.
Speaker Change: prior to patients being dosed, since the FDA had questions about donor eligibility procedures and assay quali-
Prior to patients being dose since the SBA had questions about donor eligibility procedures and assay qualification.
Speaker Change: We are actively working with the FDA to address their comments to enable an IND acceptance and study initiation. This year, we plan to initiate dosing in this phase one, two study. Moving to our newest product candidates.
We are actively working with the FDA to address their comments to enable an IMD acceptance and study initiation. This year, we plan to initiate dosing in this phase one two study.
Moving to our newest product candidates are genetically modified Nam NK enabled.
Cell therapy programs.
Speaker Change: Last year, we were excited to establish a broad pipeline of NK product candidates that utilize CAR and CRISPR-mediated strategies to increase targeting, potency, and persistence against hemodialysis.
Last year we.
We're excited to establish a broad pipeline of NK product candidates that utilize car and CRISPR mediated strategies to increase targeting potency and persistence against hematologic malignancies and solid tumors.
Speaker Change: Robust preclinical evidence gives us the confidence that these new NAM-enabled NK product can.
Robust preclinical evidence gives us the confidence that these new NAV enabled NK product candidates hold promise as a potentially curative therapies for both heme.
Speaker Change: hold promise as potentially curative therapies for both hematologic cancer.
The logic cancers and solid tumors.
Speaker Change: Furthermore, we announced a research collaboration with the Dana-Farber Cancer Institute for GDAC.
Furthermore, we announced a research collaboration with the Dana Farber Cancer Institute for GTA, six Oh, what a C D. A.
Speaker Change: CD38 CRISPR knockout combined with a CD38 CAR NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines. We are excited to leverage the expertise.
CD 38, CRISPR knockout combined with a CD 38 car NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines.
We are excited to leverage the expertise of researchers at Dana Farber.
Speaker Change: to study the in vitro NK cell killing activity of GD8-601 in multiple myeloma.
To study the in vitro NK cell, killing activity of <unk> 601 in multiple myeloma.
Speaker Change: Throughout 2022, we plan to execute preclinical proof of concept.
Throughout 2022, we plan to execute preclinical proof of concept studies.
Speaker Change: for these genetically-modified NK therapeutic targets, and by the end of 2022, select a pipeline candidate for IND-enabling.
For these genetically modified NK therapeutic targets and by the end of 2020 to select a pipeline candidate for IMD, enabling studies.
Speaker Change: With the progress we achieved in 2021, we are encouraged about what the future holds for gametocel in 2020.
With the progress we achieved in 2021, we are encouraged about what the future holds for give me the sell in 'twenty two.
Speaker Change: And of course, this wouldn't be possible without our employees, whose dedication is focused on advancing therapies to help address unmet needs for patients.
And of course, this wouldn't be possible without our employees, whose dedication is focused on advancing therapies to help address unmet needs for patients.
Speaker Change: I am grateful for and proud of their continued determination and focus on patients, which has
I am grateful for and proud of their continued determination and focus on patients, which has brought us to where we are today.
Speaker Change: Before turning the call over to Ronit, I would like to take a moment to congratulate her on.
Before turning the call over to Rohit I would like to take a moment to congratulate.
Her on her recent promotion.
Ronit: now assuming the role of not only chief medical officer, but also chief scientific officer.
Now assuming the role of not only Chief Medicine Medical Officer, but also chief Scientific officer.
We had committed to thank you all for your contributions.
Ronit: thus far, and look forward to your continued work towards division with your expanded role.
Thus far and look forward to your continued work towards division with your expanded role Rooney.
Roni.
Speaker Change: Thanks, Jillian, and good morning, everyone. Thank you for joining us on our call.
Thanks, Julian and good morning, everyone. Thank you for joining us on our call.
Speaker Change: In 2021, we had the opportunity to present a broad range of scientific and clinical data on Oviduva cell.
In 2021, we have the opportunity to present, a broad range of scientific and clinical data on over to the south.
Speaker Change: Tying together preclinical and translational analyses with clinical data, patient experience, long-term outcomes, and value to the healthcare system.
Together preclinical and translational analyses with clinical data patient experience long term outcome and value to the health care system.
Speaker Change: In preclinical presentations in 2021, we demonstrated that our nicotinamide or NAM platform generates a unique cellular phenotype through modulation of metabolic pathways leading to highly functional and potent stem cells.
In preclinical presentations in 2021, we demonstrated that our nicotinamide on Nam platform generates a unique cellular phenotype modulation of metabolic pathways, leading to highly functional and potent stem cell.
Speaker Change: In translational data, we showed that patients treated with Omoduba cell had robust functional reconstitution of T and B cell subsets, dendritic cells, and natural killer cells in the days and weeks following transplant.
And translational data, we showed that patients treated with <unk> had robust functional reconstitution of T and b cell subsets dendritic cells and natural killer cells in the days and weeks following transplant.
Speaker Change: The translational data provided mechanistic support for the clinical results of our global phase three randomized trial, the results of which were published in October 2021, demonstrating rapid hematopoietic recovery, significantly decreased infections, and shorter duration of hospitalization for patients transplanted with Omiduva cells.
The translational data provided mechanistic support for the clinical results of our global Phase III randomized trial.
Both of which were published in October 2021, demonstrating rapid hematopoietic recovery significantly decreased infection and shorter duration hospitalization for patients transplanted with Oh Madhu itself.
