Q4 2022 Alaunos Therapeutics Inc Earnings Call

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Good day, and thank you for standing by and welcome to the Yamana Therapeutics fourth quarter 2022 financial results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you'll need to press star one one on your telephone.

You will then hear an automated message advising you. Your hand is raised to withdraw your question. Please press star one again please.

Please be advised that today's conference is being recorded I would now like to have the conference over to your speaker today Daniele Dungeon with Stern IR. Please go ahead.

Good morning, and welcome to the <unk> Therapeutics fourth quarter and full year 2022 financial results conference call and audio webcast earlier.

Earlier this morning, <unk> issued a press release announcing financial results for the three months and full year ended December 31 2022.

We encourage everyone to read today's press release as well as the <unk> annual report on Form 10-K for the year ended December 31, 2022, which was filed with the <unk> with the SEC. This morning.

The company's press release and annual report will also be available on the <unk> website at <unk> Dot com.

In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.

Please note that certain information discussed on today's call is covered under the safe Harbor provision of the private Securities Litigation Reform Act of 1995.

Participants are cautioned that this conference call contains time sensitive information that is accurate only as of the date of this live broadcast March 17 2023.

Actual results could differ materially from those stated or implied by forward looking statements made today due to risks and uncertainties associated with the company's business.

Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Gov.

The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this webcast, except as may be required by applicable securities law.

With me today are Kevin Boyle, Senior Chief Executive Officer.

<unk>, Vice President of research and development.

Avi <unk> Vice President of technical operations.

And Mike Huang Vice President of Finance.

With that said I would like to turn the call over to Kevin.

Thank you Danielle.

Good morning, and thank you for joining us today for an update on the exciting progress we are making here at all on us.

2022 was a transformational year for <unk> therapeutics, as we achieved several meaningful corporate milestones, including advancing our library TCR T cell program into the clinic and subsequently achieving our first objective clinical response.

We are a highly focused company.

Committed to leading the scientific development of T cell receptor therapies to revolutionize solid cancer treatment and improve patient outcomes.

I'm extremely proud of our team's work and realizing the promise of our novel technologies and R&D efforts with clinical execution.

We believe TCR T targeting high frequency driver mutations is potentially the most promising advanced immunotherapy to kill solid tumors.

We are proud to be on the leading edge of cell therapy.

We were the first company to demonstrate an objective clinical response in a patient with a solid tumor using a non viral TCR T cell therapy.

We are encouraged and motivated by the significant interest. These results have since generated among physicians patients investors potential partners.

And other key stakeholders ever.

Every day multiple patients are reaching out to inquire into our clinical study from across the country.

This growing momentum provides a tremendous foundation for the year ahead.

We have been hard at work to ensure that we can meet our TCR T Library phase one two program milestones in 2023.

In the fourth quarter, we filed an IND amendment for the trial.

As part of this amendment, we made several critical enhancements to our enrollment and manufacturing processes.

First we combined our treatment and screening protocols streamlining enrollment, making it easier for both patients and physicians.

Second we are no longer required to retest the patients tumor mutation if more than six months has passed between screening and treatment.

Which will allow for faster accrual.

We are confident that these driver mutations will be retained as they are at the core of the cancer.

Lastly, we added cryopreservation to our manufacturing process.

Cryo reduces the manufacturing process time from 30 days to 2006 days, while simultaneously increasing flexibility for patient scheduling and treatment.

As we look ahead cryopreservation also allows us to open additional trial sites outside of Texas.

And yes, contrary to the common belief of many tax since there is a big world outside of this great state.

And this expansive IMD amendment, we again added to our industry, leading TCR library for use against solid cancers with two new TCR targeting frequent mutations and <unk>.

This addition, effectively doubles our eligible patient pool for the study with now more than 10% of all patients screened for our trial at MD Anderson matching our library TCR.

Taken together, we are confident that these changes will enable us to increase the pace of enrollment in our trial.

Allowing us to become phase II ready by the end of the year.

