Ampio Pharmaceuticals, Inc. (AMPE)·Q4 2020 Earnings Summary

Executive Summary

• Ampio reported FY 2020 results alongside its Q4 2020 business update: cash ended at $17.3M, total operating expenses fell to $15.8M, and net loss was $15.9M ($0.09 diluted loss per share) versus $13.6M in FY 2019 ($0.14 diluted loss) .
• The FDA recommended randomized, double‑blinded, placebo‑controlled Phase II trials for both inhaled (AP‑014) and IV (AP‑017) Ampion to support potential EUA for COVID‑19; management is finalizing protocols and expected to start the inhaled Phase II in early Q2 2021 .
• OAK (osteoarthritis of the knee) Phase III remains paused due to COVID; Ampio submitted a proposal to analyze existing patients under the SPA without adding new patients, awaiting written FDA confirmation before unblinding .
• Liquidity runway improved: management guides sufficient cash and access to liquidity to fund R&D and operations through Q1 2022; base business burn rate ~$0.7M/month, implying >12 months coverage without incremental clinical trial costs .
• Audit opinion includes a going‑concern qualification in the 2020 10‑K, a potential overhang; however cash strengthened via ATM and warrant exercises in 2020 (net proceeds $25.6M) .

What Went Well and What Went Wrong

• What Went Well

  • FDA feedback explicitly outlined Phase II designs for both COVID‑19 programs, creating a clearer regulatory path toward potential EUA. “They indicated that their recommended trial design for both will allow for an effective and efficient review… necessary… to consider [Ampion] for emergency use authorization (EUA)” .
  • Preliminary inhaled Ampion data (Phase I) showed favorable signals versus standard of care: all‑cause mortality 8% vs 21%, average hospital stay 7 vs 11 days, and 86% vs 75% stable/improved patients by day 5; no drug‑related serious adverse events reported .
  • Liquidity position improved: year‑end cash $17.3M (vs $6.5M prior year) driven by ATM and warrant exercises, supporting R&D continuity and trial initiation plans .

• What Went Wrong

  • The 2020 audit opinion carried a going‑concern qualification, highlighting continued financing and execution risk for a development‑stage pipeline .
  • Net loss widened to $15.9M in FY 2020 (vs $13.6M in FY 2019), primarily due to lower other income (derivative gain reversal), despite reduced R&D from trial pauses .
  • OAK Phase III remains paused and blinded; timelines depend on FDA acceptance of the proposed amendment, delaying potential BLA submission and value inflection in the core OAK indication .

Financial Results

• Annual P&L and balance highlights

• Quarterly snapshot (liquidity trajectory)

• Select quarterly operating metrics

• COVID‑19 clinical signals (preliminary, inhaled Ampion vs standard of care)

Note: Ampio did not present product revenue lines; statements of operations consist of operating expenses and other income/expense items (pre‑revenue status) .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The FDA… recommend[ed] we conduct a randomized, double‑blinded, placebo‑controlled Phase II trial in each [inhaled and IV]. They also indicated that their recommended trial design… may be considered for emergency use authorization (EUA)” .
• “We will not unblind the [OAK] data at all until we have written confirmation from the FDA that our proposal has been accepted and our existing SPA remains in effect” .
• “Preliminary [inhaled Ampion] results… indicate Ampion demonstrated an improvement in all‑cause mortality… 8% vs 21%… average hospital length of stay… 7 vs 11 days… 86%… stable or had improvement vs 75%” .
• “We expect to have sufficient cash and readily available external liquidity to fund the company’s research and development programs and overall operations into 2022” .
• “Ampion is a platform biologic… agnostic to whether it is treating a COVID patient or an osteoarthritis auto‑immune condition… directly and effectively addresses inflammation” .

Q&A Highlights

• Analysts pressed on OAK unblinding and statistical robustness; management emphasized using existing large KL4 datasets and awaiting FDA acceptance to preserve SPA before unblinding .
• Safety questions on IV and inhaled Ampion: management reported no safety issues to date and noted FDA’s willingness to expand trials with placebo controls .
• Timing concerns: delays hinge on IRB approvals, hospital logistics, and aligning Israeli protocol adjustments with FDA EUA guidance; management outlined complexities and readiness on drug, training, and site selection .
• Liquidity clarity: base business burn ~$0.7M/month; management expects runway into first quarter next year even excluding further financing, with clinical trial costs variable by design/timing .

Estimates Context

• S&P Global consensus for Q4 2020 EPS and revenue was unavailable due to missing CIQ mapping for AMPE in the S&P database (tool error indicated no CIQ company mapping). As a result, comparisons to Wall Street estimates could not be made. Estimates via S&P Global were unavailable for this ticker at the time of analysis.

Key Takeaways for Investors

• Regulatory clarity improved materially: formal FDA guidance to run randomized Phase II for both inhaled and IV Ampion is a tangible step toward potential EUA; successful Phase II outcomes would be a significant catalyst .
• Early clinical signals in inhaled Ampion are encouraging (mortality, LOS, clinical improvement), supporting investment in Phase II; monitor protocol finalization and enrollment start in early Q2 2021 .
• OAK remains a swing factor: if FDA accepts the SPA amendment to analyze existing patients and unblinding shows statistical significance, BLA filing could re‑anchor the long‑term thesis in the core OA indication .
• Liquidity runway has strengthened, but the going‑concern qualification and reliance on equity financing remain risks; stock moves may be sensitive to financing updates and trial cost visibility .
• Near‑term trading setup: headlines on FDA feedback, Phase II start, and preliminary readouts (including Long Hauler inhaled trial commencement) likely drive volatility; positioning should reflect binary event risk typical of small‑cap biotech .
• Medium‑term thesis: platform biologic approach across inflammation indications (COVID respiratory, Long Haulers, kidney injury, pediatric PLE) broadens optionality, but execution in OAK and COVID programs will be tested in larger, controlled trials .
• Watch for partnering/licensing discussions as data matures—management flagged increased focus on monetization beyond EUA/BLA pathways .