Q3 2021 Entasis Therapeutics Holdings Inc Earnings Call
Ladies and gentlemen, you are currently on hold for today's the emphasis therapeutics third quarter 2021, the earnings conference call. We're assembling today's audience. It wouldn't be underway. Shortly thank you for your patience and please continue to hold.
[music].
Good day and welcome to the Anthos Therapeutics third quarter 2021 earnings Conference call. Today's conference is being recorded at this time.
Now I will turn the call over to Bruce managing director with the lifestyle Advisors. Please go ahead Sir.
Thank you operator before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S Federal Securities laws.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
The forward looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward looking statements information presented on this call is contained in the press release, we issued this morning, which may be accessed from the investors page of this website.
Joining me on today's call from emphasis Armando Perez, President and Chief Executive Officer, and Mike <unk>, Chief Financial Officer Mats will provide a brief summary of highlights of the quarter and recent weeks before turning it over to Mike for a review of the financial results. Following their prepared remarks, David alter chief met.
Lobster and energy S Triolet, Chief commercial officer will join Medicine for our question and answer session I will now turn the call over to nanos.
Thank you Bruce and good morning, everyone. Thank you for joining us today's call.
What has been a really exciting corporate practices.
Data from our lead program <unk>.
The prospect of a safe and effective lifesaving treatment for seriously ill assume you get back to patients.
Bonnie we issued a press release.
Other highlights for the period as well as our third quarter financial results.
I'll spend a few moments summarizing some of the most significant pipeline and corporate developments before turning the call over to Mike What would you view of our financials.
We will be happy to take your questions.
The major news that appeared was of course, the top line data from the phase III trial that evaluated so I could go back to them or sold door for the treatment of Zika virus infection.
Lambert study solar demonstrate efficacy in 28 day, all cause mortality with all the analysis of safety data unequivocally say bring solar.
In addition, there was <unk>.
Statistically significant difference in clinical cure rates at the end of treatment and they spoke to were also paper in solar.
So there was also generally well tolerated with fewer drug related adverse events, but back to the standards of care.
Typically a significant reduction in different toxicity with a P value of zero point zero zero zero.
Do you think is particularly meaningful for patients who are already vulnerable and may suffer from multiple comorbidities, which sounds as care options frequently exacerbate.
<unk> is the first investigational agent to demonstrate efficacy in a well controlled trial in patients with SMA get back.
Rarely seen computation of efficacy and safety in seriously give patients suffering from drug resistant gram negative infections.
Our data is unequivocal and compelling I know many of you have found an antibacterial feel we're in recent years, we have seen most of the incremental improvements this.
This is not by chance.
First of all solar was designed and developed to treat the sneaker back there from the drawing board of a lot forward.
In fact, we started sold door in critically ill patients with few treatment options.
These are the patients who benefit from solar if approved.
Attack was designed to be the single pivotal study, which will underlie filings regulatory agencies in the U S Europe and China.
These may be your first meeting materials, but the idea of salary in clinical studies to provide clear efficacy and safety in the appropriate patient population is not new.
The St Jude medical landscape as well as our own work over the past six years enabled and that's back to your personalized medicine approach that ensures the right drug in the right patient at the right time.
This is an approach that has really made a difference in many other therapeutic areas like oncology and rare diseases.
The R&D strategy, we have.
Some of the same principles that underlie the success in those areas.
Yeah, well characterization of the medical need.
Actually look the right molecular target and pathology and the.
Select the patients who would benefit most Glenn you treat those.
It is this unique edwards emphasis over the past six years, which led to the successful outcome, albeit that drive.
With a strong top line results that we disclosed we have high confidence in the data package that we are assembling for regulatory submissions as well as a highly innovative.
And stream.
Approach.
Speaking of which the beta that we disclosed this past week is not compelling proof of the validity birthday. If you took approach. It also provides evidence which is becoming the foundation of our promotional strategy.
Here's a few numbers from the attack trial that really bring this message home.
Approximately 95% will get me to back the patients enrolled in the fact that they care about.
Pendant resistant infection.
Almost 30% of those patients that spend more than 14 days.
Before they would even involved.
And with <unk>, they started with CAD.
32% Sadly died within 28 days and that despite being involved in a well controlled clinical trial and randomized the best get Watkins receive today, whereas to meet the bacteria infection.
Most of the property that real world mortality numbers with these patients often exceed 40% leading.
The World Health organization to recognize Sumit go back to a research a research and development priority.
