Q2 2021 Entasis Therapeutics Holdings Inc Earnings Call
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Yeah.
Good morning, ladies and gentlemen, and welcome to the Axis Therapeutics second quarter results Conference call.
Currently all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
As a reminder, this conference call is being recorded.
I will now turn the call over to Bruce Mackle, managing director with lifestyle Advisors. Please go ahead Sir.
Thank you Alex 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.
They 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 yesterday and in our form 10-Q, which may be accessed from the investors page of the website.
Joining me on today's call from Entasis, Armando Perez, President and Chief Executive Officer, Mike <unk>, Chief Financial Officer, and Chief Business Officer, and David <unk>, Chief Medical Officer will provide a summary of the company's progress during the quarter and recent weeks before.
Turning it over to Mike for a review of the company's financial results.
Following their prepared remarks, the management team will be available for your questions I will now turn the call over to medicine.
Thank you Bruce and good morning, everyone. Thank you for joining us on behalf of the management team and all of Us and its employees welcome to the inaugural emphasis quarterly results call.
As the company progresses toward commercial stage. It is our intention to formalize our investor outreach and provides regulatory opportunities for interactive dialogue. We appreciate your attendance today and look forward to our discussion on peace and future quarterly calls.
Yesterday after market close we issued a press release outlining our second quarter financial results as well as the progress made advancing our pipeline.
I'll spend just a few brief moments summarizing these developments before turning the call over to Mike for a review of our financials.
And we will be happy to take your questions.
I'll begin with our tax phase III Registrational trial that is a value.
<unk> our novel combination so back from doing more back them or sold or.
For the treatment of us into back to infections, including multi drug resistant or Mds trains.
As we announced recently together with our partner <unk> lab, we completed patient enrollment in July.
Expect to release top line data early in the fourth quarter.
As a reminder attack is a phase III registrational trial evaluating the safety and efficacy of <unk> in patients with confirmed cobre, Panama resistant acinetobacter infections.
In total we have enrolled over 200 patients in the trial in part a which evaluates the efficacy of <unk> compared to <unk> in patients with pneumonia and bloodstream infections. We have enrolled over 120, evaluable patients of which approximately one quarter were enrolled in China.
Part B of the trial, which enrolled over 25 patients is a non randomized cohort of patients with confirmed <unk> back to infections.
Treated with solar but are not eligible for park.
Due to factors that could include calista resistance intolerance or estimates of Baxter infection in another body side unresponsive to <unk> therapy.
Completion of attack enrollment is a significant milestone for both emphasis in dialogue and we thank the patients their families and health care professionals for the collective effort.
Gold is to complete enrollment during such challenging times to our knowledge attack is the largest antibiotic resistant pathogen specific which essentially will trial to be conducted globally and the first two focused specifically on cobre panam resistant acinetobacter infections.
We look forward to announcing top line data in the coming months.
Concurrent with yet that trial, we made solar available via an expanded access protocol from compassionate use cases in the U S.
One case originating from our AAP program was the subject of a study published recently in antimicrobial agents immunotherapy that publication of the American Society of Microbiology.
The case study by doctors item Hornack, Andrew most of the University of Texas Medical branch in Galveston, Texas highlighted the problem of a critical yield patient due to Covid 19, respiratory failure, who develop extremely drug resistant acinetobacter <unk> pneumonia and septic shock.
Patients received a combination of a cocktail of antibiotics, culminating in 14 days of solar plus epidural.
Spot a very poor prognosis the patients significantly improve their therapy recovering well enough to eventually be discharged and return home. We believe this case highlights both the growing threat of antimicrobial drug resistant.
The resistance excuse me as well as the potential of <unk> to address a critical unmet medical need.
As we look beyond topline data release and begin our commercialization planning for solar and our other programs. We are pleased to welcome <unk> as our new Chief commercial officer.
And that comes to us from summit Therapeutics, where she was instrumental in developing the commercial strategy for the company's first product against C difficile infections.
