Executive Summary

Net loss was $3.63M and diluted EPS was $(0.02); operating expenses were $3.85M; cash and cash equivalents were $17.12M as of quarter-end. R&D rose 57% YoY on COVID trials and AP‑013 database validation, while G&A fell 24% YoY on lower legal/insurance costs .
Guidance was raised: liquidity runway extended to fund operations through Q1 2023 versus Q4 2022 previously and Q2 2022 at Q1, supported by residual ATM capacity of ~$13.3M disclosed on the call .
Clinical execution advanced: the AP‑013 osteoarthritis pivotal trial database was locked and analysis is underway; Phase 2 inhaled Ampion enrollment and treatment commenced in India; an FDA meeting on AP‑013 is targeted for H1 2022 .
Key near-term catalysts are interim analysis for the inhaled Ampion AP‑019 study after 150 patients (anticipated completion Q2 2022) and potential EUA pathways for inhaled and IV Ampion, per FDA-reviewed protocols .

What Went Well and What Went Wrong

What Went Well

Database locked for the Phase 3 AP‑013 pivotal OAK trial; analysis ongoing, with management framing Ampion as a potential “significant treatment option” for severely disabled patients .
COVID program execution: Phase 2 inhaled Ampion enrollment/treatment began in India under DCGI approval; FDA-reviewed protocols contemplate interim analysis and potential EUA support .
Cost discipline in G&A: legal and insurance costs declined, driving a 24% YoY reduction in G&A for Q3 and a 15% YTD decrease .

What Went Wrong

R&D expenses rose 57% YoY (+$0.94M), reflecting higher clinical trial costs (COVID studies) and AP‑013 validation/CRO activities; OpEx increased 17% YoY as a result .
Net loss widened YoY by 8% to $3.63M, driven by higher OpEx; other income was only $0.22M, despite a derivative gain .
Cash declined to $17.12M from $20.55M in Q2, with operating cash needs partially offset by ATM/warrant/option proceeds; continued reliance on external liquidity and equity financing persists .

Financial Results

Quarterly Financials (Q1–Q3 2021)

Metric	Q1 2021	Q2 2021	Q3 2021
Operating Expenses ($USD)	$3,819,000	$3,673,000	$3,851,000
R&D ($USD)	$2,296,000	$2,273,000	$2,594,000
G&A ($USD)	$1,523,000	$1,400,000	$1,257,000
Other Income (Expense) ($USD)	$152,000	$117,000	$223,000
Net Loss ($USD)	$(3,667,000)	$(3,556,000)	$(3,628,000)
Diluted EPS ($USD)	$(0.02)	$(0.02)	$(0.02)
Cash & Cash Equivalents ($USD)	$15,804,000	$20,549,000	$17,118,000
Shares Outstanding (period-end)	195,689,128	200,070,419	200,458,263

Note: Ampio reported no product revenue; statements of operations present operating expenses and other income without revenue lines .

Q3 2021 vs Q3 2020 (YoY)

Metric	Q3 2020	Q3 2021	YoY Change
Operating Expenses ($USD)	$3,302,000	$3,851,000	+17%
Net Loss ($USD)	$(3,368,000)	$(3,628,000)	+8%
Diluted EPS ($USD)	$(0.02)	$(0.02)	0%
R&D ($USD)	$1,655,000	$2,594,000	+57%
G&A ($USD)	$1,647,000	$1,257,000	−24%

Estimates vs Actuals

Consensus estimates via S&P Global were unavailable for AMPE; beat/miss vs Street cannot be assessed.

Metric	Q1 2021	Q2 2021	Q3 2021
Consensus EPS ($USD)	N/A	N/A	N/A
Actual Diluted EPS ($USD)	$(0.02)	$(0.02)	$(0.02)
Consensus Revenue ($USD)	N/A	N/A	N/A
Actual Revenue ($USD)	$0	$0	$0

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Liquidity Runway	Funding sufficiency	Sufficient through Q4 2022 (Q2 disclosure)	Sufficient through Q1 2023	Raised
Liquidity Runway	Funding sufficiency	Sufficient through Q2 2022 (Q1 disclosure)	Sufficient through Q4 2022 (Q2 disclosure)	Raised
ATM Residual Capacity	As of Nov 11, 2021	Not disclosed	~$13.3M remaining	New disclosure
AP‑013 FDA Meeting Timeline	Regulatory	Not specified in Q2	Target H1 2022	New/updated
Revenue/Margins/Tax Rate Guidance	FY/Qtr	Not provided	Not provided	Maintained none

