Q3 2022 Mink Therapeutics Inc Earnings Call
[music].
Good morning, and welcome to make Therapeutics third quarter 2022 conference call and webcast.
All participants will be in a listen only mode until the question and answer session. Please note. This event is being recorded if anyone has any objections you may disconnect at this time.
Today's call is being web cast it and will be available on our website for replay I'd like to remind you that this call will contain forward looking statements, including statements regarding our clinical development regulatory and commercial plans as well as timeline for data released in partnership opportunities. These statements are subject to risk.
Asks and uncertainties and we refer you to our SEC filings for more details on these risks.
Wanting me today, our Doctor, Jennifer <unk>, President and Chief Executive Officer, and Christine class skin principal financial and accounting officer now I'd like to turn the call over to Doctor bills highlight our progress and speak to our outlook for the remainder of the year.
Thank you very much good morning, and thanks for joining our third quarter earnings call.
Today I'm going to keep my corporate update short and invite you to join US for two very exciting events next week.
The first.
Make with selected to present five abstract.
Presentation at the society of immune therapy for cancer conference or otherwise known as <unk>.
Conference The conference will be held in her home city of Boston next week.
And following their presentations.
We will host our inaugural Orange D day event, which will include presentations from leaders.
Of amused therapy for diseases of the immune system, including cancer infections and auto immunity.
The event will be invite only for in person or.
Dissipation, but will also be publicly webcasting the conference as well.
These activities or a combination of significant progress at menk. We've continued to advance are invariant natural killer T. Sal R. I N K T cell platform through multiple clinical trials with our lead product candidates agents 797797, allogeneic or off the shelf product in clinical trials.
Designed to administer the product alone or in combination with keytruda or up tivo and solid tumor cancers.
We also have advanced or clinical trials in multiple myeloma and severe viral acute respiratory distress syndrome.
We've got these trials to important milestones, which include enrollment completion and data read out.
Both of which you'll be hearing more about it the upcoming conference.
Our next generation pipelines advancing very rapidly, we recently announced too exciting car I N K T programs. These.
These include a novel Strommel targeting that.
Carr I N K T for solid tumor cancers, and a soon to be disclosed armored B C. M. A car T program.
The letter of which is designed as a next generation scalable approach to deliver durable benefit without lymphodepletion in patients with multiple myeloma.
These car and Katie programs are advancing in I N D. Enabling studies and we announced that are fat car I N. K T will be file to an I N D. In 2023 next year, both programs are advancing and into I N D studies at this time.
Our engineered car I N K T programs are built from Apple pie to Ricardas platform.
This is designed for the selection of therapeutic candidates that have an optimal safety programs profile and key biologic advantages over available products will tell you more about our card is platform at the upcoming R&D day.
Our presentation <unk> will include updates and three clinical programs of agents 797, and heavily pretreated solid tumor cancers in combination with backbone Io therapy as well as data from our child and viral acute respiratory distress syndrome and multiple myeloma.
Additionally.
Our team will present data on our novel car I N K T pipeline candidates demonstrating potential first in class features with an allergy <unk> car I N K T approach.
Finally, we will be reporting on novel mechanisms that have not yet been observed an I N K T biology, as we advance the science of these cells and continue to believe that these features support the optimal therapeutic platform for delivering.
Scalable south therapy product.
Before we head into the conference I'm Gonna take a moment just to provide a refresher on I N. K Ts. These cells are a subset of T cells, they modulate boats, and Nate and adaptive immunity and and cancer I N K T. As can directly kill tumor cells. They also modulate myeloid biology, specifically suppress.
Guessing Milo drives suppressor cells. They also recruit additional immune support by driving T cells, and natural killer or N K cells to the location of need.
These mechanisms support earlier independent data.
Showing that Ah <unk> K T cells are clinically beneficial and solid tumor cancers, an area in which other cell therapy approaches have not yet shown benefit.
We'll discuss these mechanisms at a much deeper level at the upcoming Sippy confidence.
Beyond cancer, our team was explored the application of these cells is a variant agnostic approach for severe infections.
<unk> a R. D. S takes the lives of approximately 40 per cent of patients in the intensive care unit and there are no approved products to address this indication. We previously reported in over 75 per cent survival rate and severely sick patients suffering from the R. D S.
Marked improvement over the expected 22 per cent survival.
New findings from our phase one clinical trial will be presented at the <unk> conference by Doctor to raise Hammond to raise is the medical director of the cardiac care unit and I see you at Saint John's Health Center.
And she's a pulmonary critical care expert specializing in critical care medicine acute respiratory failure and Ecmo and has pioneered the COVID-19 efforts as a matter of fact Doctor Hammond was courageously on the front lines with this started the pandemic and one of the first to take patient samples and help identify the Sars.
Kobe to virus.