Brian for summit.
Held commercial leadership roles at flexion Therapeutics, Chasma, Cubist and Biogen.
With her track record of commercializing products across multiple therapeutic areas, including antibacterial. We are delighted to welcome her to our leadership team and look forward to working with her to build our commercialization capabilities, which will complement our R&D platform.
Completing our update on Salvador later this month, we will be hosting an expert perspectives webinar on estimate tobacco infections with.
This program will feature presentations by infectious disease experts doctors Davidson Duane of UNC Chapel Hill and Dr. Michael buyback when staging diversity, who will discuss the burden and the current treatment landscape of acinetobacter infections.
We believe will be informative and timely discussion ahead of top line data readout from the adapt trial and are delighted to have such a distinguished experts speaking about the medical need associated with associated with this multi drug resistant infection.
The program is open to all interested parties and registration details are available on our website.
Turning now to the next candidate in our portfolio, we continue to support the global antibiotic research and development partnership or GARP.
And the phase III Registrational trial Obsoletes, we're pacing for the treatment of uncomplicated gonorrhea.
The trial designed to assess the safety and efficacy of a single oral doses that will flow pacing versus the global standards of care, which is a combination of intramuscular ceftriaxone plus oral azithromycin is actively enrolling patients with uncomplicated gonorrhea, including infections potentially caused by multi drug resistant strains of nasiriya going.
Maria.
Our partner of the program got Pete has now activated clinical trial sites in the U S. The Netherlands, Thailand, and South Africa.
Unfortunately, due to ongoing challenges with the pace of patient enrollment related to the ongoing Covid 19 pandemic, we remain unable to provide guidance for completion of the trial at this time.
We will provide enrollment updates and guidance for completion of the trial when appropriate.
Finally, we also continue to make progress with our early portfolio programs.
Month, we participated in the World Micro Forum, where we presented 11 process across the portfolio and we're very pleased to be selected for an oral presentation highlighting <unk> 0462, a novel first in class, there's a basic locked in one molecule.
<unk> is our initial product candidates from a non beta lactam <unk> inhibitor of penicillin binding proteins or MBP platform, which we're developing with support from <unk>.
We believe mbps constitute a potential new class of Gram negative antibacterial agents that are designed to target a broad spectrum of multi drug resistant bacterial pathogens that overcomes. The main source of beta lactam resistance, which is driven by better like the Macy's.
We selected <unk> as our initial candidate given its anti microbial activity against multiple gram negative pathogens, including Pseudomonas aeruginosa as well as a number of high priority bioterror pathogens.
We are currently working to complete the required preclinical activities to advance <unk> into the clinic and look forward to updating you all on the progress of this exciting program.
With that I will now turn it over to Mike for a review of our financial results and business developments.
Thanks, Matt.
During our second quarter and as previously announced in June we strengthened our balance sheet by finalizing a private placement agreement with a subsidiary of Aviva, Inc. Our largest shareholder which provided net proceeds to the company of approximately $20 million.
We intend to use the proceeds from this transaction were finalizing the attack trial NDA filing preparation sold door launch readiness as well as working capital and other general corporate purposes.
We reported a net loss of $12 million for the three months ended June 32021.
Impaired to a net loss of $13.4 million for the same period in the prior year the.
The decrease in net loss was primarily related to an increase in grant income during the second quarter of 2021 versus the prior year.
Research and development expenses were $10 million during the three months ended June 32021, compared to $10.2 million for the same period of the prior year.
Largely attributable to advancement of Salvador, and the attack Phase III trial.
Our general and administrative expenses were $3.3 million for the three months ended June 32021, compared to $3.2 million for.
For the same period of the prior year.
As of June 32021, cash and cash equivalents were $56.4 million compared to $53.2 million as of December 31, 2020 based.
Based on our current operating plan, we believe that our existing cash and cash equivalents, including amounts received from the most recent private offering will be sufficient to fund our operating expense requirements through the second quarter of 2022.
