Ampio Pharmaceuticals(AMPE)
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Ampio Pharmaceuticals(AMPE) - 2021 Q4 - Earnings Call Transcript
2022-03-29 22:41
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 ...
Ampio Pharmaceuticals(AMPE) - 2021 Q3 - Earnings Call Transcript
2021-11-11 03:17
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 ...
Ampio Pharmaceuticals(AMPE) - 2021 Q2 - Earnings Call Transcript
2021-08-04 23:18
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(AMPE) - 2021 Q1 - Earnings Call Transcript
2021-05-07 15:19
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(AMPE) - 2020 Q4 - Earnings Call Transcript
2021-03-04 04:04
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 ...