I'd like to talk about our TCR T Library phase one two trial.

And what this year will look like as we move towards phase II readiness.

As you will recall this is a basket trial targeting driver mutations across six solid tumor indications.

Non small cell lung colon, endometrium, pancreas, ovary and bile duct cancers.

We are actively enrolling patients at MD Anderson with any one of these six cancers based on matching both a specific mutation and HOA combination to a TCR that is available in our library.

As a result of the most recent IMD Amendment, our TCR Library now consist of 12 Tcr's.

<unk> six <unk> 53, and one egfr.

In December we successfully dosed the third patient in the trial.

This patient was diagnosed with pancreatic cancer with a tumor expressing HLA a 11.

And <unk> V mutation matching one of the TCR is within our TCR library.

The patient was treated at the second dose level with 58 billion TCR T cells.

As with the first two patients patient III had a manageable safety profile with no dlt's or icons observed.

The flexibility of our platform is astonishing with the first three patients on the study representing three distinct indications being treated with three different tcr's.

As we treat additional patients we believe that presenting safety and efficacy data on multiple patients at the same time as the most credible.

Clinically meaningful.

And industry standard practice, and we look forward to sharing additional patient III data with other patient results later this year.

We will remain flexible on what venues we used to provide patient updates when we provide updates and how many patients will be included in each update based on what is in the best interest of the company.

In total we anticipate trading between 12 and 15 patients in the phase one portion of the trial.

With three patients having been dosed in 2022, we are confident that our growing patient pipeline and manufacturing capacity will support treating the remaining balance of patients this year.

Our resolve and commitment to developing the best in class TCR T cell therapies has been strengthened by the growing momentum we are seeing in the patient and physician interest in our trial.

Now before I hand, the call over to drew ill briefly speak to our financial position.

In December we completed a follow on offering where we raised approximately $15 million in gross proceeds despite the most challenging market conditions facing the biotech industry over the past five years.

As responsible stewards of the company.

The board carefully evaluated all available financing options and firmly believes that this was the right decision to allow the company to continue to advance our pioneering science.

For perspective in 2022.

Only 58 follow on financings were completed compared to over 200 in the years prior.

As one of the few companies to close the financing.

At market terms without issuing warrants the.

The promise of our science and technology was recognized by investors.

The additional cash has allowed us to extend our runway into the fourth quarter and should enable us to accelerate the enrollment of patients and the manufacturing of clinical products to generate additional meaningful clinical data this year.

Now, let me hand, the call over to drew to highlight our ongoing R&D efforts and discuss where we see opportunities to explore next generation TCR T cell therapies to further deepen clinical responses.

<unk>.

Thank you Kevin.

I'm excited to share today that we were pushing full speed ahead, and our R&D efforts, we continue to ramp up our 100 TCR discovery platform to increase the number of patients who can benefit from them TCR T cell therapy.

We are generating foundational data from the translational assessments in our treated patient.

And we are using the translational data to guide our next generation TCR T cell endeavors that will fuel our pipeline for the long term.

Let me start with Hunter.

We continue to strongly believe that hunter is at the cutting edge of innovation and has significant advantages over traditional TCR discovery methods.

We've been very successful in identifying novel exclusively owned mutation reactive TCR.

And our emboldened to increase throughput and focus on high value targets.

Our TCR or source from T cells infiltrating the tumor expressing the driver mutation and the natural context of HLA.

We can then use the TCR to add to the library for the benefits of another patient who has the same target.

At the 2022 Sissy conference, we presented proof of concept data supporting Hunter's ability to evaluate hundreds of thousands of <unk> mutations in PCR combinations in a high throughput setting with our proprietary technology.

As Kevin referenced in the fourth quarter, we added two new Tcr's to our library targeting frequent driver mutations and isolates.

The addition of these two Tcr's has had a major impact on the potential addressable market for our TCR T program effectively doubling.

We are pleased to show now.

Greater than a 10% match rate and the patient prescreening process.

The addition of these new TCR is a Prime example of our two pronged library expansion strategy.

