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AP

Ampio Pharmaceuticals, Inc. (AMPE)·Q2 2021 Earnings Summary

Executive Summary

  • Ampio reported Q2 2021 net loss of $3.56M (diluted EPS $(0.02)), with operating expenses up 41% year over year to $3.67M, driven by AP‑013 database work and COVID trial start-up; cash rose to $20.5M, extending runway to at least Q4 2022 .
  • Management decided to unblind the paused AP‑013 OAK Phase 3 using FDA’s sensitivity/supplementary analysis guidance; results were targeted for release shortly after data cleaning and validation “later this quarter,” positioning as a near-term catalyst .
  • COVID-19 program advanced: Phase II inhaled and IV studies initiated, with inhaled trial expanded to 7–10 sites in India to accelerate enrollment; a Phase I at‑home long‑COVID inhalation study is enrolling .
  • A Phase I inhaled Ampion trial previously showed a 78% reduction in all‑cause mortality vs Standard of Care, underpinning Phase II and potential EUA path if efficacy is confirmed; management highlighted platform potential beyond OAK and COVID .
  • Stock catalysts: AP‑013 unblinded data readout, first India dosing for the inhaled Phase II, and visibility on EUA pathway and partnering discussions; inclusion in the Russell 2000/3000 indexes may broaden investor awareness .

What Went Well and What Went Wrong

What Went Well

  • Phase I inhaled Ampion showed compelling signal: 78% reduction in all‑cause mortality vs SOC, enabling Phase II inhaled and IV studies and potential EUA if efficacy is confirmed .
  • OAK pathway clarity improved: FDA issued sensitivity/supplementary analysis guidance in May; company will unblind AP‑013 with this analysis, removing a key overhang and enabling partnership discussions .
  • Operational momentum and visibility: cash increased to $20.5M; runway extended through Q4 2022, limiting near‑term financing risk; management emphasized readiness to scale manufacturing for IV and inhaled formats if EUA is granted .
  • Quote: “We have decided to proceed forward and unblind the study utilizing the sensitivity analysis to eliminate any bias from the pandemic… [and] share it with the public” .
  • Quote: “We completed our Phase I trial utilizing inhaled Ampion… which showed that Ampion reduced all-cause mortality by 78%… [and] worked with the FDA to initiate Phase II trials” .

What Went Wrong

  • Operating expenses up 41% YoY and net loss widened to $3.56M due to higher R&D (AP‑013 database work and COVID trial start‑up), offsetting benefits from lower G&A; EPS flat YoY at $(0.02) .
  • AP‑013 pause persisted through Q2, pushing timelines; data cleaning/validation and sensitivity analysis added complexity and cost before unblinding could occur .
  • Consensus estimates were unavailable via S&P Global for AMPE in Q2 2021, limiting external benchmark comparisons; management continues to reference expected access to equity financing to support the runway, implying potential dilution risk at future funding points .

Financial Results

Sequential comparison (Q1 2021 → Q2 2021)

MetricQ1 2021Q2 2021
Operating Expenses ($)$3,819,000 $3,673,000
Net Loss ($)$(3,667,000) $(3,556,000)
Diluted EPS ($)$(0.02) $(0.02)
R&D Expense ($)$2,296,000 $2,273,000
G&A Expense ($)$1,523,000 $1,400,000
Cash & Equivalents ($)$15,804,000 $20,549,000
Shares Outstanding (end of period)195,689,128 200,070,419

Year-over-year comparison (Q2 2020 → Q2 2021)

MetricQ2 2020Q2 2021
Operating Expenses ($)$2,600,000 $3,673,000
Net Loss ($)$(2,731,000) $(3,556,000)
Diluted EPS ($)$(0.02) $(0.02)
R&D Expense ($)$1,118,000 $2,273,000
G&A Expense ($)$1,482,000 $1,400,000

Consensus vs Actual (Q2 2021)

MetricConsensusActual
Revenue ($)N/A (S&P Global consensus unavailable)N/A (no revenue reported in condensed statements)
Diluted EPS ($)N/A (S&P Global consensus unavailable)$(0.02)

Note: We attempted to retrieve S&P Global consensus but data was unavailable via our connection for AMPE in Q2 2021.

KPIs and Balance Sheet Highlights

KPIQ1 2021Q2 2021
Cash & Equivalents ($)$15,804,000 $20,549,000
Warrant Derivative Liability ($)$2,456,000 $2,340,000
Total Liabilities ($)$4,949,000 $6,348,000
Stockholders’ Equity ($)$16,777,000 $20,361,000

Drivers and commentary:

  • R&D +103% YoY on AP‑013 database cleaning and COVID-19 trial start‑up (AP‑017, AP‑018, AP‑019) .
  • G&A down 6% YoY on lower litigation-related legal costs following dismissal of cases in Q3 2020 .
  • Cash increased primarily from $9.5M ATM proceeds, offset by $6.5M operating cash use in H1 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Liquidity runwayCorporateCash and access to liquidity sufficient through Q2 2022 (as of Q1 2021) Cash and access to external liquidity sufficient through Q4 2022 (as of Q2 2021) Raised (extended)