Speaker Change: Of note, the patients in our clinical trial were in critical need of allogeneic transplant for hematologic malignancies, with few or no alternatives available.
Of note the patients in our clinical trial work in critical need of allogeneic transplant for hematologic malignancies with few or no alternatives available.
Speaker Change: Looking back at the totality of our experience with Omiduba cell, we presented follow-up data from over 10 years of clinical studies demonstrating long-term sustainable hematopoiesis and immune competence in patients.
Looking back at the totality of our experience with Oh Madhu, Michelle we presented follow up data from over 10 years of clinical study demonstrating long term sustainable Kanata polices and immune competence in patients.
Speaker Change: We then went on to show that Omiduba cell could decrease the cost to the healthcare system.
We then went on to show that Oh, Madhu, So could decrease the cost to the health care system.
Speaker Change: as patients treated with Omidubicel had reduced healthcare resource utilization, including blood transfusions, outpatient procedures, and time in intensive care units.
As patients treated with Oh, Madhu, Michelle had reduced healthcare resource utilization, including blood transfusion outpatient procedures and time in intensive care unit.
Speaker Change: At next month's transplantation and cellular therapy meetings in Salt Lake City, we have eight abstracts accepted and plan to report new data focused on patient outcomes and health-related quality of life.
At next month's transplantation and cellular therapy meetings in Salt Lake City, we have eight abstracts accepted and plan to report new data focused on patient outcomes and health related quality of life.
Speaker Change: Taken together, we have continued to add to the body of evidence supporting the mechanism of action, clinical activity, patient experience, and value of Omiduva cell as a potential life-saving therapy.
Taken together, we have continued to add to the body of evidence supporting the mechanism of action clinical activity patient experience and value of only to the south as a potential life saving therapy.
Speaker Change: Moreover, we are confident in the scientific and clinical package we have assembled in our efforts to make omodubicil available to patients in need of a HMAD-poetic stem cell transplant.
Moreover, we are confident in the scientific and clinical package, we have assembled.
Efforts to make Oh, Madhu <unk> available to patients in need behind that quite extent cell transplants.
Speaker Change: We also made considerable progress in our NAM-based natural killer cell platform.
We also made considerable progress in our NAND based natural killer cell platform, we presented.
Speaker Change: We presented preclinical data characterizing the properties of GDA-201.
Preclinical data characterizing the properties of GDA 201.
Speaker Change: We showed that NAM mediates a set of cellular processes expanding NK cells while downregulating differentiation, cellular stress, and exhaustion pathways that are typically activated in culture.
We showed that Nam mediate set of cellular processes, expanding NK cells, while down regulating differentiation cellular stress and exhaustion pathways that are typically activated and culture.
Speaker Change: GDA201 cells are characterized by a rejuvenated NK phenotype similar to cytokine-induced memory-like NK cells.
D D to a one cell are characterized by a rejuvenated NK phenotype similar to cytokine induced memory like NK cell and.
Speaker Change: and were shown to be highly cytotoxic in in vitro and in vivo assays.
And were shown to be highly cytotoxic and in vitro and in vivo assays.
Speaker Change: These findings were supported by the clinical data reported in the phase one investigator-sponsored study at the University of Minnesota.
These findings were supported by the clinical data reported in the phase one investigator sponsored study at the University of Minnesota.
Speaker Change: At ASH, we presented two-year follow-up data in patients with non-Hodgkin lymphoma showing an overall response rate of 74% including 13 out of 14 complete responses with a median duration of response of 16 months.
At Ash, we presented two year follow up data in patients with non Hodgkin lymphoma, showing an overall response rate of 74%, including 13 out of 14 complete responses with a median duration of response of 16 months.
Speaker Change: 78% overall survival and toxicities in line with those reported previously for GDA-201.
78% overall survival and toxicities in line with those reported previously forgive me at 201.
Speaker Change: We've now developed a cryo-preserved formulation and plan to initiate a multi-center company-sponsored study this year in patients with follicular lymphoma and a few Thargeby cell lymphomas.
We've now developed a cryopreserved formulation and plan to initiate a multi center company sponsored study this year in patients with Follicular lymphoma, and diffuse large b cell lymphoma.
Speaker Change: In addition, we reported that we have expanded upon our NAM platform to develop genetically modified NK cells, GDA301, GDA501, and GDA601, each of which is proceeding with preclinical proof of concept studies as we advance towards IND-enabling studies.
In addition, we reported that we've expanded upon our Nam platform to develop genetically modified NK cells G. D 301, TD five in one engine a stick the one each of which is proceeding with preclinical proof of concept studies as we advance towards IND, enabling studies.
Speaker Change: Overall, 2021 was a tremendously productive year in research and development and clinical research as we look towards continuing to validate the therapeutic potential of our product candidates.
Overall 2021 was a tremendously productive year in research and development and clinical research, we look towards continuing to validate the therapeutic potential of our product candidate.
Speaker Change: I will now turn the call over to Michelle, who will talk more about our launch readiness for Omidugisel.
I will now turn the call over to Michelle who will talk more about our launch readiness to only do the cell Michelle.
Michelle Corfin: Thank you, Rony, and good morning, everyone. This year has started off strong already, as last month we initiated our rolling BLA submission for Amadou Bacel.
