Q1 2023 Acasti Pharma Inc Earnings Call
Good day and welcome to the Argos before my first quarter fiscal year 2023 financial results Conference call.
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I would now like to turn the conference over to Robert Blum with with some partners. Please go ahead.
Thank you very much Rocco welcome to a coffee farmers first quarter fiscal 2023 conference call on.
On the call with US. This afternoon is Jan <unk>, President and CEO , Bryan Ford Chief Financial Officer.
Pierre Lemieux, Chief operating and scientific officer, and Prashant coli VP of commercial operations.
Following managements prepared remarks, there will be a Q&A session should any questions remain after the call. Please feel free to contact me at 6028899700.
I'd also like to remind everyone that statements on this conference call that are not statements of historical or current facts constitute forward looking information within the meaning of the Canadian securities laws and forward looking statements within the meaning of the U S. Private Securities Litigation Reform Act of 1995, and the securities in <unk>.
Exchange Act of 1934.
Such forward looking statements involve known and unknown risks and uncertainties that could cause the actual results to be materially different from those expressed or implied by such forward looking statements.
In addition to statements, which explicitly describe such risks and uncertainties listeners are urged to consider statements labeled with terms belief expects intends anticipates potential should may will plans continue targeted or other similar expressions to be uncertain.
And forward looking listeners are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call.
Forward looking statements. During this conference call May include but are not limited to the success and timing of regulatory submissions of the planned phase III study for Gtx, one of four and a coffee as other preclinical and clinical trials.
Regulatory requirements or developments in the outcome of meetings with the F D. A.
Changes to clinical trial designs, and regulatory pathways legislative regulatory political and economic developments and costs associated with the Coffey as clinical trials.
The forward looking statements made during this conference call are expressly qualified in their entirety by this cautionary statement. The cautionary note regarding forward looking information section and the risk factors contained in our costs. These documents that have been filed and are filed by Coffey from time to time with the Securities Exchange Commission and Canadian Securities.
Others, which are available on Edgar at Www Dot F E C dot Gov on SEDAR at Www Dot SEDAR dot com and on the investors section of our coffees website at Www Dot a coffee pharma dotcom and.
In addition, any forward looking statements represent a cost these views as of today and should not be relied upon as representing our views of any subsequent date Koskey undertakes no obligation to update such statements to reflect events that occur or circumstances that exist. After the date on which they were made except as required by applicable.
A bowl Securities law.
With that said I'd like to turn the call over to gender Elv's President CEO Bakowski pharma Jan. Please proceed.
Thank you Robert and I want to thank everyone for joining the call today, we're really excited to update you today on the strong progress, we're making on our three clinical programs.
Each of which has key clinical trials either underway or planned to be initiated in this new fiscal year. As a reminder, our strategy is to leverage the company's novel drug delivery and formulation technologies to improve marketed drugs for orphan indications, where a significant unmet need exist now well understood.
Cassini safety profiles of these marketed compounds provides the opportunity for us to utilize the F. D. A section five O five b two regulatory pathway for the development of our drug candidates and therefore may potentially provide a shorter less risky and less costly path to regulatory approval for those.
Not familiar under section 505 be too.
Evidence of our products safety and efficacy.
Either through previous FDA experience or sufficiently within the scientific literature and may eliminate the need to conduct some of the preclinical and clinical studies that new drug candidates might otherwise require.
All three of our drug candidates have already received orphan drug designation from the FDA and each one has the potential to be considered for fast track review and approval orphan drug designation provides for seven years of marketing exclusivity in the United States Post lunch provided certain conditions are met and 10 years and execute.
Exclusivity in Europe . These rare diseases also typically involve clinical trials with fewer patients and they often require a much smaller more targeted commercial infrastructure to realize the market potential it's important to point out that the specific diseases targeted for drug development by a costly.
Well understood. Although these patient populations may remain poorly served by current available therapies.
For example in the case of our Gtx 102 for children with ataxia Telecheck Tcf approved drug therapies do not yet exist. Our aim is to effectively treat the debilitating symptoms that result result from these underlying diseases with the ultimate goal of improving quality of life and pace.