Our work and I and K P. As in severe infections has been selected as fundable by DARPA and contract negotiations are under way to find the advancement of agents 797 and diseases of immune Dysregulation, we look forward to additional announcements on this program.
Finally, our presentations at <unk> will also outline our key pipeline programs, namely <unk>.
<unk> 215, an allogeneic fat car I N K T, which we believe has the potential to be a differentiated therapeutic agent for solid tumor cancers.
We'll also disclose details regarding mink 413, and armored B C. M. A car I N K T, which is an off the shelf product designed as a next generation scalable approach to deliver benefit without lymphodepletion and.
In patients with multiple myeloma.
This is a program that we continue to consider to advance through strategic collaborations.
Again. These programs are the culmination of our strong advancements it makes Spanish keep pillars across research clinical data and manufacturing earlier. This year, we announced our internalization of our G. M. P manufacturer to enable independence and delivering these cells at scale, you'll be hearing more about our manufacturing.
Abilities from Dr. Joy <unk>, our head of manufacturing that are upcoming R&D day.
I'm Gonna stop there and invite you to learn more at our upcoming R&D day in November 10th from four to six P. M.
Features speakers will include members of our management team are leading scientists and pioneering leaders and cancer immunology and biology, including document <unk>.
Chief Hematology and I'm College that well Cornell Medical Center in New York.
Dr. Lydia Lynch head of the Lynch lab at Harvard and Freedom Doctor to race Hammond Ah.
The program director of the C C U and I see you at Providence, Saint John's Hospital in California, and the lead investigator on R. A R. D. S program Doctor, David Einstein Ah, leading medical oncologist specialists into you oncology at the Harvard Beth Israel Deaconess Medical Center and lead investigator on our <unk>.
Solid tumor cancer program.
B R N D day will be webcast live in institutional.
Investors analysts and others are invited to attend in person through special invitation.
We look forward to providing further updates on her progress and upcoming data releases at <unk> and there are in D day.
I will now turn the call over to Christine to go over our financials.
Thank you Jan.
We ended the third quarter 2022, with a cash balance of $24.2 million as compared to $38.9 million Ah December 31 2021.
Cash used in operations for the nine months in third quarter ended September 30th 2022 was $14.4 million and $5.6 million respectively.
Compares to $11.1 million and $3.5 million for the same periods in 2021.
[noise] expanded funding was primary related primarily related to the internalization of our manufacturing of agents 797 that Gen just mentioned.
Net loss for the quarter ended September 30th 2022, $6.3 million.19 per share compared to a net loss for the same period of 2021 $14.3 million or 59 cents per share.
Net loss for the nine months ended September 30th 2022, with $20.2 million or 60 cents per share compared to $24.4 million or one dollar one cents per share for the nine months ended September 30th 2021.
I will now turn the call over to our operator.
At this time, if you'd like to ask a question <unk> on your telephone keypad.
Emily Butner or was it <unk> <unk>.
Hi, Good morning, I am thanks for taking my questions I just talk to an agent 797 first when do you think you'll evaluate other combination agents like those suits you away for inhibitors do you have plans. So it may be evaluated other combination besides checkpoint inhibitors and then.
On the phase one study in your combination arm I believe you're evaluating patients tore a checkpoint inhibitor experienced so do you think you would evaluate patients who are a checkpoint naive at any point.
Do you have any plans to do that thanks.
Emily Thank you so much for for your remarks, and you've given me an opportunity to just remind the participants about a couple of things.
We presented data previously at the American Association of Cancer Research. The a C. R conference showing that when you take these cells a model of of lung metastatic lung disease preclinical motto.
When you look at therapeutic approaches to eliminate the metastatic lung lesions in what we presented was when you take available mmm molecules set with a P. D. One or even a next generation C. T. L. A for you see some reduction in liver Mets and those populations. When you add the I N K T as you actually.
We see a marked improvement in in the elimination of these cancer lesions in that model and when you conduct either a doublet of the I N K T cells with a C. T. L. D for agent predominantly a next generation C. T L. A for a boat and sell them App, which is advancing and a genesis.
Lifeline.
Or a triplet combination with with that she PLE for N. P. D. One you see near complete tumor eradication.
Most day to have supported are clinical development concepts to advance now we started it as with the allowance of the regulators who mandate that early clinical new agents be tested and later disease settings. After patients are refractory to.
Prior therapies, we know that that's not an optimal setting to test, but we certainly have been able to leverage those trials not only to provide data showing that these cells can be administered at multiple doses tolerably, but also in combination with backbone I owe therapy, such as P. D. One keytruda an app.
<unk> in the case of our trials.
So we've met a regulatory obligation of demonstrating tolerability and now we have the flexibility to start developing in areas, where we believe that the sales would bring even greater impact of patients such as the earlier disease setting or in combination with important agents boat and sell them App is an F.