Thank you Ronnie and good morning, everyone. This year has started off strong already as last month, we initiated our rolling BLA submission for <unk>.
Michelle Corfin: We continue to make excellent progress advancing our Gamida-owned manufacturing facility in Israel.
We continue to make excellent progress advancing our gamete of owned manufacturing facility in Israel.
Michelle Corfin: The FDA acknowledgment of the analytical comparability from our planned Gameta commercial facility as compared to the facility used for the phase three study was an important milestone as we work towards advancing Amiduva cells.
The F D. A acknowledgment of the analytical comparability from our planned to meet our commercial facility as compared to the facility used for the phase III study was an important milestone as we work towards advancing Ahmedou myself.
Michelle Corfin: The commercial opportunity for Amadou Bissell is extremely encouraging based on our continued assessment of market insights, and we continue to focus on our commercial preparation.
The commercial opportunity from a deep itself is extremely encouraging based on our continued assessment of market insights and we continue to focus on our commercial preparation.
Michelle Corfin: In parallel with our rolling BLA submission, we are additionally assessing strategic alternatives for the potential commercialization of Amadoubicel, including potentially partnerships to expand the reach of Amadoubicel.
In parallel with our rolling BLA submission, we are additionally, assessing strategic alternatives for the potential commercialization of <unk>, including potentially partnerships to expand the reach of Ahmedou myself.
Michelle Corfin: Almodubacil has the potential to be the first FDA-approved advanced cell therapy product for allogeneic stem cell transplant in patients with hematologic malignancy.
I'm Gonna do but so has the potential to be the first FDA approved advanced cell therapy product for allogeneic stem cell transplant in patients with hematology hematologic malignancies.
Michelle Corfin: For patients with hematologic malignancies that are deemed eligible for an allogeneic stem cell transplant, the procedure is their best chance for a potential cure.
For patients with hematologic malignancies that are deemed eligible for an allogeneic stem cell transplant procedure is their best chance for a potential cure.
Michelle Corfin: In the U.S. there are approximately 8,000 patients above the age of 12 with hematologic malignancies who undergo an allogeneic stem cell transplant each year.
In the U S. There are approximately 8000 patients above the age of 12 with hematologic malignancies, who undergo an allogeneic stem cell transplant each year.
Michelle Corfin: Unfortunately though, there are approximately 1,200 patients each year who are also ages 12 and up with hematologic malignancies who are deemed eligible for an allogeneic stem cell transplant but cannot find an appropriate donor.
Unfortunately, though there are approximately 1200 patients each year, who are also ages 12 and up with hematologic malignancies, who are deemed eligible for an allogeneic stem cell transplant, but cannot find an appropriate donor.
Michelle Corfin: Unfortunately, we observe racial disparity in the U.S. in regards to access to allogeneic stem cell transplants.
Unfortunately, we observe racial disparity in the U S. In regards to access to allogeneic stem cell transplants fewer non Caucasian and do not have access to a family member donor you have a very low likelihood of finding a match in the public database.
Michelle Corfin: If you are non-Caucasian and do not have access to a family member donor, you have a very low likelihood of finding a match in the public database.
Michelle Corfin: For example, patients who are African-American may only have about a 20% chance of finding a match.
For example, patients who are African American may only have about a 20% chance of finding a match.
Michelle Corfin: For patients in need of a stem cell transplant, this is often their only chance for a cure.
For patients in need of a stem cell transplant. This is often their only chance for a cure we are diligently working to advance ahmedou myself and to expand access to patients.
Michelle Corfin: We are diligently working to advance Omiduba cell and to expand access to
Michelle Corfin: Based on encouraging clinical data and the less stringent matching criteria, transplanter feedback indicates that amidobicel has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor.
Based on encouraging clinical data and the less stringent matching criteria transplant or feedback indicates that I'm a deep itself has the potential to improve outcomes for allogeneic stem cell transplant patients compared to other donor sources and expand access for patients who cannot find a suitable donor.
Michelle Corfin: In the U.S., there are approximately 200 transplant centers that perform allogeneic stem cell transplants.
In the U S. There are approximately 200 transplant centers that perform allogeneic stem cell transplants 70 of those centers conduct about 80% of the transplants and our medical team continues to engage with those top 70 centers through one on one meetings and at medical conferences.
Michelle Corfin: 70 of those centers conduct about 80% of the transplants. And our medical team continues to engage with those top 70 centers through one-on-one meetings and at medical conferences.
Michelle Corfin: We also continue to assess market insights from transplanters in the U.S.
We also continue to assess market insights from transplant centers in the U S. Based on extensive market research, we see the potential for <unk> to treat approximately 2000 to 2500 patients per year upon reaching peak market share. This equates to approximately 20% to 25% market share of the addressable population.
Michelle Corfin: Based on extensive market research, we see the potential for amidobacil to treat approximately 2,000 to 2,500 patients per year upon reaching peak market share. This equates to approximately 20 to 25% market share of the addressable population.
Michelle Corfin: Our market access team is also actively engaging in meetings with national and regional commercial payers, and the feedback continues to be very encouraging. Payers recognize the overall value proposition, including the strength of the Omiduba cell clinical data and the health economic data we have published to date.
Our market access team is also actively engaging in meetings with national and regional commercial payers and the feedback continues to be very encouraging payers recognize the overall value proposition, including the strength of the on the <unk> clinical data and the health economic data, we have published to date.