<unk> outcomes.
We believe by leveraging the section five O five b two regulatory pathway for the development of our novel Reformulated versions of these drugs provides us with highly attractive opportunities in orphan disease indications with little or no competition.
So with that as a background, let me give you a quick overview of our lead drug candidate Gtx One O four and then I'll provide an update on the status of our ongoing clinical efforts.
As a reminder, gtx one O four is a novel formulation of Nimodipine to be administered via a continuous intravenous infusion designed specifically for patients with subarachnoid hemorrhage or S. H, which is a condition caused by bleeding on the brain due to a ruptured aneurysm S. C. H presents a life.
Threatening emergency for the patient and our new proprietary IV drug formulation addresses a vital need in the critical care market that has seen little innovation in over the last 30 years. The condition of S. H patients is so critical that 10% to 15% of them die before ever reaching them.
Hospital and about one third ultimately do not survive. Another third of these patients required dependent care for the rest of their lives.
And C. H is estimated to affect about 50000 patients per year in the United States alone and based on our market research. We believe that Gtx one O. Four represents a total addressable market in the U S are more than $300 million.
The current standard of care is an orally administered drug called Nimodipine, which is approved by the F. D. A way back in 1988 Nimodipine is a potent calcium channel blocker that relaxes the blood vessels in the brain and lowers blood pressure to allow more oxygenated blood flow into the brain to enhance healing.
Japan is typically get in throughout the entire time that the patient remains in the hospital, which can be up to three to four weeks.
<unk> is available in the U S. Only as an orally administered capsular liquid solution, which is problematic because many of these S. H patients are not conscious or if they're away because they have a hard time swallowing oral drugs.
Consequently, nimodipine must often be delivered via nasogastric tube, which leads to a lot of variability and dosing as the drug can stick to the inside of the tube, making it difficult to control the resulting blood pressure the patient. Furthermore, often nimodipine is subject to a large variation in blood levels.
Due to a food effect as well as Diana variations caused by changes in blood flow renal function and hepatic metabolism over the course of a 24 hour a day.
Which can affect absorption of an oral drug.
So we believe that Gtx, one O four delivered intravenously could be a game changer for patients with SaaS as a more convenient and efficient and precise way to deliver nimodipine directly into the patient's bloodstream.
With that brief overview, let me share the latest updates on our rapidly advancing clinical program for Gtx one O four.
As we discussed on our last conference call, we announced on May 18th they're a gtx one O for a pharmacokinetic bridging study had successfully met all of its endpoints. The primary objective of the study was to evaluate the relative bioavailability of Gtx one O four administered intravenous.
Honestly compared to oral nimodipine and healthy adult male and female subjects, while the secondary objective was to assess its safety and Tolerability. The results showed statistically no difference in the maximum in total exposure between Gtx, one O four and the oral formulation of Nimodipine and no serious Ed.
Events were observed.
This meant that Gtx one O four delivered intravenously can be considered essentially bioequivalence to oral nimodipine.
Importantly, the inter and intra subject PK variability was also much lower for Gtx, one O four as compared with oral Nimodipine, we believe that because of its better absorption profile and more consistent blood levels Gtx, one O four may provide physicians with the more reliable.
And more effective treatment for patients with S. H.
This could be a key advantage as gtx, one O four could help to reduce the incidence of hypertensive events and visa spasm, which require immediate and costly intervention and can lead to worse outcomes for the patient.
We plan to submit our recent PK bridging study results to the FTA in calendar Q3.
And we plan to request a type C meeting to get the Fda's guidance on the final dosing regimen that.
That we are now recommending for our phase III safety study based on our excellent PK results. We also want to review our proposed design for the Phase III safety study with the F D. A.
To obtain their feedback and guidance before initiating the study.
There was a 75 day response time following our meeting request for the F D. A.
For them to provide their comments. So we would expect to have the fda's feedback by the end of this calendar year or at the very latest early in 2023 as a result, we expect to start our phase III study in the first half of calendar 2023.