With that I'll turn it back over to <unk> for concluding remarks.
Thank you Mike to conclude we have made exciting progress over the quarter completing enrollment in the attack trial with topline data expected early in the fourth quarter and significantly advancing our pipeline.
The additional financing now secured we look forward to preparing for NDA submission and launch readiness of solar.
Alex we are now ready to take questions.
Thank you.
At this time, we'll be conducting a question and answer session.
You'd like to ask a question. Please press star one on your telephone keypad.
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For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Our first question comes from Matthew Luchini with BMO capital. Please proceed with your question.
Hi.
Excuse me Hi, good morning, guys. Thanks for taking the questions and congrats on.
Fully enrolling attack so first on data obviously, when we got into the 28 day.
Mortality endpoint and safety, but can you just remind us what other key.
Secondary measures, you'll be sharing and that you would want us to particularly be focused on when that initial data comes out and then I have a follow.
A follow up from there.
Good morning, Matthew and thank you for the question I will ask David to answer this.
Yes, Hi, Hi, Matthew Thanks for the question so.
The top line data will reflect as you noted.
Primary efficacy endpoint, which is the 28 day all cause mortality.
And also the data around the primary safety endpoint, which is <unk>.
Nephrotoxicity per the rifle score.
When we announced top line data, we'll have some we'll have some other endpoints some of them were key secondary endpoints, including clinical outcome, which is an important which is important outcome.
For the purposes of.
Showing efficacy.
We will have additional 14 day, all cause mortality as well.
And we will have.
The patient demographics.
Have type of infection will have some sub analyses and then on the safety side.
We will be looking as I mentioned on the rifle score for nephrotoxicity, but well also be looking at treatment emerging adverse events.
On a side by side comparison.
And we will we will also be looking at drug related safety endpoints in the side by side comparison.
You are also aware that we have a part b in the study in.
And part B as Magnus mentioned as the open label arm.
For patients who are eligible for <unk> because of colistin resistance and we will do will be presenting both 28 day 14 day, all cause mortality in part B as well as safety from that alarm as well.
And then top line data will obviously be followed up with a complete data set.
That is included in the study and those endpoints are all.
Documented in our clinical trials.
Post spin as well as other public statements that we've made but it'll it'll be.
A continuation of.
Some sub analyses that we've had from our topline data.
Okay, great. Thank you and.
How I guess are you prepared to make any.
Two sort of related questions. Here are you prepared to provide any color on timing of regulatory filings post BLA what.
Or at least what key steps remain between topline data and submission and then for and I guess my question would be.
Where can you provide a little bit more color on where you stand from a pre commercial perspective, and what are the key.
The key gating key next steps ahead of any launch thank you.
So again a lot of help at all.
Alright.
Alright, so I will.
I'll ask David to answer your first follow up question.
And just for your information is unfortunately, not participate on the call today by faster David because.
Finished his answer I will I will cover some some of the additional folks that we have on pre commercial.
Yeah. So so as you all know after topline data.
As presented there.
There will be a series of additional steps that will need to take as I mentioned, a moment ago, we will have to review of the entire dataset.
Which will which will follow.
Upon.
The full assessment of the complete data we plan to have a hopefully pre NDA meeting we.
We will certainly have a meeting with the FDA, we hope that it's a pre NDA meeting.
And based on the outcome of that meeting that would determine.
Timing around any regulatory filing in the United States, but the major next step effort topline data. It's full data analysis, and then a discussion with the FDA on filing plans.
Thanks, David and matched for the for your second follow up question.
As you as we just mentioned.
Yes, we I'll, let John joined US just a few weeks ago, a couple of weeks ago.
Starting obviously engaging with us on preparing for commercialization readiness, we have done a lot of work ahead of data, but ultimately.
The launch and strategy.
Will be determined by the data we get at the end of Phase III.