Michelle Corfin: In summary, we are excited by the potential of OmidubaCell to be the first FDA-approved cell therapy for allogeneic stem cell transplant, and we are also encouraged by the clinical data and feedback from physicians.
In summary, we are excited by the potential of Ahmedou myself to be the first FDA approved cell therapy for allogeneic stem cell transplant and we are also encouraged by the clinical data and feedback from physicians and payers.
Michelle Corfin: I will now turn the call over to Shai to review our financial results.
I will now turn the call over to Shai to review our financial results.
Shai Lankry: Thank you, Michelle, and good morning, everyone. Today, I will summarize our financial results for the full year of 2021.
Thank you Michelle and good morning, everyone today, I will summarize our financial results for the full year of 2021.
Shai Lankry: As of December 31st, 2021, our total cash position was approximately $96 million compared to $127.2 million as of December 31st of last year.
As of December 31, 2021 are we taking cash position was approximately $96 million compared to $127 $2 million until December 31 of last year.
Shai Lankry: Research and development expenses for the year were $50.2 million compared to $38.9 million for the same period in 2020. The increase was primarily due to a $5.4 million increase in Omidubi's commercial manufacturing readiness activities and the advancements of our NK programs, as well as an increase of $5.9 million in broadening our scientific capabilities and talents.
Research and development expenses for the year were $52 million compared to $38 9 million for the same period in 2020.
The increase was primarily due to a $5 $4 million, increasing let me give you some commercial manufacturing readiness activities and the advanced thankful for NK program.
Well as an increase of five point mangan indoors in broadening our scientific capabilities and talent.
Shai Lankry: Commercial expenses in 2021 were $20 million, compared to $8.9 million in 2020. The increase was mainly due to a $6.5 million increase in commercial readiness expenses and a $4.6 million increase in ad count within our commercial organization.
Commercial expenses in 2021 were $20 million compared to $8 $9 million in 2020 increase was mainly due to a $6 five single data increasing commercial readiness expenses and if.
$4 6 million increase in head count, leading our commercial organization.
Shai Lankry: Going forward, we anticipate reducing our near-term commercial readiness expenses.
Going forward again.
Reducing our near term commercial readiness expenses.
Shai Lankry: as we are assessing alternatives for the commercialization of homey doobie sales, including potential U.S. or global partnerships.
We are assessing alternative with the commercial division from Adobe sale, including potential U S Army Global partnership.
Shai Lankry: General administrative expenses were $17 million in 2021 compared to $13.2 million in 2020. The increase was mainly due to
General and administrative expenses were $17 million in 2021 compared to $13 $2 million in 2020.
Increase was mainly due to.
Shai Lankry: a $2.6 million increase in professional services expenses and a $1.2 million increase in ad count and related expenses.
$2 $6 million increase in professional services expenses, and a $1 $2 million increase in headcount and related expenses.
Shai Lankry: Finance expenses net were $2.6 million in 2021 compared to $0.6 million in 2020. The increase was primarily due to a $4.4 million interest expenses from our convertible notes offset by a $2.1 million capitalization and other non-cash income and a $0.3 million increase in interest income from cash management.
Finally, <unk> expenses were $2 $6 million in 2021 compared to zero point $6 million in 2020, the increase was primarily due to a $4 $4 million interest expenses.
Convertible notes offset by $2 1 million Daus computer vision and other noncash income and zero point tuning in dollars increase in interest income from cash management.
Shai Lankry: Net loss in 2021 was $89.8 million compared to a net loss of $61.6 million in 2020.
Net loss in 2021 with $89 $8 million compared to a net loss of.
61 $6 million in 2020.
Shai Lankry: We continue to expect cash use for ongoing operating activity this year to range from $60 to $70 million. We anticipate that our current total cash position will support our ongoing operating activities into mid-2023.
We continue to expect cash used for ongoing operating activities. This year to range from $60 million to $70 million, we anticipate the recurring total cash position will support our ongoing operating activities into mid 2023.
Shai Lankry: This cash runway guidance is based on our current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken. I will now turn the call back over to Julian.
This cash runway guidance is based on our current operational plan and exclude any additional funding that may be received or business development activities.
Be undertaken.
I'll now turn the call back over to Julien.
Thank you Shai.
Julian Adams: As we look ahead into what we have set out to accomplish in this year.
As we look ahead into what we have set out to accomplish in this year.
2022.
Julian Adams: I believe we are well positioned to deliver on our mission of developing potentially curative cell therapies.
I believe we are well positioned to deliver on our mission of developing potentially curative cell therapies for patients with blood cancers solid tumors and other serious blood disorders.
Julian Adams: patients with blood cancers, solid tumors, and other serious blood disorders.
Julian Adams: We look towards our full BLA submission for Omidubicel, expected in the second quarter of this year.
We look towards our full BLA submission for <unk> expected in the second quarter of this year and the planned initiation of our phase one two multicenter gamete of cells sponsored study for GDA 201 in non Hodgkin lymphoma.
Julian Adams: and the planned initiation of our Phase I-II multi-centered gametocel-sponsored study for GDA-201.
Julian Adams: We are excited for the opportunity to continue leveraging our unique NAM-enabled platform across a broad range of cell therapies, and I look forward to providing updates throughout.
We are excited for the opportunity to continue leveraging our unique Nam enabled platform across a broad range of cell therapies, and I look forward to providing updates throughout the year.
