Q4 2021 Ampio Pharmaceuticals Inc Earnings Call
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<unk> Q4 year end 2021 will be starting in a few minutes time.
Ampio's Pharmaceuticals Q4 year end 2021 will be starting in a few moments time.
Please stand by once we allow all participants to connect to today's call before the game.
Please standby, we will see allow participants to conduct today's call before we begin.
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Good day, everyone, and welcome to MPO's fourth quarter 2021 Earnings Conference School.
Good day, everyone and welcome to <unk> fourth quarter 2021 earnings conference call.
Today's call is being recorded.
At this time, I would like to turn the call over to Mr Dan Stokesy, Chief Financial Officer. Please go ahead, sir.
This time I would like to turn the call over to Mr. John <unk> Chief Financial Officer.
Please go ahead Sir.
Dan Stokeley: Hello everyone and welcome to Ampio's fourth quarter 2021 financial results and business update call. My name is Dan Stokely and I'm joined today by Chairman and CEO Mike Martino and President and Chief Operating Officer, Holly Cherevka.
Hello, everyone and welcome to <unk> fourth quarter 2021 financial results and business update call. My name is Dan Stokely.
Joined today by Chairman and CEO , Mike Martino.
And Chief operating Officer Holly.
Dan Stokeley: Our fourth quarter 2021 10K and earnings information was released today, March 29th 2022 at 4 10 p.m. Eastern time and can be found in the investor section on our website apiopharma.com under financial filing.
Sure.
Our fourth quarter 2021, and 10-K and earnings information was released today March 29, 2022 at <unk> PM Eastern time and can be found in the Investor section on our website <unk> pharma dot com under financial followings.
Dan Stokeley: Before we begin, I'd like to remind our listeners that this presentation may contain forward-looking statements about our business.
Before we begin I would like to remind our listeners that this presentation may contain forward looking statements about our business.
Dan Stokeley: You should not place undue reliance on forward-looking statements as these statements are based upon our current expectations, forecasts, and assumptions and are subject to significant risks and uncertainties.
You should not place undue reliance on forward looking statements. These statements are based upon our current expectations forecasts and assumptions.
And are subject to significant risks and uncertainties.
Dan Stokeley: These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe.
Statements, maybe identified by words such as May.
Well should.
Good.
Expect intend plan anticipate believe.
Dan Stokeley: estimate, predict, potential, forecast, continue, or the negative of these terms or other words or terms of similar meaning.
Estimate predict.
Gentle forecasts.
Continue or the negative of these terms or other words or terms of similar meaning.
Dan Stokeley: risks and uncertainties that could cause our actual results.
Risks and uncertainties that could cause our actual results to differ materially from those set forth in any forward. Looking statements include but are not limited to the matters listed under risk factors in our annual report on Form 10-K for the year ended December 31 2021.
Dan Stokeley: to differ materially from those set forth, and any forward-looking statements include but are not limited to the matters listed under risk factors in our annual report on Form 10-K for the year ended December 31st, 2021, which is also on file with the Securities and Exchange Commission.
Which is also on file with the Securities and Exchange Commission as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission.
Dan Stokeley: as well as other risks detailed in our subsequent filings with the Securities and Exchange Commission.
These reports are also available at Www SEC Gov.
Dan Stokeley: These reports are also available at www.sec.gov.
Dan Stokeley: statements and information in this presentation, including forward-looking statements.
Statements and information in this presentation, including forward looking statements speak only as of the date they are made or provided.
Dan Stokeley: speak only as of the date they are made or provided unless an earlier date is indicated. And we do not undertake any obligation to publicly update any statements or information, including forelooking statements, whether as a result of new information, future events, or otherwise, except as required by law.
Unless an earlier date as indicated and we do not undertake any obligation.
Publicly update any statements or information, including forward looking statements.
As a result of new information future events or otherwise.
As required by law.
Speaker Change: Now I would like to turn the call over to Chairman and CEO Mike Martinez.
Now I would like to turn the call over to chairman and CEO , Mike <unk>.
Yes.
Mike Min: Thank you, Dan. Good afternoon, everyone. Before I proceed, I'd like to take this opportunity to welcome Elizabeth Jobes to our Board of Directors.
Thank you Dan good.
Good afternoon, everyone.