On one hand, we are working to add more <unk> to the existing K Ras <unk>, three and Egfr mutations in the library, which we did by adding Dr. <unk>.

<unk> 12 feet.

On the other hand, we are adding new mutations within our targeted gene families, which we did with <unk> 53 or $2 73.

This year, we expect to grow the library to 15 Tcr's.

And over time, we imagine that the library could be above 40, tcr's to expand the number of patients that could potentially benefit from our TCR T cell therapy.

We believe <unk> is uniquely situated to effectively deliver more than one PCR to a patient on a commercial scale, which we call multi flexing.

From a therapeutic perspective multiplexing is advantageous because the more targets we attack the better chances we have of achieving long term durable emissions of cancer.

We are highly encouraged that roughly one in five of our patients match to more than one TCR library right now.

Multiplex in TCR T is therefore, a unique opportunity for us in the near term.

We expect the number of patients with single and multiple matches to continue to grow as we expand the library and.

And given the pace of our Hunter successes, we believe we can further weaponized TCR T cells to benefit patients with driver mutations.

Our non viral sleeping beauty system enables us to build the library of Tcr's quickly and cost effectively in a way that we believe no other company can.

In addition to expanding the addressable market and reach of our TCR T cell therapy through the TCR Library. We are also using our translational data from the clinical trial to help guide our next generation TCR T efforts.

We will make data driven decisions to address factors relevant for limiting exhaustion and maximizing the therapeutic potential of our TCR T cells.

We are delighted to say that we have detected persistence of our TCR T cells in the peripheral blood without exhaustion markers such as PD one.

Further we have observed effector cells and a diverse group of T cell memory subsets, including team memories.

<unk> sells.

Post treatment biopsies of retained the targeted HLA and mutation.

T cells grown from post treatment biopsies containing TCR T cells capable of responding to the appropriate driver mutation.

And therefore, our cells are making it to the tumor microenvironment and are functional.

This is what we were hoping to see and are thrilled to have these translational data with the sleeping beauty TCR T experience.

Okay.

We continue to develop novel strategies that generate IP for the company and build upon our early successes, while being supported by the translational assessments.

We routinely engage with our scientific advisory board chaired by Dr. Carl June leading experts at MD Anderson and a host of other advisors consultants and key opinion leaders on these topics who believe in the promise of our platform and support our Trailblazing.

Pat.

Given our demonstration of proof of concepts, we are marching towards commercialization of the first ever driver mutation TCR T cell therapy.

Now, let me turn the call over to Avi to highlight the tremendous progress. This team has been making in our manufacturing process Avi.

Thank you Joe.

As Kevin undue has discussed we continue to be very excited about the progress we are making in our TCR T Library Tyler.

Last year was a critical ear firms as we initiated.

Efforts to advance and accelerate our clinical program.

I'd like to highlight three major efforts.

First.

We have successfully manufactured at <unk> C patients product using three different <unk> in different tumor indications.

All the manufactured products had fantastic characteristics relating to liability PRT and PCR positivity.

Our manufacturing process works consistently for the PCR in our liability.

Irrespective of mutations at <unk>.

Second we have doubled our manufacturing capacity by implementing new mlps that allow for simultaneous production of multiple products in our DLP seats.

And third we continue to invest to improve process development.

Further refining our manufacturing platform.

In the fourth quarter of 2022.

We work to further optimize our manufacturing process.

IMD Amendment, you'll move from Chris to prior preserved health product.

Kyle enabled us to reduce the manufacturing process time from 32 to 2006 days, representing a 13% decrease.

I'm happy to report that we have already implemented the prior manufacturing process. This year.

This new process now provides us with greater flexibility.

Patient scheduling and treatment with the possibility to collect the patient if leases.

Earlier in their treatment journey.

We can then manufacture the drug product and carrier preserve it until the patient is ready for the infusion.

This is a good start and our long term goal is to further deal with the manufacturing time.

<unk> date.