And the centers for disease control as an urgent antibiotic resistant threat.
I assume it is truly a global unmet medical needs, which the days treatment options simply are not able to address.
Beyond the undeniable impact on patients and their families acinetobacter puts a significant burden on the healthcare system.
<unk> be some serious pathogen also cause time and costs money.
Can you talk about the cost side the patient length of stay in the hospital will be measured in weeks instead of base.
You need to Baidu also cost money that goes to a patient can exceed $75000 in the U S. Why does the mutual batteries are Brad pathogen.
Using a variety of sites of care, including large urban hospital, icu's and outpatient specialty centers, such as transplant cancer and burn centers.
In addition to Dave Bruce that Yeah. Acinetobacter is also found in the variety of multi sites, including the lung the bloodstream.
Great shots and wounds.
They may be patients survive concert will live longer asset lives after Oregon's dislocation.
These patients are amongst the ones most vulnerable to drug resistant bacterial infections acquired in the hospital.
These tremendous medical advances and the significant resources dedicated to treating these patients should not be undermined, but what's basic infectious such as excuse me to Baxter, which used to be and could still be treatable with the right that's about it.
It would be tough to treat patient population the robust data, both safety and efficacy, making a compelling case could be adoption of sole Dori group is the <unk>.
Life saving medicines.
As we complete the analysis will get that trial data and preparing for submission of a new drug application in mid 2022.
We continue to develop and refine our commercialization approach was sold.
This would be a targeted commercial approach best suited to maximize the value of solar by focusing those sites of care with Sumitomo the patients can benefit the most from a professional lifesaving option.
Even the unmet medical need and the strength of our phase III data. We believe that if approved we can create a different commercial go to market strategy that will be pathogen focus and result in a more streamlined effort.
The next steps are focused on building awareness site of care identification of the personalization patient identification and payer engagement.
These initiatives will enable us to focus our commercialization efforts of the select areas, where the burden of the vessels back there is higher with the goal of supporting early uptake of solar.
Equally important these efforts will highlight this public health concern that is associated with increased morbidity and mortality due to the limited therapeutic options.
Finally.
We will continue to solicit physician and payer feedback on the top line results that will further inform our commercialization strategy and support the value proposition of sober visa.
These elements are foundational to creating a differentiated commercial approach that is based on the successes and lessons learned in this space and from other product launches focused on red life threatening diseases.
To meet these rapidly developing efforts and that transition to a commercial stage company in the past quarter, we welcomed on it yesterday, all that as our new Chief commercial officer.
All that comes to us from summit Therapeutics, which was instrumental in developing the commercial strategy for the company's first product.
The track record for commercializing products across multiple therapeutic areas, including chronic graft and that effective products. We are delighted to have her spearheading our effort to build the commercialization capabilities needed to bring soldier to market and to complement our R&D platform.
Before turning the call over to Mike I'd like to say a few more words about the progress we made in the rest of the pipeline.
With regards to the liquidating we are pleased with the improving the enrollment in the past quarter in partnership with got Pete We're continuing enrollment in the global Phase III trial in patients with clinical trial sites in the U S Europe, Asia and Africa and blogging.
In addition, we are continuing development.
By products.
Ports from our partners <unk> NDA NIH or these efforts I would like to highlight the introduction of a new first in class candidates E X 046.
This is a novel Theres, a bicoastal thing, which I think microbial activity against multiple gram negative pathogens, including supermodel Savage Nossa is what with several high priority by food pathogens.
The discovery story of <unk> zero of course speaks to as the many scientific advances that underlie our rational design Nevertheless about.
We recently published in the prestigious journal nature. This.
This is a significant recognition of the work of our scientists and external validation of the quality of our R&D platform.
With that I'll turn it over to Mike for a review of our financial results Mike.
Thank you Matt Us <unk>.
During our third quarter, we reported a net loss of $12 4 million compared to a net loss of $11 1 million for the same period of the prior year. The increase in net loss was primarily related to an increase in general and administrative expenses as the company initiated select pre commercialization activities.
Research and development expenses for the third quarter were $9 3 million compared to $9 4 million in the same period of the prior year. The decrease of 0.1 million was primarily due to a decrease of <unk> 5 million in expenses related to cell door and a decrease of <unk> 2 million in expenses.
Related to our E. T X O 462 program, partially offset by an increase of <unk> 6 million in personnel expenses.
General and administrative expenses were $4 3 million for the third quarter compared to $3 2 million during the same period of the prior year the.