I'll remind everyone that while the major objective of our phase III safety study is to show that the safety profile of our Gtx, one O four and S. H patients is similar to our no worse than oral Nimodipine. We also want to collect additional pharma collect anomic data compared to the oral for future.
Publication and marketing purposes.
Based on the discussions we're having with our key opinion leaders, we plan to collect important data such as the amount and intensity of nursing time associated with drug administration and patient follow up for Gtx, one O four compared to oral nimodipine.
Also the number of hypotensive events and the length of stay in the ICU for each drug and so on therefore, we believe that getting the fda's guidance in the form of the type C meeting before starting this study will be really important and the net effect of obtaining their input in advance will ultimately reduce regulatory risk.
And increase the programs likelihood for success as.
As a reminder to everyone. The phase III safety study is expected to be the final clinical step required to seek regulatory approval under the five O five b two regulatory pathway before submitting a new drug application to the FDA for Gtx, one O four to treat S. H patients we're extremely excited about the.
And I need to bring this new treatment option to patients with S. H.
So now let me transition to Gtx, one O two and I'll start with a brief program overview again as a reminder, gtx one or two is a novel concentrated or all mucosal spray of data and that's a zone intended to improve the neurological symptoms of ataxia challenge, a TCR or a T.
For which there are currently no FDA approved therapies.
He is a progressive genetic neurodegenerative disorder that primarily affects young children, causing severe disability impairment of the immune system and an increasing susceptibility to infections in cancer.
Patients typically die in their mid twenties from complications of lung disease or cancer.
Our market research study commissioned by a coffee.
And that a T affects approximately 4300 patients per year in the United States and has a potential total addressable market of about $150 million based on the estimated number of treatable patients.
Gtx 102 is comprised of a novel concentrated formulation of the glucose corticosteroid beta mechanism that can be sprayed conveniently over the tongue of the a T patients who often have difficulty swallowing. So I'm pleased to report that we remain on schedule to initiate the PK bridging study M D.
T X one or two in the third quarter of 2022.
This study will be a randomized open label crossover study in healthy male and female subjects to evaluate the comparative bioavailability pharmacokinetics and safety M. Gtx wanted to administered as an oral spray.
We plan to compare Gtx, one or two in this study to an intramuscular injection of data methods zone, which is the reference product for U S filing purposes, and we'll also compare it to an oral solution in beta and that is which would be the reference product for filing purposes in Europe .
This study will be conducted in Canada, and a total of 48 healthy adult male and female subjects will be enrolled in this single center study comparing five different treatments, including the oral and I am forms of data message zone.
And three different treatment doses of Gtx 102.
And a crossover study design blood levels and safety measures will be compared to beta Methisazone I am injectable ended the beta message on oral solution.
As I mentioned earlier, we plan to initiate this PK bridging study in the third calendar quarter of 2022, and we expect to report out top line results before the end of 2022.
Assuming the PK bridging study meets its primary endpoint, we plan to conduct a phase III safety and efficacy trial for Gtx 102 in a T patients and like T. T X. One O four we plan to request a type b our end of phase one meeting with the FDA. Following the completion of the PK study to confirm the phase III study.
Design.
The phase III study is expected to be initiated in the second half of calendar 'twenty 'twenty three if both studies meet their primary endpoints and NDA filing for Gtx 102 under section 505 be too would follow.
Okay and finally, let me discuss the nice progress that's being made on Gtx 101, our novel non narcotic thin film Biolay adhesive topical the pivot cane spray design.
Designed to treat ph and the severe and often debilitating nerve pain that can persist following a shingles infection.
It's important to point out that market studies suggest a significant unmet need exists for treating patients with ph and approximately 40% of the patients that are prescribed the standard of care, which includes oral gabapentin and lidocaine patches experienced insufficient pain relief and gabapentin has unpleasant side effects.
And also has to be abuse potential.
The benefits of Gtx, one O. One could include faster onset of action, which is an inherent characteristic of our active ingredient bupivacaine versus lidocaine as well as a longer more sustained duration of pain relief Gtx 101 can be conveniently sprayed on the skin wherever the pain is located and based on the PK profile.
