Q3 2022 Gamida Cell Ltd Earnings Call

November 14, 2022

The conference will begin shortly to raise your hand during Q&A you can dial star one one.

[music].

Ladies and gentlemen, thank you for standing by and welcome to <unk> Conference call for the third quarter 2022 financial results. My name is Shannon and I'll be your operator for todays call. Please be advised that this call is being recorded at the meter sales requests.

Now I would like to introduce your host for today's conference.

Heather the Vecchia meter sales director of Investor Relations and corporate Communications. Please go ahead.

Thank you Shannon and good morning, everyone welcome to today's call during which we will provide an update on the company and review our financial results for the third quarter of 2022.

Earlier. This morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www Dot can meet its all dotcom.

Here with me on our call today are Abbey Jenkins, President and Chief Executive Officer, Mohit, <unk>, Chief Medical Officer, and Scientific Officer, Michel Corbin, Chief operating Officer, and Chief Commercial Officer, and Shai language Chief Financial Officer.

During this call we may make forward looking statements about our future expectations and plans, including with respect to the timing of initiation and progress on <unk> and data reported from the preclinical and clinical trials of our product candidates regulatory filings, including the review of the BLA for IDE cel by the FDA.

One patient planning efforts, the potential lifesaving Archer and therapeutic and commercial potential of <unk> product candidates, including GDA 201, and I'm Gonna do yourself.

And our expectations regarding our projected cash cash equivalents and investments to be used for operating activities.

Our actual results may differ materially from what we project today due to a number of important factors.

Putting the impacts of COVID-19 pandemic on our operations the scope progress and expansion of our clinical trials and impacts to the cost thereof, clinical scientific regulatory and technical development those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics.

And in the endeavor of building a business around such product candidates.

Well is those considerations described in the risk factors section of our most recent quarterly report on Form 10-Q, and other filings that we make with the SEC from time to time.

These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information or future events, except as required by applicable law.

Now I'd like to turn the call over to our recently appointed President and CEO Abbey Jenkins.

Thank you Heather and thanks to everyone for joining us this morning.

It is an exhilarating time forgive me to sell as we marked another quarter of meaningful progress and prepare to shift from clinical to commercial stage with a potential approval of our transformative stem cell therapy candidate Army do yourself.

I would like to start off by saying how excited I am to speak with everyone. Today on my first earnings call as <unk>, President and CEO a role that I assumed in September .

I was drawn to get me to sell for three reasons the mission the science and the team.

I've worked to bring innovative therapies with the promise of addressing diseases of high unmet need for over 25 years well many of those products made an impact through treatment for disease prevention, none at the potential to be truly curative.

Our mission of developing curative therapies for people with cancer or other serious diseases is incredibly inspiring and is made possible because of our remarkable science.

Our NAV technology, both increases the number.

Stem cells and immune cells and enhances their functionality, enabling us to create potentially transformative cell therapies that go beyond what is possible with the existing approaches.

Now is the power behind Amit <unk>, our lead product candidate candidate, which has breakthrough status and is currently under priority review with the FDA with a <unk> date of January 32023.

I mean, <unk> has the potential to transform the treatment landscape for patients in need of a stem cell transplant.

Our phase III clinical data demonstrate <unk> significantly reduced the time to neutrophil <unk> from 'twenty, two to 12 days versus standard cord blood transplant.

Neutrophil <unk> is a key predictor of patient outcomes.

Earlier. This month, we further showed that in real World data Army do the self produced the shortest median time for neutrophil <unk> of any matter poetic stem cell transplant option, including that of a match related donor source.

I mean do they sell achieve neutrophil <unk> in 10 days as compared with 15 to 20 days for other donor sources.

We believe that army <unk> offers a meaningful new transplant option at the data support the neutrophil and grassman occurs rapidly and it's durable maintaining an effect for up to 10 years based on clinical studies in.

In addition army <unk> reduces total days hospitalized post transplant, which improves outcomes, while reducing cost to the health care system.

If approved <unk> will be the first FDA approved allogeneic hematopoietic stem cell therapy to address an expanding unmet need for patients with blood cancers and need of a stem cell transplant.

Nam is also the power behind our pipeline of allogeneic NK cell therapies, including our clinical stage therapy GDA 201.