I am so proud of our fully committed technical operations team and our Universal TCR manufacturing platform.

And I remain excited about the investment we are making in process development that will close the system automates the process.

And decrease the cost while preparing us for phase III.

I would now like to turn the call over to Mike long to review the financial results for the fourth quarter and full year Mike.

Thank you Avi allow me to review our financials for the three months ended December 31 2022.

For the fourth quarter of 2022, we reported a net loss of approximately $9 2 million.

<unk> net loss per share.

Compared to a net loss of approximately 11 $8 million or <unk> <unk> net loss per share at the same period in 2021.

Research and development expenses were approximately $5 6 million for the fourth quarter of 2022.

Compared to approximately $8 2 million for the fourth quarter of 2021, a decrease of 32%.

The decrease was primarily due to reduced program related costs and lower employee related and consulting expenses.

General and administrative expenses were approximately $2 9 million.

The fourth quarter of 2022.

<unk> to approximately $2 1 million.

Fourth quarter of 2021.

An increase of approximately $800000.

Primarily due to higher legal and accounting expenses.

Our operating cash burn for the fourth quarter of 2022.

It was approximately $7 $1 million.

<unk> to approximately $15 $5 million.

In the fourth quarter of 2021.

A decrease of approximately $8 million or 53%.

And now I will review the results for the full year ended December 31 2022.

For the year ended December 31 2022.

We reported a net loss of approximately $37 $7 million.

<unk> 17 net loss per share.

Compared to a net loss of approximately $78.

$8 million or 37% net loss per share for the year ended December 31, two.

2021.

An impressive year over year reduction of 52%.

Collaboration revenue of approximately $2 $9 million for the year ended December 31 2022.

Compared to approximately $400000 for the year ended December 31 2021.

The increase in collaboration revenue was primarily due to the achievement of sales based milestones of Darrin a person in Japan.

Which was largely offset by a one time research and development expense that I'll touch on shortly.

Research and development expenses were approximately $25 million for the year ended December 31st 2022.

Compared to approximately $49 $6 million.

Year ended December 31, 2021.

A decrease of 50%.

The decrease in research and development expenses was primarily.

Primarily due to reduced program related costs, and lower employee related and consulting expenses.

These decreases were partially offset by a one time $2 $5 million.

Milestone payments to MD Anderson for Darrin the Parsons.

For the year 2022.

General and administrative expenses were approximately $13 $1 million.

Compared to approximately $27 $6 million at the year ended December 31 2021.

Decreased 52%.

Decrease in general and administrative expenses was primarily due to lower employee related and professional services expenses.

As of December 31, 2022, <unk> had approximately $53 million in cash balances.

Which includes restricted cash of approximately $13 $9 million.

Serving as collateral for our outstanding debt.

Our operating cash burn for the year ended December 31 2022.

Approximately $29 2 million.

Compared to approximately 61 $5 million for the year ended December 31 2021.

A decrease of approximately $32 2 million or 52%.

Reflecting the full year impact of our cost reduction efforts and are focused on being good stewards of capital.

Based on our current operating plans, we expect our operating cash flows excluding debt service costs for 2023 to be between approximately $35 million to $40 million.

We expect to have sufficient cash resources to.

To fund research and development programs and operations into Q4 of 2023.

I wanted to highlight some of the work we're doing on the corporate side to further build upon our growing momentum.

<unk> is the leader in TCR T targeting driver mutations.

And as we look to further solidify the presence and raised our profile among the industry and media <unk>.

We recently engaged six degrees and established public relations firm specializing in and serving the biotech industry.

Our innovative technology and exciting clinical program remain on the cutting edge of research and the TCR and solid tumor space and we look forward to engaging with and building relationships with media audiences.

In addition to six degrees, we recently engaged additional Investor Relations resources.

Cultivate existing and develop new investor relationships.

I would now like to turn the call to Kevin Clark.

The thing remarks.

Thank you Mike.

As we look to the year ahead, we are dedicated to revolutionizing how solid tumors are being treated using our disruptive technology and the clinical manufacturing and research teams are committed to this objective.