The active again.
We believe the Gtx one O. One may need may only need to be applied once or twice a day for 24, seven pain relief. Although this dosing schedule will need to be confirmed in our clinical trials. We believe gtx one O. One has the potential to be a disruptive therapy as a non opioid analgesic for ph and patient.
Who suffer from this debilitating pain.
We completed a mini pig skin sensitivity study in the second quarter of 2022 and on July 26th we initiated our plan single dose pharmacokinetic bridging study to evaluate the relative bioavailability of our topical spray form of bupivacaine Gtx, one O one compared to <unk>.
The reference listed intramuscular injectable form of the drug in 48 healthy subjects. The initiation of this study in Canada, followed feedback from the FDA on the study protocol and then non objection letter from the from Health Canada.
The PK study is a phase one randomized single dose folk for cohort parallel study.
Designed to evaluate the pharmacokinetics dose proportionality safety and Tolerability of Gtx, one O one compared to the subcutaneous injectable form of bupivacaine in healthy subjects. The primary objective is to assess the pharmacokinetics and pharmacodynamics of three dose levels.
[noise] of Gtx, one O one given as a single dose topical application via a metered spray as.
As mentioned the study will enroll up to 48 subjects with 12 subjects per cohort.
Subjects in cohorts, one two and three will receive gtx one O one at three different dosage levels respectively.
Subjects in cohort four will receive a single subcutaneous injection of the active control.
In addition, a pharmacodynamic assessment measuring skin sensation and sensitivity will be performed to collect early information on efficacy and to guide important further decisions for advancing Gtx, one O one clinical development.
The initiation of this single dose PK study for Gtx, one and one is yet another accomplishment achieved so far in 2022 by the coffee team. This study as the next step in our proposed five O five b two regulatory pathway for Gtx, one O one and it's expected to be completed on schedule by the end of calendar 'twenty.
22 <unk>.
<unk> will provide important information on the dose and dosing frequency for Gtx, one O one which will guide the design of our multiple ascending dose study to be conducted in healthy human volunteers next year, followed quickly by our planned phase two study in ph and patience.
So let me recap quickly before I turn the call over to Brian for a quick review of our Q1 numbers first we're planning to initiate a phase III study for Gtx one O four in the first half of 2023 and all of the planning is underway now as mentioned will be requesting a type C meeting with the FDA before initiating the phase III study.
To confirm the study design and final dosing regimen based on our excellent PK results and also to obtain the agency's feedback on the additional pharmacokinetic data that we would like to collect which could help to support our marketing and commercialization efforts. Once the product is approved well this means that our phase III trial.
Now start a month or two later than originally planned we believe the net effect of obtaining this clarification and guidance from the FDA reduces regulatory risk and will ultimately benefit the program's opportunity for clinical and commercial success.
We remain on schedule to initiate the PK bridging study of Gtx 102 in the third calendar quarter of 2022, and we continue to expect to report out our topline results as planned before the end of calendar 2022 assuming the PK bridging study meets its primary endpoint and based on the Fda's guidance, we plan to conduct it.
Phase III safety and efficacy trial in 80 patients in the second half of calendar 2023.
In July we initiated on schedule, our single dose PK bridging study to evaluate the relative bioavailability of Gtx 101 compared to the reference listed drug the pivot came in 48 healthy subjects. This study is expected to be completed as planned by the end of calendar 2022, and it'll provide it.
<unk> information on the dose and dosing frequency in humans that will guide the design of our multiple ascending dose study in healthy human volunteers as well as our phase two study in ph and patients.
And while Brian will expand on this in a moment I think it's important to also point out that given our continued focus on tightly managing cash we've identified and implemented additional operating efficiencies across the organization and we now believe that we have sufficient capital to fund at least 21 months of operations through March of 'twenty 'twenty four.
For this capital will continue to support the advancement of Gtx, One O four three phase III and Gtx 102 in one O. One two important additional key value inflection points.
