Sign in

You're signed outSign in or to get full access.

AP

Ampio Pharmaceuticals, Inc. (AMPE)·Q1 2021 Earnings Summary

Executive Summary

  • Q1 2021 net loss narrowed to $3.667M ($0.02 diluted EPS) from $5.179M ($0.04 diluted EPS) in Q1 2020, driven by lower clinical trial spend as OAK AP-013 remained paused; cash ended at $15.804M, down from $17.346M at year-end .
  • FDA provided multiple pathways to maintain the OAK Phase III SPA; management is cleaning/blinded and preparing to unblind data once the partner and FDA pathway are set, with partnering discussions re-engaged and ongoing .
  • COVID-19 platform advanced: AP-014 Phase I inhaled Ampion met safety/tolerability and showed a 78% reduction in all-cause mortality vs SOC (5% vs 24%); Ampio plans to commence double-blind, placebo-controlled Phase II trials (inhaled and IV) and a Long-COVID Phase I in Q2 2021, with EUA targeted upon confirmation .
  • Liquidity runway extended: guidance now to fund operations through Q2 2022 (vs Q1 2022 prior), supported by ATM proceeds and warrant exercises; focus remains on a strategic partnership to monetize the Ampion platform .
  • Scientific updates highlighted differentiated anti-inflammatory MoA: TLR7 inhibition (up to 96% cytokine/chemokine reduction), macrophage M2 polarization, and thrombomodulin upregulation (anti-coagulation relevance), expanding platform potential beyond OAK and COVID .

What Went Well and What Went Wrong

What Went Well

  • AP-014 Phase I results: mortality reduced to 5% with Ampion vs 24% SOC; shorter hospital stays (7 vs 11 days), better oxygen requirements, and improved stability by Day 5, supporting progression to double-blind Phase II and potential EUA path .
  • FDA engagement delivered options to keep the OAK SPA intact and statistical/enrollment frameworks suited for COVID-impacted trials, enabling a clearer path forward without restarting AP-013 .
  • Platform science advances: Ampion significantly inhibits TLR7 pathway and directs anti-inflammatory M2 macrophages; thrombomodulin upregulation may mitigate inflammation-associated clotting—broadening addressable indications with favorable safety vs steroids .

What Went Wrong

  • Operating cash burn of $4.1M in the quarter reduced cash by $1.5M despite ATM/warrant proceeds, underscoring continued financing dependency without revenue .
  • Other income fell YoY ($0.152M vs $0.842M) due to lower derivative gains, removing a prior tailwind and contributing to net loss, though still narrower than Q1 2020 .
  • OAK and COVID trial start timelines faced IRB and protocol modification delays; management emphasized dependencies on FDA, IRBs, hospital training, and international regulators (e.g., Israel/India), limiting definitive scheduling .

Financial Results

Income Statement (Q1 YoY)

MetricQ1 2020Q1 2021
Research & Development ($USD Millions)$4.254 $2.296
General & Administrative ($USD Millions)$1.767 $1.523
Total Operating Expenses ($USD Millions)$6.021 $3.819
Other Income ($USD Millions)$0.842 $0.152
Net Loss ($USD Millions)$5.179 $3.667
Basic EPS ($USD)$(0.03) $(0.02)
Diluted EPS ($USD)$(0.04) $(0.02)

Liquidity and Shares

MetricDec 31, 2020Mar 31, 2021
Cash & Cash Equivalents ($USD Millions)$17.346 $15.804
Common Shares Outstanding (Units)193,378,996 195,689,128

Sequential Indicators

MetricQ4 2020Q1 2021
R&D Expense ($USD Millions)$2.1 $2.296
Cash & Cash Equivalents ($USD Millions)$17.346 $15.804

Clinical KPIs (COVID-19 AP-014 Phase I)

KPIResultPeriod
All-cause mortality (Ampion vs SOC)5% vs 24% Phase I
Reduction vs SOC78% reduction Phase I
Avg hospital stay (days)7 vs 11 (Ampion vs SOC) Phase I
Stability/Improvement by Day 586% Ampion vs 75% SOC Phase I
Safety/TolerabilityMet primary endpoint Phase I

Note: Ampio did not report product revenue; financial statements comprise operating expenses, other income and net loss .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity runwayOperations fundingThrough Q1 2022 Through Q2 2022 Raised
COVID-19 trials (Phase II)Inhaled & IVNot previously scheduled in detailBegin U.S. enrollment in Q2 2021 Initiated timeline
Long-COVID trial (Phase I)InhaledNot previously scheduled in detailExpected to commence U.S. enrollment in Q2 2021 Initiated timeline
OAK AP-013 SPAPhase III pathSPA amendment submitted; remain blinded pending FDA FDA response provides options to maintain SPA and choose path with partner; remain blinded while cleaning data Clarified options