Through the groundwork we have laid in our recent IND Amendment, where we added additional tcr's and transitioned to cryo preservation, we will greatly enhance patient throughput and treatment flexibility for our TCR T Library phase one two trial.

We remain confident the positive momentum we have built among patients and physicians will lead to even greater accomplishments as we expect to treat the remaining balance of patients in the phase one portion of our <unk> Library trial.

Share additional patient data.

And become phase II ready by the end of the year.

Looking beyond 2023, we envision being in the phase two stage of our existing IND.

Our A&D enables us to conduct multiple independent indication specific phase III trials simultaneously.

Oftentimes certain TCR is may be associated with specific cancer types.

For instance, non small cell lung cancer, commonly has egfr NK Ras mutations. So we may expect to enrol lung cancer patients with predominantly these TCR.

Colon cancer on the other hand is associated with <unk> and <unk> hundred 53, mutations, which could be a second phase III trial.

Overtime, we expect to initiate multiple phase II trials across several solid tumor indications as we believe our TCR T cell therapy is applicable across a broad range of solid tumor types.

To our knowledge, we are the only company taking those type of unique approach utilizing a TCR library targeting driver mutations against solid tumors.

As we continue to build a long term potential of TCR T cell therapies from a lot of US. We are actively developing next generation treatments, which hold the potential to deepen clinical responses through combination approaches and multiplexed TCR T cell therapies.

We are working to conduct translational assessments of treated patients to guide. These next gen approaches.

In the near term our membrane bound IL 15, TCR T cell therapy program is advancing towards an IND, which we anticipate submitting later this year.

We remain very optimistic about our Hunter TCR discovery platform, which is firing on all cylinders.

Expanding our library with proprietary TCR, we increase the addressable market and the number of patients that might benefit from our single or multiplex TCR T cell therapies.

It is truly astonishing what this platform is capable of and I look forward to what the future holds for Hunter.

In sum bolstered by the early and encouraging clinical results. We believe 2023 will prove to be an exciting year filled with promise and progress for <unk> as we advance our pipeline of innovative TCR therapies.

I want to express my deepest gratitude to our patients shareholders and employees for their support as we continue our mission to improve the lives of patients with solid tumors.

We will now open the call to questions Michelle.

Thank you as a reminder, please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment, while we compile the Q&A roster.

Our first question comes from the line of Cracker Agarwal with Cantor. Your line is open. Please go ahead.

Hi, Thanks for taking my questions and congrats on <unk>, So Kevin and team My first question.

Have there been additional patients dosed since patient number three in Q4, given Goldman progress the key focus for the company. So I appreciate any color here on <unk>.

Just to confirm that you have the green light from the FDA on those specific enhancements to the IMD and there are no further regulatory approvals required.

And I had a couple of follow ups.

Good morning, good to hear from you with regards to patient enrollment as we said we are very excited about the progress that is being made and the interest in this trial stemming from our first objective clinical response.

We are not going to report on a patient by patient basis, but we're going to look for the right venue to provide further updates on number of patients treated and the data associated with that but.

We're feeling quite confident based on the interest that has grown and the excitement around the response and the data that we've seen thus far out of the first three patients.

And with regards to the IND amendment in the fourth quarter, where we added two additional TCR and made <unk>.

Enhancements in the clinical trial designed to further facilitate and accelerate the enrollment there are no outstanding questions from the IND.

Which is really shown our unique trial design and the relationship with the agency. The fact that we have had multiple IND amendments with very minimal comments. So this is a unique trial design for sure. One that we believe is a differentiator for this company.

And quite a positive way and very excited about these driver mutations.

Benefiting cancer patients.

Got it thank you and the second question.

Opportunity for multiplex PCR was noted.

In the press release and the comments.

For patients who are matching more than <unk>. So maybe if you can expand on how this will be this could be implemented in the trial, whether it be a separate R&D.

If you can expand on the scientific rationale for multiplex PCR. Thank you.

