Executive Summary

Q1 2023 delivered grant/licensing revenue of $1.082M, net loss of $6.816M ($0.22 loss per share), and cash, cash equivalents and restricted cash of $1.820M; revenue rose sequentially vs Q3 2022 ($0.399M) and Q2 2022 ($0.292M) but liquidity tightened materially .
Clinical execution advanced: AR-501 met Phase 2a safety and PK endpoints (sputum uptake >50x over target), and AR-301 Phase 3 showed meaningful efficacy in older adults; FDA provided positive feedback on a single confirmatory Phase 3 with expanded patient populations (VAP, ventilated HAP, ventilated CAP) .
Balance-sheet risk elevated: management disclosed substantial doubt about going concern and the need for near-term financing; Streeterville debt was restructured post-quarter, and AR-320 is on temporary clinical hold amid a MedImmune license dispute .
No formal financial guidance was issued; near-term stock reaction catalysts center on clinical/regulatory developments (AR-301 pathway, AR-320 resolution) and funding visibility .

What Went Well and What Went Wrong

What Went Well
- AR-501 Phase 2a met primary safety and secondary PK endpoints; CF patients achieved high respiratory uptake (>50-fold over inhibitory threshold), supporting inhaled delivery potential: “We are pleased that both primary and secondary endpoints in the AR-501 Phase 2a study have been met” — Vu Truong, Ph.D., CEO .
- AR-301 Phase 3 delivered encouraging efficacy in older adults: +34% improvement at Day 21 (p=0.057) and +38% at Day 28 (p=0.025), versus +11% in overall population (p=0.24) .
- FDA agreed to a single confirmatory Phase 3 design for AR-301 and expansion to ventilated HAP and ventilated CAP, potentially accelerating path to BLA: “We are extremely pleased with the positive response we received from the FDA…” — Vu Truong, Ph.D. .
What Went Wrong
- Revenue fell year-over-year to $1.1M (from $3.1M in Q1 2022) on lower grant/licensing recognition; net interest swung negative and the change in fair value of notes payable widened (to $(605)k) .
- Liquidity tightened: cash, cash equivalents and restricted cash declined to $1.820M; management disclosed substantial doubt about going concern without additional financing .
- AR-320 program disruptions: program placed on temporary clinical hold; MedImmune issued termination notice for non-payment, with the company disputing breach (puts AR-320 Phase 3 timeline at risk) .

Financial Results

Metric	Q2 2022	Q3 2022	Q1 2023
Revenue ($USD Millions)	$0.292	$0.399	$1.082
R&D Expense ($USD Millions)	$6.348	$6.118	$5.531
G&A Expense ($USD Millions)	$1.681	$1.693	$1.814
Loss from Operations ($USD Millions)	$(7.737)	$(7.412)	$(6.263)
Net Loss ($USD Millions)	$(7.979)	$(8.239)	$(6.816)
EPS ($USD)	$(0.45)	$(0.47)	$(0.22)
Cash, Cash Equivalents & Restricted ($USD Millions)	$8.000	$3.100	$1.820

KPIs

KPI	Q2 2022	Q3 2022	Q1 2023
Weighted Avg Shares (Basic/Diluted)	17,701,592	17,701,592	30,414,865
AR-301 efficacy – older adults Day 21	n/a	n/a	+34% (p=0.057)
AR-301 efficacy – older adults Day 28	n/a	n/a	+38% (p=0.025)
AR-301 efficacy – overall population	n/a	n/a	+11% (p=0.24)
AR-501 sputum uptake vs inhibitory threshold	n/a	n/a	>50x higher

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Quarter	Not provided	Not provided	Maintained (no guidance)
R&D/OpEx	FY/Quarter	Not provided	Not provided	Maintained (no guidance)
Margins (Gross/EBIT/Net)	FY/Quarter	Not provided	Not provided	Maintained (no guidance)
Tax Rate / OI&E	FY/Quarter	Not provided	Not provided	Maintained (no guidance)
Dividends	FY/Quarter	Not provided	Not provided	Maintained (no guidance)

