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Healthcare - Biotechnology - NASDAQ - FR
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$ 189 M
Market Cap
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q4
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Operator

Greetings and welcome to the Cellectis Fourth Quarter and Full Year 2015 Financial Results Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Simon Harnest, Vice President of Corporate Strategy and Finance. Please go ahead, sir..

Simon Harnest

Thank you. Thanks everyone and welcome to the Cellectis fourth quarter and yearend 2015 financial results conference call. Joining me on the call today with prepared remarks are André Choulika, our Chairman and Chief Executive Officer; and Eric Dutang our Chief Financial Officer.

Yesterday evening, Cellectis issued a press release reporting our financial results for the fourth quarter and year ended December 31, 2015. This press release is available on our website at www.cellectis.com. As a remainder, we will make forward-looking statements regarding financial outlook in addition to regulatory and product development plans.

These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our more recent Form 10-K on file with the SEC. I would now like to turn the call over to André..

André Choulika

Thank you very much, Simon. Good morning, everyone. Thank you for joining us today as we discuss recent update and reviews for year 2015. So for 16 years, Cellectis has pioneered the field of gene editing and we have been developing in this arena since then.

We have been working on number of gene editing technologies such as meganucleases which are homing endonucleases, CRISPR, Mega-TALs and we finally selected TALEN as the best gene-editing tool currently available. TALEN allowed us to edit genes with like any gene with high precision insertion, deletion, repair and replacement of DNA sequences.

We are leveraging TALEN transformative potentials in two ways. First, as you’re probably most familiar with, through cell engineering platform to deliver therapeutics; second, our wholly-owned subsidiary Calyxt has built a plant engineering platform to delivery healthier food to consumers.

At this time, I would like to review some of the 2016 highlights and then I will turn the call over to our newly appointed Chief Financial Officer, Eric Dutang, who will review the financial results. So, in 2015, Cellectis made significant strides toward achieving our underlying vision, realizing the therapeutic potential of gene-editing.

This progress ultimately culminated in the first-in-man compassionate use of UCART19, the first off-the-shelf CART ever used in human. In June, under a special license granted to the Great Ormond Street Hospital in London, UCART19 was administrated to an infant with an aggressive form of ALL who had exhausted all available treatment option.

The poster detailing GOSH clinical experience in this single patient was presented at the 2015 ASH Annual Meeting in December. In November 2015, pursuant to an amendment to the collaboration agreement we signed with Servier in February 2014, Servier exercised its license option on UCART19 ahead of schedule.

As a result of this option exercise, Servier entered into a license and collaboration agreement with Pfizer. In consideration for the execution of this amendment, Cellectis received from Servier an upfront payment of $38.5 million.

In addition, we may receive up to $974 million in milestones and option exercise payment from Servier as well as a high single-digit royalty on potential sale in addition to our R&D cost reimbursement. We’re truly proud of the great teamwork between Servier and Pfizer and us, leading us to a seamless transition of responsibility regarding UCART19.

In December, Cellectis submitted a clinical trial application, a CTA to the Medicine Health & Healthcare Products Regulatory Agency, the MHRA, requesting an approval to initiate Phase 1 clinical trial of UCART19 in leukemia in the United Kingdom. Following this option exercise, our focus has turned to the development of a wholly owned program.

The first product candidate UCART123 is a CD123 targeted off-the-shelf CAR T therapeutic candidate for the treatment of AML as well as an orphan type of cancer, BPDCN. Last year, we were thrilled to sign a series of clinical collaborations with world-class research institutions.

For UCART123, Weill Cornell Medical College under the leadership of Professor Gail Roboz will take in charge a clinical trial for AML. BPDCN is one of the targets we partnered with MD Anderson Cancer Center under the leadership of Professor Robert Orlowski.

It is truly an honor to work with these principal investigators in these institutions, the expertise in patient care and the leadership in translational medicine are guiding the development of our extended clinical trial.

In close collaboration with these two institutions, Cellectis is developing new UCART123 in order to meet the need of patient and the acceptability to the drug. We expect to file investigational new drug INDs applications with the FDA by the end of 2016 to begin Phase 1 clinical trial for UCART123.