Just a few weeks now to go to the early part of fourth quarter, we will be able to provide you a more fulsome picture of.
Outside of what we're working on.
The next call.
Okay. Thank you for taking the questions.
Thank you.
As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.
Our next question comes from Ed Arce with H C. Wainwright and company. Please proceed with your question.
Great. Thanks for taking my questions and let me add my congrats on the full enrollment of attack.
Yeah.
Exciting to see the completion, there and look forward to the topline readout.
Few questions for me.
On.
Attack.
Couple of questions first on the open label part B.
A portion of the study.
And you mentioned.
<unk> enrolled over 25 patients in that.
Just wondering how will this fit.
In the overall NDA.
Is there any potential here for inclusion of those types of patients in the label.
And then related question you mentioned.
In addition that there are.
Certain criteria around appropriate body sites for soldier.
If you could just remind us which of those are.
Areas, where it would be appropriate.
And then I have a couple of follow ups.
Thank you. Thank you Ed and good morning, and thank you for the questions.
I think thats another one for a photographer David I'll check part B and embolic side David.
Yeah, Hi, Ed Thanks for the question so.
So the part D.
<unk> is a critical.
Part of the study it is part of the overall study in.
Data from part D will be included and.
The application so.
The intent of part D. As I said was to enable the enrollment of patients who.
Colistin, either resistant or colistin unresponsive.
And.
So as a play.
Evaluating those patients we design the study with a part B, which was.
Open label fell back down below backed down plus plus in Panama.
Patients from part D. Any efficacy data from part B as agreed to with with regulatory agencies will reflect descriptive efficacy that will that will not be included in the primary efficacy analysis.
But any data from that including as I mentioned, the 28 day or 14 day all cause mortality.
Clinical outcomes will be included.
In the overall.
Benefit with <unk>.
In totality of data from a descriptive standpoint.
But part D patients will be included in the overall safety database.
So they are part of the overall safety database given that they had been exposed to and receive sell backend draw back.
So to your question there will be a critical part of the NDA.
Representing supportive and descriptive efficacy and.
And as part of the primary safety database.
With respect to body side.
For patients enrolled in part a.
We're required to have either a hospital acquired bacterial pneumonia ventilator associated pneumonia.
Or bloodstream infection.
However in part D at Manav mentioned.
Those patients who had colistin resistant acinetobacter infections from any body side, if they met all of the other eligibility requirements.
We're able to be enrolled in part D and so.
So data from that.
<unk> will be generated from the part b of the trial with respect to your question.
Labeling.
Clearly, it's a little premature.
Two to comment on what kind of labeling we might get.
But yes.
Actually my my background is actually significantly in the regulatory space and I've had a lot of experience in <unk>.
Labeling.
And I would think that.
Given the design of the trial given that all of these were pre specified and agreed to and clinically relevant endpoints.
That we would we would push strongly to include that descriptive information and the product labeling.
While the regulatory agencies would agree remains to be seen.
But clearly the data represent the totality of the data and from our perspective would be meaningful.
For prescribers. So so we would we would obviously.
Planned to have that in product labeling, but ultimately that will be based on the regulatory assessment by regulatory agencies.
Great Thats very helpful.
And then a couple of quick follow ups as well.
In other areas of your pipeline.
Firstly.
With the.
The.
<unk>.
Program that you have with your collaborator.
Aye.
Okay.
Yeah.
Knowledge that you cannot really give an update just yet on the enrollment completion.
Just wondering if you could.
Share with us at least qualitatively.
Any any sort of.
Since for.
No.
Progress, there and sort of thinking about ultimately getting.
The study completed if theres been any sort of further changes or amendments.
Or any sort of efforts to accelerate that.
And then lastly on your MPV program.
462.
Recognize that Pseudomonas is that the primary target here, but you did also mention a couple.
A number of high priority bio threat pathogens and so I'm wondering if you might be able to disclose which dose in particular.