So bottom line, we're very excited about the prospects ahead for the company and I look forward to keeping you apprised of our progress towards our many milestones in this new fiscal year.
Now I'd like to turn the call over to Bryan Ford, Our CFO to review our financial results at the conclusion of Brian's remarks, we'll open the call for your questions Brian .
Thank you, Jim and welcome everybody to the call.
Please note that unless otherwise indicated all financial numbers that we discussed are denominated in U S dollars and it is.
Naturals are reported.
It's informative to U S GAAP guidelines.
We should.
We also should note that we are a clinical stage company. Thus, we do not yet generate revenues or have any cost goods expenses research and development expenses net of government assistance for the three months ended June .
June 30 of 2022.
$2 6 million compared to $8 $5 million million.
For the three months ended June 32021.
Our research and development during the quarter I just wanted to June 30 of 'twenty to focus primarily on it.
They called development programs for Gtx, one Oh core Gtx 102, and Gtx, one O one drug candidate.
Research and development expenses during the three months ended June 32021 related to the completion of our trilogy phase III clinical program for our former drug candidate free.
General and administrative expenses for the quarter ended June 32022.
We're 1.9 billion compared to $2 seven for the quarter ended June 32021. This decrease was a result of decreased legal.
The accounting and other professional fees that we incurred.
Sure, it's a great merger.
Renewal of our at the market program during the three months ended.
June 30 of 2021.
Yes.
The decrease in professional fees was partially offset by an increase in salaries and benefits.
The renewal of our employee incentive bonus program.
Loss from operating activities for the quarter ended June 32022 was $4 7 million compared to $3 1 billion in losses for the quarter ended June 32021.
Net loss and total comprehensive loss for the quarter ended June 30 of 2022 was $4 5 billion or 10.
Loss per share compared to a net loss of $3 1 billion.
<unk> 12 cents loss per share for the quarter ended June 30 of 2021.
Cash cash equivalents and short term investments totaled $38 4 million as of June 30.
Compared to $43 7 million in cash.
Oh is that March 31, 2022.
As Jim mentioned.
We have identified numerous opportunities and overall efficiencies.
Across the organization that we now believe we have sufficient capital.
The operations through at least March.
2020 core which would include the ability to fund our lead asset Gtx, one O four through to NDA submission Gtx 102 in one O one.
Two additional important milestones.
With that I'll now turn the call back over to John .
Thanks, Brian before I turn it over to the operator for questions I wanted to let everyone know that we'll be participating in the H C. Wainwright Investor Conference from September 12 through the 16th as long as the Lytham partners fall 2022 Investor Conference on September 28, and 29th so if you'd like.
Like to arrange a meeting with us at either conference. Please reach out to Robert Blum at lithium.
With that I'd like to now turn the call over to the operator.
<unk> can you open it up for questions. Please.
Absolutely love it as well.
Got it.
Two questions. Please first of all.
It isn't one or the other touchtone phone.
Today's first question comes from Lee longer so with Oppenheimer. Please go ahead.
Good afternoon, and thanks for taking my my question and glad to hear all the progress.
Just to ask a question.
<unk> Chan with respect to the one or two opportunity in <unk>.
T. I wanted to ask you know this is a.
Condition, obviously that begins at early age genetically driven.
Lot of variability in terms of just the neurological signs and symptoms as well as other if you could just kind of put into context, where you would see that cannot be.
Developed initially and perhaps find its initial useful in terms of that.
Evolving and progressive disorder as patients get get older.
And also if you could.
Maybe let us know if there's any additional work you may need to do.
To show that beyond obviously, the 505 Btu requirements and I guess this may hark back to the data showed most notably in the patients that were reviewed and in that study. If you could just remind us kind of what the picture of those patients had looked like from as an only thank you.
Sure.
Maybe a push on a if I could turn the first question over to you I think you've had you know long deep discussions with the Kols on how they would anticipate using this my sense is that they would use this and children once they're diagnosed and use a chronically but could you expand on that.
England shorthand.
So.