CAR T-cell therapeutics has demonstrated a new level of efficacy in certain type of hematological malignancies. Gene-editing allows us to develop CAR T-cell product with the potential to treat an expanded universe of patients, including patients that were previously not eligible for CART therapy.

We are very enthusiastic about our pipeline of two CAR T programs to meet the need of global population to be compatible with different combination therapies. UCARTCS1 is being developed in multiple myeloma, and we intend to start manufacturing of this product in the second half of 2016.

UCART38 is being developed in multiple myeloma, T-cell ALL and mantle cell lymphoma. UCART22 is being developed in ALL and refractory relapse CD19 negative ALL patients. As we have said before, one of the most important components of CART therapeutics is manufacturing.

Last year, we reached a major milestone with the implementation of our manufacturing process for UCART19 in JMP condition. We are not translating our knowledge gained from UCART19 to the manufacturing of UCART123 in clinical batches during the first half of 2016. In March 2016, we opened our U.S.

research facility in the Alexandria Center for Life Science center in New York, home to our R&D lab and offices. Our program advances, our team has grown to include several new key hire as well as expanded research team. So, in March 2016, Arjan Roozen, joined our management team as Vice President of Manufacturing.

He has done tremendous job in building out our GMP manufacturing process and capabilities. Before joining Cellectis, Arjan headed the sale manufacturing at Pharmacell and previously also at Crucell and number of other pharma companies. In January 2016, we announced that Dr.

Loan Hoang-Sayag joined Cellectis as Chief Medical Officer, building our clinical capability gain to key priorities. I’m honored to have Dr. Hoang-Sayag join our team. Dr. Hoang-Sayag joined from Quintiles Translational, where she was more recently Senior Director of Medical Science.

She will work closely with our clinical collaborators overseeing Cellectis transition into clinical stage company. In February 2016, we appointed Eric Dutang to the position of Chief Financial Officer, Eric previously served as Deputy Chief Financial Officer and we welcome him to his new role. Eric was formerly with KPMG.

Now, I’d like speak about Calyxt, our wholly own subsidiary focus on plant sciences. I’m extremely excited by the progress this company has made in a very period of time, based on the power of -- and precision of TALEN gene-editing platform. Calyxt is a Minnesota-based company that has Prof. Dan Voytas as a Chief Scientific Officer.

Dan is one of the key investor of TALEN technology together with Feng Zhang, our Chief Operating Officer and he’s a world key opinion leader in the field of plant biotechnology. The growing Calyxt team is developing new crop and seeds with clear health benefit to consumer as well as advantages to farmer.

From mid-2014 and throughout 2015, the USDA granted non-regulated status to four of our lead crop development programs, one potato, two soybean breeds, and lastly the wheat. The status was granted on the basis that TALEN gene-editing disable gene but do not insert genes or any foreign DNA in the organs of the plants.

In practical term, the power of gene technology and knowhow translate into the path to market and development costs that are a fraction of traditional GMO [ph] approaches. From their D up to the commercialization, we can develop a new crop within six years for about $6 million.

Calyxt elite program is a non-transgenic variety of soybean that has the highest oleic oil content in the industry as well as low linolineic oil content. When user find, our soybean oil does not create trans fat. This program supports the recent U.S. government guidance to get rid of all trans fat by 2018 from the food chain.

Calyxt variety has a fatty acid profile similar olive oil. Our Calyxt soybeans are already in the field, we have agreement in place with farmers, both in the U.S. as well as in Argentina where we also received non-regulated status for our crops. The two geographic locations enable two harvests per year, so two harvests per year.

In fall 2015, we harvested over 1 ton of soybean in the U.S. which we shipped to Argentina. We expect a 30 fold [ph] increase by spring 2016. We anticipate this amplification to continue up to commercial launch in 2018. We also have a non-transgenic improved quality in potato.

In Calyxt potato the enzyme responsible for cold induced degradation of sugar in the tuber is inactivated. This reduces the sugar conversion of cold-stored potato which could otherwise lead to the creation of acrylamide, a carcinogen when fried. Our cold-storable potatoes are already in the field in the U.S.

and we anticipate the commercial launch by 2019. This spring, we anticipate entering in the field of our first wheat product, powdery mildew-resistant wheat. It should suppress the need of using fungicides and reduce pollution in nature.

