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AP

Aridis Pharmaceuticals, Inc. (ARDS)·Q3 2022 Earnings Summary

Executive Summary

  • Q3 2022 was defined by operational execution (AR-301 Phase 3 enrollment closed; top-line data targeted for December) and disciplined expense control, with net loss improving sharply year-over-year to $8.239M (-$0.47 EPS) from $24.143M (-$1.94 EPS) in Q3 2021, though slightly worse sequentially versus Q2 2022 .
  • Liquidity remained tight at quarter-end (cash and cash equivalents $1.886M; total cash, cash equivalents and restricted cash ≈$3.1M), but the company raised $8.0M on October 7 via common shares, pre-funded warrants, and unregistered warrants, and later received a $4.85M equity investment from the Cystic Fibrosis Foundation (Dec 12) to extend runway into key clinical readouts .
  • Catalyst path: AR-301 Phase 3 VAP top-line data expected in December 2022; AR-501 Phase 2a top-line now expected in Q1 2023; AR-320 Phase 3 actively enrolling; AR-701 reported macaque inhalation efficacy—collectively positioning multiple program readouts as near-term stock drivers .
  • Risk update: Nasdaq notified ARDS on Sep 29 of non-compliance with the $35M minimum market value requirement, with a March 28, 2023 deadline to regain compliance—a potential overhang until resolved .

What Went Well and What Went Wrong

What Went Well

  • Closed AR-301 Phase 3 enrollment and guided to December top-line data; CEO: “we have raised additional funding to extend capital runway beyond data delivery… deliver potentially transformative data readouts from our Phase 3 study of AR-301 and our Phase 2a study of AR-501” .
  • AR-320 Phase 3 (SAATELLITE-2) actively enrolling with up to €25M IMI funding; prior Phase 2 showed a statistically significant 47% relative risk reduction in under-65 population, supporting Phase 3 design .
  • Operating discipline: R&D expense fell to $6.118M from $19.842M YoY due to the absence of a one-time $11.5M MedImmune (AZ) licensing expense in Q3 2021 and reduced manufacturing spend on AR-320 and AR-301; G&A remained stable at ~$1.7M .

What Went Wrong

  • Liquidity constraints at Q3 end (cash and cash equivalents $1.886M; total cash, cash equivalents and restricted cash ≈$3.1M), necessitating subsequent financings to support operations into pivotal data events .
  • Sequential net loss widened slightly to $8.239M vs $7.979M in Q2; EPS -$0.47 vs -$0.45; change in fair value of note payable increased by ~$823k in Q3 .
  • Listing risk: Nasdaq deficiency notice for minimum market value requirement introduces potential delisting overhang if compliance is not regained by March 28, 2023 .

Financial Results

Quarterly P&L (oldest → newest)

MetricQ1 2022Q2 2022Q3 2022
Revenue ($USD Millions)$1.187 $0.292 $0.399
R&D Expense ($USD Millions)$6.450 $6.348 $6.118
G&A Expense ($USD Millions)$2.161 $1.681 $1.693
Loss from Operations ($USD Millions)$(7.424) $(7.737) $(7.412)
Net Loss ($USD Millions)$(7.766) $(7.979) $(8.239)
Diluted EPS ($USD)$(0.44) $(0.45) $(0.47)
Weighted Avg Shares (Shares)17,701,592 17,701,592 17,701,592

Notes: Q2 total revenue excludes license revenue in Q3 (none disclosed); Q3 revenue comprised grant revenue .

Year-over-Year Comparison (Q3 2021 vs Q3 2022)

MetricQ3 2021Q3 2022
Revenue ($USD Millions)$0.515 $0.399
R&D Expense ($USD Millions)$19.842 $6.118
G&A Expense ($USD Millions)$1.699 $1.693
Net Loss to Common ($USD Millions)$(24.143) $(8.239)
Diluted EPS ($USD)$(1.94) $(0.47)

Drivers: YoY R&D decline primarily reflects the absence of a Q3 2021 one-time $11.5M AZ licensing expense and lower AR-320/AR-301 manufacturing activity .