Absolutely I'll, what drew comment on that.

Yes. Good morning. Thanks for the question, we're very excited about the potential for multiplex things a lot of it's TBD for now.

Excited to see that roughly one in five of our patients are matched one of the tcr's on our prescreening process have more than one match. So we do think that this is something that's feasible for us we think that through our sleeping beauty non viral system, we have a unique position to deliver more than one TCR that to your point about the <unk>.

<unk> now.

Going back to more than one target at a given time has more than one chance to affect.

Cancer.

So we're excited about that.

Okay.

And we're looking forward to bringing in the IL 15 as our.

In the second half of this year for an IMD amendment, maybe even potentially adding thats multiplexing in the long term.

Got it thank you.

Thank you and one moment for our next question.

Our next question comes from the line of Yale Jen with.

<unk>. Your line is open. Please go ahead.

Good morning.

Thanks for taking the questions.

My first question is.

In terms of what you characterized the TCR cell.

Certain characteristics.

Could you elaborate more in terms of whether those.

Aspect functional or and then I have a follow up as well.

Yes.

Good morning, Yale Yes, Great question. Thanks for the question, we're very excited by what we're seeing in the translational assessments.

And all and then specifically in regards to the cells that are persisting in the blood of our patients that have been treated are showing limited exhaustion, we're seeing T memory stem cells and then within the.

Tumor.

Biopsies that have happened post treatment, we've seen retention of the HLA and the mutation by the tumor and.

T cells that we've grown from those tumors of pills.

<unk> had TCR T cells those are empty functional against with driver mutations. So we're really encouraged that our cells are getting there.

It looks to be functional in a book to have limited exhaustion.

Okay, Great. That's very helpful. Maybe a follow up here, which is that.

Giving you guys start to progress a little bit more.

More patients.

And goes.

Are you guys thinking about any potential.

Business development opportunities and.

If so how would those things could be.

Defying all characterized that.

You will.

Still retaining a good portion of the assets in house.

Yes.

Sure Yeah, I'll like like all biotechs, we're always in active discussion with potential partners and business development opportunities. We're very excited about the interest that our TCR T platform targeting driver mutation has generated within.

Discussions with other folks and we're also very motivated by the potential of our Hunter platform. We really believe that is quite interesting and novel because we can develop.

Through this very high put throughput of single cell sequencing that drew as mentioned identify novel targets with proprietary.

So a very strong patent position both to bolster our own TCR library of <unk>, TB 53, and Egfr mutations, but at the same time Hunter identifies and has the capability of identifying other novel targets that would be of interest to potential partners.

<unk>.

We really have something special here and I believe.

Strongly that others see that very opportunity and potential as well.

Okay, Great. That's very very helpful. Maybe just squeezing one more.

Are you currently assume.

You have a certain level of debt.

Hollywood.

I'll start and managing debt and things.

Thanks, Thanks for the question.

As of year end, our outstanding debt balance was approximately $16 $7 million and we started principal repayments in September of 2022, and we expect to have that fully repaid by August of this year.

Okay, great. Thanks, a lot I really appreciate it.

Thank you and one moment for our next question.

Our next question comes from the line of Thomas Flaten with Lake Street. Your line is open. Please go ahead.

Good morning, Thanks for taking the questions. Kevin I was wondering if you could expand a little bit more on what qualifies you is phase II ready.

From the patient number any other things we should be looking for there.

Thomas Good morning, when we look towards what we wanted to accomplish in the phase one first and foremost it's about safety.

It's identifying a maximum tolerated dose and then it's also identifying the recommended phase II dose. So those are going to be the three items that we look for safety maximum tolerated dose recommended phase II dose and what's really nice is the station design allows us.

To accelerate achieving this objective and that is why our relatively low patient number in phase. One is all that is required to achieve these objectives. So as you may recall, Thomas we only had a dose one patient at the first dose level and.

