Q3 2020 Aerpio Pharmaceuticals Inc Earnings Call
Greetings and welcome to the appeal Pharmaceuticals third quarter 2020 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note this conference is being recorded.
Now I'll turn the conference over to you you know Mary Vice President of Finance you may begin.
Good morning, and thank you for joining us for Air Pmts third quarter 2020 earnings call.
Joining me on the call today from Air PEO is Joseph Gardner, President and founder and Kevin Peters, Chief Science and Medical Officer.
This morning Air PEO released financial results for the third quarter ended September Thirtyth 2020, if.
If you have not received the news release or if you would like to be added to the company's distribution list you can do so on the Investor Relations page of our website at <unk> Dot com.
I'd also like to remind you the remarks made on the call. Today include forward looking statements about air piano such.
Such statements May include but are not limited to those related to air PEO when its business and its product candidates, including RASM Pertussis also called 8-K, B 9778 Air P. 15, 36, and the bi specific antibody asset the clinical development plan therefore in therapy.
Peter potential thereof, our.
Our plans and expectations with respect to RASM part of that and the development, therefore, and therapeutic potential thereof in addressing COVID-19, and the intended benefits from Rps collaboration with Geismar Bio Inc. For G. B 004.
Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement.
A more complete description of these and other material risks can be found in their Peos reports filed from time to time with the FCC.
Air PEO does not undertake any obligation to update publicly any forward looking statement, whether as a result of new information future events or otherwise.
I will now turn the call over to our President and founder Joseph Gardner Joseph.
Yes. Good morning. This is Joseph Gardner President Javier pure pharmaceuticals.
I'm very pleased to share an update on her 2020 progress with our investors as.
As announced previously we have completed enrollment in our phase two clinical trial.
Topical ocular formulation of rapid prototype in glaucoma.
For which we expect top line results by the end of year 2020.
We now have 194 patients enrolled all of whom have completed the 28 day washout period and completed the 28 day dosing period.
Having closed our trial to further patient enrollment we are now in the process of final database cleaning activities in conducting all the appropriate quality control trucks.
The company remains on track to report topline results from this study in December or possibly early.
Early in January 2021 to consult to coincide with the seasonal health care industry conferences that you all are familiar with.
You may recall that we opted to progress into phase two after a highly encouraging results in a small phase one trial were 43 core core patients.
Who had baseline intraocular pressures for Lps, ranging from 17 to 27 millimeters of Mercury.
Had a 1.58 millimeter of Mercury incremental reduction in diurnal I O P on day seven.
As it pretty well.
It was added once daily on top of existing standard of care Prosigna in treatment.
Our product was.
Associated with a statistically significant reduction and I hope he on top of standard of care Prosigna therapy, and these effects were not only clinically meaningful deem to be potentially best in class for adjunctive therapies, our clinical advisors.
Equally important the data suggested a favorable tolerability profile for a topical drug candidate.
Putting a low incidence of hyperemia for Red eye.
No systemic safety concerns.
The Tolerability profile, a RASM protocol is a clear differentiator in todays market versus all other adjunctive therapies for glaucoma.
On the corporate front, we are also making progress with her subcutaneous formulation progressive protocol.
In two ongoing COVID-19 clinical trials.
First is the I spy trial for the treatment of acute respiratory distress syndrome, or any R&D house in COVID-19 patients.
We are actively dosing patients and there have been no safety concerns or eight years associated with drug treatment. Therefore.
Therefore, the trial is continuing.
Our second COVID-19 trial is run in collaboration with Amtech, The medical Technology Enterprise consortium, which is funded by the U.S. military.
The goal of this study is to assess resure profit potential to prevent the rds in patients with moderate to severe COVID-19 infections.
Yeah I'm Tech trial is a standalone study managed by air appeal that will evaluate earlier stage patients are moderate to severe cold with 19.
These are patients presenting prior to requiring high flow oxygen.
Being on a ventilator.
The trial is proceeding with active screening and enrollment of patients across multiple U.S. clinical sites.
The two trials are complementary as they will assess resident proto fib across a range of disease severity and COVID-19 patients.
Potentially demonstrating the ability to prevent the areas in moderate to severe patients.
And or treat ongoing areas in critically ill patients.
The two trial approach will optimize our ability to determine how best to utilize resident protocell to potentially save lives in patients with COVID-19.
We expect to be able to provide an update on our progress in the first half of 2021.
Now we have had significant scientific support from the scientific community on Ur COVID-19 program.
Our scientific advisory panel believes that riser Proto fibs tied to activating mechanism, maybe broadly applicable across other disease indications, where the disease produces a severe acute respiratory distress syndrome.
The broader application a riser proto Phil may produce a life threatening a lifesaving therapy for critically ill patients across the spectrum of 80 or s. producing infections for example, influenza and pneumonia.