Early stage programs include lower saturated fat canola oil and a gluten reduced wheat and high starch wheat for lower sugar intake and a better digestibility.

In addition to consumer oriented program, Calyxt is developing a series of farmer oriented traits such as non-transgenic glyphosate resistant, high yield production, [Indiscernible] pest resistant such as nematode resistant trade as well as nitrogen use deficiency and drought resistance.

In December 2015, Calyxt signed a research collaboration agreement with Plant Bioscience Limited or PBL. This collaboration includes the option to exceed the license to certain new crop developed with gene-editing by the Institute of Genetics and Developmental Biology, so the IGDB of the Chinese Academy of Science in Beijing.

Gene-edited wheat, rice and corn with new trait are currently at the very stage of development. Gene-editing utilized in this research collaboration to improve the quality and increasing yield. To accommodate Calyxt rapid expansion, we’re currently building an expanded facility. The Calyxt team is growing and currently has 22 employees.

We will be opportunistic about building our management team with the focus on key hires. We will keep our focus on getting better crops to consumers and access to better organic germplasm under market. In 2015, pursuant to our plan Cellectis made a $40 million investment in Calyxt.

As our progress continues to accelerate, we remain opportunistic about the future strategic and financing options. Cellectis today is well capitalized to pursue recognition on all fronts. In March 2015, we raised $228 million in gross proceeds in an IPO in the U.S. on the NASDAQ.

The proceeds from this listing as well as our partnership revenue stream put Cellectis in the strong financial position to fund our operations through 2018 with the current cash position over to $350 million. With that, I’ll turn it over to Eric for a discussion on our financial results..

Eric Dutang

Thank you, André. As at December 31, 2015, Cellectis had €314.2 million in cash and cash equivalents compared to €112.3 million as of December 31, 2014. This increase of €201.9 million was primarily attributable to $228 million of gross proceeds from the U.S.

IPO in March 2015 and €42.8 million of proceeds including tax received from Servier in connection with the amendment signed in November 2015. This was partly offset by offset by €39.5 million of net cash flows used in operating activities and €7 million used in investigating activities during the 12 months of 2015.

Cellectis expects that its balance of cash, cash equivalents and investment would be sufficient to fund the Company operations until of 2018. Total revenues and other income were €29.2 million for Q4 2015 and primarily comprised €26.8 million of collaboration revenues.

For the 12 months period, total revenues and other income were €56.4 million an increase of €27.2 million compared to the full year 2014 and primarily comprised €48.3 million of collaboration revenues.

Total operating expenses and other operating income were €28 million for Q4 2015 and €84.3 million for the 12 months, representing an increase of €56.3 million over the full year 2014 witnessing the total investment strategy of the Company.

These operating expenses include non-cash stock-based compensation expense of €12.6 million for Q4 and €30.1 million in the full year 2015 and cash social charges on stock-based compensation of €12.2 million in 2015.

Adjusted net income attributable to shareholders of Cellectis for the Q4 2015, which excludes the non-cash stock-based compensation expense of €12.6 million, was €20.9 million, or €0.59 per share on both a basic and a diluted basis.

For the full year 2015, adjusted net income attributable to shareholders of Cellectis which excludes the non-cash stock-based compensation expense of €30.1 million was €9.6 million or €0.28 per share on the basis and diluted basis compared to €9 million in 2014, notwithstanding total increase in operating expenditures.

Our objective is to grow the Company at high speed while maintaining the Company well-financed with a long [ph] cash horizon. I know turn the presentation back over to André for closing remarks..

André Choulika

Thanks, Eric. Well, with this exceptional P&L for 2015 and the IPO on the NASDAQ, Cellectis has today a strong balance sheet and we remain well-positioned to continue our progress into the years ahead. I want to reiterate what a remarkable year 2015 was for Cellectis and for the field of gene-editing altogether.

I believe I speak for the other leaders in outfield when I say that we look forward to building on this momentum to create advancement in the field of medicine that would create a real difference to patients and their families.