Your.
Focusing on and if there is any.
Potential opportunity here ultimately.
To work with BARDA.
For those threats. Thanks, so much.
Thank you Ed and let me, let me take a stab at the second question on <unk> two first.
And I will then.
Turn it over to David to give you a qualitative update on the progress for liquidation in the course of the trial there.
So for <unk> zero for six two as you rightly pointed out.
The focus is on drug resistant pseudomonas.
Our presentations.
Microbe.
Both the process of Europe presentation, we did disclose.
A number of other gram negative pathogens against which <unk> has good activity.
And as well as the number of bioterror pathogens.
With them out of the top of my head right now, but there is a number of them and we have been working with government agencies.
Two.
To produce the data.
Let's have that supports that statement.
We'd be more than happy to follow up.
With the published published information in more detail on the bioterror pathogens.
Do you believe that.
Data.
It's obviously.
Early early days in vitro data and some in vivo work.
So far it does support it does support further development of <unk> both from.
The gram negative across most of the moment side and on the Biopharma side.
But it's still a preclinical program and there is a lot more work to be done before we can talk about.
The stage of work with BARDA and other government agencies to support clinical work.
With gating bolting, but we'd be happy to follow up on the specifics and we'll sustain touches the program move towards the clinic.
And as far as the liquidation.
Before I turn it over to David absolutely.
<unk> and <unk>.
Since we have been working hard too.
But to mitigate to mitigate.
The delays, which are due to covid 19.
As you recall the trials have been actually.
Put on hold for about a quarter.
But.
Resumed enrollment shortly after in multiple new sites have been activated over the last few months. So David if you can provide a little bit more of an update on this I would appreciate it.
Sure sure. Thanks Manto so.
Matt has mentioned we continue to actively.
Recruit and enroll in our key countries, including the U S, Thailand, South Africa and Netherlands.
Some of the steps that that where we're looking at.
To mitigate some of the enrollment challenges include opportunities to enhance enrollment within within sites and looking at things that we can do to encourage more more enrollment.
Then within each site.
We're looking.
Within countries for opportunities to potentially open other sites.
And then and then we're also looking at opportunities potentially to move into other geographies.
If the opportunity if there are opportunities there.
We're looking at it from a very clinical operations micro standpoint, as well as a macro standpoint in terms of.
Site related.
Mitigation as well as overall study enrollment mitigation.
With respect to your question on any sort of future plans. We continue to look at how Covid 19 has impacted enrollment in the study.
And on much of what the FDA has published in their guidance on on.
Their perspective of how covid.
It hasnt impacted clinical trials and working off of that.
And ensuring that we have a well designed study we will continue to look at opportunities again.
What sort of.
What sort of opportunities there are based on clear guidance is from from regulatory agencies. So so from our perspective as Magnus mentioned, we're working very closely with guard P. We're looking at.
Mitigation at all levels.
And we will continue to look at opportunities to enter.
Hans enrollment.
And do that within that.
The regulatory guidance that we've received from from regulatory agencies.
And if I may follow up on your specific question 440462 again.
We have.
I have a number of Pfizer.
Pfizer pathogens that you asked so it is a very broad very broad spectrum of activity as I mentioned, including Brazil.
But since traces.
Youre seeing the best piece first so to the races, a number of critical data species, including <unk>.
So very very broad.
Biosphere potential coverage, but once again he takes over for six two still preclinical.
Early days and doing all the work as fast as we can with support from <unk> to move these towards the clinic.
Thank you both that's very very helpful.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session I will now turn the call over to mono Paris for closing remarks.
Thank you Alex and thank you all for participating.
We have as we mentioned earlier as we summarize today.
Another exciting quarter.
With new financing available progress across the pipeline.
Of course, the completion of <unk> trial enrollment and top line data coming early early next quarter early fourth quarter.
Look forward to continuing continue the conversation and to see you on our next quarterly call. Thank you very much.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.