The increase of $1 1 million was driven primarily by increases of zero point $3 million in legal costs zero point $3 million in personnel costs zero point $2 million in consulting costs, and zero point $1 million and insurance related costs.
As of September 30th 2021.
Cash and cash equivalents were $44 1 million compared to $53 2 million as of December 30th 2020.
Based on our current operating plan, we believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2022.
With that man hours back to you for closing remarks.
Thank you Mike.
The past quarter has set in motion a series of first rent disease.
We completed the phase III trials sold our first product candidate.
The foundations of our first regulatory submissions.
For a product that could become the first potential treatment for patients with a single tobacco.
At the same time.
Our R&D organization continues to produce World class Science.
The talented team that I have the privilege to lead is committed to translating our accomplishments into value for our shareholders.
And looking beyond the many numbers that we shared with you to date.
We recognize that our work is ultimately about patients and we are proud to bring these future lifesaving treatments to patients who need them.
Operator, we are ready to take questions.
Thank you if you wish to ask a question at this time, placing a lot by pressing star one on your telephone keypads. Please make sure you missed function on your phone is switched off till August signal to wish them equipment.
Again, Please press star one to ask a question.
Our first question comes from Louise Chen from Cantor. Please go ahead.
Hi, Good morning, everyone. This is carvey if it relief we have a couple of questions here. So following the positive topline data for our phase III Salvador for part of this quarter.
When we can we expect a full analysis of the study are there are subgroups. They are most interested in Honduras study.
You have got a mid 2022 for soda our NDA submission. So just wanted to get a deeper understanding of the task at hand in preparation for the NDA and perhaps talk a little bit about some of the contingency factors that might sway your timeline. Thank you so much.
Good morning, and thank you for the question.
I'll turn it over to David to address both your questions, David <unk> <unk> Chief Medical Officer.
But before I do that just a repeat.
Repeat something that we mentioned on our webinar a couple of weeks ago, when we announced the data.
It is a fairly comprehensive set of top line data from our phase III trial, while we do expect as you pointed out additional cuts of the data and additional analysis, we see the data that we presented from the topline analysis is pretty definitely when it comes to the to the key endpoints both ward.
But suppose relevant breakthrough approval and as I mentioned earlier for the fact that we set the foundations of our commercialization.
But david over to you.
Yeah. Thanks.
As Matt mentioned when when we identified what we would include in the topline data are it was important to ensure that we effectively communicated the critical endpoints of critical analysis of this study and to that end, we reported out obviously the 28.
Day, all cause mortality the other very important clinical end point, which was a clinical cure.
The critical safety data, including the overall adverse event profile.
And the nephrotoxicity.
And as you've seen all war.
Highly highly indicative of a.
And advantage for salto compared to the comparable.
Terms of when we have additional data we are in the process of currently evaluating that data.
We obviously will report.
Obviously, we'll report that when when we had the opportunity to look at the totality of the data, but we are currently evaluating all of that is also quite a specific question. There are a couple of.
All other endpoint that we think will be informative, but will not meaningfully change our conclusions or everyone's cause conclusion based on.
The data that we reported so we'll be we'll be looking at some micro biologic outcomes will be evaluating some pharmacokinetics.
There'll be some data around.
How long patients were treated compliance to their treatment regimen.
Obviously more specifics on the safety, we reported overall safety.
But we'll have more specifics on.
Comparisons between the two treatment groups in the safety database.
And then to your specific question around subgroup analyses, we have a bunch of subgroup analyses that we'll be looking at it including breakdown by.
Things such as age gender.
Underlying condition I E pneumonia versus bloodstream infection.
Whether the patient had a mono micro BEC infection, or probably microbial infection the region of care.
There are underlying.
There their underlying condition.
Condition as well as <unk>.
The idea of other things and so well be able to report those out again that after optimal analysis.
That's great. Thanks for the question of coffee, which is the timeline.
Sure.
We've got deep guide as well you have to meet 2022 are you have you create debating with EBITDA of course, once we complete the data.
Thanks again.
Again.
We are pretty confident on the time language sticking to derail that but until we have that discussion from the FDA.
The problem with them that the package that we have.
Yeah.
We obviously will update with any changes after that.
Got it okay.
Thank you for taking my questions.
Thank you Darby.
We'll now take our next question from Jim Malloy from a G. P. Please go ahead.
Yeah.
Hey, guys. Good morning. Thank you for taking my questions I had a quick question on.