Julian Adams: Now we will open the call for questions. Operator.
Now we will open the call for questions operator.
Okay.
Speaker Change: Ladies and gentlemen, if you have a question or comment at this time, please press star then 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key.
Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
If your question has been answered or you wish to remove yourself from the queue simply press the pound key.
Speaker Change: Again, if you have a question or comment at this time, please press star then 1 on your telephone keypad.
Again, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
Speaker Change: Our first question or comment comes from the line of Jonathan Miller from Evercore ISI. Your line is open.
Our first question or comment comes from the line of Jonathan Miller from Evercore ISI. Your line is open.
Jonathan Miller: Hey guys, thanks for taking my questions. First, maybe on GDA-201, it feels like the language here seems a little bit similar to the last update, and I just wondered if you had any additional color on your recent interactions with the agency and what your current thoughts are on the ability to get that IND cleared.
Hey, guys. Thanks for taking my questions.
The first maybe on GDA 201, it feels like the language here seems a little bit similar to last update and I. Just wondered if you had any additional color on your recent interactions with the agency.
What's your current thoughts are on ability to get that <unk>.
Jonathan Miller: And then maybe secondly, I'm happy to see the runway guidance reinstated, but just wanted to get some clarity, how much commercial prep is included in the current runway guidance, and maybe how much clinical work for GDA 201 is included in that clinical guidance?
And then maybe secondly on that either.
The runway guidance reinstated.
But just wanted to get some clarity how much Marshall prep is included in the current runway guidance and and maybe how much clinical work for GDA 201 is is included in that clinical guidance.
Speaker Change: So let me begin by addressing the first part of your question. We haven't had any direct communication with the FDA. The FDA provided absolute clarity on what issues we needed to resolve. Most of those issues are resolved, and we are getting ready to resubmit the amendment to the IND.
So let me begin by.
Addressing the first part of your question.
We haven't had any direct communication with the FDA the FDA provided us absolute clarity on what.
Issues, we needed to resolve most of those issues are resolved and we are getting ready to resubmit the.
The amendment to the IMD.
Speaker Change: and we'll be announcing when the IND is.
Will.
Be announcing when the IND is accepted.
Speaker Change: Regarding runway guidance, let me turn it over to Michelle and Shai to talk about
Regarding.
Runway guidance, let me turn it over to Michelle and shy to talk about.
Michelle Corfin: launch readiness and use of caching for support of GDA-201.
<unk>.
<unk> readiness and.
Use of cash at.
Forge supportive GDA 201.
Speaker Change: Thank you, Julian, and good morning, Jonathan. So, Jonathan, I'll start and then I'll turn to Shai for the additional financials. So, in regards to runway guidance, so for 2021, we were able to complete a lot of the key milestones for commercial preparation that led to the increase that Shai discussed for OPEX. So,
Michelle.
Thank you Julian and good morning, Jonathan So Jonathan I'll start and then I'll turn to Shanghai for the the additional financials. So in regards to the runway guidance. So for 'twenty 'twenty. One we were able to complete a lot of the key milestones for our commercial preparation that led to the increase that Chuck discussed for Opex. So.
Speaker Change: Some of those included the market insights such as quantitative assessments from transplanters and feedback from payers.
Are those included you know the the market insights such as quantitative assessments from transplant centers and feedback from payers. In addition, a very very important milestone for us in 2021 was the readiness of gamete Astellas Seth although it can be to sell assist sits within the commercial organization. It plays a critical role in starting the Ciena Vida.
Speaker Change: In addition, a very, very important milestone for us in 2021 was the readiness of gametocel assist. Although gametocel assist sits within the commercial organization, it plays a critical role in starting the chain of identity and monitoring the chain of identity and chain of custody. Although amidobacil has a less stringent requirement, it is still an individualized therapy, and hence we need to demonstrate chain of identity, chain of custody.
Entity and monitoring the ciena of identity and chain of custody, although on the deepest of Jose less stringent requirement. It is still an individualized therapy and hence we need to demonstrate chain of identity chain of custody that key work for gamete of cell assist including building the team developing the processes and establishing the I T infrastructure was all completed in 2021.
Speaker Change: That key work for Gamuta CellAssist, including building the team, developing the processes, and establishing the IT infrastructure, was all completed in 2021. So what that allowed us to do in 2022, as we are assessing our strategic alternatives or potential strategic alternatives for launch, it allowed us to decrease the spend in regards to some of the commercial preparation because of the fact that so much had been done in 21.
So what that allowed us to do in 2022, as we are assessing our strategic alternatives or potential strategic alternatives for launch it allowed us to decrease the spend in regards to some of the commercial preparation because of the fact that so much had been done in 'twenty one so.
Speaker Change: So let me turn to Shai to give us the actual financial details, and then Jonathan, we'll see if you have any follow-up questions.
So let me turn to shy to give us the actual financial details and then Jonathan will see if you have any follow up questions.
Shai Lankry: Thank you, Michel. So Jonathan, for your question, I would divide the answer into two. As Michel alluded for the commercial, we did an internal robust process of prioritization our expense in 2022 in order to meet the cash one-way guidance.
Thank you Michele so Jonathan for your question I would divide the answer into two.
Michelle alluded to.
Commercial.
And internally robust process.
Nation are our expense in 2022 in order to meet the cash runway guidance.
