Ampio Pharmaceuticals, Inc. (NYSE:AMPE) Q4 2021 Earnings Conference Call March 29, 2022 4:30 AM ET Company Participants Michael Martino - Chairman and Chief Executive Officer Dan Stokely - CFO Holli Cherevka - President and COO Howard Levy - Chief Medical Officer Nicolas Johnson - Russo Partners, LLC Conference Call Participants Operator Good day everyone and welcome to Ampio'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 M ...

Product Development and Clinical Trials - Ampio Pharmaceuticals is focused on developing immunomodulatory therapies for pain from osteoarthritis, with its lead product candidate, Ampion, targeting severe osteoarthritis of the knee and COVID-19 related conditions[15]. - Ampion is currently involved in four clinical trials, including a Phase 3 study for severe osteoarthritis of the knee and Phase 2 studies for COVID-19 patients requiring oxygen supplementation[15]. - The ongoing clinical trials include an intra-articular injection for knee pain, inhalation for respiratory distress in COVID-19 patients, and intravenous administration for severe COVID-19 cases[19]. - Ampion is being developed as an intra-articular injection for severe osteoarthritis (OAK), addressing an unmet medical need with no existing licensed therapy available[21]. - The AP-003-A Phase 3 trial showed a statistically significant reduction in pain of over 40% from baseline at 12 weeks for patients treated with Ampion compared to saline control[23]. - The AP-013 study, which enrolled 1,043 patients, demonstrated a significant reduction in pain (p=0.042) and trends towards functional improvement in severely diseased OAK patients[25]. - The Per-Protocol analysis of the AP-013 study showed statistical superiority of Ampion for pain (p=0.020) and function (p=0.027) compared to saline[27]. - In the AP-014 study, the mortality rate for COVID-19 patients treated with inhaled Ampion was 5%, compared to 24% in the standard of care group, representing an almost 80% improvement[31]. - Patients treated with Ampion in the AP-014 study had an average hospital stay four days shorter than those receiving standard of care[31]. - The Phase 2 study, AP-017, is designed to enroll approximately 200 patients to evaluate the safety and efficacy of intravenous Ampion in COVID-19 patients requiring oxygen supplementation[32]. - The AP-019 study for inhaled Ampion treatment has commenced enrollment in the U.S. with approximately 200 patients targeted, utilizing an interim analysis at 150 patients for sample size re-estimation[34]. - The AP-018 study, focusing on Ampion for Long-COVID, enrolled 32 patients and aims to complete safety and efficacy measures by Q1 2022[35]. Market Potential and Financial Outlook - The osteoarthritis treatment market was valued at approximately $5.8 billion in 2020 and is expected to reach $8.2 billion by 2026, growing at a compound annual growth rate of 5.8%[22]. - Ampio Pharmaceuticals has incurred significant losses since inception and expects to continue incurring net losses for the foreseeable future[10]. - The company is actively seeking strategic partnerships and collaborations to enhance its development and commercialization efforts[12]. - Ampio's ability to navigate the regulatory approval process and secure funding will be critical for its future operations and product development[10]. - Ampion's marketing outside the U.S. depends on obtaining foreign regulatory approvals, which may take longer than anticipated[46]. - The company has incurred significant losses since inception and expects to continue incurring net losses for at least the next several years[10]. Regulatory and Compliance - The FDA application user fee for a BLA is