And because of the favorable safety profile that we've seen we were able to accelerate that to the second dose level. So we're we're very excited we also have a higher dose level you may recall because of the safety profile should be rather favorable the targets. We're going after these driver mutations by definition are at the core of the heart of the <unk>.

Answer and do not appear on healthy tissue cells like some of our other TCR competitors that are targeting different targets. So we believe we have a superior target and our driver mutation with our TCR is going after these.

<unk> targets that are only in the cells of the cancer.

And therefore, we can use higher doses and we believe that will lead to greater efficacy.

That's great I appreciate the color.

<unk>.

The enrollment target that you have of 12 to 15 can we assume that that would be achievable with the current.

Stable of TCR cell. So the 12 or does that imply that youre going to have to add a few more during the year in order to hit that hit that enrollment goal.

Oh I would tell you we feel very confident with the number of patients that we're seeing in our pipeline.

Any additional tcr's are just building towards the future building towards our goal of multiplexing.

So.

As a reminder, anytime we add a TCR, we can absolutely use it to start treating patients right away.

We're very confident with what we see right now with the engagement of our <unk> at MD Anderson that with our phase one we will be successful in treating the required number of patients.

And we will do so in a very expeditious manner, and we have our own manufacturing capacity with our own employees being able to execute on that being able to manufacture multiple products at the same time and what's nice with this as well with the cryopreservation Thomas as we're able to start manufacturing now.

Earlier in the patient's journey. So we can manufacture products it can be waiting in the freezer for win Unfortunately, if a treatment fails a patient. We can then take that product that we made early in 2023 and infuse that patient when they are ready. So it's really a very important enhancement that we have.

We believe we're going to end up with more fit sales by taking the <unk> earlier in the patient's journey, we can manufacture that product cryo preserve the cells and then be ready for that patient when unfortunately, if theyre failure.

Our current therapy fails them.

Excellent and then just one final one just to segue off of manufacturing I believe the Avi said during the call that the goal was to reduce the manufacturing.

Timeline from 26% to 15 days I was just wondering if you could comment on.

Whats required to hit that goal and over what timeframe, we might expect to see you guys kind of whittle that timing there.

Sure.

And I do think albeit some of the aspects the kind of three aspects within.

That we're working on in addition to reducing costs, but I'll be one should go ahead and talk to Tom Mr. Tom So.

We are investing in multi prong manufacturing strategy to really cut down our manufacturing time VR constantly investing in process development.

Flooding the system, providing the automation in our manufacturing platform and by doing so we are very confident that we'll be able to reduce the manufacturing time too.

The 15 days as we reached to the commercialization stage.

Okay. Thanks for taking the question Oh, sorry, sorry, sorry go ahead.

Yes.

And just wanted to highlight that the how much cryopreservation has provided us the power of flexibility by utilizing that type of duration will be able to manufacture the better product and.

Overall efficacy.

But what I'll quality, yes.

Yes, Thomas just important I think to highlight here is one of the things that cryopreservation does when fresh sales you had a patient that was ready to be infused immediately so timing really mattered right now the fact that we're able to manufacturer of the cells ahead of time in this phase one portion of the trial with the cryo preservation whether.

It's 2006 days or 15 days, it's still earlier in the patient's journey, where they are not quite ready to be infused yet. So the time is less relevant at this stage. So we have the time to be able by the time as Avi said when we hit commercial it'll be reduced that will be very important but as of right now the timeframe.

Taking the manufacturing the cells is less relevant because the cells will be frozen down and be available immediately when the patient is ready.

Excellent appreciate it thank you guys.

Thank you Thomas.

Thank you and this does conclude today's question and answer session, Ladies and gentlemen. This also does conclude today's conference call. Thank you for participating you may now disconnect everyone have a great day.

The conference will begin shortly to raise and lower Johan during Q&A you can dial one one.

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[music].

Q4 2022 Alaunos Therapeutics Inc Earnings Call

Demo

Alaunos

Earnings

Q4 2022 Alaunos Therapeutics Inc Earnings Call

TCRT

Tuesday, March 7th, 2023 at 1:30 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

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