<unk> engineered T T L E four which is showing benefit beyond what any prior C. T. L. D. Four has demonstrated clinically in history in the past we have the opportunity to our collaboration agreement with the genus to actually advanced combinations of I N K Ts with this particular product and where.
We'll be announcing our plans to do so relatively soon so to answer your question, Yes, we will be exploring other combinations. We do believe that a C. T. L. A four plus the cells can bring optical benefit and we've demonstrated such a through preclinical models and we'll be looking forward to doing so in the clinic. Additionally, there are.
Our other so these molecules as a reminder, I N K T as having an variant T. C. R that binds to a specific <unk> that particular like M. C. D. Wendy's up regulated following some standard of care chemotherapy, such as <unk> and and others, so well known why.
Lee used mm mm molecules and these the Upregulation may actually enable tumor escape and we believe that these cells in combination with standard of care chemotherapy may actually help mitigate that and the mechanisms by which these cells can do so we will be disclosing.
<unk> at the upcoming 50 conference.
The conference, we will be able to showcase and support our upcoming clinical development plans with this molecule beyond P. D. One and also in an earlier disease setting, where we believe the cells can bring a greater benefit to patients now that we've demonstrated tolerability and early signals of clinical benefit.
And we'll also disclose areas, where we believe these cells can be added to widely used therapies and expand the benefit this will enable us to have a past and which dropping the cells on top of standard of care agents will a neighbor enable are much faster path for for development of the <unk>.
<unk> on their own.
I hope that answers your question.
<unk>.
<unk> with William Blair. Your line is open.
Hi, This is a hunter on for about a couple of questions for US first off could you update us on the status of your plans for starting the O J.
Trial for the previously <unk> before the end of this year, but it seems like we've been language had changed and you're too far away.
I've been working towards for you.
<unk> presentation next week.
<unk> noticed that it's sharing it will also help data for multiple myeloma trial. So is it safe to assume that one of those will be the primary focus of the presentation.
Do you honestly will they'll be <unk>, so persistence localization loose studies as well.
Thank you very much for your question, let me address the first which issue mm inquiry about gvhd and we will be announcing.
Our our intentions with T V. H P V cells actually naturally work in that setting and that setting has become.
From a regulatory perspective, there are some consideration that that will require us.
To make some revisions so that we can accelerate our development plans will be discussing that at our upcoming R&D day, how do you plan to take advantage of the natural capability of these cells.
For a development opportunity and patience with Gvhd that includes not only in graph meant success, but also mitigation gvhd. So stay tuned for that and it will be a topic of the discussion at our upcoming R&D day, where we will be making some announcements related to gvhd.
Next will be the emphasis of the data. So we have advanced the cells of course in multiple myeloma, because smoking myeloma is a tumor type it not only allows us translational information and insights because it's inaccessible tumor. It's also very rich and C. D. One D ligand and.
That's M natural homing. We've previously discussed earliest case in the study where we showed that a patient treated with the south not only where it sells well tolerated no neurotoxicity no Crs, but also visa signals of clinical improvement, including longterm disease stabilization exceeding 10 months and <unk>.
<unk>, who had failed six prior therapy as we also saw suppression of Biomarkers, we will be expanding that data set and reporting on it at the upcoming conference. The showcase of the conference though to your earlier point is on solid tumors given that we launch the trial just recently.
<unk> just in May and we have seen unprecedented interest and activity. We've been bowled over 40 patients into the trial and will be releasing data on a cohort of patients who have at least achieve some early disease assessments now as you can imagine. These these data are still <unk>.
Sure Uhm, but they allowed us the opportunity not only to see some early signals of safety clinical activity, but also uhm disease modulating translational markers. So we will be looking and sharing information with respect to the translation of Biomarkers that we're evaluating.
And the trial at the upcoming confidence.
Draco and root beer your line is open.
Great. Thank you so much and congratulations with T mobile progress made over the court.
Recorded I think everyone's excited about the safety presentation. So maybe I'll spell that out for you a little bit about.
That.
These transitional Biomarkers responsible last question I was hoping you could die with a little bit more deeply into <unk> bedroom will be looking for it and then.
As it relates to the idea of this study David combination trial could you provide some carpets around what are you looking working out as far as the <unk>.
For success Okay.
Thanks, Thanks, Jack So to your first question I think <unk>, what what what is known about these cells as they actually uhm are incredibly active at secreting tumor, killing <unk> like interferon gamma uhm and immune regulatory side of times on the tumor side of things we will be.
Showcasing data and which we've evaluated both peripheral as well as local.
Information on the biology of the cells that will give us signals of persistence.
Some of the underlying mechanisms that we believe are supporting the clinical efficacy that was observed autolycus setting, but also I'm being observed and the hour allogeneic setting. So I would say there are some known mechanisms of these cells in which they can directly block and kill they can life's too.