To further explain the scientific rationale we will be featuring two air Diaz experts as we are hosting a webcast with to thought leaders at 11 am Eastern standard time. This Thursday on November 12.
Information about this event is found in the investors section of our web site we.
We have two highly renowned physicians presenting on her behalf.
The first is Dr. Wesley self.
As vice President of clinical research networks and strategy at Vanderbilt University Medical Center.
Over the past decade, Dr. self has led numerous trials in arid, yes, sepsis and pneumonia and has been at the forefront of COVID-19 trials, including the orchid trial, which demonstrated that hydroxy core Quinn was not effective.
And he is now on the steering committees for multiple ongoing NIH funded trials and a member of the scientific Advisory unit.
For the NHL beyond my error D.S. network on development of COVID-19 trials.
The second physician will be Dr. Samir Perrigo. He is professor of Medicine, and director of the center for vascular biology at Beth Israel Deaconess Hospital.
Harvard Medical school.
Dr Creek has made seminal discoveries regarding the potential basket or protective effects of the tie to pathway in areas, which are particularly relevant to cope with my team.
Dr. Preconceive also intimately involved in COVID-19 clinical trials.
As he currently chairs the data safety monitoring board for the M.I.D. Teekays Cobot studies.
On our call doctors Perrigo and self will provide an overview of the basket or pathology in acute respiratory distress syndrome associated with the COVID-19, and the potential of it stabilization with our drug residue prototype.
We encourage everybody to the 10 that call as I believe it will be of interest to anybody in the cobot space.
Hi in RASM protocol, we have several other value drivers for the company.
Everyone knows second asset a ARPI 15, 36 is a humanized monoclonal antibody observe to activate tied to receptors in a dose dependent manner in preclinical models.
Airfield believes air P. 15, 36 holds potential as a monthly or biweekly systemic therapy to treat diabetic complications, including diabetic nephropathy.
We also have a bi specific antibody that binds both bed Jeff.
And the Pos the taste enzyme D PDP.
And this antibody inhibits VEGF activation and activates tied to.
Despite specific antibody has the potential to be an improved product for the treatment of wet age related macular degeneration and diabetic macular edema.
These antibodies would be dosage ritually ended the guy in the same fashion its current anti VEGF drugs like idea most centers.
Lastly, but very importantly, the company has a fourth partnered assets GBS 004, which is not related to tie to activation.
The drug candidate is a hypoxia inducible factor activator that is being developed for ulcerative colitis buy or partner Gossamer buyer.
Recently indicated that they have already started their 12 week phase two trial in patients with mild to moderate bolstered apply to us.
Oh Summer also presented new phase one b data updates.
On this molecule at the United European Gastroenterology Virtual week Conference Joe.
Just this past October.
We thank you for your attention during this call.
We are very excited about the prospects for air appeal, and we believe that both our glaucoma program and our COVID-19 program could be transformative for the company.
I'll now turn the call back over to Gina to review the financials for the quarter.
Do you know.
Thank you Joseph the.
The earnings release details our financial results for the third quarter 2020, but those interested you can find additional details on our operations results and financial condition beyond what is presented in our press release and our 10-Q filed this morning.
I would now like to walk you through the key a few key items, let me start with the income statement.
For the three months ended September Thirtyth 2020.
Net loss or net loss was 5 million in the third quarter of 2019, we reported a net loss of 4.6 million.
Operating expenses for the third quarter 2020 were 5.9 million compared to 5 million for the same period in 2019.
Research and development expenses for the quarter ended September Thirtyth 2020 increased by approximately 1.1 million or 40.1% to 4 million from approximately 2.9 million for the same period in 2019.
This was the result of increased spending on our lead candidate rather proud to say primarily for the glaucoma and air Diaz for COVID-19 development programs.
General and administrative expenses for the quarter ended Sept September Thirtyth 2020 decreased by approximately 300000 or 13.2% to 1.9 million from 2.2 million in 2019.
This decrease was primarily attributable to decreased employee related expenses and stock compensation.
One quick note on the balance sheet, our cash position at September Thirtyth was 47.3 million and we have no debt, we have sufficient cash to get us to top line data for our current clinical trials.
Three the fourth quarter of 2022.
This concludes our presentation on the financial statements at this time I will turn it back over to Joseph for final comments Joseph.
Yes, Thank you Tina and thank everyone for.
Participating in this morning's call. We appreciate your interest and your support and we will now take your questions and.
Providing answers.
And at this time, we'll be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation code will indicate your line is in the question queue.
They press star two if he like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before personal talkies.
One moment, please while we pull for questions.
And our first question is from Yi Chen with H.C. Wainwright. Please proceed with your question.