Rohit will be going into more details in this regard following my remarks.

Speaking of and bringing us to the third reason I was trying to get me to sell the team.

The advancement of our NAV enabled cell therapies as possible as a result of our talented team of experienced leaders like Rohit and Michelle who have successfully developed and launched multiple life enhancing treatments and hematology and oncology including cell therapies.

We have many experienced and talented team members across can meet yourself, discovering developing and preparing to deliver our advanced cell therapies to patients in need.

Let's turn now to Q3 results.

This was an important quarter marked by continued progress towards larger inflection point.

Our BLA for <unk> was accepted by the FDA granted priority review.

<unk>, we progressed our phase one two clinical study evaluating a cryo preserved readily available formulation of GDA 201, our lead nano enabled NK cell therapy for the treatment of Follicular and diffuse large b cell lymphoma.

GDA 201 holds tremendous promise and we look forward to its continued progression in the clinic.

Beyond GDA 201, we continue to be excited by our NK pipeline of cell therapy candidates and we believe our NAND technology increases targeting potency and persistence of a broad range of innate and adaptive cell types, including NK cells.

However, we are going to hold on selecting the next IND candidate from the NK pipeline at this time to both prioritize resources to the commercialization of <unk> and advancement of GDA 201, as well as enable development activities on these candidates further progress.

Next we highlighted promising preclinical and clinical results across our pipeline at multiple medical and scientific meetings, including cord blood connect.

The society of hematologic oncology and the society for immunotherapy of cancers.

Additionally, we strengthened our financial position with a public offering in September 2022, raising $20 million as well as obtaining a commitment letter for hybrid capital for a $25 million senior.

Senior secured convertible term loan.

With this capital raise and with our FDA review of I mean, do we sell progressing on track we are accelerating into launch mode Michel.

Michelle will provide more details on this very important initiatives later on the call.

I believe give me to sell is a company that is poised for long term success and I want to thank my predecessor, Julian Adams for his vision and leadership and bringing the company to where it is today.

Julian leaves us an incredible legacy of scientific innovation, which enabled us to develop assets like army <unk> and GDA 201, we.

We are grateful to continue to benefit from his guidance on our board of directors and wish him well in his retirement.

I would also like to take an opportunity to commend my new colleagues I am continually inspired by your teamwork and dedication with our important work every day and that you are putting patients first in all we do as we advance on our mission.

Additionally, I would like to sincerely. Thank all of the clinical trial sites and the patients and their families that have been such an important partners as we advance our pipeline of NAV enabled cell therapies.

We believe we have truly transformative therapy with a truly transformative therapy with army <unk> and we're motivated everyday by the meaningful impact it can have on patients' lives.

With that I will now turn the call over to Tony to take us through key data supporting our NAV enabled cell therapies Rooney.

Thank you Abby and good morning, everyone. Thank you for joining us on our call.

This morning, I will review, our clinical data and only do the cell.

Provide an update on long term follow up quality of life and immune reconstitution data presented over this past quarter and preview our upcoming real world data presentation.

I will then discuss our GDA 201 study and the rest of our pipeline.

As we eagerly approach our <unk> date of January 30th 2023, we continue to add to the body of scientific and clinical evidence demonstrating the potential of <unk> to address unmet needs in patients undergoing allogeneic stem cell transplant.

Most relevant to our regulatory submission is our successful phase III global randomized study, which met its primary and all secondary endpoints.

The study was comprised of 125 patients ages, 12% to 65% with high risk hematologic malignancies, who are in need of an allogeneic stem cell transplant, but had no readily available matched donor.

The study demonstrated a median time to neutrophil <unk> of 12 days for patients randomized to omit itself compared to 22 days for the comparative group transplanted with standard cord blood.

These results were not only statistically significant but also highly clinically significant as neutrophil and <unk> is a key milestone in recovery of patients undergoing stem cell transplant.

This quarter, we presented long term follow up data from the <unk> clinical program at the society of hematologic oncology or Soho meeting supporting the durable clinical benefit of I'm going to sell in the years after transplant.

These data included follow up of 105 patients transplanted with only due to sell in our phase one two and three studies between 2006 and 2020.

The data demonstrated three year overall survival and disease free survival of 63% and 56% respectively.