Tumors, they can recruit T cells and N K cells for a direct attack as well as for a terrible memory responses uhm and they do so through a series of mechanisms some of which can be elucidated looking up.
<unk> profile other immune immune markers and we'll be sharing that data I think it will I think you'll be enthusiastic about about some of the mechanisms that we've been elucidating here and send data in which we can show them how the cells helped.
Other immune cells like C D H T cells actually traffic and function. This is a very important part and I'm I'm hesitant to say much more because I because of our restrictions with the data presentations at city, but our data will reveal some very important into.
<unk> between I N K T cells, and other very important sells and their function that will help us better understand how these cells are working in eliminating disease uhm.
I think that what you had another question, which escapes me right now.
Alright, I was wondering if you could help Kentucky five would be perfect successes everybody to give it that is going to be a combination regimen.
<unk> Oh, okay important. Thank you very much okay. So so we we actually uhm in negotiation with the agency, we were able to go into a setting in which patients.
Have been treated as standard of care with Keytruda or up Devo Uhm those patients progress on those agents and in some cases there is nothing more for those patients. So they remain on the approved checkpoint in the case of non small cell lung cancer patients for grass on Keytruda and then the only option for them really is now.
Oh, that's a tactical which is about a 9% response rate and so those patients many of whom will actually if they can tolerate it they remain on on Keytruda, we were able to see based on the mechanism of these cells. If we can add these onto that regimen and actually reverse the progression and and.
Expand the benefit of the approved agents. So the bar here is really any signal. These patients are progressing on standard of care commercially available standard of care and.
And we're adding ourselves to actually change the disease trajectory and those patience uhm and that means first certainly we want to look at Tolerability, but next we're looking at very very low response rates impatience with sign moma's cholangiocarcinoma non small cell lung cancer, a padded cellular.
Carcinoma once the refractory to to to check point modulating antibodies. So the bar is low we we will be showcasing what these cells can do both clinically and translation Holly as well as you know are they tolerable and and that's an important marker for what we then can.
Take these cells into based on these features.
Great. Thank <unk>.
As a reminder, you can hit star one on your telephone keypad to ask a question <unk> would be Riley security your logins open.
Good morning. This is Andy on for <unk>. Thank you for taking questions and congratulations on the progress looking forward to the upcoming since the posters and are indeed day, we've seen other emerging cell types, such as <unk>. So garner more partnership entrust surrounding engineered <unk>.
<unk> as opposed to an added itself are you seeing a similar trend with your <unk> and any more general commentary regarding your approach partnerships would be helpful. Thank you.
Thank you for the question and I'll tell you. We are the most advanced company, bringing an allogeneic I N K T. That's not engineered into the clinic. So this is really first of its kind of data and observations uhm compared to what we see with some other cell types. We also have of course.
Capabilities in the engineering <unk>, which is you know I believe best in class here and I'll tell you I'm just as a reminder, mink was born out of a long standing immune oncology company of Janice, which both really one of the most productive R&D pipeline Mark Mendez, because they're two scientific officer.
Had joined through an acquisition was a part of the leadership team at a genus and he's two scientific officer of Mink Mark had designed the antibody discovery platforms at Genmab, <unk>, Janice and and he's been able to actually uhm engineer some extraordinary platforms on.
Four mink and that includes our ability through the card is platform to engineer cells, which you're gonna hear much more about it. The 50 conference also to apply the technology to create I N K T engage your technology, which you're also going to hear more about and we've previously disclosed the platforms capability to reproduce simply.
<unk> generate high quality T C ours, the productivity of our research engine sets us up for an opportunity to actually leverage that research productivity for partnerships. We have we have already engaged a number of strategic discussions on leveraging partner.
<unk>, who could help us accelerate the advancement of some of these technologies as well as continue to support and expand are are financial.
Capability, so that will allow us to take advantage of molecules in engineering capabilities in our research productivity not only to finance a business, but also to accelerate the the development of our innovations. So you'll hear more about these conversations as we continue to.
<unk> advanced than what we have disclosed on the infectious disease side, and we do have an opportunity and we are in contract negotiations with DARPA. We were selected as Fundable to advance these cells in their native form.
A variance agnostic approach to emerging viral an infectious threats that is an important partnership for us not only to support or clinical I preclinical progress, but also to expand the Ah clinical benefit of these advancement so the cells in their native form theirs.
No comparator, because we're class leading here and the shelves and they're engineered form certainly have quite a bit of interest. There's a lot of interest in both directions than than native as well as the engineered both of which we will take advantage of through less dilutive financing opportunities.
There are no further questions at this time or would go like to turn the call back over to the presenters for closing comments.
Thank you very much I appreciate your time on the call today and look forward to speaking with you again next week talk with you soon.