The translation of many years of science into potential product that was used for the first time in 2015 to treat the patient is a milestone that will continue to inspire everything that we work for at Cellectis. I look forward to updating you on our progress over the next, the coming months.

I want to thank you very much for your attention and like to open the call to questions. Joining me for the Q&A will be Eric Dutang, our CFO, Dan Voytas our Chief Scientific Officer of Calyxt. Operator, please go ahead..

Operator

[Operator Instructions] Our first question today is coming from Colin Bristow of Bank of America. Please proceed with your question..

Unidentified Analyst

This is Vernon [ph] for Colin. Thanks for taking questions.

First on the status of the infant, which was treated through the compassionate use program; can you provide an update on that? And then could you walk us through the key update data readout we should expect this year? And then lastly, with the CTA application filed, what is the timeline for approval and trial start, and are there any other gating factors?.

André Choulika

Well, actually you one thing that should be clear is that the UCART19 clinical development is within the hands of Servier.

One thing that I can definitely say is the patient that has been disclosed at ASH is to my -- to our knowledge is still in complete information today, so we’re like those in June and like up to the March, which is significant I would say. So, we’re still in CR.

And for the start of the Phase 1, actually I cannot disclose this because I would think that like it’s more on Servier side to speak about that..

Unidentified Analyst

Okay.

And then any update to data readout this year?.

André Choulika

Well, we are extremely eager to communicate on data for 2016. We know that this has to be discussed with our partners Servier and Pfizer. Nevertheless, we’d be looking at, at least producing certain intermediary data during 2016. And this is something, Cellectis would be extremely positive on moving hard..

Unidentified Analyst

Okay, great. Thank you..

André Choulika

It will have to be discussed; potentially, we’d make our best efforts to have this information disclosed..

Unidentified Analyst

Okay.

And then I guess lastly just on, 123 and CS1, could you just describe the role of CELLforCURE and the manufacturing processes and what else needs to be put in place this year?.

André Choulika

Yes, we started manufacturing of UCART123 now, it’s like the older process of transferring the technology to our CMO under process. This should be I hope completed by the second half. We’re doing two indications which is like AML and BPDCN. And BPDCN we would like to do pivotal trial because there is like finish indication.

Therefore, it would require to produce a lot of doses. So, it will be a lot process to do all this. We’ll have to go through series of different batches to produce all the vials to do this pretty large scale clinical trial that we’re envisaging for this.

We hope that AML IND will be filed this year; for BPDCN, we’ll try to target 2016 but it could potentially the 2017. CS1, the product will start manufacturing, probably during second half of 2016. So, we’re preparing the process of transfer but we’re not there yet..

Operator

Thank you. Our next question is coming from Chris Marai from Oppenheimer. Please proceed with your question..

Chris Marai

Hi. Good morning and thanks for taking the questions. Congrats on the quarter and the year. First, really just on manufacturing; you touched upon that again.

What’s the biggest gating factor there; is it just that you haven’t -- getting that out scaled up for the first time and it’s going to take you longer for other technical concerns in consideration that you need to solve prior to getting material ready for your upcoming potential trials? And then secondly with respect to your cash run rate guidance, I was wondering if that includes a potential spinout of the plant sciences division? Thank you..

André Choulika

So, answer the first question, second, and then the second question first. So, no, it does not include any potential new spinout of Calyxt or anything like this. It’s the execution of very aggressive business plan and roadmap for the Company without any new financing through 2018; this is it.

So, it’s up as we would say on the Company, so the run rate for the Company. Coming back to the first question, the manufacturing, the question was the gating factor is -- we don’t have any gating factor I think -- that carefully manufacturing runs well.

We would like to raise of course the yield but the idea is to manufacture products that are GMP and that are QC, QA that are totally standardized. And this requires a lot of volume at the end.

It doesn’t differ that much of producing for example monoclonal antibodies or others, it’s the new type of product; it’s a totally new kind of product that we’re producing. It’s primarily cells that are gene-edited and that -- they’re like also gene transfer, which is very sophisticated product.