Moreover, follow up data of up to 10 years showed durable production of blood cells and immune cells, indicating sustained long term recovery of the bone marrow and patients transplanted with <unk>.

Patient health related quality of life data from our Phase III study were also presented at the Soho meeting and recently published in the journal transplantation and cellular therapy.

Official publication of the American Society for transplantation and cellular therapy.

And an analysis of 108 patients who completed validated health related quality of life survey at screening and through the first year after transplant measures of physical and functional wellbeing as well as other health related quality of life scores were more favorable than we do the sell them with control.

These data suggest clinically meaningful and continual improvements in the physical function on overall overall well being of patients treated with <unk>.

Prior to Soho, we presented translational data at the cord blood connect meeting in September demonstrating recovery of immune cells in patients treated with only to yourself.

And an analysis of the T cell recovery in a subset of 37 patients from the phase III trial patients transplanted with <unk> had more rapid robust and diverse immune cell reconstitution, including higher numbers of recent seismic immigrants in the blood at one year post transplant compared to patients Pan Trans transplants with standard cord blood.

These immune reconstitution data may provide mechanistic support for the observation that patients transplanted with <unk> have lower rates of bacterial and viral infections after transplant.

While our phase III data compared <unk> cel standard cord blood now in collaboration with the center for international Blood and marrow transplant research or CIB MTR, we have explored the effectiveness effectiveness of <unk> compared to other allogeneic transplant donor sources used in clinical practice.

Yes.

As recently announced these data have been accepted as a podium presentation at the annual meeting of the American Society of hematology or Ash meeting.

We compared results from 52 patients who received <unk> in our phase III clinical trial with results from 807 patients in the CIB MTR database with similar demographics and clinical characteristics, who were transplanted with other donor sources, including matched unrelated mismatched unrelated can have flow.

Identical donors.

Our data show that <unk> was associated with significantly more rapid neutrophil recovery and importantly, other outcomes, including graft versus host disease relapse and overall survival were comparable across donor sources.

These real world data are the first to demonstrate the comparative efficacy of <unk> cell to donor sources beyond standard court the.

The abstract has been posted on the ash website and the data will be shared at ash in December .

Okay.

The new data presented this quarter continues to support the clinical benefit and safety of <unk> and give us confidence as we prepare to bring potential therapy to patients following FDA approval.

Before turning to Michelle who will provide an update on our plans to launch <unk> in the U S market upon potential FDA approval.

I would like to give you an update on GDA 201.

Our lead product candidate in our NK cell therapy pipeline.

GDA 201, Leverages, our proprietary NAV technology in the expansion of NK cells to enhance functionality tumor cell, killing properties and antibody dependent cellular cytotoxicity or ADC.

Data from the investigator led study at the University of Minnesota on the fresh formulation of GDA 201 were reported at Ash in December of last year and demonstrated an overall response rate of 74% with durable responses and two year survival of 78% and heavily pre treated patients with non hodgkin lymphoma.

Despite the recent advances in the development of therapy for patients with non Hodgkin lymphoma. We continue to hear from experts that there is a high unmet need among patients who have active disease after treatment.

Our company sponsored phase <unk> clinical study evaluating the prior preserved formulation of <unk> is progressing on track and we are continuing to enroll patients in the phase one dose escalation portion of the study.

The study includes patients who are relapsed or refractory lymphoma. After at least two prior treatments, which may include car T cell therapy or stem cell transplant.

Phase one includes patients with Follicular diffuse large b cell marginal zone and mantle cell lymphoma histology.

The phase one portion of the study is designed to evaluate the safety of increasing doses of GDA 201 with dosing similar to that in the previous investigator led study.

Up to four dose levels will be tested to determine the maximum tolerated dose and recommended phase two dose based on dose limiting toxicities.

The phase II expansion portion of the study is designed to evaluate the safety and efficacy of GDA 201 in two separate patient cohorts of approximately 30 patients each with Follicular lymphoma, and diffuse large b cell lymphoma.

The phase one is currently ongoing and we're looking forward to continuing to progress. This important therapy candidate through the clinic.

In our expanding cell therapy pipeline. We are also developing our genetically modified Nam enabled NK cell therapies, and hematologic malignancies and solid tumors.

Our novel product candidates leverage car and CRISPR mediated technologies to.