This concludes today's call. Thank you for your participation.
Disconnect.
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Good morning, and welcome to make therapeutics third quarter 2022 conference call and webcast all participants will be in a listen only mode until the question and answer session. Please note. This event is being recorded if anyone has any objections you may disconnect at this time.
Today's call is being web cast and will be available on our web site for replay I'd like to remind you that this call will contain forward looking statements, including statements regarding our clinical development regulatory and commercial plans as well as timelines for data release and partnership opportunities. These statements are subject to risks.
And uncertainties and we refer you to our SEC filings for more details on these risks.
Turning me today, our Doctor, Jennifer Buell, President and Chief Executive Officer, and Christine class skin principal financial and accounting officer now I'd like to turn the call over to Doctor bills highlight our progress and speak to our outlook for the remainder of the year.
Thank you very much good morning, and thanks for joining our third quarter earnings call.
Today I'm going to keep my corporate update short and invite you to join US for two very exciting events next week.
The first.
<unk> was selected to present five abstracts.
For presentation at the society of immunotherapy for cancer conference or otherwise known as should see.
Conference The conference will be held at our home city of Boston next week.
And following our presentations.
We will host our inaugural R&D day event, which will include presentations from our leaders of immune therapies for diseases of the immune system, including cancer infections in autoimmunity.
The event will be invite only for in person participation, but will also be publicly webcasting the conference as well.
These activities are a combination of significant progress at bank. We've continued to advance our invariant natural killer T cell or I N K T cell platform through multiple clinical trials with our lead product candidate <unk>.
790, 779, and 17 allogeneic or off the shelf product in clinical trials designed to administer the product alone or in combination with keytruda or opdivo and solid tumor cancers.
We also have advanced our clinical trials in multiple myeloma and severe viral acute respiratory distress syndrome.
We brought these trials to important milestones, which include enrollment completion and data readout.
Both of which you'll be hearing more about at the upcoming conference.
Our next generation pipeline is advancing very rapidly, we recently announced two exciting car I N. K T. Programs. These include our novel Stromal targeting that car I N K T for solid tumor cancers.
A soon to be disclosed armored be CMA car T program.
The latter of which is designed as a next generation scalable approach to deliver durable benefit without lymphoid depletion in patients with multiple myeloma.
These car T programs are advancing in IND, enabling studies, and we announced that our car I N. K T will be filed to an IND in 2023 next year.
These programs are advancing and into <unk> studies at this time.
Our engineered car IMTT programs are built from our proprietary hardest platform. This is designed for the selection of therapeutic candidates that have an optimal safety program profile and key biologic advantages over available products will tell you more about our <unk> platform.
The upcoming R&D day.
Our presentations will include updates on three clinical programs of agents 797, and heavily pretreated solid tumor cancers in combination with backbone Io therapy as well as data from our trials and viral acute respiratory distress syndrome and multiple myeloma.
Additionally, our team will present data on our novel car IMTT pipeline candidates demonstrating potential first in class features with an allogeneic car.
T approach.
Finally, we will be reporting on novel mechanisms that have not yet been observed on I N K T biology, as we advance the science of these cells.
We continue to believe that these features support the optimal therapeutic platform.
We're delivering a scalable cell therapy <unk>.
<unk>.
Before we head into the conference I want to take a moment just to provide a refresher on I N. K T's. These cells are a subset of T cells there.
Modulate, both innate and adaptive immunity and in cancer I am Kt's can directly kill tumor cells. They also modulate myeloid biology, specifically suppressive myeloid derived suppressor cells. They also recruit additional immune support by driving T cells, and natural killer or NK cells to the location of need.
These mechanisms support earlier independent data.
Selling that autologous NK T cells are clinically beneficial and solid tumor cancers in area in which other cell therapy approaches have not yet shown benefit.
We'll discuss these mechanisms at a much deeper level at the upcoming Citi Conference.
Beyond cancer, our team has explored the application of these cells as a variant agnostic approach for severe infections.
Viral <unk> takes the lives of approximately 40% of patients in the intensive care unit and there are no approved products to address the syndication. We previously reported in over 75% survival rate and severely sick patients suffering from the Rds.
A marked improvement over the expected 22% survival.
New findings from our phase one clinical trial will be presented at the Citi Conference by Dr to raise Hammond.
This is the medical director of the cardiac care unit and ICU at St. John's Health Center.
And she's a pulmonary critical care experts specializing in critical care medicine acute respiratory failure and Ecmo and has pioneered the COVID-19 efforts as a matter of fact, Dr. Hammond was courageously on the front lines of the start of the pandemic and one of the first to take patient samples and help identify the Sars.
Koby to virus.