approximately $3.1 million, with a potential waiver for small businesses, which Ampio intends to apply for[43]. - The FDA has committed to a goal of 60 days to determine if a BLA application will be accepted for filing, with standard reviews typically taking ten months[43]. - The company has advanced through late-stage clinical trials for Ampion's treatment of OAK in the U.S., but final regulatory approval is not guaranteed[44]. - Emergency Use Authorization (EUA) may be granted under specific conditions, but the data from ongoing studies may not secure EUA for Ampion[45]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of BLA approval, which can significantly impact market potential[49]. - The company is subject to various federal and state regulations, including those related to pricing transparency and healthcare compliance[50][52]. - The regulatory landscape may impact the commercialization and profitability of Ampion if it is not considered cost-effective by payors[52]. - The company faces ongoing regulatory scrutiny and potential penalties related to compliance with healthcare laws and pricing regulations[50]. Intellectual Property - The company has a robust patent portfolio for Ampion, with protection extending through 2037 for osteoarthritis and 2041 for viral respiratory conditions, potentially qualifying for 12-year FDA market exclusivity if approved as a novel biologic[15]. - The company has a patent portfolio for Ampion consisting of nine families, with expiration dates ranging from 2024 to 2041[56][58]. - The first patent family for Ampion, related to treating inflammatory diseases, will expire in 2024[56]. - The second patent family, focused on degenerative joint diseases, has a standard expiration in 2032[56]. - The third patent family, concerning stem cell treatment, will expire in 2034[56]. - The ninth patent family, which includes claims for treating viral respiratory conditions like COVID-19, will expire in 2041[58]. - The company is focusing on maintaining patent protection for Ampion, with a strategic reduction in the overall number of patents while ensuring coverage in key jurisdictions[56]. Manufacturing and Supply Chain - The manufacturing facility has a maximum capacity of approximately 8 million 5 mL vials per year, with a significant number of vials produced to support the BLA filing[36]. - The company has successfully produced Ampion and placebo for clinical trials, demonstrating its capability to meet international quality standards[36]. - The company is currently sourcing key components for Ampion from major suppliers, including Nova Biologics and Sartorius Stedim[62]. - The company plans to identify secondary suppliers post commercialization to mitigate risks associated with sole source suppliers[62]. - The company has obtained clinical trial liability coverage for human clinical trials and plans to secure appropriate product liability insurance upon regulatory approval of Ampion[62]. Employee and Operational Insights - As of February 15, 2021, the company had 21 full-time employees and a voluntary turnover rate of 15%[63]. - The company has implemented a flexible paid time off policy to support employee work-life balance[63]. - The company provides 100% coverage of employees' medical benefits and a 401(k) employer matching contribution, effective January 1, 2022, to enhance employee retention[63]. - The company believes it is in compliance with current environmental protection requirements, with costs attributable to compliance not currently material[61]. - The company has established internal controls related to information systems, which are deemed adequate for managing core business operations[55].