To increase targeting potency and persistence and are supported by robust preclinical data.

We are evaluating multiple product candidates, including <unk> hundred one <unk> hundred one TD five of one <unk> hundred one.

This quarter, we announced new preclinical data supporting GTA fiber one at the <unk> meeting.

In a poster presentation GBP 501 of her two car Nam NK cell displayed significantly enhanced in vitro cytotoxicity when cultured with her two positive cancer cells.

Further GDA 201 showed increased potency based on Biomarkers and elevated levels of pro inflammatory cytokines compared with control sell.

Importantly, increased cytotoxicity and potency with persistent.

These preclinical data demonstrated potent anti tumor activity of <unk> 501, and support its therapeutic potential.

Novel cell therapy against her two positive cancers.

With that I will turn the call over to Michelle who will talk more about <unk>, and our advancements and manufacturing and our commercialization plans Michelle.

Thank you Ronnie and good morning, everyone I would like to reiterate how excited we are to be in this position as we are poised to bring our first NIM enabled cell therapy on the <unk> to the U S market, which if approved will be the first and only FDA approved allogeneic hematopoietic stem cell.

Cell therapy for patients with blood cancers in need of a stem cell transplant.

The potential clinical benefit of <unk> continues to be supported by a growing body of data that has been reported in block for our phase III data and in well recognized medical meetings.

Based on these data we have her consistent positive feedback from transplant or focus on our clinical outcomes, including rapid time to neutral and craftsman durability of response and quality of life for their patients.

As we approach the January 32023, <unk> date for <unk>, we continue to work toward our goal of maximizing a positive patient and transplant center experience when using <unk> as the donor source of choice.

As Rohit review the data that will be presented at Ash. In addition to extensive market insulet feedback transplant or 10 consider arm of <unk> not just as an alternative to standard cord blood, but as an alternative to all other donor sources.

Upon approval, we are ready to deliver on the <unk> transplant centers, we will work closely with transplant centers to make sure they have the necessary procedures and logistics in place to deliver a cell therapy like <unk> to sell to patients in need.

Importantly, we continue to hear positive feedback from Payors, recognizing the meaningful impact of <unk> for patients potentially setting us up for well defined paths for coverage and reimbursement.

I am proud of all the work we have completed thus far to define the unmet need that on the <unk> could address and have a clear launch strategy and a well defined launch plan.

As a result of the successful financing this past quarter. We are now in a position to continue building out a specialized and integrated organization and preparation for launch following potential FDA approval.

This integrated team, including commercial medical affairs quality in operations is focused on ensuring that we are ready to provide patients with access at the time of launch and we have now moved to launch execution.

During 2023, we will be primarily focused on ramping up transplant centers throughout the U S.

As we have discussed this will be a targeted launch as we know 70 transplant centers make up approximately 80% of the transplants.

This part of the launch execution from <unk> will be critical to ensure a positive patient experience and includes important programs, such as education and training sessions and process and logistics review.

Although <unk> has a less stringent mentioned criteria than other sources. There is still a matching requirement. So we need to work with centers to assure appropriate trained up identity and chain of custody.

In addition, a time a potential FDA approval, we will have a patient support system in place to facilitate access.

No I would like to share with you some of our market research that drives our strategy and plans of action.

As a result of extensive market insight studies, we are determined to critical differentiators that can position <unk> as a treatment of choice for transplant centers and their patients.

The first is driven by clinical studies and transplant or experience that leads hundreds of transplant and market insight studies indicate that they feel <unk> delivers better outcomes compared to other donor sources.

And second the benefit of <unk>, increasing access so patients have broader access to transplant.

Let me start with improving outcomes improved outcome results in capturing share from current donor sources.

We have learned from our extensive insights that <unk> has the potential to capture share from all donor sources.

From a donor source distribution, we know that matched unrelated donor shares approximately 45% halfway identical approximately 22% match related donor approximately 22% mismatched unrelated donor approximately 7% and cord blood about 5%.

Insight support share capture across all donors sources.

Starting with matched unrelated donors in the United States. The key unmet need that <unk> will address is time.

It takes on average about two to three months to align an unrelated donor to the patients.

That puts the patient at risk for relapse, and then not being able to proceed to transplant.