You know in terms of the primary market research that we conducted with Gtx, one one or two with 80 patients.
The handful of center of excellence that treat for.
For this portfolio.
Conditions, such as Johns Hopkins.
The interaction with the with the physicians based on as an early data.
Do you anticipate using the drug chronically once the patient is diagnosed.
There are precedents with glucocorticoid that is dosed chronically.
For Duchenne muscular dystrophy. For example, so there are some analogs in the in the market and where where patients are treated for a number of years.
Our understanding is that is how physicians would anticipate treating pediatric.
Pediatric patients with Gtx 102.
However, this is a key area that we intend to tease out and flesh out and our ongoing discussions with with Kols as well as when we get closer to designing the pivotal phase III study.
<unk> study.
With 80 patients.
Jan.
Yeah. Thanks, Thanks for Sean and maybe you are or peer could also comment I know that.
These patients arent typically kept on the drug constantly right. They they are wins symptom flare they tend to ramp up on the drug and then stay on it and and then potential play taper down.
Yeah.
Yep.
So Cora so currently obviously.
Drug is not approved in the market nor is any such a product used in 80 patients.
<unk> is the only trial did include a crossover design with.
The tapering strategy that you were alluding to it.
Yeah.
This is something that I went to Florida, we are told dogma.
Leland Leland.
We can hear you maybe you could go on mute.
Sorry about that.
Yes, sorry go ahead Krishna.
Yeah, I was just going to comment.
You want to jump in about specifically the doesn't only trial design, which did include the tapering concept that John was alluding to.
Yeah.
No definitely.
This trial by the way that was published.
You know I.
I think the data that came out of the.
13 patients.
The example, but still you know there was some significant improvements of the Oh.
Our scores.
So depending on on the physicians, we're extremely cautious about how to.
Give this you know this formulation of.
It's a better medicine.
But overall.
I think what was monitored very closely and that was very positive from that study was the posture.
Indeed disturbances that were really improve such as there was also some kinetic functions in speech disorders.
I would say, yes scored attached to these conditions improve.
Improved significantly so there was only one particular disorder, which is the.
Ocular motor D. These kids tends to have a.
An issue, where there is no worries about the mi sector, and we'd say that was not necessarily corrected the betterment. There is one but the rest is very promising.
And that's why you know that a physician would certainly be one perhaps two we'd like to have this formulation probably develop like we're doing it right now developing it right now, making it more easily to swallow keep that in mind. So these kids are young.
Uhm formulation that is available that has large volume so it's not very user friendly I would say.
So I think you know we can certainly probably.
B in a better position to control the dosage because of all of our spring up Brazil developed and that is applied to the phone.
Yeah, Thanks, Pierre and to that point.
What is important also is that you know our novel formulation really concentrates the beta messes them, but we're delivering one seven deaths of the dose is significantly less of this corticosteroid.
And getting the same kind of reaching the same blood levels, we hope it'll translate into efficacy as well.
So we're hopeful that that this will be more conducive to long term chronic use and have less of a risk of side effects. As a result, so leland I don't know if that answered your question.
Yes, Thank you very much Dan and team. Thank you.
Did you have any other questions.
No. That's that's all from me. Thank you very much okay. Thank you appreciate it.
Well, ladies and gentlemen.
I wanted to ask a question. Please press Star then one.
You know Jan maybe I've I've got a couple here that have come in and I just wanted to maybe wrong. These bodies. If there's any other questions. While we wait you know the first one here is that we're hearing some rumors that many federal agencies are understaffed. Obviously that includes the FDA are you or your regulatory.
<unk> is experiencing any issues or delays and dealing with them right now.
You know it's interesting we have experienced.
A little bit of a delay we we've had to file an updated <unk> for these these PK studies that are underway or about to start and we've seen a delay of just a few days so nothing significant.
So we're really hopeful that particularly as we move forward and requester our type C meeting for Gtx one O. Four here shortly that that you know that that will go forward and we will get our meeting you know.
And in time I mean, it's a 75 day clock. So we're hopeful that we can you know get a meeting within that window, but I would say a little bit of delay not not bad.