Shai Lankry: and I can tell you that all the critical activities will continue to be advanced. In addition, as we mentioned in the previous comment, we did reduce some of the spending which are less critical for the next few months.
I can tell you that all the critical activities will continuously to be advanced.
In addition, as we mentioned in the previous comment we did reduce some of the spending which are less critical for the next few months.
Shai Lankry: As for the R&D GDA-201 in particular, I can assure you that we continue to advance the GDA-201. As part of the prioritization, we didn't reduce any of the GDA-201. We continue to advance this program, including the potential initiation of trials later this year and first patient in.
As for the R&D GDA two one in particular.
I can assure you that we continue to advance the GDA two one.
We did as part of its.
Part of the prioritization, we didn't reduce annual did you do to one we continued to advance.
This program.
Including the potential initiation of trials later this year and first patient in.
Thanks, So much guys my question.
Thank you John .
Speaker Change: Thank you. Our next question or comment comes from the line of Ted Penhoff from Piper Sandler. Your line is open.
Thank you. Our next question or comment comes from the line of Ted Pinho from Piper Sandler Your line is open.
Ted Penhoff: Great, thank you very much and good morning, everybody. So, I wanna dig in a little bit more to the considerations with respect to when we do this, so marketing. To me, it seems like the greatest value would be retained if this is a therapy that you take to market yourselves. But can you give us a little bit more, just in terms of kind of how you're assessing this?
Great. Thank you very much and good morning, everybody. So I.
I wanted to dig in a little bit more to the considerations with respect to when we would give us some marketing.
To me it seems like the greatest value would be retained.
As a therapy that you take to market yourselves, but can you give us a little bit more just in terms of kind of how you're assessing this.
Ted Penhoff: you know, could this be overseas deal where you keep the U.S., could this be a global deal, you know, give us maybe a sense for how and what kinds of options you're considering.
Could this be overseas deal, where you keep the U S could this be a global deal.
Maybe a sense for how.
What kinds of options you're considering.
Speaker Change: So Ted, thank you for your question and good morning. As was mentioned in the script, we're assessing our strategic alternatives for Omidubicel.
So Ted Thank you for your question and good morning.
As was mentioned in the script, we're assessing our strategic alternatives.
Four Oh Madhu Michelle.
And that's.
Speaker Change: driven by our desire to see as many patients as possible gain access to Omiduma.
Driven by our desire to see as many patients as possible gain access to <unk>. So we are discussing regional deals potentially regional deals as well as potentially U S deals.
Speaker Change: So we are discussing regional deals, potential regional deals, as well as potentially U.S. deals with partners that may have a unique interest in the hematology-oncology franchise and that pairs up with their portfolio and already has significant infrastructure to be able to...
With partners that May have.
A unique interest.
In the hematology oncology franchise and that pairs up with their portfolio.
And already has significant infrastructure to be able to.
Speaker Change: deliver Omidubicel to as many patients as possible.
Deliver on Madhu Michelle to.
As many patients as possible.
Speaker Change: Our involvement will always be very intimate because we are the manufacturer, and as you know in cell therapies, the manufacturing facilities is critical to supporting any kind of commercial product. So we haven't made any choices yet, and we're starting, and certainly, once the BLA is fully filed and accepted, that will open up avenues for conversations with interested parties.
Our involvement will always be.
Very intimate because we are the manufacturer.
And.
As you know in cell therapies manufacturing facilities is critical to supporting any kind of commercial product. So we haven't made any choices yet and.
And we're starting and certainly.
Once the BLA is fully filed and accepted that will open up avenues for conversations.
With interested parties.
Speaker Change: Yep, very helpful, Julie, and I appreciate that it is in color.
Yep very helpful Troy and I appreciate that additional color.
My pleasure.
Speaker Change: Thank you. Our next question or comment comes from the line of Jason Butler from JMP Securities. Your line is open.
Thank you. Our next question or comment comes from the line of Jason Butler from JMP Securities. Your line is open.
Jason Butler: Hi, thanks for taking the question. Just another on Omidu Basel. Can you just talk about plans for additional data presentations this year, including from the Open Label Extension or Expanded Access Program? Thank you.
Hi, Thanks for taking the question just another one on the cell can you just talk about plans for our additional data presentations this year, including from the open label extension or extended expanded access program. Thank you.
Speaker Change: So thank you, Jason, for your question. Ronit mentioned during the prepared remarks that we have eight abstract at TCT, but maybe, Ronit, you could perhaps highlight other venues where we might present the maturing data set for Omoduba.
So thank you Jason for your question.
<unk> mentioned.
During the prepared remarks that we have eight abstract at TCT, but maybe Rodney you could perhaps highlight other venues where we might present the.
Maturing dataset for <unk>.
Ronit: Absolutely. And thank you, Jason, for your question. So, with TCT, as I mentioned, we'll be focusing on long-term follow-up information, as well as patient-reported outcomes, health-related quality of life, additional immune reconstitution data, and some preclinical data as well, and some...
Absolutely and thank you Jason for your question. So at TCT as I've mentioned, we'll be focusing on long term follow up information as well as patient reported outcome health related quality of life additional immune reconstitution data and some preclinical data as well.
And some of the information on the value and cost of care in terms of the expanded access program. We are continuing to recruit patients for the expanded access program.