I think it would fast track in Q I D. P designation I think the expectations for potentially a priority review now when would you expect to know.
Could you get that.
And if you'll get that and then can you talk a little bit about again assuming that.
You get a good review and an approval.
A little more detail potentially on on the U S sales team sort of the size the call points and the status of bringing them onboard.
Good morning, Jim and thank you for the questions.
I will take the first question.
Yes sure.
To answer to give you an outline oh.
Forward looking thoughts on commercial built.
In terms of the of the product and submission and the review timeline Youre absolutely correct. We are <unk> products. We have fast track review would you expect as you know I think the clock is.
Six months plus two months for review.
We're not guiding on an approval or launch, but you can you can fund your own numbers.
And and after that.
Thank you Doug.
We can do lots of product as close as possible to approval, we'd be making the necessary investments both on the manufacturing side and then on the joining us last quarter, we're starting to prepare for the commercial launch. So Amit do you want to give Jim a little bit of an overview.
How do you see things develop over the next over the next few months.
Sure, Yes, good morning happy to so with the topline results that really supporting the commercial strategy. I think we can now begin to imagine a new go to market approach. So our strategy will focus on this bad pathogen and on health care organization, where we now estimated that there is a problem today.
And we are still that can potentially save my read.
And the topline data.
Based on our current analysis.
And at least 500 health care, if I can.
Whereas when you get back there is a problem. So this is great because it allows us to really focus on these type of care that have limited treatment options and as a result.
See the unintended consequences of increased hospital length of stay increased cost per patient and an increased mortality rate.
Furthermore, I think that also allows us to be very okay. Considering mind in building the commercial team. The sales force ramp will be informed by the NDA submission and the anticipated okay. Okay. They have guy, but by focusing on this way of packaging. We believe that you do not need.
Southwest to address without the Kennedy.
<unk> is to build a leading our commercial footprint with associated infrastructure that allows us to really maximize the value is still there and we think a company like ours can be very successful in addressing the unmet need of treating patients with acne.
Now I'll turn it back over to you.
Thanks, Alan and Jim.
Hopefully we answered your questions.
Yes. Thank you.
I was hoping it might have an idea of all the number on the Salesforce, but then it goes through.
Could you talk a little bit about the EU and the time I know, you're you've publicly stated youre anticipating a partner in the EU.
In thinking on the timeline for EU filing and potential approval there.
Vis vis the U S and Central partners signed time timeline. Please.
Okay.
So it's not to speak of a partnering strategy as you pointed out.
<unk>.
Looking for a partner for European launch.
And we do have a partner in Asia Pacific with dial up as you know we have under study.
China is a global trial, which should lead to.
Two are relatively short.
Combined for Chinese regulatory submissions.
Of course these are supposed to be with you about partners dialogue and our priority is the company. He's of course, yes. This is a company our size.
It can.
Make the biggest difference.
For Europe, we look for partnerships, Mike can you give a little bit of a <unk> strategy that.
Yeah happy to do that thanks for the question Jim This is Mike.
So I think as we've discussed previously and as you're aware as a multi drug resistant acinetobacter is a global has health issue.
And and there are a significant patient need not only in Europe. As you mentioned, but also in Russia, the middle East and Israel and South America. So our objective is to try to make sure that we provide access to sole door to all of these patients that need them.
Two to maximize the value of Salvador so.
Not only are we in discussions to try to find a partner for Europe, but ideally we would like to find a partner a global partner outside the U S to bring cell door to all of these patients in need obviously I can't comment on any ongoing discussions at this time, but we'll certainly update when appropriate.
Great. Thank you guys taking the questions.
Our next question comes from that.
<unk> <unk> from H C. Wain Wainright. Please go ahead.
Initial study might look like you can look back at what we've done with our existing programs.
<unk> <unk> and for both of these.
Had a very thorough.
Valuation of the program pre clinically and then in phase one to establish both Pharmacodynamic pharmacokinetics pharmacodynamics relationships and exposures at the right body sites before proceeding to a patient study.
I mean, it is likely that we will follow a similar approach with <unk>. We believe that methodical approach is the best.
Best table too.
To provide.
Data for regulatory submission and the review.
And to inform the design and the.
The conduct of the phase two and phase III trials.
Okay that makes sense speak enough salary for basin.
Can you tell us.
What are your goals in anticipation for the program in the next coming year 2022.
Yes, absolutely.
No.
Program that we are developing in partnership with Pete and got Pete has.