No revenue, margin, OpEx or tax-rate guidance was provided beyond liquidity runway disclosures in the press release and call .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2020, Q1 2021)Current Period (Q2 2021)Trend
OAK AP‑013 (Phase 3)FDA dialog on paths to maintain SPA during COVID; SPA amendment submitted; trial paused and blinded Decision to unblind with FDA’s May sensitivity/supplementary analysis; data cleaning/validation ongoing; results targeted “later this quarter” Increased clarity and urgency; data readout near-term
COVID-19 inhaled/IVFDA recommended randomized, double‑blind, placebo‑controlled Phase II for both inhaled and IV to support EUA; Phase II initiation planned for Q2 2021 Phase II inhaled and IV initiated; inhaled expanded to 7–10 sites in India to accelerate enrollment Execution ramping; geographic expansion
Long COVIDStudy planned to commence enrollment in Q2 2021 Phase I at‑home inhaled study enrolling; no known effective treatment in market highlighted Execution started; market opportunity framed
PartneringContinuous dialogue with potential partners; positioning Ampion as platform Engaged new global advisory firm; “quality ongoing discussions with pharma” continue Engagement deepening alongside catalysts
Manufacturing readinessExpanded capabilities to IV bags and inhalation vials Ready to scale if EUA; rapid transition between formats demonstrated Capacity confirmed
LiquidityRunway into 2022 (varying by update) Runway through Q4 2022 (with expected access to equity financing) Extended

Management Commentary

  • Strategic focus and catalysts: “We have decided to proceed forward and unblind the study utilizing the sensitivity analysis to eliminate any bias from the pandemic… [with] results released to the public shortly thereafter.” (CEO) .
  • COVID-19 expansion rationale: “We currently expect to run this trial in 7 to 10 hospital sites in India and finish enrollment… faster than… in the United States.” (CEO) .
  • Platform perspective: “Ampion is a platform biologic… agnostic to whether it is treating a COVID patient or an osteoarthritis… condition.” (Press release) .
  • Execution and readiness: “We have IV bags made… vials… and… snap-off [caps] for the nebulizer… With emergency use… we have to increase production. But we'll do that really quickly.” (CEO) .
  • Liquidity: “Ampio expects to have cash and cash equivalents along with access to external sources of liquidity sufficient to fund… through the fourth quarter of 2022.” (Press release) .

Q&A Highlights

  • AP‑013 unblinding decision: Management weighed continuing blinded vs unblinding; new FDA guidance (end of May) tipped decision to unblind with sensitivity analysis; goal is statistical significance or strong positive trend given smaller sample size than original plan (1,000–1,500) .
  • Post‑readout plan: Aim to partner for commercialization rather than go it alone; partner to drive label, pricing, and regulatory strategy; ongoing discussions with pharma .
  • India timeline: Sites identified, import license in process with DCGI; dosing expected “this quarter,” pending final approvals; drug product and equipment ready to ship .
  • Additional indications: Mechanistic work suggests TLR7/8 pathway suppression; potential in lupus nephritis explored in preclinical, with abstracts submitted to upcoming congresses .
  • EUA readiness: Company asserts manufacturing capability to support IV and inhaled supply rapidly if EUA granted .

Estimates Context

  • We attempted to retrieve S&P Global consensus for Q2 2021 EPS and revenue; consensus data for AMPE was unavailable via our connection. As a result, we cannot assess beat/miss versus Street for Q2 2021. We will update if/when S&P Global mappings become available.
  • Given Ampio’s development-stage status and absence of reported revenues in Q2 2021 condensed statements, consensus revenue and EPS are often sparse or not published for micro-cap, pre‑revenue biopharma names .

Key Takeaways for Investors

  • Near‑term binary-ish catalyst: AP‑013 unblinded data (sensitivity‑adjusted) could validate OAK efficacy narrative; strong results would likely accelerate partnering and re‑rate the equity; weaker trends could reset timelines and strategy .
  • COVID-19 program momentum: Inhaled/IV Phase II trials underway with India expansion to accelerate enrollment; Phase I mortality signal (‑78% vs SOC) raises the stakes for confirmation and potential EUA pursuit if efficacy and safety are demonstrated .
  • Liquidity extended to Q4 2022 reduces immediate financing pressure, but management’s “expected access to equity financing” language implies potential future raises; monitor cash burn alongside clinical cadence .
  • Manufacturing readiness de‑risks time‑to‑market in an EUA scenario (IV and inhaled formats in place), a differentiator for rapid deployment if clinical and regulatory hurdles are cleared .
  • Scientific platform narrative broadening (TLR7/8, macrophage polarization, thrombomodulin) opens optionality in inflammatory indications (e.g., lupus nephritis, long‑COVID), adding medium‑term value creation paths .
  • Index inclusion (Russell 2000/3000) may improve liquidity and visibility; however, stock will remain catalyst‑driven near‑term with heightened event risk around AP‑013 readout and COVID Phase II interim updates .

Appendix: Additional Data Points

  • Operating expense mix (Q2 2021): R&D $2.27M (+103% YoY), G&A $1.40M (‑6% YoY) .
  • H1 2021 net loss: $7.22M vs $7.91M in H1 2020 (improved on lower YTD OpEx) .
  • Shares outstanding increased to 200.07M as of 6/30/21 (ATM usage and options/warrants), up from 193.38M at 12/31/20 .

All figures and statements are sourced from Ampio’s Q2 2021 8‑K/press release and earnings call transcript unless otherwise noted: . For prior comparisons, see Q1 2021 and Q4 2020 8‑Ks and calls: .