Ronit: information on the value and cost of care. In terms of the Expanded Access Program, we are continuing to recruit patients for the Expanded Access Program, have not made a definitive decision about what the appropriate time would be to present that growing cohort of patients, but when there is a, I think, critical amount of information that's
<unk> not made a definitive decision about what the appropriate time would be to present that are growing.
<unk> cohort of patients, but when there is a I think critical amount of information that's.
Ronit: work presenting, we certainly will do that either by the end of the year at a hematologic meeting or maybe next year at a transplant meeting.
Presenting we certainly will do that either by the end of the year at hematologic meeting or or maybe next year at the transplant meeting.
Great. Thank you.
Speaker Change: Thank you. Our next question or comment comes from the line of Gil Bloom from Needleman Company. Your line is open.
Thank you. Our next question or comment comes from the line of Gil Blum from Needham and company. Your line is open.
Gil Bloom: Good morning, everyone. And thanks for taking our questions. So this one's for Michelle, from your discussions with physicians, what feedback have you been getting regarding their interest in an FDA approved transplant versus what they've been doing to date? The focus here being.
Good morning, everyone and thanks for taking our questions.
So this one is for Michelle.
From your discussions with physicians, what feedback you've been getting regarding their enterprise.
The approved transplant versus what they've been doing to date.
The focus here being.
Michelle Corfin: whether they have an opinion on something that is FDA approved and kind of feedback that we've heard so far.
Whether they.
Having an opinion on something that is FDA approved and kind of feedback that you've heard so far.
Speaker Change: And thank you, Gil, and good morning. We've done a lot of work speaking to physicians.
Thank you Gill and good morning, we've we've done a lot of work speaking to physicians and what what is encouraging for them about ahmadullah cell, which falls into the category of an FDA approved therapy as is the following so first off can be to sell will take on.
Speaker Change: What is encouraging for them about Omiduba cell, which falls into the category of an FDA-approved therapy, is the following. So, you know, first off, good.
Speaker Change: Gametocel will take on the responsibility around chain of identity and chain of custody from the time of the patient selection from Adubacel all the way through the return of the therapy to the center. So that's an important responsibility and that's something that comes with being an FDA approved therapy.
The responsibility around chain of identity and chain of custody from the time of the patient selection from Dubai sell all the way through the return of the therapy to the center. So that's an important responsibility and that's something that comes with being an FDA approved therapy. The other aspect is around the ahmedou to sell itself.
Speaker Change: The other aspect is around the Amadoubis cell itself.
Speaker Change: You know, so the NAM technology allows us to not only expand, but enhance the cells. And, you know, some of the challenges associated with using other donor sources is if you have an adequate number of cells. You know, does the donor potentially have some, you know, comorbidities that could potentially be affecting the donor ability. So the fact with Omiduba cell that we will be sort of a FDA regulated therapy with sort of a defined threshold around release criteria, you know, that is viewed as a positive.
So that then the Nam technology allows us to not only expand but enhanced the cells and you know some of the challenges associated with using other donor sources is do you have an adequate number of cells doesn't donor potentially have some you know comorbidities that could potentially be affecting the the the donor ability. So the fact that all madiba cell.
That we will be sort of the F. D. A regulated therapy with sort of a defined threshold around release criteria.
That is viewed as a positive I will say consistently the feedback we hear from U S transplant or is that when they see the armor data so clinical data they see on the <unk> cell opportunity for their patients falling into two key categories. The first from the physician's perception perspective is the ability to improve outcomes as compared to donor sources.
Speaker Change: You know, I will say consistently the feedback we hear from U.S. transplanters is that when they see the Amadouba cell clinical data, they see Amadouba cell opportunity for their patients falling into two key categories. The first, from the physician's perspective, is the ability to improve outcomes as compared to donor sources that they're currently using.
Speaker Change: And then the second, that very critical one of those patients who are deemed eligible for transplant but can't find a match, they see a very important opportunity for amidobacil given the fact we have a less stringent matching criteria. We demonstrated in our clinical study, we had approximately 40 percent of patients that were non-Caucasian in our clinical study. So those two key opportunities really do resonate consistently when we speak to physicians.
That they're currently using and then the second not very critical one of those patients who are deemed eligible for transplant or can't find a match. They see a very important opportunity for <unk> given the fact, we have a less stringent matching criteria. We demonstrated in our clinical study we had approximately 40% of patients that were non Caucasian in our clinical study so those two.
Key opportunities really do resonate consistently when we speak to physicians.
And if I may add Michelle.
Speaker Change: You know, there's no question that having a quality assured product.
Theres no.
Question that having a quality assured product.
Speaker Change: with specifications and an FDA label clearly gives us the opportunity to engage with physicians and educate. And over time, this is an exercise in behavioral economics, if you will. If physicians
Specifications and.
And then FDA label.
Clearly gives us the opportunity to engage with physicians.
And educate and overtime.
This is an exercise in.
Behavioral economics, if you will.
If physicians.
Speaker Change: find patients that are suitable for omodubicel and have a good experience uh... that will go a long way to uh... encouraging them to continue to prescribe omodubicel
Find patients that are suitable for <unk> and have a good experience.
That will go a long way to encouraging them to continue to prescribe when window. Michelle. So we think that an FDA label for the first ever sponsored.
Speaker Change: So we think that an FDA label for the first ever sponsored randomized phase three study is a significant game changer for the field of hematopoietic stem cell treatment.