We’ve been very successful running series of batches on UCART19. We would like to raise the yields at the end and reduce the cost of goods as much as possible, but one thing that we’re putting a lot of emphasis is reproducibility and quality of the product.

And gating factor that we had the start of this which was essentially the reproducibility has been also more than a year now.

And the Company would like to translate all the knowledge that has been developed on CD -- like UCART19 in UCART123 and CS1 and will probably do during 2016 or maybe during 2017, an update on the progress that has been done in the space because the Company has evolved since the first batch is made on UCART19 and I think all-in all it has been built and company ability to produce high quality product has been spectacular up to now..

Chris Marai

Okay, great. And then, you mentioned the yields, to follow up on that, I mean with respect to cost of goods and I guess previous sort of guidance within that range.

Are your yields sufficient to get you to COGS in the prior guidance range or do you still need no work there?.

André Choulika

The prior guidance range that we had for like the first batches for like the Phase 1 for UCART19 is approximately 15,000 the dose. Our goal is to keep the same target, which is less than $5,000 per dose. We’re not there yet. But still we think that this is an achievable target by the end because we’re processing only one quarter of [indiscernible].

So, we can full [indiscernible] and with the same cost at the end. The second thing that we’re working on is the filtration because there is a lot of retention of product on the column and we would like to have that air filtration process which would also increase the yield. So, that’s second access of work that we’re developing on.

And the third access is of course automating the full finish and freeze, which is a limiting factor. And we think that all these problems or these technical issues that are in the current development of the product would help us probably to achieve our goals in the coming future.

But we think that the current pricing that we get for the COGS on differed vials that we have pretty already addressing compared to our competition..

Chris Marai

And one more if may just on the additional knockouts that you might be able include some of the upcoming products.

How far are you along on ramping that, can you incorporate at sort of reasonable yields, say yields that get you that 15,000 per dose? And then lastly, would we expect any updates on preclinical data at AACR, or ASH or ASCO later this year? Thanks..

André Choulika

Yes, Cellectis will present series of clinical data at the coming conferences. And I strongly invite you to come and look at them because I think it will be interesting for all of you to be informed by the factors that we’ve been having on these products.

The knockouts that we have, we think that with current electroporation technology that we’ve developing for the past five years, PulseAgile, Cellectis has reached a very high yield of knockouts. So, we can do single, double, triple, can triple knockouts in the single cell. We’re working on the process development to improve this efficiency.

And also on the machine PulseAgile itself which we own, we think that this is a very strong point on the Company in owing our own electroporation technology. And developing on the technology allowed us to have like large volume of electroporation chamber which allow us to this 1 billion cell electroporation.

The two things that are very important involved in this tail and combined with PulseAgile is that you can have over 90% of cells that are transduced with PulseAgile. The survival of the post electroporation is over 90% and the help of the cells is really great for the quality of the cells that come out.

And the knockout efficiency in manufacturing, I don’t mean this is like a research result that would not be reproducible, it means vials that can expand it, can survive post electroporation and then can be used as a product that can be [indiscernible] for example for a double knockout like around like 60%, 70% or close to over 50% for triple knockout for UCART19 which is a spectacular result, considering the quality of the product that you get at the end.

Electroporation gets you a high quality product that we have high quality product and also as a factor of reduction of cost at the end..

Chris Marai

Just to clarify on the first point, is it clinical data would be expected later this year or did you mean preclinical data later this year at….

André Choulika

Preclinical..

Chris Marai

Preclinical, okay, I missed that. Thank you..

Operator

Thank you. Our next question is coming from Biren Amin from Jefferies. Please proceed with your question..

Biren Amin

Maybe on UCART19, can you tell us if there are any new patients were treated under the compassionate use?.

André Choulika

It’s like question I cannot answer this question. Sorry about that..

Biren Amin

Okay. André, you’ve got a couple of titles that have been disclosed for AACR, one disclosing a non-lethal switch poster.

Are any of the current programs like UCART123 or CS1 are incorporating to switch?.

André Choulika

Not yet, no. This is like a new type of technology that is currently coming to us on innovation before it goes into production, as a second step though, so not 2016. So, the switch is very interesting because what we would like to do is harness the expansion and the compartment where the CART must be active.