Before I proceed I would like to take this opportunity to welcome Elizabeth jobs to our board of directors.
Mike Min: Liz has nearly three decades of legal and compliance experience.
<unk> has nearly three decades of legal and compliance experience for her.
Mike Min: Her addition and skill set are essential to our future as we correspond with the FDA, organize our biologics license application, and pursue strategic partnerships. We're pleased to have
Edition and skills that are essential to our future as we correspond with the FDA.
Organize our biologics license application and pursue strategic partnerships.
We're pleased that we're has joined the board.
Just a few weeks ago on March 2nd we hosted a webinar to disclose and discuss AP 13 data.
Mike Min: Just a few weeks ago, on March 2nd, we hosted a webinar to disclose and discuss AP13 data.
Mike Min: update you on the status of our discussions with FDA and update you on the status
You on the status of our discussions with FDA.
And update you on the status of the Covid trials.
Mike Min: Frankly, and as expected, not much has changed in the past few weeks.
Frankly and as expected.
Not much has changed in the past few weeks.
Mike Min: So this call will be a quick refresher, primarily focused on updating our financial results and answering questions.
So this call will be a quick refresher primarily focused on updating our financial results and answering questions.
Mike Min: To begin, I'd like to summarize what we believe are the major takeaways from our webinar call regarding the status of AP13 and discussions with FDA as follows.
To begin I'd like to summarize what we believe are the major takeaways from our weapon in our call regarding the status of AP 13, and discussions with FDA as follows.
Mike Min: We enrolled 1,043 patients in AP13 versus a targeted enrollment of 1,034 patients.
We enrolled 1043 patients and AAP 13 versus a targeted enrollment of 1034 patients.
Mike Min: COVID-19 had a material impact on the tribe.
COVID-19 had a material impact on the <unk> specifically.
Mike Min: specifically impacting sites and patient examination visits.
Specifically impacting sites and patient examination visits and.
Mike Min: and resulting in a material amount of missing efficacy data.
And resulting in a material amount of missing efficacy data.
Mike Min: The FDA recommended we conduct a sensitivity analysis.
The FDA recommended we conduct a sensitivity analysis to detect the impact of COVID-19 on the study.
Mike Min: to detect the impact of COVID-19 on the study.
Mike Min: which we outlined and documented in a study plan prior to unblinding the study data.
Which we outlined and documented study plan prior to on blinding the study data.
Mike Min: this assessment determined that there were, in fact, two patient populations.
This assessment determined that there were in fact two patient populations.
Mike Min: a pre-COVID population with approximately 7% missing data.
Pre COVID-19 population was approximately 7% missing data.
Mike Min: and a during COVID population with approximately 70% missing data.
And a during COVID-19 population with approximately 70% missing data.
Consistent with that plan and analysis.
Mike Min: Consistent with that plan and analysis, we have proposed a modified intent to treat or M-I-T-T population with an end of 600 million.
We have proposed a modified intent to treat.
PT.
PT population.
With an end of 618 patients.
Mike Min: to evaluate efficacy in the AP13 trial.
To evaluate efficacy and the AP 13 trial.
Mike Min: Applying the statistical analysis plan and the trial protocol, we have determined the following.
Applying the statistical analysis plan on the trial protocol, we have determined the following.
Mike Min: First, the intent to treat was not statistically significant for either pain or function.
The intent to treat was not statistically significant for either pain or function.
Mike Min: which is frankly not surprising given the large amount of missing data and mandated imputation.
Which is frankly not surprising given the large amount of missing data and mandated amputation.
Second.
Mike Min: Modified intensity over 12 weeks was statistically significant for pain and trended toward functional improvement without statistical significance for function.
Modified intent to treat over 12 weeks was statistically significant for pain.
And trended toward functional improvement without statistical significance for function.
Furthermore, modified intent to treat at 12 weeks was statistically significant for both pain and function.
Mike Min: Furthermore, modified intent to treat at 12 weeks was statistically significant for both pain and function.
Mike Min: Finally, the protocol analysis in an N of 580 patients.
Finally, the per protocol analysis and in an up 580 patients.
Mike Min: demonstrated statistical superiority for both pain and function.
Demonstrated statistical superiority for both pain and function.
Mike Min: Now, Holly covered these points in detail in the prior webinar.