Note: No formal financial guidance was disclosed in Q1 2023 press release or 10-Q .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2022)	Previous Mentions (Q3 2022)	Current Period (Q1 2023)	Trend
AR-301 clinical progress	Continued Phase 3 enrollment; top-line expected 2H22	Enrollment closed; top-line expected Dec 2022	Positive efficacy in older adults; FDA backed single confirmatory Phase 3 with expansion	Improving validation; clearer regulatory path
AR-501 program	Active Phase 2a enrollment; higher dose cohort allowed	Active enrollment; top-line expected 1Q23	Phase 2a endpoints met; high sputum uptake	Advancing; de-risked safety/PK
AR-320 program	Phase 3 initiated after FDA/EMA feedback	Actively enrolling globally	Temporary clinical hold; MedImmune termination dispute	Negative; timeline risk
Funding/Liquidity	Cash $8.0M	Cash $3.1M; $8.0M raise post-quarter	Cash $1.820M; going concern disclosed; $2.28M raise; Streeterville restructuring post-quarter	Deteriorating liquidity; reliant on external financing
AR-701 (COVID-19)	Strong preclinical efficacy; inhalation delivery	Preclinical efficacy reiterated	Reduced spend on AR-701 manufacturing noted	Deprioritizing spend amid constraints
Regulatory/Listing	n/a	n/a	Nasdaq non-compliance and delisting risk (subsequent events)	New risk factor

Management Commentary

“Our first quarter results demonstrate the continued progress and momentum of Aridis Pharmaceuticals. We are pleased that both primary and secondary endpoints in the AR-501 Phase 2a study have been met.” — Vu Truong, Ph.D., CEO .
“The positive results from our first Phase 3 study of AR-301 in the older adult population are particularly encouraging… Our focus on improving clinical cure rates for this vulnerable population is consistent with our commitment to address unmet medical needs.” — Vu Truong, Ph.D. .
“We are extremely pleased with the positive response we received from the FDA regarding our proposed single confirmatory Phase 3 study of AR-301… expand our study to include… VAP, HAP and CAP…” — Vu Truong, Ph.D. .

Q&A Highlights

No Q1 2023 earnings call transcript was available in the document catalog; accordingly, there were no public Q&A disclosures to analyze [ListDocuments result: 0 earnings-call-transcript].

Estimates Context

Wall Street consensus (S&P Global/Capital IQ) for ARDS was unavailable due to missing CIQ mapping in SPGI; therefore, comparison to estimates cannot be provided at this time. Values retrieved from S&P Global were unavailable.

Key Takeaways for Investors

Clinical de-risking: AR-501 met Phase 2a endpoints with compelling PK, and AR-301 showed meaningful efficacy signals in older adults, supporting continued development momentum .
Regulatory clarity: FDA’s agreement on a single confirmatory Phase 3 for AR-301 with expanded ventilated populations improves probability of a streamlined path to BLA submission .
Liquidity constraints: Cash of $1.820M and going concern disclosure indicate urgent funding needs; watch for near-term equity/debt raises and potential non-dilutive grants/partnerships .
Program risk: AR-320’s temporary hold and MedImmune termination dispute create uncertainty around the prevention strategy; resolution timeline is a key overhang .
Operational discipline: R&D expense declined sequentially to $5.531M, reflecting wind-down costs and program prioritization; however, net loss remains sizable, requiring financing or cost actions .
Trading implications (near term): Headlines around FDA interactions (AR-301), financing announcements, and AR-320 dispute outcomes are likely to drive stock volatility; absence of guidance heightens sensitivity to news flow .
Medium-term thesis: If AR-301 confirmatory trial aligns with FDA feedback and AR-501 advances with CFF support, the pipeline can re-rate despite near-term funding risks; partnerships/licensing could be catalysts to reduce burn and validate assets .

Citations: Q1 2023 8-K press release and exhibits ; Q1 2023 10-Q, including financial statements, MD&A, legal proceedings, liquidity and subsequent events ; Prior quarters’ earnings 8-K press releases for Q2 and Q3 2022 .

Aridis Pharmaceuticals, Inc. (ARDS)·Q1 2023 Earnings Summary