And what we would like to have is something that is very responsive and immediate response. For example, if the CAR can be activated at the DNA level, you have a lag of time where the DNA have to express RNA, the RNA have to be translated in protein and the protein is expressed on the surface of the cell like say CAR for example.

And if you want to stop the expression, so you can shut down the DNA and the expression of the protein has to disappear on the surface of the cell. It’s like braking in the CAR and have long brake, so you need miles to stop the CAR.

In this case, the stop occurs immediately at the level of the protein on the surface of the cell where you have the CAR that is switched off with the small molecule and you can add the small molecule to turn the CAR on within minutes. And then the CAR is on while the small molecule is here.

When you clear out the small molecule with short half time, you can get the T cells that are totally shutdown very rapidly.

So, it helps to monitor the space for example where the CAR key should be active for example, the blood and the if the T cell gets out in certain compartment where the T cells should not be active, for example crossing the blood-brain barrier than the T cell would be shut down because of small molecule won’t cross the blood-brain barrier at the same time.

And so you would reduce like toxicity in such cases. It’s a very important type of switch that we have developed here and we have like a second version that is the opposite of this that will come up also. So, it’s something that will be key in the development of our drug in certain indication where you have to monitor exactly the T cell expansion.

And don’t lose your T cells if you want to stop the therapy itself. So, you can keep the T cell present and the T cell won’t be active but can resume activity once you add again the small molecule. This is a very important point. You don’t have to readout the patient with T cell but can only readout the patient with the small molecule.

It’s also one thing that is important about this T cell is that it’s this CAR is a multi-chain CAR which is our new version of CAR that we think is extremely powerful because it allows to work in certain conditions where single chain CAR cannot work. And these developments are going to come not in 2016, in the coming years after.

But we’re very bullish on this product as we’re bullish on UCART19 and the results that we could produce like this year..

Biren Amin

And then, maybe if I could ask a question on ag business. I think you said the commercial launch for soybean is in 2018.

How do you plan to compete with I guess 90% of the soybean market is roundup ready whereas your seeds would not be roundup ready?.

André Choulika

First of all, we’re working on a roundup ready resistant that is non-GMO that we think is very powerful but the second thing that we have is that the strategy of Calyxt is to launch our crop in niche markets.

Here the launch will occur in the non-transgenic non-GMO space and also where competition has agreed that don’t grow in the same geographic region as ours. So, the strategy of Calyxt is having niche launches first, it’s like similar to a niche market for a drug.

And then, if the thing works well, then you can outbreed the soybean and expand it after this with high yield or maybe glyphosate resistant or other type of resistant that Calyxt is working currently and expand this product into the commodity markets, mean largest market.

Nevertheless, already in the niche market like the soybean markets, like $40 billion market and like we are at 0.5% of the market, which is expected to be our first market line for our soybean, which is definitely piece of the niche. It’s already pretty aggressive on our side..

Biren Amin

Thank you..

André Choulika

So, launch the niche and expand after this in commodity straight to the success of the product as I said..

Operator

Thank you. Our next question comes from Jerry Yang from Piper Jaffray. Please proceed with your question..

Jerry Yang

This is Jerry for Josh. Thank you for taking our questions. We’re just wondering what the current soybean yield for your product and then over the next 2 or 3 years how do you plan to expand and also scale up your production? Thank you..

André Choulika

Okay. So, the current yield of our soybean is approximately 3 tons per hector, which is definitely in the mean of like elite germplasm. Of course you can go up to like 5.5 tons or 6 ton per hector in very specific regions and for specific year. But this is something like more the standard is around 3 tons. Initially we initiated the trial with Bert.

We were very positively impressed by the yield that Bert produced, which is around 3 tons per hector. We’re currently using of course like south of Argentina farmers and in Minnesota, Wisconsin and North Dakota famers and expanding by doing like transportation of soybean between south and north and north and south.

So, we have two seasons a year and each new plantation is multiplication by 30 to 45. Maybe Dan, you want to say some. Actually I forgot you, like are under cover..