Now Holly cover these points in detail in the prior weapons.
Mike Min: and I'd point you to the recording with slides that is archived on our website.
And I'd point, you to the recording with slides that is archived on our website.
As reported we have submitted these analysis in a type C meeting request to the FDA.
Mike Min: As reported, we have submitted these analysis in a type C meeting request to the FDA.
Mike Min: The central question in that request is whether FDA will accept the AP-13 trial as a confirmatory trial to AP-3A in support of a BLA.
The central question in that request is whether FDA will accept the ADP <unk> trial.
As a confirmatory trial to AP three in support of a BLA.
Mike Min: FDA has acknowledged that meeting request and committed to answering our questions and writing.
FDA has acknowledged that meeting request and committed to answering your questions in writing.
I want to reiterate that as previously communicated.
Mike Min: I want to reiterate that as previously communicated.
Mike Min: We are on track to have clarity on that question by the end of the first half of this year.
We are on track to have clarity on that question by the end of the first half of this year.
Additionally, I want to update you on our three active COVID-19 trials.
Mike Min: Additionally, I want to update you on our three active COVID trials.
Mike Min: AP17, AP19, and AP18.
17, AP 19, and AEP 18.
Mike Min: Before doing that, however, I want to put this update into context by highlighting data in our first two COVID studies, AP-14 and AP-16.
Before doing that however, I want to put this update in the context by highlighting data in our first two Covid studies.
2014 and 16.
Mike Min: As a reminder, prior to AP 17, 18, and 19,
As a reminder.
Prior to AP, 17, 18 and 19.
Mike Min: The company conducted two studies in respiratory distress in a very different COVID lens.
Company conducted two studies in respiratory distress.
Very different COVID-19 landscape.
Mike Min: AP-14 studied 40 patients with inhaled ampion versus standard of care and demonstrated a nearly 80% reduction in mortality in the ampion harm versus standard of care.
AP 14 studied 40 patients with inhaled <unk> versus standard of care.
And demonstrated a nearly 80% reduction in mortality in the MP on harm versus standard of care.
April 16.
Mike Min: AP-16 studied 10 patients with IV-ampion versus standard of care and demonstrated no difference in mortality rates between the arms.
10 patients with IV and beyond versus standard of care and demonstrated no difference in mortality rates between the arms.
So where are we with current studies.
Mike Min: Well, firstly, AP17 was designed as a follow-on to AP16.
Well firstly.
17 was designed as a follow on to <unk> 16.
Mike Min: to evaluate IV-ampion treatment in up to 200 severe COVID-19 patients.
To evaluate IV <unk> treatment and up to 200 severe COVID-19 patients.
Mike Min: with a planned interim analysis at 30 patients for sample size re-estimation.
With a planned interim analysis at 30 patients for a sample size re estimation.
The interim enrollment and analysis is complete.
The observed safety profile of IV <unk> treatment has been excellent to date.
Mike Min: The observed safety profile of IV ampion treatment has been excellent to date and supports further study of IV administration.
And support further study of IV administration.
However.
Mike Min: However, enrollment today has been slow.
Enrollment to date has been slow.
Mike Min: And this is due to both the changing nature of COVID
And this is due to both the changing nature of Covid.
Mike Min: as well as increased competition for clinical trial patients from both approved drugs and other drugs in clinical trials.
As well as increased competition for our clinical trial patients from both approved drugs and other drugs in clinical trials.
Mike Min: In addition, we have simply not observed sufficient differentiation in the treatment signal between the two study arms and the 30 patients enrolled in the interim analysis.
In addition.
We are simply not observed sufficient differentiation and the treatment signal.
Between the two study arms in the 30 patients enrolled in the interim analysis.
Finally, given these factors it will.
Mike Min: it would take a significant increase in time and money to expand countries
Take a significant increase in time and money.
To expand countries and clinical sites.
Mike Min: to enroll more than the 200 patients originally planned to have the power to demonstrate
To enroll more than 200 patients originally planned.
To have the power to demonstrate clinical benefit.
Mike Min: Therefore, we have stopped further enrollment in AP 17.
Therefore.
We have stopped further enrollment in <unk> 17.
Mike Min: will analyze the data completely to determine next steps for the use of IP NPR.
We will analyze the data completely to determine next steps for the use of IP MPR.