<unk> has consistently been delivered back to the transplant center in about 30 days.

So this is a key aspect that would lead a transplant or to choose <unk> over an unrelated donor.

For Hep identical donor. So this is a family member that is a 50% match the challenges that <unk> can address involve patient outcomes.

Due to the partial match halfway identical donor results and a delayed time to mutual fund grassman on average about 18 days. According to published literature as well as an increased risk of infection and graft versus host disease or gvhd.

Although post transplant cyclophosphamide is used to mitigate gvhd that also introduces risk for the patient, especially due to cyclophosphamide cardio toxicity.

On the <unk> rapid time to neutrophil graph, but of 10 days and encouraging outcomes for infection rates in gvhd, Lee transplant or to indicate they see a benefit from <unk> over halfway identical which would allow for greater access.

Naturally the donor challenges focus on donor age the average age of diagnosis for an adult leukemia patients is about 60 years of age.

Chances are your sibling, who could be your match related donor would also be in the $50 $60 or seventies.

Clinical data supports the older the donor the worse the patient outcomes are.

On the <unk> with our starting material being cord blood prior to the expansion enhancement of our manufacturing does not have an H concerned since our starting material comes from a newborn.

This matched unrelated donor poses to concerns for transplant or the partial match leads to suboptimal outcomes and the concern around the two to three months on average to align the patient and the donor.

Mismatched unrelated donors have on average about 17 days to neutrophil <unk> and again, the <unk> clinical data in 30 day turnaround positions on the <unk> itself to take market share from mismatch unrelated donor sources.

And finally cord blood based on the statistically significant results from our pivotal phase III study transplants or anticipate a strong share capture from the <unk> zone.

Moving to increase access it is estimated in the United States that there is approximately 1200 patients 12 years of age and older with hematologic malignancies that are eligible for transplant, but cannot find an appropriate donor.

Unfortunately, there has helped US therapies. If you are non Caucasian and you do not have access to family members for donor source. It is incredibly difficult to find a match in the public database.

For example, a patient who is black has less than a 20% chance of finding a donor source in a public database.

Because of all the <unk> less stringent metric criteria, we can match a diversity of patients quickly.

Our phase III demographics supported that with 40% of the patients being non caucasians, most oncology clinical trials are probably under 10% of non Caucasian patients.

With the combination of improving outcomes, which means capturing share from other donors sources and increasing access upon reaching peak market share <unk> has the potential to capture 20% to 25% of the addressable patient population, which would equate to 2000 to 2500 patients per year in the United States.

In terms of launch readiness the leadership of our commercial medical Affairs and operations teams are working diligently to assure we are now in launch prep execution mode. The teams have had preliminary discussions with many of the top transplant centers to assess their needs for introducing a new cell therapy into their facilities.

<unk>.

We have our full payer team in place for launch reimbursement mechanisms are also defined on both the commercial and Medicare sites, including the recent issuance of the CMS ICD 10, Pcs code from <unk> potentially allowing for payers to cover on the tube itself upon FDA approval without formulary review.

<unk>, which has created reimbursement challenges for other novel cell therapies in the past.

A very important aspect of a successful cell therapy launch is manufacturing we have been successfully manufacturing clinical batches at the <unk> facility.

The head of our manufacturing teams widen your mill Mccall's brings 25 years of experience with manufacturing a septic therapies and his expertise with bringing therapies through regulatory approvals from the manufacturing perspective.

The team under <unk> leadership has not only develop the required processes for commercial manufacturing, but we have also validated those processes.

Upon FDA approval of <unk>, our manufacturing facility is ready.

Knowing that transplant is the only potential curative option for patients with certain hematologic malignancies January 32023 will be a very important day for patients transplants and <unk>. So.

We have the opportunity upon potential FDA approval to provide access to <unk> and address the unmet needs that we consistently hear from transplant or <unk>.

We have a clear understanding of the unmet needs are well thought out launch strategy and we are now executing on our launch plan.

We have a great experience launch leadership team in place that knows the importance of providing a life enhancing therapies like <unk> to patients realizing the sense of urgency and the important role that <unk> plays for patients with blood cancers, and how on the tube itself can change the way patients are treated in the future.

I would now like to turn the call over to Shai to review our financial results.