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
Osteoarthritis (AP‑013)	FDA response provided multiple pathways; SPA flexibility; trial paused; OAK program highlighted	Database locked; analysis underway; FDA meeting targeted H1 2022; positioning Ampion for severe OAK patients	Advancing toward regulatory engagement
COVID‑19 Inhaled Ampion	Phase 1 met primary endpoint; 78% reduction in all‑cause mortality vs SOC; initiating Phase 2 inhaled/IV trials	Enrollment/treatment started in India for Phase 2 inhaled; U.S. IND-reviewed protocols; interim analysis after 150 patients; EUA pathway discussed	Scaling enrollment; broadened geography
COVID‑19 IV Ampion	Initiation plans for Phase 2 IV Ampion	Phase 2 IV study designed for 200 patients; interim analysis at 40; EUA consideration	Design clarity; approaching interim
Long COVID (At‑home inhalation)	New Phase 1 study announced; expected U.S. enrollment in Q2 2021	30‑patient randomized controlled Phase 1 study; enrollment expected complete by year‑end	Execution progressing
Manufacturing	NA	Facility rapidly reprogrammed to support multiple Ampion production platforms; ISPE presentation noted	Capacity expanded
Index/Macro	Russell 2000/3000 inclusion noted (Q2)	NA	Stable awareness
Legal/Insurance	Securities cases dismissed; G&A down	G&A down YoY/YTD on lower litigation/insurance	Continued cost tailwind

Management Commentary

“This quarter marked an exciting period of growth for drug development in the Ampion platform therapy, both in clinical and preclinical development.” – Holli Cherevka, President & COO .
“We have locked the osteoarthritis Phase 3 pivotal trial database, and are currently analyzing the data…” – Holli Cherevka .
“Enrollment and treatment of COVID‑19 patients in India for the Phase 2 AP‑019 study…has commenced.” – Holli Cherevka .
CFO reiterated funding sufficiency through Q1 2023, supported by ~$13.3M residual ATM capacity .
CMO emphasized robust preclinical immunomodulatory evidence and strict GCP execution across trials, with AP‑019 India enrollment underway and AP‑013 analysis preparing for an FDA meeting in H1 2022 .

Q&A Highlights

The company indicated questions would be addressed via webcast; the conference line was listen‑only, and the transcript provided does not include the Q&A segment .
Management on the call clarified liquidity runway and ATM capacity, citing ~$13.3M remaining and runway through Q1 2023 .
Clinical timelines were reiterated: AP‑019 interim analysis after 150 patients (anticipated Q2 2022) and AP‑013 FDA meeting targeted H1 2022 .

Estimates Context

Wall Street consensus via S&P Global was unavailable for AMPE (consensus EPS and revenue not retrievable). As a development‑stage company without reported product revenue, Street models likely hinge on operating spend cadence; however, without S&P data, we cannot assess beat/miss or quantify estimate revisions.

Key Takeaways for Investors

Liquidity runway extended to Q1 2023, improving funding visibility; residual ATM capacity of ~$13.3M provides optionality for continued execution .
Osteoarthritis AP‑013 pivotal database locked; FDA meeting planned for H1 2022 is a pivotal regulatory milestone for Ampion .
COVID‑19 program broadened: Phase 2 inhaled Ampion enrollment/treatment in India commenced; interim analysis after 150 patients targeted for Q2 2022, with EUA pathways under FDA‑reviewed protocols .
Cost structure shows mixed signals: R&D up 57% YoY on trial activity, while G&A down 24% YoY on reduced legal/insurance, highlighting execution intensity with some overhead relief .
Cash of $17.12M at quarter‑end versus $20.55M in Q2 underscores ongoing cash use for operations; external financing remains part of the plan .
Share count rose to 200.46M, reflecting ATM and option/warrant exercises, a continued consideration for dilution-sensitive investors .
With Street estimates unavailable, trading catalysts are likely to be clinical/regulatory headlines (AP‑019 interim, AP‑013 FDA meeting) rather than beat/miss dynamics .

Ampio Pharmaceuticals, Inc. (AMPE)·Q3 2021 Earnings Summary