Next.
Mike Min: AP-19 was designed as a follow-up to AP-14.
19 was designed as a follow up to <unk> 40.
Mike Min: to evaluate inhaled MPM treatment and up to 200 severe COVID-19 patients.
To evaluate inhaled <unk> treatment and up to 200 severe COVID-19 patients again with an interim analysis for sample size re estimation.
Mike Min: again with an interim analysis for simplified re-estimation.
Mike Min: Planned interim enrollment was completed with 129 patients in the first quarter of 2022.
Planned interim enrollment was completed with 129 patients in the first quarter of 2022.
Mike Min: We're on track to complete the data analysis by the end of the second quarter of this year at which time we'll determine and communicate next steps for this study.
We're on track to complete the data analysis by the end of the second quarter of this year.
At which time, we will determine and communicate next steps for this study.
Mike Min: However, it's important to note that we've observed a significantly lower death rate in the 129 patients enrolled in AP-19.
However.
It is important to note that we've observed a significantly lower death rate in the 129 patients enrolled in AEP 19.
Mike Min: than in the 40 patients enrolled in AP 14.
Then on the 40 patients enrolled in <unk> 14.
Mike Min: We believe this reflects the significant evolution in the COVID-19 standard of care.
We believe this reflects the significant evolution in the COVID-19 standard of care.
Mike Min: from that which existed with the AP-14 and, in fact, AP-16 trials were initiated.
From that which existed with the AP 14, and in fact April 16 trials were initiated.
The impact of this evolution of care on the AP 19 analysis remains to be seen.
Mike Min: The impact of this evolution of care on the AP-19 analysis remains to be seen.
And then finally AP 18 was designed to study inhaled and beyond use at home.
Mike Min: And then finally, AP-18 was designed to study inhaled ampion use at home in long COVID patients.
Long COVID-19 patients.
Mike Min: We completed the planned enrollment of 32 patients in December 2021.
We completed the planned enrollment of 32 patients in December 2021.
Mike Min: and are currently performing planned day 60 post-treatment safety and efficacy evaluation.
And are currently performing planned days 60 post treatment safety and efficacy evaluations.
Mike Min: which we expect to be completed during this first quarter.
Which we expect to be completed during this first quarter.
Mike Min: Once we have final study results, we will determine and communicate next steps for this program.
Once we have final study results.
We'll determine and communicate next steps for this program.
Sure.
Mike Min: With that, I'd like to turn the call back to Jan Stokely, our CFO , to update our financials.
With that I'd like to turn the call back to Dan <unk>, our CFO to update our financials great.
Jan Stokeley: Thank you, Mike. The following is an overview of our results from Operation
Thank you Mike.
The following is an overview of our results from operations for the fourth quarter and 12 months periods ending December 2021 and 2020.
Jan Stokeley: for the fourth quarter and 12-month periods ending December 2021 and 2020. We realized a net loss of $6.2 million for the fourth quarter of 2021 compared to a net loss of $4.6 million for the fourth quarter of 2020. And $17.1 million.
We realized a net loss of $6 2 million for the fourth quarter of 2021.
To a net loss of $4 6 million for the fourth quarter of 2020.
And $17 1 million.
Jan Stokeley: for the year of 2021 compared to a loss of 15.9 million for the year ending December 31, 2020.
For the year of 2021 compared to a loss of $15 9 million for the year ending December 31 2020.
Jan Stokeley: A breakdown of the key variances are as follows.
A breakdown of the key variances are as follows.
Jan Stokeley: Research and development expenses were $4.7 million for the 2021 fourth quarter compared to $2.1 million for the fourth quarter of 2020.
Search and development expenses were $4 7 million.
The 2021 and fourth quarter.
The $2 1 million for the fourth quarter of 2020.
Jan Stokeley: $11.9 million for the 2021 year compared to $9.2 million for the year ending December 31, 2020. The primary drivers of the year
At 11 9 million for the 2021 year compared to $9 2 million for the year ending December 31 2020.
The primary drivers of the year over year increase or incremental costs associated with the COVID-19 phase.
Jan Stokeley: were incremental costs associated with the COVID-19 Phase 1 and 2 studies which were initiated late in 2020 and continued during the 2021 period.
Phase one and two studies, which were initiated late in 2020 and continued during the 2021 period.