Our work in Imtt's and severe infections has been selected as fungible by DARPA and contract negotiations are underway to fund the advancement of agents 787 in diseases of immune Dysregulation, we look forward to additional announcements on this program.
Finally, our presentations at CIT C will also outline our key pipeline programs, namely <unk>.
215, and allogeneic <unk> car <unk> K T, which we believe has the potential to be a differentiated therapeutic agent for solid tumor cancers.
We will also disclose details regarding mink for one three and armored be CMA car I N K T, which is an off the shelf product designed as a next generation scalable approach to deliver benefit without lymphoid depletions.
Patients with multiple myeloma.
This is a program that we continue to consider to advance through strategic collaborations.
Again these programs with a combination of our strong advancements that make spanning key pillars across research clinical data and manufacturing earlier. This year, we announced our internalization of our GMP manufacturer to enable independence and delivering these cells at scale, you'll be hearing more about our manufacturing.
Abilities from Dr. Joy Zell, our head of manufacturing that are upcoming R&D day.
I'm going to stop there and invite you to learn more at our upcoming R&D day in November 10th from four to six P. M.
Featured speakers will include members of our management team are leading scientists and pioneering leaders in cancer immunology and biology, including Dr. Manuel Hidalgo.
Chief Hematology and oncology at Weill Cornell Medical Center in New York.
Doctor Lydia Lynch head of the Lynch lab at Harvard and Brigham Dr to raise Hammond.
The program director of the CCU in ICU at Providence, St. John's Hospital in California, and the lead investigator on our <unk> program, Dr. David Einstein, a leading medical oncologists and specialists into you oncology at the Harvard Beth Israel Deaconess Medical Center and lead investigator on our salt.
The tumor cancer program.
The R&D day will be webcast live in institutional.
Theres analysts and others are invited to attend in person through special invitation.
We look forward to providing further updates on our progress and upcoming data releases at cincy and their R&D day.
I will now turn the call over to Christine to go over our financials.
Yeah.
Thank you Jen.
We ended the third quarter 2022, with a cash balance of $24 $2 million as compared to $38 $9 million at December 31, 2021.
Used in operations for the nine months and third quarter ended September 32022 was $14 4 million and $5 $6 million, respectively. This compares to $11 $1 million and $3 $5 million for the same periods in 2021.
This expanded funding was primarily related primarily related to the internalization of our manufacturing of agents 197 that Jim just mentioned.
Net loss for the quarter ended September 32020 to $6 $3 million or <unk> 19 per share compared to a net loss for the same period of 2021, a $14 $3 million or <unk> 59 per share.
Net loss for the nine months ended September 32022 was $22 million or <unk> 60 per share compared to $24 $4 million or $1 one per share for the nine months ended September 32021.
I will now turn the call over to our operator.
Okay.
At this time, if you'd like to ask a question. Please press star one on your telephone keypad.
Emily partner with H C. Wainwright your line is open.
Hi, good morning, and thanks for taking my questions.
Talk to an agent southern 97.
First when do you think you'll evaluate other combination agents like the <unk> four inhibitors do you have plans to maybe evaluate other combinations. Besides checkpoint inhibitors and then.
On the phase one study in your combination arm I believe you're evaluating patients who are checkpoint inhibitor experienced.
Or do you think you would evaluate patients who are checkpoint naive at any point.
Do you have any plans to do that.
Emily Thank you so much for for your remarks, and you've given me an opportunity to just remind the participants of about a couple of things.
We presented data previously at the American Association of Cancer Research the ACR conference showing that when you take the cells are model.
Along a metastatic lung disease preclinical model.
When you look at therapeutic approaches to eliminate the metastatic lung lesions and what we presented was when you take our available.
Molecules, such as a PD, one or even a next generation <unk> four you see some reduction in liver Mets in those populations. When you add the <unk> you actually see a marked improvement in our in the elimination of these cancer lesions in that model and when you conduct either a doublet.
Of the Iron J T cells with a <unk> four agent predominantly a next generation <unk> four.
Boat and sell them Mab, which is advancing in a genesis pipeline.
Or a triplet combination with with that <unk>, four and PD one you see near.
<unk> tumor eradication those data have supported our clinical development concepts to advance now we started it as with the allowance of the regulators who mandate that our early clinical new agents be tested and later disease.
These settings after patients are refractory to prior therapies, we know that that's not an optimal setting to test, but we certainly have been able to leverage those trials not only to.
Provide data showing that these cells can be administered at multiple doses tolerably, but also in combination with backbone I O therapies, such as PD, one keytruda and Opdivo in the case of our trials.
So we've met a regulatory obligation of demonstrating tolerability and now we have the flexibility.
The ability to start developing in areas, where we believe that these cells will bring even greater impact to patients such as the earlier disease setting or in combination with important agents a boat and fill them up is an FC engineered <unk>, four which is showing benefit beyond what any prior CTO.