Balance Sheet Snapshot (Quarter-Ends)

MetricMar 31, 2022Jun 30, 2022Sep 30, 2022
Cash & Cash Equivalents ($USD Millions)$12.475 $6.317 $1.886
Total Assets ($USD Millions)$23.817 $16.686 $12.120
Total Liabilities ($USD Millions)$44.226 $44.619 $47.943
Stockholders’ Deficit ($USD Millions)$(20.409) $(27.933) $(35.823)

Subsequent liquidity events: $8.0M financing on Oct 7 (shares, pre-funded warrants, unregistered warrants) and $4.85M CF Foundation equity investment on Dec 12 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AR-301 Phase 3 Top-line Data (VAP)CY 2022“Late 2H 2022” “December 2022” Narrowed timing window
AR-501 Phase 2a Top-line (CF)CY 2022/2023“2H 2022” “Q1 2023” Pushed ~1–2 quarters
AR-320 Phase 3 (SAATELLITE-2)CY 2022“Launched Phase 3” “Actively enrolling; IMI funding up to €25M” Execution progress
AR-701 (COVID-19 mAb cocktail)CY 2022“Initiate Phase 1 late 2H 2022” “Macaque inhalation efficacy announced; ongoing Gates grant POC work” Updated preclinical; clinical start not reiterated

No financial guidance (revenue, margins, OpEx, OI&E, tax, dividends) was provided in Q3 materials .

Earnings Call Themes & Trends

Note: No Q3 earnings call transcript was available in the document set; themes below reflect disclosures across Q1–Q3 press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
R&D execution & trial timelinesQ1: AR-301/AR-501 on track for 2H; AR-320 Phase 3 launch targeted mid-2022; AR-701 Phase 1 late 2H . Q2: AR-301/AR-501 top-line in 2H; AR-320 Phase 3 launched .AR-301 enrollment closed; Dec top-line; AR-501 top-line moved to Q1 2023; AR-320 actively enrolling .Generally progressing; AR-501 timing extended
Funding/partnershipsQ1: CF Foundation, Gates grants; Streeterville debt disclosed . Q2: IMI funding for AR-320 .$8.0M raise post-Q3; later $4.85M CF Foundation equity investment .Liquidity augmented via equity raises
Regulatory/macroQ1: Ukraine/Russia conflict impacted AR-301 enrollment; FDA/EMA aligned on AR-320 single pivotal plan . Q2: EMA/FDA feedback incorporated; Phase 3 launched .No new regulatory hurdles; DSMC safety monitoring ongoing .Stable regulatory posture
Nasdaq listing riskNot highlighted in Q1/Q2.Nasdaq deficiency notice for minimum market value .New listing overhang
COVID-19 program (AR-701)Omicron neutralization; anticipated Phase 1 late 2H .Macaque inhalation efficacy; Gates-funded POC for transmission prevention .Strengthened preclinical dataset

Management Commentary

  • “Despite a protracted challenging capital market, we have raised additional funding to extend capital runway beyond data delivery… potentially transformative data readouts from our Phase 3 study of AR-301 in VAP and our Phase 2a study of AR-501 in cystic fibrosis.” — Vu Truong, Ph.D., CEO .
  • “The company is on track to report top-line data from the AR-301 Phase 3 study… and the AR-501 Phase 2a study… significant and transformative milestones… launched the global Phase 3 trial of AR-320.” — Vu Truong, Ph.D., CEO (Q2 release) .
  • “We remain focused on building our leadership in the respiratory health space and appreciate the financial support of organizations like the Gates Foundation and European Commission’s IMI program…” — Q1 release .

Q&A Highlights

  • No Q3 2022 earnings call transcript was available in the retrieved document set; therefore, Q&A themes and clarifications could not be sourced. The analysis relies on the 8-K/exhibit press releases and program updates .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2022 EPS and revenue was unavailable for ARDS due to missing SPGI mapping, so beat/miss analysis versus S&P Global could not be performed. Estimates may need updating post-AR-301 top-line data and funding events [GetEstimates error].

Key Takeaways for Investors

  • Near-term binary catalyst: AR-301 Phase 3 top-line data in December; transformative potential in VAP could drive outsized stock reaction; DSMC reported no safety concerns to date .
  • AR-501 timing pushed to Q1 2023; anticipate top-line in CF, with CF Foundation’s $4.85M equity support signaling strategic alignment and potential validation .
  • Liquidity improved post-quarter via $8.0M raise and CF Foundation investment, but quarter-end cash was low; monitor runway and additional financing needs into data readouts .
  • Expense discipline evident; R&D fell sharply YoY due to one-time 2021 expense absence and lower manufacturing spend; net loss improved materially YoY, though slightly worse sequentially .
  • Listing overhang: Nasdaq minimum market value deficiency notice introduces risk; any positive clinical outcomes could aid compliance; absence of compliance could pressure valuation .
  • Program breadth (AR-320 prevention, AR-101/AR-201 licenses, AR-701 COVID) offers multiple shots on goal; favorable AR-320 Phase 2 signal (under 65) supports Phase 3 .
  • Actionable: Position sizing should reflect binary clinical risk; consider trading around AR-301 data window with contingency for financing/volatility; reassess medium-term thesis post-readouts and listing resolution .