Ampio Pharmaceuticals(AMPE) - 2021 Q2 - Earnings Call Transcript

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]