Ampio Pharmaceuticals, Inc. (NYSE:AMPE) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Dan Stokely - CFO Holli Cherevka - President and COO David Bar-Or - Director and Founder Howard Levy - Chief Medical Officer Conference Call Participants Operator Good afternoon and welcome to Ampio Pharmaceuticals 2021 Third Quarter Earnings Results and Corporate Update call. We'll be the event specialist running today's event. [Operator Instructions] As a reminder, this call is being ...

Financial Data and Key Metrics Changes - Cash and cash equivalents increased to $20.5 million as of June 30, 2021, from $17.3 million on December 31, 2020, primarily due to net proceeds from an ATM equity offering of approximately $9.5 million, partially offset by $6.5 million used for business operations [7] - The net loss for Q2 2021 was $3.6 million, compared to a net loss of $2.7 million in Q2 2020, with operating expenses rising to $3.7 million in 2021 from $2.6 million in 2020 [8][9] - For the six months ended June 30, 2021, the net loss was $7.2 million, a decrease from $7.9 million in the same period in 2020 [9] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses for Q2 2021 were $2.3 million, reflecting a 103% increase from the same period in 2020, attributed to costs from new trials and CRO efforts [9][10] - General and administrative (G&A) expenses decreased by $0.1 million or 6% in Q2 2021 compared to Q2 2020, and by $0.3 million or 10% for the six months ended June 30, 2021, due to reduced litigation-related legal costs [11][12] Market Data and Key Metrics Changes - The company is expanding its clinical trials for inhaled Ampion to India, which is expected to accelerate enrollment and results due to the high density of COVID-19 infections in the region [19][26] - The FDA has provided guidance on the sensitivity analysis for the OAK trial, which will be incorporated into the study to account for the impact of COVID-19 [24] Company Strategy and Development Direction - The company is focused on unblinding the OAK Phase 3 study data using a sensitivity analysis to minimize pandemic-related biases, with results expected to be released shortly after data validation [15][17] - Ampio has engaged a new global strategic advisory firm to assist with partnering objectives, focusing on OAK and inflammatory conditions [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the pressures on the sector and stock but emphasized ongoing discussions with pharmaceutical partners and the importance of data quality in attracting interest [14][62] - The company expects to have sufficient cash and liquidity to fund operations through Q4 2022, indicating a stable financial position [12] Other Important Information - The company is actively enrolling patients in multiple clinical trials, including studies for COVID-19 and long COVID, with promising early results reported [26][27] - Ampio is positioned as a novel treatment for osteoarthritis, with ongoing research into its applications for other inflammatory diseases, including lupus [30] Q&A Session Summary Question: Has the Delta variant or vaccine hesitancy affected COVID trial enrollment? - Management noted that enrollment remains challenging due to regulatory hurdles and the complexity of American trials, despite efforts to ensure patient access to Ampion clinical trials [33][34] Question: How does the current lower death rate from COVID affect the evaluation of mortality in trials? - The study continues to focus on severe and critical patients, with mortality rates still significant among ventilated patients, indicating ongoing relevance for the trial [36][37] Question: What is the timeline for unblinding Phase III data for potential partners? - Management confirmed that unblinding is in progress and is expected to generate interest based on the quality of the data [39] Question: Can you explain the decision-making process for unblinding the data? - The decision was made to unblind the data to facilitate discussions with potential partners, leveraging historical data to support the trial's outcomes [42][43] Question: What are the next steps assuming good data from the trials? - The goal is to partner with a company that has global distribution capabilities, rather than commercializing the drug independently [49] Question: What is the expected timeline for distributing Ampion in India? - Management indicated that dosing in India could begin within the current quarter, pending regulatory approvals [52][53] Question: Will potential partners provide funding for Ampion? - Partnering discussions typically involve upfront payments, milestones, and royalties, with a focus on securing non-dilutive capital [54] Question: What is the application of Ampion in lupus treatment? - Research is ongoing into Ampion's effects on toll-like receptor 7, which could have significant implications for treating lupus nephritis [55][56] Question: How quickly can production ramp up if EUA is granted? - The company is prepared to transition quickly to production, with capabilities already in place for various formulations of Ampion [58][59]

Ampio Pharmaceuticals, Inc. (NYSE:AMPE) Q1 2021 Earnings Conference Call May 5, 2021 4:30 PM ET Company Participants Dan Stokely - Chief Financial Officer Mike Macaluso - Chairman and Chief Executive Officer Dr. David Bar-Or - Director and Founder Holli Cherevka - Chief Operating Officer Conference Call Participants Jonathan Aschoff - Roth Capital Operator Thank you, and welcome to the Ampio Pharmaceuticals First Quarter 2021 Earnings Result and Business Update Webinar. As a reminder, this call is being rec ...

Ampio Pharmaceuticals, Inc. (OTC:AMPE) Q4 2020 Earnings Conference Call March 3, 2021 4:30 PM ET Company Participants Dan Stokely – Chief Financial Officer Mike Macaluso – Chairman and Chief Executive Officer Holli Cherevka – Chief Operating Officer David Bar-Or – Director and Founder Conference Call Participants Jonathan Aschoff – ROTH Capital Operator Thank you, and welcome to Ampio Pharmaceuticals' 2020 Earnings Results and Corporate Update Webinar. As a reminder, this call is being recorded and all list ...