Earnings Call Themes & Trends

TopicQ3 2020 (Prior-2)Q4 2020 (Prior-1)Q1 2021 (Current)Trend
OAK Phase III (SPA)Trial paused; SPA amendment submitted; focus on FDA COVID-19 guidance Proposed analyzing existing completed 12-week data under SPA; remain blinded; target FDA acceptance before unblinding FDA provided options to maintain SPA; clean data; unblind quickly once partner path set Progressing toward resolution
COVID-19 trials (inhaled/IV)AP-014/AP-016 updates; EUA discussions; differentiated vs other therapeutics AP-014 prelim efficacy; FDA recommended randomized double-blind Phase II for EUA consideration; IV expansion to Israel; protocol updates AP-014 Phase I met safety; 78% mortality reduction; Phase II to commence Q2; IV Phase II planned; Long-COVID Phase I starting; multi-country expansion (Israel/India) Acceleration
Platform positioningEmphasis on immunology-based platform; pipeline overview Ampion agnostic to source of inflammation; broader indications beyond COVID/OAK Strong platform message; partner strategy to leverage resources; multiple animal studies/collaborations (children’s hospital, kidney disease) Broadening scope
Regulatory interactionsFDA COVID trial conduct guidance awareness Active dialogue with FDA on SPA and EUA; IRB/MoH dependencies Specific FDA statistical/enrollment guidance; path clarity to maintain SPA and progress EUA trials Improved clarity
Financing/liquidityCash $9.4M at 9/30/20; ATM utilization noted Cash $17.3M YE; going concern qualification disclosed Cash $15.8M; runway through Q2 2022; ATM/warrant proceeds offset burn Extended runway
Science/Mechanism—In vitro/clinical rationale for inflammation targeting TLR7 inhibition (up to 96% cytokine reduction), M2 polarization, thrombomodulin upregulation; cellular immunity observations with spike protein stimulation Strengthened MoA

Management Commentary

  • “Getting the deal done is my 100% focus…we never intended to file the BLA for Ampion ourselves…we need to leverage the expertise and resources of a large strategic partner.” — CEO Mike Macaluso .
  • “Cash and cash equivalents totaled $15.8 million…cash used in operating activities of $4.1 million, partially offset by ATM and warrant proceeds totaling $2.6 million.” — CFO Dan Stokely .
  • “AP-014 Phase I…met its primary endpoint of safety and tolerability, and a 78% reduction in all-cause mortality was observed…we look forward to promptly enrolling…double-blind, placebo-controlled Phase II trials…to move quickly in applying for Emergency Use Authorization.” — CEO Mike Macaluso .
  • “The FDA recently provided us with…statistical guidance…and opportunities to…maintaining…a special protocol assessment…we continue to remain blinded.” — COO Holli Cherevka .

Q&A Highlights

  • OAK next steps: Management stayed in monthly contact with potential partners; FDA confirmed no need to rerun trial; data cleaning expected to take 1–2 months; unblinding awaits FDA/partner pathway to preserve label/pricing flexibility .
  • Trial logistics: Multi-hospital, multi-country enrollment to accelerate timelines; IRB alignment delays acknowledged; India considered for inhalation study due to patient availability .
  • Safety: FDA emphasis on safety persists; early IV and inhaled experiences showed no safety issues; expansion with placebo control endorsed by FDA .
  • Indication expansion: Peripheral neuropathy cream concept; broader ARDS/COPD/asthma applicability discussed, post-COVID platform vision reiterated .

Estimates Context

  • Attempts to retrieve S&P Global consensus (EPS and Revenue) for AMPE Q1 2021 failed due to missing Capital IQ mapping, rendering Wall Street estimate comparisons unavailable for this quarter. If S&P Global estimates become available, we will anchor comparisons to consensus means and note beats/misses explicitly. Values would be retrieved from S&P Global.*

Key Takeaways for Investors

  • Sequential pivot toward value-creating catalysts: Phase II (inhaled/IV) trial initiations and potential EUA could be near-term stock movers; monitor enrollment start and initial readouts .
  • Partnering is core to the commercialization strategy; OAK SPA preservation and unblinding timing hinge on partner preferences (label/pricing), likely a key inflection .
  • Scientific differentiation underpins platform optionality: TLR7/Thrombomodulin/M2 macrophage data bolster COVID and non-COVID indications; supports medium-term pipeline breadth .
  • Financial runway extended to Q2 2022; however, continued burn and lack of revenue keep financing risk present—prior going concern qualification underscores diligence on funding sources .
  • Near-term narrative drivers: FDA feedback updates (SPA/EUA), IRB approvals, multi-country site ramp, and any early Phase II efficacy signals.
  • Risk factors: Regulatory timing uncertainties, trial operational dependencies (IRBs/hospital training), derivative gains variability, and macro COVID waves could affect trial cadence .
  • Actionable: Position sizing should reflect binary/regulatory catalysts; consider event-driven strategies around Phase II enrollment commencements and OAK unblinding milestones .