Thank you Michelle and good morning, everyone today, a roof summarize our financial results the third quarter of 2022.

At September 32022, our total cash position, including the recent $20 million equity financing with growth of September 30 was approximately $61 $3 million.

First the $96 million as of December 31, 2021.

Research and development expenses for the quarter with $9 $9 million compared to $11 $7 million in the same quarter last year the decrease.

This was mainly due to the $146 million a decrease in clinical activities related to the conclusion of our phase three clinical trial and a decrease of zero point $2 million and the GDA 201 clinical program.

Commercial expenses for the quarter with $2 8 million compared to $48 million in the third quarter of 2021. The decrease was primarily due to the $2 5 million barrel decrease in launch readiness activities and zero point $6 million decrease in <unk>.

<unk> related expenses.

General and administrative expenses grew full confirming the doors in the third quarter of 2022 compared to frankly, even in the same period in 2021. The decrease was mainly driven by.

Zero point $6 million decrease in professional services expenses and zero point $2 million decrease in headcount related expenses.

Finance expenses net <unk> $7 million, both in the third quarter of 2002, and 31 with no material changes.

Net loss for the third quarter of 2022 was $17 8 million doors compared to a net loss of $23 $2 million in the third quarter of last year.

We anticipate that our current total cash position will support our ongoing operating activities into mid 2023, excluding the cost of commercializing when we do pursue beyond the initial launch which is now underway.

Our cash runway guidance is based on our current operational plan and excludes any additional funding that may be received will be used as a brokerage activities that may be undertaken.

I will turn the call back over to Abbe.

Shai.

Before I turn the call over to the operator for questions I would like to reiterate how excited we are to be in this position on the verge of a turning point for the company as we rapidly approach our <unk> date and target action date of January 32023.

We believe in the compelling value proposition of <unk> and the potential it is.

To transform patients' lives, we continue to advance our NAV enabled NK cell therapy pipeline led by GDA 201.

With all that we've accomplished this quarter and this year overall, we will enter 2023 with strong momentum and poised now more than ever to deliver long term growth for all of our stakeholders.

Now, let's open the call for questions Shannon.

Thank you as a reminder to ask a question you will need to press star one on your telephone please standby, while we compile the Q&A roster.

Our first question comes from the line of Edward <unk> with Piper Sandler Your line is now open.

Great. Thank you very much and congrats on all the progress.

Looking forward to the upcoming <unk> data, obviously and really appreciate all the detail with respect to the Lord Corporation.

Turning to the.

For what kind of.

Sales force.

The field in order to.

Cover those cop 70 centers.

<unk>.

How many of those centers have been involved in.

The clinical trials from already have.

The Brazil experience from trying to get a sense for sort of what kind of cadence to expect from some of those customers going forward.

Great Michelle do you want to take that yes, absolutely good morning Ted.

Sue.

Ted in regards to the first part of your question. So we know Theres approximately 70 transplant centers that are responsible for about 80% of the transplants and we already have relationships with many of those centers, including both their clinical experience with <unk> through clinical trials and our EAP program.

As previously discussed and our approach has not changed that we see up to.

<unk> 25, a commercial account managers to address the footprints of the transplant centers in the United States and in addition, Roni and her team will have medical science liaisons also.

Even with <unk> to your second part of the question, let me turn to ROE need to discuss the number of centers in the United States that were part of our phase III study.

Sure Hi, Ted.

So in our clinical trials for <unk>, which included both the phase III trial in our previous trials in non hematologic malignancies. It's total of about 19 centers in the U S. Who've had some experience with <unk> over the past several years.

Great that's really helpful.

Let me get a sense.

So I'm trying to get a sense sort of how many.

<unk>, maybe fit within this correlates to 25% of our covenant transplants are performed.

The monthly or quarterly basis, again sort of the cadence of comedy Transcon Skip peripheral goodby Silverstein.

So Ted I'll talk about the 20% to 25%. So we talk about that as peak market share, where we would estimate the addressable transplant population to be approximately 10000 to 11000 patients each year.

So that's helpful. I can work it out from there. Thanks so much.

Perfect. Thank you Ted.

Thank you.

Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open.

Hi, guys. Thanks for taking my question.

Also I'll echo the congrats on the progress.

Coming to <unk>.