<unk> four has demonstrated clinically and in the past we have the opportunity through our collaboration agreement with Genesis to actually advance combinations of <unk> with this particular product and where we'll be announcing our plans to do so relatively soon so to answer your question yes.
We will be exploring other combinations, we do believe that a C. T. L. A four plus these cells can bring optimal benefit we've demonstrated such through preclinical models and we'll be looking forward to doing so in the clinic.
Additionally, there are other so these molecules as a reminder, <unk> have an invariant TCR that bind to a specific ligand and a lot that particular like M. <unk> is up regulated following some standard of care chemotherapy such as.
Gemcitabine and others, so well known widely used molecules and these the upregulation may actually enable tumor escape and we believe that these cells in combination with standard of care chemotherapy may actually help mitigate that.
In the mechanisms by which these cells can do so we will be disclosing at the upcoming Citi Conference. So from the conference, we will be able to showcase and support.
Our upcoming clinical development plans with this molecule beyond PD one and.
And also in an earlier disease, setting, where we believe the cells can bring a greater benefit to patients now that we've demonstrated tolerability and early signals of clinical benefit and we will also disclose areas, where we believe these cells can be added to a widely used therapies and expands the benefit this.
Will enable us to have a path and which dropping the cells on top of standard of care agents willing neighborhood enable a much faster path for development of the cells on their own.
I hope that answers your question.
They both bring front.
Matt Phipps with William Blair. Your line is open.
Hi, This is hunter on for Matt.
A couple of questions for us first off.
Could you update us on the status of your plans for starting the Gvhd trial I know previously you had guided to I think before the end of this year, but it seems like maybe the language has changed in your Q filing.
And then looking towards the.
Solid tumor presentation next week.
One noticed that it's sharing.
It also have data from the multiple myeloma trial. So is it safe to assume that one of those will be the primary focus of the presentation.
Then.
Maybe lastly will there be data sort of on.
Cell persistence localization and those studies as well.
Thank you very much for your question, let me address the first such as your inquiry about Gvhd and we will be announcing.
Our our intentions with Gvhd these cells actually naturally work in that setting.
In that setting has become from a regulatory perspective, there are some considerations that that will require us to make some revisions. So that we can accelerate our development plans, we will be discussing that at our upcoming R&D day, how we plan to take advantage of the natural capability of these cells.
For a development opportunity and patients with Gvhd that includes not only in graft meant success, but also mitigation gvhd. So stay tuned for that and it will be a topic of discussion at our upcoming R&D day, where we will be making some announcements related to gvhd.
Next will be the emphasis of the data so we have advance.
Advance the cells of course, and multiple myeloma, because multimodal myeloma is a tumor type that not only allows us translational information and insights because it's an accessible tumor. It's also very rich in C. D. One day ligand and that's a natural homing. We've previously discussed our earliest case in the study were.
We showed that a patient treated with the cells not only where the cells well tolerated no neurotoxicity no Crs, but also we saw signals of clinical improvement, including long term disease stabilization exceeding 10 months in the patients who had failed six prior therapies. We also saw suppression of Biomarkers.
We will be expanding that dataset and reporting on it at.
At the upcoming conference the showcase of the conference, though to your earlier point is on solid tumors given that we launched the trial. Just recently just in May and we have seen unprecedented interest.
Activity, we've enrolled over 40 patients into the trial and we'll be releasing data on a cohort of patients who have.
At least achieved some early disease assessments now as you can imagine.
These data are still immature, but they allowed us the opportunity not only to see some early signals of safety clinical activity, but also disease modulating.
Translational markers, so we will be looking and sharing information with respect to the translational biomarkers that we're evaluating in the trial at the upcoming conference.
Yeah.
Jack Cohen with Baird. Your line is open.
Great. Thank you so much and congratulations to the team on the progress made over the quarter. So of course of the quarter I think everyone's excited about the 60 presentation. So maybe I'll start by asking a little bit about that.
You mentioned these translational biomarkers in a responsible last question I was hoping you could dive a little bit more deeply into exactly what measures we will be looking for and then.
As it relates to the idea of this study being a combination.
Kyle can you provide some context around what youre looking at looking at as far as the Barclays group for success.
Got it.
Thanks, Thanks, Jack so onto your first question I think what what is known about themselves as they actually.
Our incredibly active at secreting tumor, killing cytokines like interferon gamma and immune regulatory cytokines on the tumor side of things, we will be showcasing data in which we evaluated both peripheral as well as local inc.
Information.
The biology of the cells that will give us signals of persistence.
Some of the underlying mechanisms that we believe are supporting the clinical efficacy that was observed in the autologous setting, but also being observed and the our allogeneic setting. So I would say there are some known mechanisms of b cells in which they can directly block and kill they can light tool.