Okay on that topic, you just mentioned to you on that so maybe two more and maybe talk about why the change to conduct the type C. Meeting I know you mentioned some of it in your prepared remarks, where maybe you can expand upon that just a bit more yeah, and just to say I don't think I don't think it's a change you know we just as good practice, we typically requested.
A type C meeting, particularly prior to starting a phase III study.
So in this case.
Feel that's very important to confirm with the FDA. The design of this study the dosing remember that we did these PK studies are to really you know confirm you know the the dosing regimen. So it will be an initial loading dose followed.
By continuous infusion.
We want to take the FTA through that data and get their support for that dosing regimen going forward in phase III, but you know we also wanted to get their input on collecting additional important pharmacodynamic data as I mentioned earlier you know this this is going to be really important we believe because of the more consistent.
<unk>.
Blood levels that we're seeing with Gtx one O four that this should improve safety right it'll translate into better control of blood pressure.
Hopefully a reduction in hypertensive hypotensive events.
And we would hope to see you know improved safety over over the oral we also expect to see that this is gonna be a lot easier for the nursing staff to handle them today, they have to take a part of capsule deliver it through a nasogastric tube and because dosing is so.
Inconsistent Ah.
Oftentimes they back off on the dose maybe deliver half the dose every two hours. So it's it's it's really a very burdensome from a nursing perspective, and it's prone to mistakes. That's the other thing. So we really think that Gtx one O four is.
It's going to.
It'd be much easier and less of a burden for the nursing staff and we hope that we see a reduced need for rescue therapies, and hopefully that will translate into shorter length of stay. So that's the kind of data that you know, we we really want to collect and we wanted to get the fda's guidance on that as well.
Okay, Great and then last one for either maybe yourself O'brien here can you maybe talk about the changes.
Do you know in some more detail to the extent you can on the cash flow runway being extended and what sort of the current cash burn rate looks like.
Sure Brian do you want to take that one.
Yeah.
Yes sure.
Like a lot of other companies are.
The current economy is people are concerned about interest rates and cash in markets.
So we've always been looking at ways to preserve our cash and extend our operating one way over the last quarter.
We identified and implemented a lot of internal efficiencies. This is really a fairly detailed look.
All of our overheads, and and then making sure that we're managing them.
Appropriately.
So we've been able to negotiate contracts and other efficiencies.
We've extended our runway by about six months.
Through at least March 2024.
So.
And this gives us about a breathing space cash was to complete the gtx one O four.
Through its phase III NDA submission.
And I might add thank you, Brian I might I might also add that you know when we put our budget together at the beginning of the fiscal year. We had planned. These studies, but we didn't have the actual proposals from crows and so we were careful to make sure that we plan.
And for enough cash for those studies, but I want to acknowledge a pair and the team have done a terrific job not only selecting really good see arrows, but negotiating really good contracts with them and we were able to you know save relative to budget on the actual cost of these studies as well so it was really a.
A combination of those things.
And just really you know kind of really rigorous a careful review of our cash on a.
Daily weekly monthly basis.
Okay, great. Thank you for addressing those Rocco I guess I'll turn it back over to you if there's any other questions or.
Absolutely I'm not I'm actually not showing any further questions. At this time, so I wanted to turn it back to Jan for closing remarks, Okay. Great. Thank you Rocco.
And again I want to thank you all for taking the time to be with US today on this call.
I hope you can hear from us that it's a really exciting time at Ekati, we've got multiple drugs in the clinic that leverage of costs. These novel drug delivery technologies and Theyre now rapidly progressing towards what we believe to be important value enhancing milestones in this fiscal year, we believe our strategy to improve the performance of currently marketed draw.
<unk> by achieving faster onset of action enhanced efficacy reduce side effects and more convenient drug delivery provides us with significant upside potential while minimizing our downside risk our enthusiasm is high and we look forward to reporting back to all of you in the quarters to come. So thank you again and have a great rest of your.
De Rocco I'll turn the call back to you for closing.
Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.