Jan Stokeley: These costs were partially offset by a reduction in costs associated with the AP013 study, which was paused in the 2020 period.
These costs were partially offset by a reduction in costs associated with the AP.
013 study, which was pause in the 2020 period.
Jan Stokeley: General and administrative expenses were $4.5 million for the 2021 fourth quarter compared to $1.8 million for the fourth quarter of 2020.
General and administrative expenses were $4 5 million for the 2021 fourth quarter compared to a $1 8 million for the fourth quarter of 2020.
Jan Stokeley: an 8.7 million for the 2021 year compared to 6.7 million for the year ended December 31, 2020.
$8 7 million for the 2021 year.
Compared to $6 7 million for the year ended.
December 31 2020.
Jan Stokeley: The increase was primarily attributable to increase in non-cash share-based compensation along with professional fees for legal and other advisory services.
The increase was primarily attributable to increase long cash share based compensation, along with professional fees for legal and other advisory services.
Cash and cash equivalents on December 31, 2021 totaled $33 9 million.
Jan Stokeley: Cash and cash equivalents on December 31 2021 total $33.9 million.
Jan Stokeley: compared to 17.3 million as of December 31, 2020.
Third to $17 3 million as of December 31, 2020.
Jan Stokeley: This increase was driven primarily from net proceeds received from the closing of a Registered Direct Offering in December of 2021, totally 20.7 million.
This increase was driven primarily.
From net proceeds received from the closing of a registered direct offering in December of 2021 totaling $27 million.
Jan Stokeley: and net proceeds of $10 million from the sale of common stock with the at-the-market equity offering program throughout the year.
And net proceeds of $10 million from the sale of common stock with the aftermarket equity offering program.
We're out the year.
Jan Stokeley: This increase was partially offset by cash used in operating activities totaling $14 million.
This increase was partially offset by cash used in operating activities.
Totaling $14 1 million.
Jan Stokeley: We expect that our cash position will fund current operations into the second half of 2023.
We expect that our cash position.
<unk> current operations into the second half of 2023.
Speaker Change: I would now like to turn the call over to Nick Johnson with Rousseau Partners, who will coordinate the Q&As.
I would now like to turn the call over to Nick Johnson with Russo partners, who will coordinate the Q&A session.
Sure.
Nick Johnson: Thank you, Dan. As a reminder, in order to submit questions, participants must have Internet connectivity. If questions will only be addressed via the webcast, the conference call line will be in listen-only mode.
Thank you Dan as a reminder, in order to submit questions participants.
Internet connectivity.
<unk> will only be addressed via the webcast. The conference call line will be in listen only mode.
Nick Johnson: First question, what is a realistic timing if all goes smoothly to get FDA approval for the use and sale of Ampion?
First question.
Is a realistic timing.
The FDA approval.
And Sam and beyond.
Speaker Change: Thank you, Nick. You know, I think realistic timing, based on the guidance we've provided, would be clarity by the end of the first half. I think we're on track to achieve that. As previously communicated, and I know some of you have recoiled at this, but the reality is that even for large pharmaceutical companies, the typical time required to submit a BLA is about 12 months.
Thank you Nick.
I think a realistic timing based on the guidance, we've provided would be clarity by the end of.
The first half I think we are on track to achieve that.
As previously communicated and I know some of you.
Have recoiled at this but the reality is that even for large pharmaceutical companies.
Typical time required to submit a BLA is about 12 months.
Speaker Change: Now, we believe we have a jump in that process, as communicated, we've begun what's called a gap analysis to determine what we have in place and what remains to be completed and assembled for that BLA, and the guidance that we've given is end of Q2 of next year. We've also indicated that we would expect resources from a partner to potentially help us accelerate that schedule.
Now we believe we have a jump on that process as communicated we've begun what's called a gap analysis to determine what we have in place and what remains to be.
We did an assembled for that BLA and the guidance that we've given is.
End of Q2 of next year.
We've also indicated that we would expect resources from partner to potentially help us accelerate that schedule.
Speaker Change: Finally, on approval, again, I think for those specifically not accustomed to drug development, approval time can typically take up to 12 months. And with COVID, that has taken a longer period of time for many, many drugs. And that's simply beyond drug sponsors control.
Finally on approval again, I think for those specifically not accustomed to drug development.