Okay.
Development has deployed their resources.
And Anthony.
To conduct the trial.
Four continents, and we have sites that each of those locations now enrolling actively as we call. It <unk>.
This is a product that we developed for Korea.
Create is a high medical need due to resistance and we have a product that works against both direct set you can direct resistant.
<unk>.
Welcome to Ea's, Randy lethal and so we had slower anticipated enrollment due to call it.
As you May recall, we had suspended enrollment for about a quarter at the start of the pandemic 2020.
And things have been progressing I would say a more slowly than either our partners <unk> Coke as a result of that we are unable to provide guidance on.
While at this point.
We will do so.
When we are closer and closer to completion as we were for solar.
Colby remains to get repeatable as you know.
We are seeing improved enrollment.
Of course, a number of geographies.
We are confident that this product will be developed in a relatively short timeline will provide you a.
A better more times more accurate guidance.
Once again as soon as we have.
We have numbers, which are clearly more comfort about given the ongoing pandemic.
<unk> of course that the results are going to be every bit as exciting as the results from solar.
And that we can build on those to underlie a commercial commercial launch and take these products to the patients around the globe and with regard to <unk> we are.
We've kind of preempted Jim's question on how do we get these registered that's where because <unk> has a number of territories.
Developing world countries that they will take they will take the.
The need for distribution and we of course have the.
At this point.
The developed markets, including the U S and Europe.
Understood.
Thank you were careful to kind of our questions and we look forward to soldiers NDA filing.
Thank you Thomas.
Thank you as a reminder to ask a question. Please single by pressing Star One we'll now take our next question from Robert Driscoll from Wedbush Securities. Please go ahead.
Thanks. Good morning, guys. Just wondering if you could expand the patient.
Patient identification consult on one thing you might be doing on that front going forward. Thanks.
Good morning, Robert and absolutely, we will I will turn it over to <unk>, who as I mentioned that has a factor on both the infectious diseases, but also in <unk>.
Rare diseases.
You want to take <unk> discretion.
Yes, alright.
And good morning, and thank you for the question.
Yes.
The case I'm really.
Pulling from the rare disease.
To ask a question in terms of really trying to target.
Prioritize sites of care. So currently we're underway actively preparing for commercialization and an identification is a key part of understanding where does this pathogen list today.
What are the risk factors that we need to be aware of for it to emerge in the future so patient identification.
In rare diseases as it is here and we follow their way of pathogen acinetobacter and that really blends in with the other initiatives that are also in progress around focusing on patient physician and site of care identification and prioritization. So.
As you know there is no specific code for Acinetobacter and were currently underway with on Triangulating around the opportunity by considering.
The other novel branded agents in the past our historical reference.
As well as understanding.
Type of care, where no taco meal infections are today or have the potential of emerging quickly and then within that patients that demonstrate acinetobacter like.
Or indeed, acinetobacter infections, together with physician site identification prioritization and patient identification. These are the tools that we will need to be more focused and streamlined when we built the rest of the commercial team to really hone in on areas, where acinetobacter is a problem and were sold or Ken.
Potentially save lives.
All right.
Does that answer your question yes.
Yes, absolutely.
Thank you and then final reminder, please press star one to ask a question.
And with this as there are no further questions in the queue I would like to hand, the call back over to minus for any additional or closing remarks.
Yeah.
Thank you operator.
Just a couple of more minutes with a few thoughts on the past quarter.
And over the quarters to come.
Because solar.
<unk> is now pretty much behind us we are looking at lots of data and analyzing the last cohorts.
Cohorts litigations.
But the data from this trial is very much still ahead of us.
We are excited to be.
Usually meet as I pointed out to understand.
It can make the biggest difference for patients and to understand when we create the greatest value for our shareholders as we boost our commercialization efforts in the U S.
A lot of work ahead of us of course with the NDA filing and hopefully subsequent approval in a relatively brief timeline, which we're gearing up for.
Continued excitement for our pipeline <unk> also in phase III coming in hopefully close behind.
With more guidance, so that in the coming months and in the rest of our pipeline with earlier programs, including <unk> zero of course exclude now moving towards towards A&D, we're very delighted to be able to share. The news with you. We're excited about the future as we transition from an R&D organization with a pipeline.
R&D and commercial organization, taking off towards product to patients. Thank you all for participating in this morning's call and look forward to reconnecting next work.
Thank you. This concludes today's conference call. Thank you for your participation ladies and gentlemen, you may now disconnect.