Randomized phase III study.
A significant game changer for the field of no matter with hematopoietic stem cell transplant.
Speaker Change: And thank you, Michelle, and thank you, Julian, for taking our question.
It does.
Thank you Michelle and thank you Julien.
Our question.
Thank you Gil.
Thank you Jill.
Speaker Change: Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star then one on your telephone keypad. Our next question or comment comes from the line of Matthew Cross from Alliance Global. Your line is open.
Thank you again, ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad.
Our next question or comment comes from the line of Matthew Cross from Alliance Global Your line is open.
Matt Biegler: Hi, all. Good morning, and thanks for taking a couple of questions from me, both on the NK cell side. One, I wanted to ask regarding the cryo-preservation status for GDA-201. I know you'd previously tested a Moduva cell as both a cryo-preserved and non-cryo-preserved product.
Hi, good morning, and thanks for taking a couple of questions for me both on the NK cell site.
One I wanted to ask regarding the cryopreservation status for <unk> hundred one I know you'd previously tested I'm going to go sell as opposed to a cryopreserved and non cryopreserved product.
Matt Biegler: So as you're finalizing these IND requirements with the FDA for 201, I was just hoping to get a recap on kind of the clinical supply chain for that asset in terms of cold chain and what's required for that product in particular, given, you know, continuing supply issues at a broad level.
So as you're finalizing these these R&D requirements with the FDA for <unk> hundred one I was just hoping to get a recap on kind of the critical supply chain for for that asset.
In terms of cold chain, and what's required for that product in particular.
Given continuing supply issues at a broad level.
Speaker Change: So let me take that on. The team has worked very diligently through 2021 to perfect and optimize the cryopreservation.
So.
Let me take that on the.
The team has worked very diligently through 2021.
To perfect and optimize the cryopreservation.
Speaker Change: We now have product instability with many months of stability maintained at liquid nitrogen. So the goal of this is to have an off-the-shelf product.
Now have product on stability with.
With many months of stability.
Maintained its liquid nitrogen so the goal of this is to have an off the shelf.
Product.
Speaker Change: to enable a multi-center Phase I-II study and be able to recruit patients.
To enable a multicenter phase one two study.
And be able to recruit patients.
Speaker Change: with a single treatment with GDA-201. So all of those activities have been attended to and we're just finalizing the amendment to the IND to resubmit to the FDA and begin the clinical study in 2020.
With a.
A single.
Treatment with GDA 201, so all of those activities have been.
Attended to and we're just finalizing.
The.
Amendment to the IMD.
Resubmit to the FDA.
Begin the clinical study in 2022.
Speaker Change: Got it. Okay. Thanks, Julian. I appreciate the confirmation there. And then you, you know, had stated that you're looking to select a candidate for IND-enabling studies this year out of the genetically modified NK cell program. We just wanted to confirm whether I'm taking that statement overly literally. Are you looking at advancing one of these four programs to pre-IND this year and kind of tabling the rest for a bit? Or are all of these kind of making progress and maybe just one will become a front runner during the year? Thanks.
Got it okay. Thanks, Joel I appreciate the confirmation there.
And then you had stated that you are looking to select a candidate for IND, enabling studies. This year out of genetically modified T cell program, but just wanted to confirm whether I'm taking that statement overly literally are you looking at advancing one of these four programs.
And this year and kind of tabling the rest for a bit.
Or all of these kind of making progress and maybe just one will become a front runner during the year.
Speaker Change: So Matt, thank you for your very important question. So right now we have three candidates that are progressing. It's all data-driven.
So Matt Thank you for your <unk>.
Very important question. So right now we have three candidates that are progressing it's all data driven.
And.
Julian Adams: My comments about GDA-601 further allowed us to expand our collaboration with Dana-Farber to look at multiple myeloma cell lines, as well as fresh patient isolations.
My comments about <unk> 601.
Further allowed us to expand our collaboration with Dana Farber to look at multiple myeloma cell lines as well as fresh patient isolates.
Julian Adams: patients who have been heavily pre-treated. So the idea is progress all three, but select one candidate for IMD-enabling studies, and then subsequently continue to make progress on the other candidates.
Patients who have been heavily pretreated so.
The idea is.
Progress all three but select.
One candidate for IMD, enabling studies.
And then subsequently continue to.
To make progress on the other candidates.
Julian Adams: Again, it'll all be data-driven and we'll select the candidate with the most compelling data going forward.
Again, it'll all be data driven and we'll selected the.
Candidate with the most compelling data going forward.
Speaker Change: Great, okay. Thanks for the clarification there as well. I appreciate all the answers.
Great. Okay. Thanks for the clarification, there as well I appreciate all the answers.
Speaker Change: Thank you. I'm showing no additional questions in the queue at this time. I'd like to turn the conference back over to Julian Adams for any closing remarks.
Thank you I'm showing no additional in the queue with additional questions in the queue. At this time I'd like to turn the conference back over to Julian Adams for any closing remarks.
Julian Adams: Thank you, Operator, and thank you, everyone, for joining us on today's call. We look forward to engaging with you, and have a good day.
Thank you operator, and thank you everyone for joining us on today's call.
Look forward to engaging with you.
Sure.
And.
Have a good day, everyone and.
See you next quarter.
Speaker Change: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.
Speaker Change: Thank you for watching!
[music].