Approval time can typically take up to 12 months and with Covid that.
That has taken a longer period of time for many many drugs.
And thats simply beyond drug sponsors control.
Speaker Change: So, you know, I think a safe assumption is end of second quarter of next year for submission of the BLA.
No.
I think.
Safe assumption is end of second quarter of next year for submission of the BLA.
Speaker Change: and for an approval cycle to take up to a year.
And for an approval cycle to take up to a year.
Next question you had.
Speaker Change: Next question, do you anticipate that the same or a different partner will handle implementation of Antion for different medical conditions? Example one for me, one for long-term COVID.
The same or a different partner will handle implementation of Amp yacht.
Brent Medical condition example, one for me one for long term.
Speaker Change: Nick, I appreciate the question, and I think at this point I have to repeat what we said on the last call, which is at this point in time, all potential sizes, shapes, and flavors of partnerships are on the table. And I think once we have a heads of agreement in hand and can actually announce that, we'll be in a better position to provide clarity.
Nick I appreciate the question.
And I think at this point I have to repeat what we said on the last call which is at this point in time, all potential sizes shapes and flavors of partnerships are on the table and I think once we have.
A heads of agreement on a hand in hand, and can actually announced that we will be in a better position to provide clarity.
Next question.
Speaker Change: Next question, with COVID-19 cases dwindling down in the U.S., at the moment, what are your prospective plans for Antion for COVID-19 and log COVID, following the completion of the current COVID trial?
19 cases dwindling down in the U S.
At the moment what are your prospective plans for E&P on for COVID-19 and monitor.
Following the completion of it.
<unk>.
Speaker Change: Well, again, I think that that is a question will be better prepared to answer once we have the totality of data from the three current trials in addition to the two initial pilot studies that were conducted. One thing is very, very clear, and that is the COVID landscape has evolved rapidly.
Well again I think that that is a question, we'll be better prepared to answer once we have the totality of data from the three current trials. In addition to the two.
Our initial pilot studies that were conducted.
Conducted.
One thing is very very clear on that as the Covid landscape has evolved.
Rapidly.
Speaker Change: We're in the process of completing some externally conducted market research, for example, that suggests that since we initiated 17, 18, and 19, there are a lot of different ways to do this.
We're in the process of completing some externally conducted market research for example that suggests that since we initiated 17 18 and 19.
There are.
Eight new drugs available for the treatment of Covid.
Speaker Change: eight new drugs available for the treatment of COVID that weren't available when we initiated those trials. One is a neutralizing monoclonal antibody, three are antivirals, four are anti-inflammatories, and that's in addition of course to the significantly ramped up use of vaccines.
Werent available when we initiated those trials one is a neutralizing monoclonal antibody three or anti virals for our anti Inflammatories and that's in addition of course to the significantly ramped our fuse.
Vaccines.
Speaker Change: So I think what I can say at this time with clarity.
So I think what I can say at this time with clarity.
Speaker Change: is that we are very pleased with the safety profile for IV Ampion that emerged in our AP17 trial and that gives us encouragement in fact that IV administration of Ampion is a viable potential administration route.
Is that we are very pleased with the safety profile for IV and beyond.
That emerged in our ADP <unk> trial and that gives us encouragement in fact that IV administration of <unk> beyond is a viable potential administration route.
Speaker Change: I think we need to wait until we've completed the analysis of the data in the initial two trials and of course a part of that will continue to update our evaluation of market opportunities. So I think unfortunately we have to wait until about the middle of this year before we can provide further clarity on that.
I think we need to wait until we've completed the analysis of the data and an additional two trials and of course, a part of that will continue to update our evaluation of market opportunities.
So I think unfortunately, we have to wait until about the middle of this year before we can provide further clarity on that.
Okay.
Speaker Change: Next question. Are there any plans to run additional trials on other joints and other forms of arthritis?
Next question are there any plans to run additional trials in other joints and other forms of arthritis.
Speaker Change: At this point, tangible plans, no. We do not have any specific clinical trial protocols pending or approved to run additional trials.
At this point tangible plans no.
We do not have any specific clinical trial protocols pending or approve to run additional trials.
Speaker Change: However, I can tell you that both internally and in discussions with potential partners, we are very excited about the possibility to expand applications of Yampionc from treatment of pain of severe osteoarthritis and the knee to treatment of osteoarthritis and other articular joints.