Hi, This is garland dialing in for each one can you hear me okay.
Yes.
Okay, Hi, so I have two questions, but they all could be summed up under the umbrella of resurging COVID-19 pandemic. So to start off with the Docomo did you see any negative impact on the progress of the phase two trial due to the rise in cold cases.
[laughter].
Yeah, Joseph here, and I will answer that call or a question Interestingly, we were able to recruit the trial ahead of schedule, even during the cobot pandemic.
And we were able to get essentially all our patients completing the trial on time. So we saw minimal to no impact on the based on the coated pandemic I think our timing was fortunate because we started in June and we ended in October.
And I believe we had pretty much finished enrollment prior to the uptick in the covert cases here in the United States. So again, our timing was fortuitous, but we saw minimal to no impact.
Great I'm, assuming that Docomo trial is positive.
Results from the trial are positive so what would be the companys plan to advance into a pivotal program.
Sure Joseph again, I'll take that.
Yes, our plans would be to.
Take the drug into a phase three program. So we would do the typical steps of having a phase three readiness a meeting with the FDA.
And we will also explore multiple options for financing phase three.
It was it could include a dilutive approaches by raising capital or non dilutive approaches based on partner. So we will be exploring all those options in the first quarter of 2021.
Understood switching gears, a little bit on did talk about do you quoted program. So as the resurging Colby pandemic had any positive impact on your I spy on if the trial.
Oh, Yeah again, Joseph will answer that question.
The.
Unfortunately, the case numbers are going up and that is unfortunate for you know society, we are seeing an uptick in recruitment in our trials and.
And we have located sites and hot spots to facilitate that and we're pleased that you know we are able to recruit to trial and you know hopefully next year, we will be able to demonstrate that we can actually save lives in these patients but that data is yet to come.
The.
The other element of recruitment is that many other drugs have been failing in clinical trials. So we think there's going to be open space. In these clinics are for us to be able to recruit a many patients. So we are on track with recruiting and moving forward nicely.
Unfortunately, the uptick in case numbers or.
It's actually helping us in that regard.
All right that's it from me. Thank you so much.
Oh, thank you.
Our next question is from Julien Harrison.
From BTG. Please proceed with your question.
Hi, good morning, Congrats on all the recent progress and thank you for taking my question. So on the club called my programs, specifically the safety requirement for filing a possible India down the road I'm just curious how much you can lean on prior work here and what likely still needs to be done and then on your covert programs a I'm wondering how much value added to.
The levels have in terms of prognostic value and predicting responses to tie two agonists and then how applicable that says to air D. S. Part broadly thank you.
Oh, yeah, good questions I'll take the quite.
Our common one first.
Yes, we do have an extensive safety database on resident brought up.
Especially from systemic dosing based on our previous phase two trials.
One year duration and treating diabetes or we are still in the process of completing the topical drops safety formulation work.
And we do have to complete a three month [noise] animal.
Animal study with topical drops and we expect to complete that.
In 2021, so that we would be in a position to start phase three.
Late in the year so.
So those studies are ongoing and we expect to move them forward expeditiously as we always do.
[laughter] on the coated front you asked a question regarding Angiopoietin two levels for those on the call who are not aware and you're pointing to is the inhibitory ligand for tied to it.
And it is often upregulated in disease states, where there's vascular.
Instability for example in the air and yes.
As I mentioned earlier I would encourage people to listen in on the call on Thursday.
As dr. Samir per equal be discussing.
The wall of tied to in different basketball opportunities, particularly different acute respiratory distress syndrome.
And his work in other Collaboratives have demonstrated that high ends to use correlated with bad outcomes.
In patients with acute respiratory distress syndrome from a variety of different diseases. So we do think it's possible that it could be a prognostic indicator for the disease and it could be useful potentially for identifying patients that would benefit from resin Proto fed therapy are tied to.
Activator, so that is all quite possible and the science supporting that is clearly out there and published by Dr. Samir Creek and by others.
[laughter].
Great. Thank you that's helpful.
And we have reached the end of our question and answer session and I will now turn the call over to Joseph Gardner for closing remarks.
Well again I want to thank everyone for participating on the call. This morning.
It's always important for us to update investors broadly and we welcome your questions Oh, we continued to be very excited about our programs.
To be able to have a meaningful impact on vision in glaucoma patients.
Potentially to have a meaningful impact on the.
Lethality of the COVID-19 disease would be transformative for the company as I said, but it's also incredibly personally gratifying for our team.
This has been a very exciting time for us and we look forward to progressing these programs forward and benefiting our investors as well as benefiting man corn.
So thank you all for your attention. This morning, and we look forward to a reporting future progress.
And this concludes today's conference and you may disconnect. Your line at this time. Thank you for your participation.