I'd love to dig in a little bit into what you mean, when you say the <unk>.

<unk> Catherine we will cover initial launch.

What are some of the things you're thinking about there in terms of timeline of launch or maybe there are particular set of goals that you think you can cover obviously myself and doing a lot of work commercially.

Commercial here already but can you talk.

About what you still have to do that is covered by your current cash runway and what you would need additional financing to reach both after the initial launch phase is over.

Don maybe you start and then Michelle you can chime in.

Hey, John Good morning. Thank you for your question so.

As we said our cash runway to mid 2023, and this excluding the commercialization of <unk>.

Of course beyond the initial launch activity that's already underway.

This cash runway guidance does not take into account and it's a very important point the highbridge commitment letter with $25 million, which I can say that both parties are working very closely to bring it to the finish line soon.

Loan activity OLED being started and we are bringing and we are focusing to bring only give yourself to patients.

We cannot comment today on current and future financing activities.

As you can imagine this antibody as a company we are.

Always evaluating our cash needs and continue to assess all financing options and tools to support our corporate strategy. We are committed to this product and committed to ensuring there is a fully spring venture one way for this company Michelle do you want to elaborate yes, absolutely and good morning, John .

I'll start off with a very important point, we feel strongly to meter that upon FDA approval, we want to make sure that patients can have access to <unk>.

One of the very very important parts of that is manufacturing. So the positive news is our manufacturing facility is ready we've been manufacturing clinical batches and we have the production and the quality and supply chain individuals' in place for time of launch.

What we are focused on now as I alluded to with the initial launch plan is the initial hiring of personnel predominantly in the United States that will be interfacing with transplant centers, we have our respective commercial medical affairs leadership teams in place, but now the initial part of the launch plenty of the hiring and also <unk>.

Some operating expenses associated with the initial launch we do anticipate in 2023 that will be ramping up transplant centers, because we do know that transplant centers do need a period of time after FDA approval to develop their processes for cell therapies. Once they see final prescribing information.

What we also will then do is continue to ramp up our hiring as transplant centers ramp up.

I will clarify my answer to <unk> question, because I mentioned up to 25 commercial account managers will ramp up the hiring of those commercial account managers over the next few quarters.

John Let me turn back to John to see if you have any follow up questions.

Sure. Thanks, that's very helpful. I guess, then beyond the Omi maybe on.

<unk> hundred one do you have any more color on progress there.

So expecting to move to phase two portion next year.

Do you have any plan to present phase one data before that time and maybe in time.

To get a look at it before we got.

Financing.

Tony over to you.

Thanks, John .

So the GDA 201 study is proceeding in the phase one portion.

Dose escalation is ongoing.

Patients are being enrolled as prescribed by the protocol.

The full evaluation of a dose limiting toxicity period of 28 days between each patient and so you can imagine that each patient is being evaluated over about a 28 day period.

After which time the dose limiting toxicity is can be evaluated and then dose escalation can proceed this will take us as we escalate through for potential dose levels through next year.

And we don't have any particular plans to.

Sure the outcomes of the phase one portion at this point, but we will continue to examine the results of that portion and see if there is an opportunity to share data before the end of 2023 for the phase <unk>.

Hi.

As soon as our dose.

Our recommended phase II dose is identified we will then be able to start our phase III. We've already started to identify sites for phase III and begin the operational activities to allow the phase III to proceed as soon as the dose is identified.

Okay.

Okay. Thanks very much.

Okay.

Thank you.

Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.

Hi, it's Roy in for Jason Thanks for taking our questions I guess just to follow up on the last question. It sounds like the phase III start is going to be a 2024 events.

Likely assumption.

We have we havent pinpointed exactly when that phase two will start it really depends on the identification of the recommended phase II dose if the dose occurs at a lower dose level, then the highest dose and it could occur sooner.

But it's driven by.

Progressions through the dose escalation portion in any case most of next year will be spent in the phase one dose escalation portion after which the phase two will begin.

Okay got it thank you.

<unk>.

How are you guys thinking about.

Potentially partnering to supplement your own commercial efforts and then what's the uptake been in the expanded access program.

Well thanks, Jason.

What I would say on partnering is that we believe in the commercial.