However, I can tell you that both internally and in discussions with potential partners.
We are very excited about the possibility to expand application of E&P.
And beyond.
From treatment of pain of severe osteoarthritis of the knee.
The treatment of osteoarthritis and other articulate joints.
Speaker Change: And I think the plan to actually accomplish that expansion will benefit significantly from partner input. And so, once again, I think that's something we'll be able to provide clarity on later in the year.
And I think the plan to actually accomplish that expansion will benefit significantly from partner input and so.
Once again, I think thats, something we will be able to provide clarity on later in the year.
Speaker Change: Next question, do you see any potential earning differences between Q421 and Q122?
Next question do you see any potential earning differences between Q4 'twenty one in Q1 'twenty two.
Yeah, Hi, Nick it's a.
Speaker Change: Yeah, it's a good question. If you look at our earnings release, Q4 of 2021 had a fairly significant skew compared to the prior year.
Good question, if you look at R.
Our earnings release Q4.
2021.
A significant scale compared to the prior year.
Speaker Change: and even if you were to look at the prior quarter in the current year.
And even if you were to look at the prior quarter in the current year.
Speaker Change: And, you know, one of the large, and we spell it out in the earnings release, one of the large anomalies.
One of the large and we spelled out in the earnings release, one of the large anomalies.
Speaker Change: was that we issued some restricted stock units in the fourth quarter.
<unk>.
We issued some restricted stock units in the fourth quarter.
Speaker Change: And as we put it on press release, those are non-cash.
Sure.
And as we put our press release those are noncash.
Speaker Change: expenses and there was a piece of that that was vested upon issuance.
<unk> and there was there is a piece of that that was vested upon issuance.
Speaker Change: and it was best about 20% per year, so there is an acceleration of cost.
Does that about 20% per year. So there is an acceleration of costs.
Speaker Change: On-Cast in the fourth quarter, there was also
On cash in the fourth quarter there was also.
Speaker Change: some professional fees that I would consider to be more weighted in the fourth quarter. On the R&D side...
Professional fees that I would consider to be more weighted in the fourth quarter.
On the R&D side.
Speaker Change: In the fourth quarter, there was a fairly substantial enrollment.
In the fourth quarter there was a.
A fairly substantial enrollment.
Speaker Change: up quick on the COVID program specifically on 019 and the completion of 018 and as we
Uptake on the Covid program, specifically I don't know one nine.
Felicia.
Right.
As we as we have.
Speaker Change: And so, you know, I would expect the run rating Q1 from a cash burn standpoint to probably use slightly lower.
So to the public markets.
Has finished enrollment.
And so I would expect.
The run rate in Q1.
Cash a cash burn standpoint to frontload slightly lower.
Speaker Change: And then taking into account the non-cash, it would be slightly lower on that perspective as well because of the acceleration of the non-cash expense.
And then taking into account the noncash.
Yes.
This is slightly lower than that on that perspective, as well because of the acceleration of the noncash expense.
Yes.
Speaker Change: Next question. From the AP013 study, can you please explain the difference between the two modified studies submitted to the FDA?
Next question from.
AP Zero 13 study can you. Please explain the difference between the two modified study submitted to the FDA.
Speaker Change: Sure. The difference between the two modified studies submitted to the FDA, I would first say that the first study submitted 3A wasn't modified. That has been submitted and accepted by the AUC as one trial to support a BLA based on both the intent to treat and protocol endpoints that were specified in the protocol.
Sure.
The difference between the two modified studies.
Submitted to the FDA I would first say that the first studies submitted three eight.
It wasn't modified that has been submitted and accepted by the agency as one trial to support.
La based.
Based on both the intend to treat and per protocol endpoints that were specified in the protocol.
Speaker Change: I would ask Holly to review the proposed modifications to trial 13.
I would ask <unk> to review the proposed modifications to trial 13, Thanks, Mike to elaborate on what you said the AP 13 protocol increased submissions and proposal to the FDA, including the two populations just discussed the intent to treat or ITT population and the curve.
Speaker Change: Thanks, Mike. To elaborate on what you said, the AP-13 protocol includes the submission to a proposal to the FDA, includes the two populations just discussed, the intent to treat or ITT population and the per protocol population, as well as a proposed modified intent to treat to take into account an evaluation of those patients with a target indication who are not impacted by COVID-19.