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Can recruit T cells, and NK cells for a direct attack as well as for durable memory responses.
And they do so through a series of mechanisms some of which can be elucidated looking up.
Cytokine profile other immune immune markers and we'll be sharing that data I think it will I think you'll be enthusiastic about about some of the mechanisms that we've been elucidating here and some data in which we can show them. How these cells helped.
Other immune cells like CD eight T cells actually traffic and function. This is a very important part in them.
Hesitant to say much more because I because of our restrictions with the data presentations at city, but our data will reveal some very important.
<unk> between I N K T cells and other very important cells.
And their function that will help us better understand how these cells are working and eliminating disease.
I think that what you had another question, which escapes me right now.
I was wondering if you could help contextualize what the bar for success isn't the study given that it's going to be a combination regimen with immune checkpoint inhibitor Oh, okay important. Thank you very much. Okay. So so we actually in negotiation with the agency, we were able to go into a setting in which patients.
Have been treated as standard of care with Keytruda or Opdivo those patients progress on those agents and in some cases, there's nothing more for those patients. So they remain on the.
The approved checkpoint in the case of non small cell lung cancer patients for grass on Keytruda and then the only option for them really is now is <unk> ataxia, which is about a 9% response rate and so those patients many of whom will actually if they can tolerate that they remain on keytruda, we were able to see based on the mechanism of these.
So if we can add these on to that regimen and actually reverse the progression and.
And extend the benefit of the approved agents. So the bar here is really any signal of these patients are progressing on standard of care commercially available standard of care.
And we're adding ourselves to actually change the disease trajectory in those patients and.
And that means the first certainly we want to look at Tolerability, but next we're looking at very very low response rates in patients with signed Momma's cholangiocarcinoma.
Non small cell lung cancer hepatocytes carcinoma, once a refractory to two.
Two checkpoint modulating antibodies so the bar is low.
We will be showcasing what these cells can do both clinically and translation Ali.
Are they tolerable.
And that's an important marker for what we then can take these cells into based on these features.
Great. Thanks, so much.
As a reminder, you can hit star one on your telephone keypad to ask a question Celtic Patel with B Riley Securities. Your line is open.
Good morning. This is Andy on for <unk>. Thank you for taking questions and congratulations on the progress looking forward to the upcoming sets the posters and R&D day.
We've seen other emerging cell types, such as gamma Delta T cell garner more partnership interest surrounding engineered cell products as opposed to on added itself are you seeing a similar trend with your pipeline candidates and any more general commentary regarding your approach to partnerships would be helpful. Thank you.
Thank you for the question Andy I'll tell you why.
We are the most advanced company, bringing and allogeneic NK T. That's not engineered into the clinics. So this is really first of its kind of data and observations.
Compared to what we see with some other cell types. We also have of course, the capabilities and the engineering.
Construct switches I believe best in class here and I'll tell you just as a reminder, link was born out of long standing immuno oncology company of genus, which bodes really one of the most productive R&D pipeline Mark Van Dijk Who's our Chief Scientific Officer had joined.
Through an acquisition was a part of the leadership team at a genus and he's our chief Scientific officer of make Mark had designed the antibody discovery platforms that genmab, medarex genus and and he's been able to actually.
Engineers, some extraordinary platforms on.
For <unk> and that includes our ability through the Curtis platform to engineer cells, which youre going to hear much more about it at the Citi Conference also to apply the technology to create I N K T engage or technology, which you are also going to hear more about and we've previously disclosed the platform's capability to reproduce of Li <unk>.
<unk> high quality TCR is the productivity of our research engine sets us up for an opportunity to actually leverage that research productivity for partnerships. We have we have already engaged a number of strategic discussions on leveraging partners.
Who could help us accelerate the advancement of some of these technologies as well as continue to support and expand them R. R.
Financial.
Capability, so that will allow us to take advantage of molecules and engineering capabilities and our research productivity not only to finance the business, but also to accelerate the development of our innovations. So you'll hear more about these conversations as we can.
Continue to advance them, what we have disclosed on the infectious disease side, and we do have an opportunity and we are in contract negotiations with DARPA. We were selected as fungible to advance these cells in their native form.
As a variance agnostic approach to emerging viral infectious threats.
That is an important partnership for us not only to support our clinical and preclinical progress, but also to expand the clinical benefit of these advancement. So the cells in their native form there's no comparator, because we're a class leading here and the cells in their engineered form.
We certainly have quite a bit of interest there's a lot of interest in both directions than the native as well as the engineered.
Both of which we will take advantage of through less dilutive financing opportunities.
There are no further questions at this time I would now like to turn the call back over to the presenters for closing comments.
Thank you very much I appreciate your time on the call today and look forward to speaking with you again next week talking with you soon.
This concludes today's call. Thank you for your participation you may now disconnect.