<unk> <unk> in the U S and we're very focused on getting ready for that potential approval. We believe that there is an opportunity for <unk> access to expand beyond the U S into certain target ex U S markets and we are actively engaging.

In exploratory conversations with potential partners to extend that access internationally.

Okay.

And then expanded access.

Brittany happy to take that one so our expanded access program is open at six sites in the U S.

And it allows us to continue to treat patients until such time as the potential approval takes place.

There is a continual interest in enrolling patients in that study amongst the investigators who are in <unk>.

Involved in the study.

And there's a steady stream of patients including patients from all those sites.

And.

We will continue to treat those patients until we have commercialization potentially.

Okay.

Okay, Great and then on the NK pipeline I guess.

So I'll, maybe with cell launch advances as you guys expect it to when do you think you'll be in a position a nominee nominated NK pipeline candidate for an IND.

Thanks.

What I would say is it will be a combination of.

The information that we gather through.

The market landscape assessment and other things as well as the data that we're generating on that early pipeline. So at this point, we're not prepared to guide to a specific date that we're.

Intending to move forward and identify next IMT candidate at some point in the near future and what I will say is that the research is continuing and we continue to be encouraged by all of the candidates that are currently in the pipeline.

With some very exciting and interesting research going on in our development organization.

Great. Thank you.

Thank you.

Our next question comes from the line of Gil Blum with Needham <unk> Company. Your line is now open.

Good morning, just a couple of questions from us.

So on your ash abstract.

As a clear advantage in the digital investment over the other modalities that are over Portland.

Congrats mats in Midland.

How could this finding influence with potential.

Hospitalization in these patients.

Tony Thanks Gil.

So yes tailwind in <unk> is known to lag behind neutrophil <unk> in general platelet and Grassman does lag behind and it usually is not.

Factor in hospitalization because patients can receive platelet transfusions as outpatients. So generally what happens is that after neutrophil and grasp and takes place almost universally that players have not engrafted, yet and if they reach a certain low level. While they are being followed closely as out patients then they get a platelet transfusion as an outpatient.

I will say, we haven't been able to we've noticed that in our clinical trials and have not had any sort of clinical.

Sequela.

From a lag in platelet congrats munis actually expected in all types of donor transplants platelets take a little bit longer.

Thank you for that clarification and a separate question.

No.

Now technology appears to improve metabolism Upsells Broadway.

Have you guys given any thought on application outside of what you are currently pursuing NK cells and army, particularly.

Joel partnership.

Tony.

There has been interest from a number of different academic and other organizations in using our <unk> technology.

Or other types of cells and those are discussions that we have on a case by case basis and.

And may pursue at some point, we're focused on the work that we're doing now for the NK cells, which we believe are very promising.

And obviously on <unk>, but there is certainly a scientific interest in research interest in looking at other cell types.

Some of our own work in the past also indicate that other cell types are amenable to the NIM.

Technology.

So stay tuned yes. This is something of scientific interest and we hope to be able to get to that when the time is right.

Alright, Thank you for taking our questions.

Thank you as a reminder to ask a question at this time. Please press star one one on a touchtone telephone.

Our next question comes from the line of Mark Breidenbach with Oppenheimer. Your line is now open.

Okay.

Hi, Good morning, this is Jacqueline Mark from Oppenheimer.

Our first question.

Cash offshore so it looks like there was a higher rate of acute gvhd for Lasalle versus the other grafts torso.

Most of what it looks like it was a great.

Could you please comment on what factors might be driving that this cookie. Please thank you.

Absolutely. So we did notice that there was more grade to gvhd in the umbilical cord in the in the.

<unk> group.

And then in and then the other Tran.

Transplant groups.

And interestingly, we believe that it's.

Probably related to the earlier and grassman, because gvhd is a process by which the donor cells.

Recognize the hosts or the patient cell and so that doesn't happen until the immune system comes back.

The good thing about what we're seeing is that it's mild gvhd is great too when you look at grade three and four those are the same throughout.

So we don't believe that there is a concern here, we actually think it's a reflection of the recovery of the immune system, which with <unk> is not only faster, but it also is actually really durable based on the results of our immune reconstitution data.

Great. Thanks.

Q3 2022 Gamida Cell Ltd Earnings Call

Request a DemoDemo

GMDA

Gamida Cell

Earnings