Protocol population as well as the proposed modified intent to treat to take into account.
And evaluations of those patients with a target indication who are not impacted by COVID-19.
Okay.
Next question.
Speaker Change: So what will management focus on while we waste some clarity with the FDA?
So would management focused on while we wait for clarity with the FDA.
Yeah.
Speaker Change: What will we focus on? Well, number one, as I indicated earlier, we are waiting for the answer from FDA. We're beginning to assess our BLA, fill the gaps, and assemble that document.
What will we focus on as well.
Number one as I indicated earlier, we are waiting for the answer from FDA. We are beginning to assess our BLA fill the gaps and assemble that document.
Speaker Change: Number two, I think we've been pretty clear that we're pleased with the level of interest from potential partners, and that interest takes up a lot of time in terms of both confidential discussions, follow-ups and answering questions, and keeping the confidential data room to give them access to our confidential data fresh.
Number two.
I think we've been pretty clear that we're pleased with the level of interest from potential partners.
And that interest picks up a lot of time in terms of both confidential discussions.
Follow up finance are in questions and keeping the confidential data room to give them access to our confidential data.
Fresh.
Speaker Change: Number three, I hope it's been pretty clear that we are not giving up on product development. I would characterize our research and development approach as more focused.
Number three.
Hope, it's been pretty clear that we are not giving up on product development I would characterize our research and development approach as more focused.
Speaker Change: And related to that, we are undertaking to, on the one hand, update our appreciation and understanding for the oak market and what will be required to successfully launch product in that market.
And related to that we are undertaking to on the one hand update our appreciation and understanding for the <unk> market and what will be required to successfully launch product in that market.
Speaker Change: And even though we don't plan to do that ourselves, we plan to get a partner, our conversions on those issues, our level of knowledge on those issues will be a very important part of the negotiating process.
And even though we don't plan to do that ourselves we plan to get a partner.
Our conversion on those.
Issues, our level of knowledge on those issues.
A very important part of the negotiating process.
Speaker Change: And then finally, as indicated, we're very excited about the opportunity to expand ampion application from oak to other joints, perhaps beyond the treatment of other joints.
And then finally as has indicated we're very excited about the opportunity to expand beyond application from oak two other joints.
Perhaps beyond the treatment of other joints and perhaps in other dosage forms and or other formulations.
Speaker Change: and perhaps in other dosage forms and or other formulations. So, you've heard me say before that we're a 20-person team, and I would say that that team is very well engaged today on five or six key corporate goals for the coming year.
So you've heard me say before that were 20 person team.
And I would say that that team is.
Is very well engage today on five or six key corporate goals for the coming year.
That concludes our Q&A session. We will now turn the call back to Mike Martino for closing remarks.
Speaker Change: That concludes our Q&A session. We will now turn the call back to Mike Martino for closing remarks.
Yes.
<unk>.
Martine: Thank you, Nick. Listen, everybody, I want to summarize that I really believe we've made good progress, and it's maintained, and if anything, increased momentum as we move from Q4 of 2021 into Q1 of 2022. I'm extremely proud of the lean team here for their hard work in delivering this progress.
Thank you Nick listen everybody I want to summarize that I really believe we've made good progress.
<unk> maintained and if anything <unk> momentum as we move from Q4 of 2021 and into Q1 of 2022 I'm extremely proud of our lean team here for their hard work in delivering this progress.
Martine: I am very optimistic, cautiously so, about the future and specifically the next value inflection point being feedback from FDA.
Im very optimistic cautiously so about the future and specifically the next value inflection point being feedback from FDA.
Martine: And I and we look forward to updating you on our next call as we continue to make progress.
And I and we look forward to updating you on our next call as we continue to make progress.
Speaker Change: So thank you, everyone. Operator, please conclude the call.
So thank you everyone. Operator, please conclude the call.
Speaker Change: Thank you. This does conclude today's call. Thank you all for joining. You may now disconnect your line.
Thank you. This does conclude today's call. Thank you for joining you may now disconnect your line.
Okay.
Speaker Change: Thank you.
Yeah.
Okay.
Yes.
Okay.
Okay.
Okay.