Dan Voytas

Yes. And then, as André said, we’re happy with the yields of the soybean variety that we developed to-date, and then remain to continue to move our traits into more elite germplasm as we sort of stage the product launch..

Operator

Thank you. Our next question today is coming from the line of Peter Lawson from SunTrust Robinson Humphrey. Please proceed with your question..

Peter Lawson

André, I wonder if you could just talk about which candidate you think you could see Phase 1 data for first if it’s 123 or CS1?.

André Choulika

123, of course like UCART123 will be the first CART to produce data for our pipeline, which is course UCART19..

Peter Lawson

And do you think that’s most an ASH event or an ASCO event?.

André Choulika

I don’t know, it’s difficult to say..

Peter Lawson

Do you think we could see….

André Choulika

But….

Peter Lawson

Please go head..

André Choulika

It will be -- wait a second. UCART19 maybe 2016, but UCART123 is like 2017..

Peter Lawson

And do you think we could see data at ASCO for -- or any data ASCO for Cellectis?.

André Choulika

We will present preclinical data for UCART not patient data..

Peter Lawson

And then just as we think about cash guidance, does that also include any milestones?.

André Choulika

So, UCART123 and UCARTCS1, there is of course no milestones, no royalty, nothing; it’s only self-owned CARTs, it means these CARTs belong 100% to Cellectis and there is no streams attached to these.

We intend to push forward these products as far as possible in our pipeline to reach the market, if we could finance on this product up to the market, but this definitely the goal that we have set ahead of us. Therefore, Pfizer and Servier, we have no access to these products today..

Peter Lawson

And then, the small molecules switch; is that a dose dependent effect; can that be turned down gradually?.

André Choulika

Yes, it is totally dose dependent; it’s not binary effect. So, you can definitely tune up the expansion or reduce the expansion according to the dose, which is a very, very powerful feature of this technology..

Peter Lawson

Great.

And then on the manufacturing side, is there any way you can talk about how much you produced, firstly, UCART19 versus UCART123?.

André Choulika

So for UCART123, we’re not currently disclosing any data on the manufacturing, but we’re extremely positive on the current process that we have. One thing is that you have to look at this product that is described -- that you describe it as maybe more basic than UCART19 because it has only one knockout compared to UCART19 that has triple knockout.

One knockout, which is a feature I was talking compared to UCART19 that has triple knockout for two areas for CD52, and one for T-Cell. CD52 is to give to T-Cell resistant to alemtuzumab.

We have a second version of UCART123 that should have dCK inhibition [ph] that should be similar to UCART19, but this is probably a version to that we’re pushing forward. Currently the yields that we have with UCART19 is within hundreds of doses per batch. We are not reaching the thousand per batch, per batch, now we’ve done 6 batches.

But you have to expect that there is probably a big chunk of it like means 10s over like 50 doses that go for the QT, QA, stability effect and so on and all the backup that you should get. So, there should be reduced of old vials that you use for QT again. Currently our goal is to reach at least over thousand-dose per batch..

Peter Lawson

And then just a minor question for Eric, just on the other operating expense line item in the P&L, it’s like €2.8 million expense. What’s in there, because it has jumped up quarter-over-quarter? I just wondered what’s in that component..

Eric Dutang

So, in this caption you have increase in provisions and several things. But it’s mainly these kind of expenses that you have in this caption..

Peter Lawson

But it’s not one thing that’s jumped up quarter-over-quarter..

Eric Dutang

No, I think it was only Q4, but for the rest of the year you don’t have any major increase in this caption..

Operator

Thank you. We have reached end of our question-and-answer session. I’d like to turn the floor back over to management for any further or closing comments..

Simon Harnest

Thank you everyone for participating. We appreciate your continued interest in Cellectis. And we look forward to updating you with more good news over the rest of this year. Thank you..

Operator

Thank you. That does conclude today’s teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today..

ALL TRANSCRIPTS
2024 Q-4 Q-3 Q-1
2023 Q-3 Q-2 Q-1
2022 Q-4 Q-3 Q-2 Q-1
2021 Q-4 Q-3 Q-2
2020 Q-4 Q-3 Q-2 Q-1
2019 Q-4
2017 Q-4 Q-3
2015 Q-4