Ampio Pharmaceuticals, Inc.

Good day everyone and welcome to NPO's 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 Stokely, Chief Financial Officer. Please go ahead, sir.

Hello everyone and welcome to NPO'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. Our fourth quarter 2021 10-K and earnings information was released today, March 29, 2022, at 4.10 p.m. Eastern Time and can be found in the investor section on our website, ampiopharma.com, under financial filings. Before we begin, I'd like to remind our listeners that this presentation may contain forward-looking statements about our business. 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. These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe, estimate, predict, potential, forecast, continue, or the negative of these terms or other words or terms of similar meaning. Risks and uncertainties that could cause our actual results to differ materially from those set forth in any forward-looking statements include that 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, 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. Statements and information in this presentation, including forward-looking statements, 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 forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Now, I would like to turn the call over to Chairman and CEO, Mike Martino.

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. Liz has nearly three decades of legal and compliance experience. 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 Liz join the board. Just a few weeks ago, on March 2nd, We hosted a webinar to disclose and discuss AP 13 data, update you on the status of our discussions with FDA, and update you on the status of the COVID trials. Frankly, and as expected, not much has changed in the past few weeks. So this call will be a quick refresher, primarily focused on updating our financial results and answering questions. To begin, I'd like to summarize what we believe are the major takeaways from our webinar call regarding the status of AP 13 and discussions with FDA as follows. We enrolled 1,043 patients in AP 13 versus a targeted enrollment of 1,034 patients. COVID-19 had a material impact on the trial. specifically impacting sites and patient examination visits and resulting in a material amount of missing efficacy data. The FDA recommended we conduct a sensitivity analysis to detect the impact of COVID-19 on the study, which we outlined and documented in a study plan prior to unblinding the study data. This assessment determined that there were, in fact, two patient populations. A pre-COVID population with approximately 7% missing data and a during COVID population with approximately 70% missing data. Consistent with that plan and analysis, we have proposed a modified intent to treat or MITT population with an N of 618 patients to evaluate efficacy in the AP13 trial. Applying the statistical analysis plan and the trial protocol, we have determined the following. First, the intent to treat was not statistically significant for either pain or function. which is frankly not surprising given the large amount of missing data and mandated imputation. Second, 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. Finally, the protocol analysis in an N of 580 patients demonstrated statistical superiority for both pain and function. Now, Holly covered these points in detail in the prior webinar. and I'd point you to the recording with slides that is archived on our website. As reported, we have submitted these analyses in a Type C meeting request to the FDA. The central question in that request is whether FDA will accept the AP13 trial as a confirmatory trial to AP3A in support of a BLA. FDA has acknowledged that meeting request and committed to answering our questions in writing. I want to reiterate that, as previously communicated, 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 trials, AP17, AP19, and AP20. Before doing that, however, I want to put this update into context by highlighting data in our first two COVID studies, AP14 and AP16. As a reminder, prior to AP17, 18, and 19, the company conducted two studies in respiratory distress in a very different COVID landscape. AP14 studied 40 patients with inhaled Ampion versus standard of care and demonstrated a nearly 80% reduction in mortality in the Ampion arm versus standard of care. AP16 studied 10 patients with IV Ampion versus standard of care and demonstrated no difference in mortality rates between the arms. So where are we with current studies? Well, firstly, AP17 was designed as a follow-on to AP16 to evaluate IV Ampion treatment in up to 200 severe COVID-19 patients with a planned interim analysis at 30 patients for sample size re-estimation. The interim enrollment and analysis is complete. The observed safety profile of IV and beyond treatment has been excellent to date and supports further study of IV administration. However, enrollment to date has been slow, and this is due to both the changing nature of COVID as well as increased competition for clinical trial patients from both approved drugs and other drugs in clinical trials. In addition, we have simply not observed sufficient differentiation in the treatment signal between the two study arms in the 30 patients enrolled in the interim analysis. Finally, given these factors, it would take a significant increase in time and money to expand countries and clinical sites to enroll more than the 200 patients originally planned to have the power to demonstrate clinical benefit. Therefore, we have stopped further enrollment in AP17. We'll analyze the data completely to determine next steps for the use of IP Ampion. Next, AP19 was designed as a follow-up to AP14 to evaluate inhaled Ampion treatment in up to 200 severe COVID-19 patients, again with an interim analysis for sample size re-estimation. Planned interim enrollment was completed with 129 patients in the first quarter of 2022. 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. However, it's important to note that we've observed a significantly lower death rate in the 129 patients enrolled in AP19 than in the 40 patients enrolled in AP14. We believe this reflects the significant evolution in the COVID-19 standard of care from that which existed with the AP-14 and, in fact, AP-16 trials were initiated. 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 Ampion use. at home in long COVID patients. We completed the planned enrollment of 32 patients in December 2021 and are currently performing planned day 60 post-treatment safety and efficacy evaluations, which we expect to be completed during this first quarter. Once we have final study results, We will determine and communicate next steps for this program. With that, I'd like to turn the call back to Dan Stokely, our CFO, to update our financials.